bpfk layout fa 4 11...di peringkat gudang, yang telah dimulakan sebagai projek perintis. projek ini...

LAPORAN TAHUNAN

National Pharmaceutical Control Bureau (NPCB) Biro Pengawalan Farmaseutikal KebangsaanLot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia + 603-7883 5400 + 603-7956 2924www.bpfk.gov.my

2014Biro Pengawalan Farmaseutikal Kebangsaan

National Pharmaceutical Control Bureau

ANNUAL REPORT

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NATIONAL PHARMACEUTICAL CONTROL BUREAU l 2014 ANNUAL REPORT l 1

ISI KANDUNGANCONTENT

Visi, Misi, Matlamat 2Vision, Mission, Objective

Strategi 3Strategies

Perutusan Pengarah 4Director’s Foreword

Pengurusan Tertinggi 6Top Management

Sidang Pengarang 7Editorial Board

Pengenalan kepada BPFK 8Introduction to NPCB

Carta Organisasi 10Organisational Chart

Piagam Pelanggan 12Client’s Charter

Statistik Ringkas 14Brief Statistics

Pencapaian BPFK 16NPCB’s Achievements

Produk Entiti Kimia Baru yang Diluluskan 21Pendaftaran oleh PBKD pada 2014New Chemical Entity Products Approved by the DCA in 2014

Produk Biologik yang Diluluskan 23 oleh PBKD pada 2014Biologics Approved by the DCA in 2014

Pendaftaran Produk 24 Product Registration

Aktiviti Pasca Pendaftaran Produk 31 Product Post-Registration Activities

Pengujian Sampel dan Penilaian Protokol 47& Data ValidasiSample Testing and Evaluation of Protocol & Validation Data

Aktiviti Pembangunan dan Validasi Metodologi 51 Development and methodology Validation Activities

Aktiviti Pemeriksaan 53Inspection Activities

Aktiviti Pelesenan 58 Licensing Activities

Penyebaran Maklumat dan Aktiviti Latihan 60Information Dissemination and Training Activities

Laporan Kewangan 75Financial Report

Halatuju 78The Way Forward

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2 l BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN l LAPORAN TAHUNAN 2014

VISI, MISI & MATLAMATVISION, MISSION & OBJECTIVE

VISI

Biro Pengawalan Farmaseutikal Kebangsaan sebagai pusat kecemerlangan unggul dalam bidang regulatori farmaseutikal demi menjamin kesihatan dan kesejahteraan insan sejagat

MISI

Biro Pengawalan Farmaseutikal Kebangsaan akan memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui pelaksanaan undang-undang oleh tenaga kerja yang kompeten dan usahasama strategik ke arah peningkatan status kesihatan rakyat

MATLAMAT

Memastikan bahawa bahan-bahan terapeutik yang dibenarkan di pasaran tempatan adalah selamat, berkesan dan berkualiti, serta menentukan bahawa produk semulajadi dan kosmetik yang dibenarkan di pasaran adalah selamat dan berkualiti

VISION

The National Pharmaceutical Control Bureau will be a centre of excellence on pharmaceutical regulatory matters to ensure the health and well-being of mankind

MISSION

The National Pharmaceutical Control Bureau shall ensure the quality, efficacy and safety of pharmaceutical products through the implementation of relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the people

OBJECTIVE

To ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that natural products and cosmetics approved are safe and of quality



STRATEGIOBJECTIVE

STRATEGI

Memastikan kecekapan dan keberkesanan organisasi melalui pemodenan dan automasi sistem-sistem pejabat, makmal dan pendaftaran, peninjauan serta penambahbaikan perkhidmatan secara berterusan

Memperkukuh aktiviti penguatkuasaan undang-undang berkaitan

Memastikan suasana kefahaman dua hala dan kerjasama berterusan sentiasa wujud antara pihak regulatori dengan sektor swasta melalui sesi dialog dan bimbingan

Meningkatkan potensi serta kepakaran warga kerja Mewujudkan satu kumpulan tenaga kerja yang berdedikasi dan penuh komitmen melalui motivasi, penghargaan serta ganjaran yang berpatutan

Mempergiatkan aktiviti penyelidikan serta meningkatkan kemudahan-kemudahan bagi tujuan tersebut

Mewujudkan satu suasana yang menggalakkan kerja secara berpasukan dengan sikap penyayang, serta melaksanakan tugas-tugas secara professional

STRATEGIES

To ensure organisational efficiency and effectiveness through modernisation and automation of the office, laboratory and registration systems, with regular review and improvement of services

To strengthen enforcement activity of the related legislations

To ensure continuous mutual understanding and co-operation between the regulatory bodies and the private sector through dialogues and guidance

To upgrade personnel potential and expertise

To attain a dedicated and fully committed workforce through motivation, appreciation, and appropriate remuneration

To strengthen research activities and upgrade facilities for such purposes

To create working environment conducive for the personnel to work as a team with a caring attitude whilst discharging their duties in a professional manner



PERUTUSAN PENGARAHDIRECTOR’S FOREWORD

Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) telah berjaya mengharungi dan mengatasi pelbagai cabaran sejak penubuhannya. Kami sedar akan keperluan mempunyai tenaga kerja yang kompeten, berpengetahuan luas dan sentiasa peka dengan perkembangan sektor farmaseutikal di samping mempunyai fasiliti yang lengkap bagi menangani perubahan dalam isu-isu perubatan dan kesihatan yang sentiasa berkembang. Anggota BPFK yang penuh dedikasi merupakan faktor utama yang menyumbang kepada kejayaan berterusan BPFK sebagai agensi regulatori ubat-ubatan kebangsaan yang bertanggungjawab memastikan semua produk kesihatan yang berada di pasaran Malaysia adalah Selamat, Berkesan dan Berkualiti.

Pada tahun 2014, BPFK telah melaksanakan aktiviti Vaccine Lot Release di Malaysia. Aktiviti ini terdiri daripada dua komponen, iaitu penilaian protokol lot release summary dan pemeriksaan rangkaian sejuk di peringkat gudang, yang telah dimulakan sebagai projek perintis. Projek ini telah dijalankan mulai 1 Julai 2014 hingga 31 Disember 2014 dan melibatkan vaksin seperti Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio dan Human Papillomavirus (HPV). Perlaksanaan penuh aktiviti ini ke atas semua vaksin akan bermula pada 1 Januari 2015. Selaras dengan ini, BPFK juga akan menjalankan pemeriksaan Amalan Edaran Baik (AEB) ke atas pengimport dan pengedar vaksin. Aktiviti ini akan diperluaskan untuk turut merangkumi produk darah dalam masa terdekat memandangkan ianya mempunyai keperluan kawalan yang sama.

The National Pharmaceutical Control Bureau (NPCB) has faced and successfully overcome numerous challenges over the years. We are aware of the need to have a competent, well-informed workforce that is constantly updated with the current developments in the pharmaceutical sector along with a well-equipped facility, to meet the changes occurring in the ever evolving world of medicine and healthcare. It is the dedicated staff that has kept us strong throughout the years as we continue to move forward as the National Drug Regulatory Agency entrusted with the responsibility of ensuring that all medicinal products marketed in Malaysia are Safe, Efficacious and of Good Quality.

In 2014, NPCB implemented Vaccine Lot Release activity in Malaysia. This activity which involves two components, namely lot release summary protocol evaluation and cold chain inspections at warehouse level started as a Pilot Project. This project which was conducted from 1 July 2014 to 31 December 2014 involved selected vaccines such as Bacillus Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio and Human Papillomavirus (HPV). Full implementation which will involve all vaccines will commence from 1 January 2015. In line with this, NPCB will also conduct Good Distribution Practice (GDP) inspections on importers and distributors of vaccines. As it is also a requirement for blood products to undergo lot release, this activity will be expanded to include blood products in the near future.



Selain daripada aktiviti baru, kami sentiasa berusaha meningkatkan perkhidmatan kepada semua pelanggan serta pihak yang berkepentingan. Saya berbesar hati untuk mengumumkan bahawa kelulusan telah diperoleh bagi pembangunan sistem pendaftaran atas talian yang baru iaitu ‘QUEST 3+’ untuk menggantikan sistem sedia ada yang telah menerima aduan. Pembangunan sistem ‘QUEST 3+’ akan bermula pada suku tahun pertama 2015 dan dijadualkan siap pada suku tahun pertama 2016. Di samping itu, BPFK juga komited untuk membangunkan industri tempatan menerusi aktiviti - aktiviti Pusat Transformasi Luar Bandar (RTC). RTC diwujudkan oleh kerajaan di bawah National Blue Ocean Strategy 4 sebagai landasan untuk melaksanakan inisiatif bersepadu. Sejak tahun 2012, BPFK terlibat secara aktif dalam Inisiatif 7: Keselamatan Makanan dan Perkhidmatan Farmasi dengan memberikan khidmat nasihat serta latihan teknikal bagi membantu pengilang produk tradisional dan kosmetik tempatan.

Kesimpulannya, saya ingin mengucapkan ribuan terima kasih kepada semua anggota BPFK yang telah bertungkus lumus memajukan agensi ini. Semua kejayaan tidak akan tercapai tanpa kesungguhan, komitmen, dedikasi serta ketekunan semua anggota dalam memberikan perkhidmatan yang berkualiti secara berterusan kepada semua pihak yang berkepentingan. Sebagai persediaan untuk menghadapi pelbagai cabaran yang bakal dihadapi, saya mengambil kesempatan ini untuk menggalakkan dan menggesa semua anggota agar berani dan terus bekerjasama demi memastikan kejayaan berterusan BPFK.

Apart from new activities, we constantly strive to upgrade our services to all our stakeholders and clients. I am pleased to inform that approval has been obtained to develop a new on-line registration system known as QUEST 3+ to replace the existing system that has been the cause of numerous complaints. The development of the QUEST 3+ system will commence in the first quarter of 2015 and is scheduled for completion in the first quarter of 2016. In addition, NPCB is also committed to develop the local industry with the ongoing activities related to the Rural Transformation Centre (RTC). The RTC which was created as a site to implement integrated initiatives was introduced by the government under the National Blue Ocean Strategy 4. NPCB is actively involved in Initiative 7: Food Safety and Pharmaceutical Services and has been providing technical consultation and training services to assist the local traditional and cosmetic manufacturers since 2012.

In conclusion, I would like to thank all NPCB staff who had worked tirelessly for advancement of this institution. Without their passion, commitment, dedication and perseverance in providing continuous quality services to all the stakeholders, the accomplishments and achievements would not have been possible. In preparation to overcome the challenges that lies ahead, I would take this opportunity to encourage and urge them to be bold and to continue working together as one to ensure continual success for NPCB.



PENGURUSAN TERTINGGITOP MANAGEMENT

Tan Ann LingPengarah Regulatori FarmasiBiro Pengawalan Farmaseutikal Kebangsaan

Director of Regulatory PharmacyNational Pharmaceutical Control Bureau

Dr. Tajuddin AkasahTimbalan Pengarah Pusat Kawalan KualitiDeputy Director of Centre for Quality Control

Siti Aida AbdullahTimbalan PengarahPusat Pembangunan OrganisasiDeputy Director ofCentre for Organisational Development

Sameerah Shaikh Abdul RahmanTimbalan PengarahPusat Pasca Pendaftaran ProdukDeputy Director ofCentre for Post Registration of Products

Pesah AhmadKetua Pusat PentadbiranHead of Centre for Administration

Sulaiman AhmadTimbalan Pengarah Pusat Komplians dan PerlesenanDeputy Director of Centre for Compliance and Licensing

Dr. Kamaruzaman SalehTimbalan Pengarah Pusat Kajian Produk BaruDeputy Director of Centre for Investigational New Product

Noorizam IbrahimTimbalan Pengarah Pusat Pendaftaran ProdukDeputy Director of Centre for Product Registration

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SIDANG PENGARANGEDITORIAL BOARD

Kiri ke KananLeft to right

Tiada dalam gambarNot in the picture

Oh Chen Wei, Meera Kumari a/p Ram Navas, Premavathy a/p Ramasami, Carol Ling Hui Ming, Lee Wei Xin, Su Siew Ching, Syuhadah Mohamed Hassan, Yogamalar a/p Dorairajoo, Angeline Phua Wee Ling, Rema Panickar, Nor Hazwan Ali, Wayne Wong Guan Wei

Nordalila Sabuan, Balqis Abd Ghani, Sharon Ling Yu Leng, Wendy Ng Siaw Wee, Noratikah binti Khairunasir, Ahmad Izham Md. Ismail

Terima kasih kepada semua di atas kerjasama dan sumbangan anda dalam penerbitan Laporan Tahunan

BPFK 2014“Kerjasama adalah teras kejayaan”

A heartfelt thank you to all for the contribution and cooperation in the publication of NPCB Annual Report

2014“Teamwork is the key to success”



Biro Pengawalan Farmaseutikal Kebangsaan (BPFK), yang sebelum ini dikenali sebagai Makmal Pengawalan Farmaseutikal Kebangsaan, telah ditubuhkan pada Oktober 1978. Institusi ini telah ditubuhkan untuk melaksanakan kawalan kualiti ke atas produk farmaseutikal. Infrastruktur dan kemudahan institusi ini direkabentuk bagi memenuhi keperluan aktiviti kawalan dan pengujian kualiti yang dijalankan.

Bermula tahun 1985, BPFK bertanggungjawab untuk memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui penilaian data saintifik dan ujian makmal. Sistem untuk memantau produk-produk di pasaran juga telah ditubuhkan. Sejak itu, BPFK telah memperluaskan kawalan kualiti dan keselamatan ke atas produk-produk bukan preskripsi, tradisional, kosmetik, veterinari, bahan aktif farmaseutikal (API) dan seterusnya kawalan ke atas produk vaksin melalui aktiviti Vaccine Lot Release bermula tahun ini.

Dengan kepakaran dan kemampuan yang dimiliki, BPFK telah diberi pengiktirafan antarabangsa sebagai “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” pada tahun 1996. Pengiktirafan ini diberikan oleh World Health Organization (WHO) untuk sumbangan BPFK dalam bidang regulatori. Pengikhtirafan ini telah menarik minat agensi regulatori luar untuk menjalani latihan di BPFK. Selain itu, pengiktirafan ini telah meletakkan BPFK di platform antarabangsa dan meningkatkan kerjasama di antara BPFK dan agensi regulatori luar negara.

The National Pharmaceutical Control Bureau (NPCB), formerly known as the National Pharmaceutical Control Laboratory, was set up in October 1978. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities

Starting from 1985, NPCB was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through evaluation of scientific data and laboratory tests. A system to monitor products in the market was also established. Over the years, NPCB has extended the control of the quality and safety of non-prescription medicines, traditional products, cosmetics, veterinary products, active pharmaceutical ingredients (API) including the quality control of vaccine through Vaccine Lot Release activities which started this year.

In view of its technical expertise and training capabilities, NPCB was given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPCB’s contribution in the field of regulatory affairs. Apart from that, this recognition has placed NPCB on an international platform and enhanced cooperation between NPCB and other international regulatory agencies.

PENGENALAN KEPADA BPFKINTRODUCTION TO NPCB



Di samping itu, BPFK telah diterima sebagai ahli ke-26 dalam Pharmaceutical Inspection Co-operation Scheme (PIC/S) pada 1 Januari 2002. Sejak itu, BPFK telah terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa.

BPFK sentiasa berusaha dalam menaiktarafkan Sistem Pengurusan Kualiti. BPFK telah menerima pensijilan MS ISO 9001:2008 daripada SIRIM dan berjaya mengekalkannya sehingga kini. Selain itu, Pusat Kawalan Kualiti, BPFK telah memperolehi akreditasi MS ISO 17025:2005 di bawah Skim Akreditasi Makmal Malaysia (SAMM) pada tahun 2010.

BPFK telah bertanggungjawab menjaga keselamatan awam selama 36 tahun. Sejak penubuhannya, BPFK telah melalui pelbagai transformasi bagi memajukan institusi ini supaya menjadi institusi regulatori yang setanding dengan agensi regulatori antarabangsa. Dengan komitmen dan dedikasi semua kakitangan BPFK, BPFK bersedia untuk mengatasi cabaran pada masa hadapan dan akan terus memastikan bahawa ubat-ubatan di pasaran adalah selamat, berkualiti dan berkesan untuk kegunaan awam.

In addition to that, NPCB has successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPCB has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

NPCB is constantly striving towards upgrading its Quality Management System. NPCB has successfully obtained and retained the MS ISO 9001:2008 certification from SIRIM. Apart from that, NPCB has obtained MS ISO 17025:2005 accreditations for Centre for Quality Control under the Malaysian Laboratory Accreditation Scheme (SAMM) in 2010.

NPCB has been the custodian of public safety for 36 years. From the moment it was established, NPCB has gone through a series of transformation to advance itself as a regulator and to be on par with international counterparts. With the commitment and dedication of all NPCB staff, NPCB is well equipped to overcome future challenges and will continue to ensure that the medicines in the market are safe, of good quality and efficacious for public consumption.



CARTA ORGANISASIORGANISATION CHART

PENGARAH REGULATORI FARMASIDIRECTOR OF REGULATORY PHARMACY

Pusat Kawalan KualitiCentre for Quality Control

keselamatan ubat-ubatan, kosmetik dan supplemen kesihatan di pasaran

medicines, cosmetics and health supplements in the market

Pusat Komplians dan PelesenanCentre for Compliance and Licensing

mengeluarkan lesen bagi pengilang, pengimport dan pemborong

manufacturers, importers and wholesalers

Pusat Pendaftaran Produk Centre for Product Registration

atas dossier pelbagai jenis ubat-ubatan dan supplemen kesihatan

pharmaceuticals, traditional / natural products and health supplements

Pusat Pasca Pendaftaran ProdukCentre for Post Registration of Products

yang berada di pasaran

keperluan serta standard yang ditetapkan seperti mengeluarkan arahan panggil balik ke atas produk terlibat

adverse ubat daripada pengamal perubatan dan orang awam serta menjalankan siasatan ke atas laporan berkenaan bagi mengetahui punca kesan adverse tersebut

which fail to comply to the requirements of the stipulated standard

public and investigate the cause of the adverse events



Pusat Pembangunan Organisasi Centre for Organisational Development

web rasmi BPFK

antarabangsa

Helpdesk BPFK sama ada menerusi telefon, emel mahupun pertanyaan di kaunter

walk – in inquiries

Pusat PentadbiranCentre for Administration

hal ehwal pegawai, perolehan aset & stor, pengurusan akaun & hasil, pembangunan dan sebagainya.

related to staff, asset procurement and store management, account management and revenue, development and so forth.

Pusat Kajian Produk BaruCentre for Investigational New Product

Percubaan Klinikal (LIPK) dan Kebenaran Mengilang Produk Tidak Berdaftar (CTX)

Mengilang Produk Tidak Berdaftar (CTX)

dalam dan luar negara

(CTIL) and Clinical Trial Exemption



PIAGAM PELANGGANCLIENT’S CHARTER

PENDAFTARAN PRODUK MASA

Penilaian Penuh

Penilaian Ringkas

supplemen kesihatan dan produk semulajadi yang mengandungi:

PELESENAN

Kebenaran Mengilang untuk Percubaan Klinikal (CTX):

dan Advance Therapy Medicinal Product (ATMP)

MASA

210 hari bekerja*210 hari bekerja*245 hari bekerja*

116 hari bekerja*136 hari bekerja*

1 hari bekerja^15 hari bekerja*45 hari bekerja*15 hari bekerja*60 hari bekerja*

MASA

4 hari bekerja*

45 hari bekerja*

30 hari bekerja*

*Setelah permohonan lengkap diterima^Bagi permohonan yang mematuhi keperluan ASEAN Cosmetic Directive (ACD)



PRODUCT REGISTRATION

Full Evaluation

Abridged Evaluation

supplements and traditional products containing:

LICENSING

Advance Therapy Medicinal Product (ATMP)

DURATION

210 working days*210 working days*245 working days*

116 working days*136 working days*

1 working days^15 working days*45 working days*15 working days*60 working days*

DURATION

4 working days*

45 working days*

30 working days*

^For applications fulfilling ASEAN Cosmetic Directive (ACD) requirements



STATISTIK RINGKASBRIEF STATISTICS

Bilangan Produk Yang Disampel (Sampel Pasca Pendaftaran)Total Number of Products Sampled (Post–Market Sampling)

2,849Bilangan Aduan Produk Yang DiterimaTotal Product Complaints Received

1,023

Bilangan ADR Yang DiterimaTotal Number of ADR Reports Received

13,001

Bilangan Tindakan Regulatori Yang Diambil Berdasarkan Isu Keselamatan UbatNumber of Drug Safety Issues With Regulatory Action

14

Bilangan Produk Kosmetik Yang DinotifikasiNumber of New Cosmetic Products Notified

77,978Jumlah Penolakan Notifikasi Produk Kosmetik Semasa Proses PenyaringanTotal Cosmetics Notifications Rejected During Screening

487

Bilangan Produk Yang DidaftarkanNumber of Product Registered:

Aktiviti Vaccine Lot Release (VLR) (Julai–Disember 2014)Vaccine Lot Release (VLR) Activity (July–December 2014)

*(Nota: Aktiviti VLR Projek Perintis Bermula Pada Julai 2014/ *Note: VLR Pilot Study Started In July 2014)

a. Bilangan Permohonan VLR Yang Diterima/Number of VLR Application Received 81b. Bilangan Konsainan Vaksin Yang Diluluskan/Number of Vaccine Consignments Released 77 c. Bilangan Konsainan Vaksin Yang Ditolak/Number of Vaccine Consignments Rejected 5Nota: Untuk keputusan (b), 1 konsainan merupakan pelepasan separaNote: For result of (b), 1 consignment indicates partial release

a Preskripsi/Prescription 235b. Bukan Preskripsi/Non–Prescription 52c. Semula Jadi/Natural 590d. Supplemen Kesihatan/Health Supplement 128e. Veterinari/Veterinary 207

PRODU

K/PRO

DUCT



Sampel Yang Diuji Mengikut KategoriSamples Tested According To Categories:a. Pendaftaran/Registration 692b. Pengawasan/Surveillance 2,128c. Aduan/Complaint 108d. ADR/Adverse Drug Reaction 145e. Penguatkuasa Farmasi/Pharmacy Enforcement 382f. Lain-lain/Others 32

Penilaian Data Validasi Validation Data Evaluation

711Bilangan Sampel Yang Gagal UjianNumber of Failed Sample Testing

579Bilangan Pemeriksaan Amalan Perkilangan Baik (APB) Number of Good Manufacturing Practice (GMP) Inspections

360

Bilangan Lesen Dikeluarkan Number of Licenses Issued a. Pengilang/

Manufacturer 247

b. Pengimport/Importer 393c. Pemborong/Wholesaler 1,326

d. Lesen Import Percubaan Klinikal/Clinical Trial Import Licence (CTIL) 258

e. Kebenaran Mengilang/Clinical Trial Exemption

15f. Variasi/Variation 428

Bilangan Pemeriksaan Amalan Edaran Baik (AEB)Number of Good Distribution Practice (GDP) Inspections

147

Bilangan Pemeriksaan Amalan Makmal Baik Number of Good Laboratory Practice (GLP) Inspections

3Bilangan Pemeriksaan Pusat Kajian Bioekuivalens (BE) Number of Inspections on Bioequivalence Centre (BE)

21

Bilangan Pemeriksaan Tapak Kajian KlinikalNumber of Clinical Trial Site Inspections

7

Bilangan Laporan Suspected

Reaction (SUSAR) Number of Suspected

Report received

3,742

Bilangan Pelawat Yang DiterimaNumber of Visitors a. Tempatan/Local 203b. Antarabangsa/International 56

Bilangan Dialog Yang Dijalankan Dengan Pihak Industri TempatanNumber Of Dialogues Carried Out With The Local Industry

7

Bilangan Pertanyaan Yang DiterimaNumber of Queries Received a. Telefon/Telephone 4,377b. Emel & Modul Pertanyaan/

Email & Online Module 607 c. Pertanyaan Di Kaunter/Walk-In 1,133



PENCAPAIAN BPFKNPCB’S ACHIEVEMENTS

PENCAPAIAN

1. Pada Oktober 2013, BPFK telah berjaya menambah skop akreditasi MS ISO/IEC 17025: 2005 dari Jabatan Standards Malaysia untuk ujian penentuan kandungan Lovastatin di dalam produk tradisional menggunakan High Performance Liquid Chromatography (HPLC).

Berdasarkan audit pengawasan yang dijalankan pada 6 Mac 2014, BPFK telah berjaya mengekalkan skop akreditasi berikut:

a) Penentuan arsenik, plumbum dan kadmium dalam produk tradisional dengan Graphite Furnace Atomic Absorption Spectrometry

b) Penentuan had merkuri dalam produk tradisional dengan Cold Vapour Atomic Absorption Spectrometry

c) Kontaminasi microbial dalam produk tradisional berdasarkan British Pharmacopoeia 2012 dan produk komestik berdasarkan metodologi in-house

d) Pengecaian kapsul dan tablet bagi produk-produk tradisional

e) Keseragaman berat untuk kapsul dan tablet bagi produk-produk tradisional

ACHIEVEMENT

1. In October 2013, NPCB has successfully extended the scope of accreditation of MS ISO/IEC 17025:2005 by Department of Standards Malaysia for detection and determination of Lovastatin in traditional products using High Performance Liquid Chromatography (HPLC).

Based on the surveillance audit conducted on 6th March 2014, NPCB is able to maintain the following accreditation scopes:

a) Determination of arsenic, lead and cadmium in traditional products using Graphite Furnace Atomic Absorption Spectrometry

b) Determination of mercury limit in traditional products using Cold Vapour Atomic Absorption Spectrometry

c) Microbial Contamination Test in traditional and cosmetic products based on British Pharmacopoeia 2012 and in-house method respectively

d) Disintegration test for capsules and tablets in traditional products

traditional products



f) Penentuan plumbum dalam produk kosmetik dengan Graphite Furnace Atomic Absorption Spectrometry

g) Penentuan merkuri dalam produk kosmetik dengan Cold Vapour Atomic Absorption Spectrometry

h) Penentuan kandungan Hydroquinone di dalam produk krim kosmetik menggunakan HPLC

i) Penyaringan untuk identifikasi Arbutin dan Hydroquinone di dalam produk krim kosmetik menggunakan HPLC

2. Pelaksanaan aktiviti Vaccine Lot Release di Malaysia

Aktiviti Vaccine Lot Release telah mula dilaksanakan secara projek perintis dari 1 Julai 2014 sehingga 31 Disember 2014 yang melibatkan vaksin yang tertentu contohnya Bacillus Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio dan Human Papillomavirus (HPV). Ini akan diikuti dengan pelaksanaan sepenuhnya bermula 1 Januari 2014. Aktiviti ini merangkumi penilaian dokumen Lot Summary Protocol dan pemeriksaan rangkaian sejuk ke atas setiap lot vaksin yang dibawa masuk ke Malaysia. ‘Guidance Document and Guidelines for Vaccine Lot Release in Malaysia’ telah diterbitkan dan digunapakai mulai 1 Julai 2014.

3. Pembangunan Monograf Herba Malaysia

Pada tahun 2014, sebanyak 15 Monograf Herba telah diterbitkan, iaitu:

a) Persicaria minor (Huds.) Opiz (Kesum Leaves and Twigs)b) Moringa oleifera Lam. (Merunggai Leaves)c) Elaeis guineensis Jacq. Palma (Kelapa sawit leaves)d) Zingiber zerumbet L. Smith (Lempoyang rhizome)e) Piper sarmentosum Roxb. (Kadok Leaves)f) Clinacanthus nutans Lindau (Belalaigajah Leaves)g) Curcuma xanthorrhiza Roxburgh (Temu Lawak rhizome)h) Senna alata (L.) Roxb. (Gelenggang Leaves)

f) Determination of lead in cosmetic products by using Graphite Furnace Atomic Absorption Spectrometry

g) Determination of mercury in cosmetic products using Cold Vapour Atomic Absorption Spectrometry

h) Determination of Hydroquinone in cosmetic cream products by using HPLC

i) Screening for the identification of Arbutin and Hydroquinone in cosmetic cream products by using HPLC

2. Implementation of Vaccine Lot Release activity in Malaysia

Pilot study for Vaccine Lot Release was conducted from 1 July 2014 to 31 December 2014 which involved selected vaccines such as Bacillus Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio and Human Papillomavirus (HPV). This will be followed by the full implementation to all vaccines starting from 1 January 2015 onwards. This activity involves evaluation of Lot Summary Protocol and cold chain inspection on all lots of vaccines imported into Malaysia. ‘Guidance Document and Guidelines for Vaccine Lot Release in Malaysia’ was published and enforced starting 1 July 2014.

3. Development of Malaysia Herbal Monograph In 2014, 15 Herbal Monographs were published

as listed below:

a) Persicaria minor (Huds.) Opiz (Kesum Leaves and Twigs)b) Moringa oleifera Lam. (Merunggai Leaves)c) Elaeis guineensis Jacq. Palma (Kelapa sawit leaves)d) Zingiber zerumbet L. Smith (Lempoyang rhizome)e) Piper sarmentosum Roxb. (Kadok Leaves)f) Clinacanthus nutans Lindau (Belalaigajah Leaves)g) Curcuma xanthorrhiza Roxburgh (Temu Lawak rhizome)h) Senna alata (L.) Roxb. (Gelenggang Leaves)



i) Cosmos caudatus Kunth (Ulam raja leaves)j) Piper betle L. (Sireh leaves)k) Melastoma malabathricum (Senduduk leaves)l) Gynura procumbens (Lour.) Merr (Sambung

nyawa leaves)m) Tinospora crispa (L.) Hook. F & Thomson (Patawali stem)n) Zingiber officinale var. rubrum (Haliabara rhizome)o) Ocimum basilicum (Selasih leaves)

4. Dalam usaha memastikan kualiti ubat-ubatan dan kosmetik terjamin bermula daripada pemantauan proses pengilangan sehingga kepada aktiviti pengedaran kepada pengguna, BPFK telah mengemaskini serta menerbitkan beberapa garis panduan: a) Fail Induk Pengilang, Edisi Ketiga; 2014b) Supplementary Notes for Management of

Cold Chain Products

5. Pegawai pemeriksa Amalan Perkilangan Baik (APB) dari BPFK telah dipilih untuk menjalankan penilaian dan pemeriksaan ‘Inspection Service’ Thailand di bawah program ASEAN Mutual Recognition Arrangement (MRA) on GMP Inspection of Manufacturers of Medical Products dan sebagai pegawai pemeriksa untuk menjalankan penilaian dan pemeriksaan ke atas agensi Food and Drug Administration (FDA) Philipines bagi tujuan penilaian PIC/S.

6. Beberapa orang pegawai Pusat Komplians dan Pelesenan, BPFK telah menyertai Mesyuarat ASEAN Traditional Medicine and Health Supplement (TMHS) Good Manufacturing Practice (GMP) Task Force kali ke-15, 16, 17 dan 18 yang berlangsung di Malaysia, Kemboja, Thailand dan Laos PDR sepanjang tahun 2014. BPFK, Malaysia telah diberi kepercayaan untuk menerajui ASEAN TMHS GMP TF yang mula diwujudkan sejak tahun 2008. Penubuhan ASEAN TMHS GMP TF ini bertujuan untuk mengharmonikan keperluan Amalan Perkilangan Baik bagi produk tradisional dan supplemen kesihatan di kalangan negara-negara ASEAN dan mewujudkan garis panduan ASEAN Guidelines on Good Manufacturing Practice for Traditional Medicines dan Health Supplements.

7. Pusat Komplians dan Pelesenan terlibat dalam menganjurkan latihan kepada industri untuk program Pusat Transformasi Luar Bandar (RTC).

j) Piper betle L. (Sireh leaves)k) Melastoma malabathricum (Senduduk leaves)l) Gynura procumbens (Lour.) Merr (Sambungnyawa leaves)m) Tinospora crispa (L.) Hook. F & Thomson

(Patawali stem)n) Zingiber officinale var. rubrum (Haliabara rhizome)o) Ocimum basilicum (Selasih leaves)

4. In order to ensure the quality of medicines and cosmetics since the beginning of product manufacturing until the distrubution activity to consumer, NPCB had updated and published several guidelines:a) Site Master File 3rd Edition 2014b) Supplementary Notes for Management of Cold

Chain Products

5. Good Manufacturing Practice (GMP) Inspectors from NPCB was selected to evaluate Thailand’s Inspection Service under ASEAN Mutual Recognition Arrangement (MRA) on GMP Inspection of Manufacturers of Medical Products and the GMP inspectors also carried out PIC/S Assessment on Philippines Food Drug Administration (FDA) agency.

6. A few officers from the Centre for Compliance and Licensing, NPCB were involved in the 15th, 16th, 17th and 18th ASEAN Traditional Medicine and Health Supplement (TMHS) Good Manufacturing Practice (GMP) Task Force Meeting, held in Malaysia, Cambodia, Thailand, and Laos PDR throughout the year 2014. NPCB, Malaysia has been entrusted to lead the TMHS ASEAN GMP TF which was first established in 2008. The establishment of ASEAN TMHS GMP TF aims to harmonize the requirements of Good Manufacturing Practice for traditional products and health supplements among ASEAN countries and to establish guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements.

7. Centre of Compliance and Licensing was involved in organizing training under Rural Transformation Centre (RTC) programme for the industry.



Sebanyak 3 seminar telah dijalankan iaitu:a) Zon Tengah: 2-3 September 2014. Lokasi:

BPFK, Selangorb) Zon Selatan: 28-29 Oktober 2014. Lokasi: M

Suites Hotel, Johor Bahru, Johorc) Zon Utara: 25-26 November 2014. Lokasi:

Hotel Cititel Penang, Pulau Pinang

8. Malaysia telah menjadi non-Organisation for Economic Co-Operation and Development (OECD) member adhering to Mutual Acceptance Data (MAD) sistem sejak 29 Mac 2013. BPFK selaku Agensi Pemantau Pematuhan Kebangsaan (APPK) GLP telah terlibat secara aktif dalam OECD GLP Working Group Meetings sejak 2009 yang diadakan setiap tahun. Kini, Malaysia telah disenaraikan sebagai full adherent country dan National Contact Point for the Working Group bagi GLP disenaraikan dalam laman web OECD.

9. Garis panduan bertajuk “Malaysian Guideline for Safety Reporting of Investigational Products, First Edition” telah dikeluarkan pada bulan Oktober tahun 2014.

10. BPFK telah menyemak dan menerbit Garis Panduan Permohonan Lesen Import Percubaan Klinikal dan Kebenaran Mengilang Produk-produk Tidak Berdaftar untuk Tujuan Percubaan Klinikal di Malaysia, Edisi Keenam pada Oktober 2014 mengikut keperluan semasa selaras dengan perubahan keperluan regulatori terkini dan keperluan piawaian antarabangsa.

11. Malaysia dan Singapura telah berjaya menandatangani (MoU) berkaitan regulatori farmasi pada 28 Mac 2012.

Susulan daripada MoU, Mesyuarat Teknikal Dua Hala Ketiga telah diadakan di antara BPFK dan pihak Health Sciences Authority (HSA) Singapura pada 15 Ogos 2014 di Bahagian Perkhidmatan Farmasi, Petaling Jaya.

Delegasi dari kedua-dua buah negara telah mengadakan perbincangan secara berkumpulan yang meliputi aspek pendaftaran produk, penguatkuasaan farmasi dan amalan perkilangan baik. Perbincangan tersebut membutirkan peranan kedua-dua institusi di dalam meningkatkan

3 seminars were conducted:a) Central Zone: 2-3 September 2014. Location:

NPCB, Selangorb) Southern zone: 28-29 October 2014. Location:

M Suites Hotel, Johor Bahru, Johorc) Northern Zone: 25-26 November 2014. Location: Hotel Cititel Penang, Penang.

8. Malaysia has become one of the non-Organisation for Economic Co-Operation and Development (OECD) member adhering to Mutual Acceptance Data (MAD) system since 29 March 2013. NPCB as one of Malaysia’s Compliance Monitoring Authority (CMA) for monitoring compliance to OECD Principles of Good Laboratory Practice (GLP) has been actively involved in the annual OECD GLP Working Group meetings since 2009. Malaysia is now listed as a full adherent country, and the National Contact Point of the Working Group on Good Laboratory Practice is available at the OECD website.

9. Malaysian Guideline for Safety Reporting of Investigational Products, First Edition was successfully released in October 2014

10. NPCB had revised and published the Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, 6th Edition in October 2014. This is to streamline the existing guideline in accordance with the current needs, regulatory requirements and international standards.

11. On 28 March 2012, Malaysia and Singapore

matters.

Bilateral Meeting between NPCB and Health Sciences Authority (HSA) Singapore was held in Pharmaceutical Services Divisions, Petaling Jaya on 15th August 2014.

Both delegations carried out a joint group discussion which covered the aspects of product registration, pharmacy enforcement and good manufacturing practices. The discussion detailed the role of both institutions in enhancing the existing working relationship and strengthening the



hubungan kerja sedia serta mengukuhkan kerjasama antara Malaysia dan Singapura dalam regulatori farmasi untuk faedah bersama.

12. BPFK telah menerima kunjungan hormat daripada Pharmaceuticals and Medical Devices Agency (PMDA), Jepun pada 14 April 2014. Delegasi Jepun yang diketuai oleh Mr. Nobuo Uemura, selaku pemangku Pengarah Alat Peranti Perubatan, telah membincangkan cadangan kerjasama teknikal di antara kedua-dua negara. Salah satu topik perbincangan adalah penganjuran bersama 1st Malaysia-Japan Symposium pada tahun 2015.

13. BPFK telah berjaya mendapat pensijilan 5S dari Unit Pemodenan Tadbiran & Perancangan Pengurusan Malaysia (MAMPU) pada 17 Disember 2012. Pensijilan tersebut adalah untuk jangka masa 2 tahun. Walau bagaimanapun, pihak MAMPU telah melakukan penjenamaan semula 5S kepada Ekosistem Kondusif Sektor Awam (EKSA) pada tahun 2013. Oleh itu, pada 27 November 2014, MAMPU telah menjalankan audit EKSA ke atas BPFK mengikut kriteria EKSA yang baru. Berdasarkan pengauditan yang telah dilaksanakan, BPFK telah dianugerahkan pensijilan EKSA yang berkuatkuasa daripada 15 Disember 2014 sehingga 14 Disember 2016.

cooperation between Malaysia and Singapore in the pharmaceutical regulatory field for the benefit of both countries.

12. NPCB received a courtesy visit from the Pharmaceuticals and Medical Devices Agency (PMDA), Japan on 14 April 2014. The Japan delegation which was headed by Mr. Nobuo

discussed the proposed technical cooperation between the two countries. One of the topics discussed is the joint organization of 1st Malaysia-Japan Symposium in 2015.

13. NPCB have successfully obtained 5S certification from Malaysian Administrative Modernisation

17th December 2012. The certification is for a

has rebranded 5S to Public Sector Conducive Ecosystem (EKSA). Therefore, on 27th November

NPCB according to the new EKSA criteria. Based on the audit performed, NPCB was awarded the EKSA certification effective from 15th December 2014 until 14th December 2016.



PRODUK ENTITI KIMIA BARU YANG DILULUSKAN PENDAFTARAN OLEH PBKD PADA 2014NEW CHEMICAL ENTITY PRODUCTS APPROVED BY THE DCA IN 2014

BIL. NAMA PRODUK

No. Product Name

1 Forxiga 5mg Film-Coated Tablet

Forxiga 10mg Film-Coated Tablet

2 Seebri Breezhaler 50mcg Inhalation Powder Hard Capsule

3 Bydureon 2mg Powder And Solvent For Prolonged-Release Suspension For Injection

4 Dexilant Delayed-Release Capsules 30mg

Dexilant Delayed-Release Capsules 60mg

5 Abstral 100 Microgram Sublingual Tablets

Abstral 200 Microgram Sublingual Tablets

Abstral 400 Microgram Sublingual Tablets

6 Fycompa 2mg Film-Coated Tablets

Fycompa 4mg Film-Coated Tablets





7 Xofigo (Radium-223 Dichloride) 1000 kBq/ml Solution for Injection

8 Tivicay 50mg Film-Coated Tablets

9 Eligard 7.5mg Powder & Solvent for Solution for Injection

Eligard 22.5mg Powder & Solvent for Solution for Injection

Eligard 45mg Powder & Solvent for Solution for Injection

10 Norvasc ODT Orodispersible Tablet 5mg

Norvasc ODT Orodispersible Tablet 10mg

11 Pravafen 40mg/160mg Hard Capsules

12 Signifor 0.3mg/1ml Solution for Injection

Signifor 0.6mg/1ml Solution for Injection

Signifor 0.9mg/1ml Solution for Injection

13 Exelon Patch 15

14 Otrivin Complete Nasal Spray Solution



15 Giotrif 20mg Film-Coated Tablets

Giotrif 30mg Film-Coated Tablets



16 Xeljanz Film-Coated Tablets 5mg

17 Bilaxten 20mg Tablets

18 Sativex Oromucosal Spray

19 Flixotide Nebules 0.5mg/2ml

20 Adempas 0.5 mg Film-coated Tablet

Adempas 1.0 mg Film-coated Tablet




21 Menopur Multidose 600 IU Powder and Solvent for Solution for Injection

Menopur Multidose 1200 IU Powder and Solvent for Solution for Injection

22 Relvar Ellipta 100/25 micrograms Inhalation Powder, pre-dispensed

Relvar Ellipta 200/25 micrograms Inhalation Powder, pre-dispensed

23 Janumet XR 50mg/500mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets

Janumet XR 50mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets

Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets

24 Abraxane for Injectable Suspension 100 mg

25 Flutiform 50 microgram/5 microgram per actuation pressurised inhalation, suspension

Flutiform 125 microgram/5 microgram per actuation pressurised inhalation, suspension

Flutiform 250 microgram/10 microgram per actuation pressurised inhalation, suspension

26 OxyContin Controlled-Release Tablets 10mg

OxyContin Controlled-Release Tablets 20mg



27 Cialis 2.5mg Film-Coated Tablets

Cialis 5mg Film-Coated Tablets



PRODUK BIOLOGIK YANG DILULUSKAN OLEH PBKD PADA 2014BIOLOGICS APPROVED BY THE DCA IN 2014

BIL. NAMA PRODUK

No. Product Name

1 Insugen-R (Regular) Insulin Injection, Soluble 100IU/ml

Insugen-N (NPH) Insulin Injection, Isophane 100IU/ml

Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane 100IU/ml

2 Jetrea 0.5mg/0.2ml Concentrate For Solution For Injection

3 Arzerra 100mg Concentrate for Solution for Infusion

Arzerra 1000mg Concentrate for Solution for Infusion

4 Insuman Comb 50 100iu/ml, Suspension for Injection

5

6 Zaltrap 25 mg/ml Concentrate for Solution for Infusion

7 Kadcyla 100mg Powder for Concentrate for Solution for Infusion

Kadcyla 160mg Powder for Concentrate for Solution for Infusion

8 Privigen Solution for Infusion 10%

9 Rhophylac 300 microgram/2ml, Solution for Injection In Pre-Filled Syringe

10 Globalvacc Al-Shifa Hib Vaccine

11 Nesp Injection Plastic Syringe 10 mcg/0.5ml

Nesp Injection Plastic Syringe 20 mcg/0.5ml






12 Saizen Liquid 6 mg (5.83 mg/ml) Solution for Injection

Saizen Liquid 12 mg (8 mg/ml) Solution for Injection

Saizen Liquid 20 mg (8 mg/ml) Solution for Injection

13 Pegasys Pre-Filled Pen 135 mcg/ 0.5ml

Pegasys Pre-Filled Pen 180 mcg/ 0.5ml



PENDAFTARAN PRODUKPRODUCT REGISTRATION

BPFK be r tanggung jawab mengenda l i kan permohonan pendaftaran produk-produk entiti kimia baru/ubat baru, biologik, preskripsi, bukan preskripsi, supplemen kesihatan, semulajadi serta veterinar.

Permohonan pendaftaran bagi produk farmaseutikal perlu dikemukakan menerusi sistem atas talian

Permohonan pendaftaran bagi semua produk farmaseutikal dinilai dari aspek keselamatan, keberkesanan dan kualiti, manakala produk semulajadi dinilai dari aspek keselamatan dan kualiti. Produk yang telah selesai dinilai akan dibentangkan di dalam Mesyuarat PBKD untuk keputusan status pendaftaran produk tersebut.

Selain daripada itu, kawalan regulatori terhadap bahan aktif farmaseutikal (API) dijalankan bagi memastikan penggunaan API dalam formulasi produk adalah berkualiti. Kawalan ini dilaksanakan dengan menguatkuasakan keperluan teknikal tambahan berhubung API sebagai sebahagian daripada keperluan pendaftaran produk. Pelaksanaan ini telah dijalankan secara prospektif dan berperingkat, bermula secara sukarela untuk pendaftaran produk kimia baru/ubat baru mulai 1 April 2011, dan diikuti pelaksanaan secara mandatori pada 1 Januari 2012. Seterusnya, pelaksanaan ini dipanjangkan kepada produk preskripsi dalam bentuk injeksi mulai 1 Julai 2014.

The NPCB is responsible for processing registration applications for new chemical entities (NCE)/ new drugs, biologics, prescription, non-prescription, health supplements, natural as well as veterinary products

Registration applications for pharmaceutical products have to be submitted via the online system known

Applications for pharmaceutical products are evaluated for safety, efficacy and quality, whereas traditional products are evaluated for safety and quality. Products which have been evaluated will be tabled at DCA meetings for a decision on the product registration status.

In addition, regulatory control of active pharmaceutical ingredients (API) is carried out to ensure the good quality of API used in product formulation. This has been implemented with the enforcement of additional technical requirements related to API as part of the requirements in the product registration. Implementation was carried out prospectively and in stages, first voluntarily for new chemical entity (NCE)/ new drug product registration on 1 April 2011, followed by mandatory implementation on 1 January 2012. This implementation continued for registration of prescription products in parenteral dosage form on 1 July 2014.



0

150

300

450

600

750

900

1050

1200

1350

1500

20122012

521

71

426

171

PreskripsiPrescription

Bukan PreskripsiNon-Prescription

SemulajadiNatural

Supplemen KesihatanHealth Supplement

VeterinarVeterinary

Jumlah PermohonanTotal of Applications

Rajah 1: Taburan dan Jumlah Permohonan Pendaftaran yang Diterima (2012-2014)

Figure 1: Distribution and Total Registration Applications Received (2012-2014)

39Bila

ngan

Per

moh

onan

Nu

mbe

r of A

pplic

atio

nsJu

mla

h Pe

rmoh

onan

Tota

l App

licat

ions

20132013

279

55

835

202

63

20142014

292

36

524

243

52

1,228

1,434

1,147

0

150

300

450

600

750

900

1050

1200

1350

1500

20122012

357

83

565

161

PreskripsiPrescription

Bukan PreskripsiNon-Prescription

SemulajadiNatural

Suplemen KesihatanHealth Supplement

VeterinarVeterinary

Jumlah Produk Didaftar Total Products Registered

Rajah 2: Taburan dan Jumlah Produk Didaftar (2012-2014)

Figure 2: Distribution and Total Products Registered (2012-2014)

45Bila

ngan

Pro

duk

Dida

ftar

Num

ber o

f Pro

duct

s Re

gist

ered

Jum

lah

Prod

uk D

idaf

tar

Tota

l Pro

duct

s Re

gist

ered

20132013

241

54

578

85 63

20142014

235

52

590

128207

1,211

1,021

1,212

Sebanyak 12 mesyuarat PBKD telah diadakan pada tahun 2014 dengan 2,171 permohonan pendaftaran produk dibentangkan semasa mesyuarat tersebut. Sejumlah 1,212 produk telah diluluskan untuk pendaftaran.

A total of 12 DCA meetings were conducted in 2014 with 2,171 applications for product registration being reviewed by the DCA. A total of 1,212 products were approved for registration.



a. Penerimaan Permohonan Pendaftaran Produk dan Jumlah Produk yang Didaftar

Tahun 2013 menunjukkan jumlah permohonan pendaftaran yang paling tinggi diterima, manakala tahun 2014 menunjukkan jumlah produk yang paling tinggi didaftarkan. Ini berikutan penyaringan produk dilakukan secara manual, manakala proses pendaftaran produk dilakukan secara separa manual bagi produk semulajadi yang diperkenalkan pada tahun 2013. Prosedur baharu ini telah melancarkan proses pendaftaran produk semulajadi, hasilnya terdapat peningkatan sebanyak 18.71% bagi jumlah produk yang didaftarkan pada tahun 2014 berbanding tahun sebelumnya.

Produk semulajadi pula mendominasi kategori produk yang didaftarkan pada ketiga-tiga tahun tersebut, dengan mencatatkan bilangan permohonan perdaftaran tertinggi setiap tahun

b. Jumlah Pendaftaran Mengikut Status

a. Registration Applications Received and Total Products Registered

Following the implementation of manual screening as well semi-manual evaluation of natural products in 2013, the highest number of registration applications were received in year 2013, while the greatest amount of products were registered in 2014. These new procedures have expedited the registration process, resulting in an 18.71% increment in products registered in 2014 as compared to the year before.

Natural products dominated the category of

products registered in 2012, 2013 and 2014, as applications received for this product category was the highest every year.

b. Total Registration Based on Status

0

300

600

900

1200

1500

20122012

1,211

578

70 19

Daftar / Registered

Tolak / Rejected

Batal/TarikbalikCancelled/Revoked

Gantung / Suspended

Rajah 3: Jumlah Pendaftaran Mengikut Status (2012–2014)

Figure 3: Total of Registration Based on Status (2012–2014)Ju

mla

h Pe

ndaf

tara

nTo

tal

Regi

stra

tion

20132013

1,021

631

94 30

20142014

1,212

959

47 56



0

100

200

300

400

Tempatan / Local

5719

388

62

Rajah 4: Produk Tempatan dan Import Bagi Produk Didaftar Mengikut Kategori pada 2014 Figure 4: Local and Import Products Registered Based on Category in 2014

Prod

uk B

erda

ftar

Prod

ucts

Reg

iste

red

Import / Import

178

33

202

66

11790

KategoriCategory

Preskripsi / Prescription

Bukan Preskripsi / Non-Prescription

Semulajadi / Natural

Supplemen Kesihatan / Health Supplement

Veterinar / Veterinary

Malaysia

32

India

14

Germany

7

USA

4

Thailand

4

France

4

Taiwan

2

Australia

2

China

1

Indonesia

1

Others

Rajah 5: Peratusan Produk Preskripsi Berdaftar Mengikut Sumber Negara Setakat 31.12.2014 Figure 5: Percentage of Registered Prescription Products Based on Source Country as of 31.12.2014

Pera

tus

Perc

enta

ge

NegaraCountries

31

MalaysiaMalaysia

51

USA

13

Australia

5

India

4

Thailand

4

Germany

3

Indonesia

2

Taiwan

1

China

1

France

1

Others

Rajah 6: Peratusan Produk Bukan Preskripsi Berdaftar Mengikut Sumber Negara setakat 31.12.2014 Figure 6: Percentage of Registered Non-Prescription Products Based on Source Country as of 31.12.2014

Pera

tus

Perc

enta

ge

NegaraCountries

14

c. Produk Tempatan dan Import Bagi Produk Didaftar Mengikut Kategori pada 2014

d. Sumber Utama Produk Berdaftar

c. Local and Import Products Registered Based on Category in 2014

d. Main Source of Registered Products



MalaysiaMalaysia

70

China

15

Taiwan

5

USA

3

India

2

Australia

1

Indonesia

1

Others

3

Rajah 7: Peratusan Produk Semula Jadi Berdaftar Mengikut Sumber Negara Setakat 31.12.2014 Figure 7: Percentage of Registered Natural Products Based on Source Country as of 31.12.2014

Pera

tus

Perc

enta

ge

NegaraCountries

0

500

1,000

1,500

2,000

2,500

3,000

2012

2013

2014

2,247

2,555

2,785

Rajah 8: Bilangan Sijil Produk Farmaseutikal yang Dikeluarkan (2012- 2014)

Figure 8: Number of Certificate of Pharmaceutical Products Issued (2012-2014)

BilanganNumbers

10.0%Brunei

Macau

Vietnam

Myanmar

Cambodia

Rajah 9: Pengeluaran Sijil Produk Farmaseutikal ke Negara-negara Utama 2014

Figure 9: Issuance of Certificate of Pharmaceutical Product to Main Countries in 2014

2014Singapore

Hong Kong

Indonesia

Sri Lanka

China

Others

2014

7.6%

5.8%

5.3%

20.6%

0.9%

3.7%1.7%

5.3%

4.6%

34.5%

e. Aktiviti-aktiviti Lain yang berkaitan dengan Pendaftaran Produk i. Pengeluaran Sijil Produk Farmaseutikal

e. Other Activities Related to Product Registration i. Issuance of Certificate of

Pharmaceutical Product (CPP)



Rajah 10: Permohonan Pembaharuan Pendaftaran Produk yang Diluluskan (2012-2014) Figure 10: Number of Approved Applications for Renewal of Product Registration (2012-2014)0

1000

2000

3000

4000

5000

4,116 4,0383,584

Bila

ngan

/ Nu

mbe

rs

2012 2013 2014

Rajah 11: Kategori Produk bagi Pembaharuan Pendaftaran (2014) Figure 11: Registration Renewal Based on Product Category (2014)

0

10

20

30

50

40

35

15

50

Pera

tus

/ Per

cent

age

KategoriCategory




Rajah 12: Bilangan Permohonan Pertukaran Pemegang Pendaftaran Produk yang Diluluskan (2012-2014) Figure 12: Number of Approved Applications for Change of Product Registration Holder (2012-2014)

0

200

400

600

800

1000

847

346 305

Bila

ngan

/ Nu

mbe

rs

2012 2013 2014

Rajah 13: Bilangan Verifikasi Status Pendaftaran Produk (2012-2014) Figure 13: Number of Product Registration Status Verification (2012-2014)

0

5000

10000

15000

20000

1580314741

10074

Bila

ngan

/ Nu

mbe

rs

2012 2013 2014

ii. Pembaharuan Pendaftaran Produk

Bagi setiap produk berdaftar di Malaysia, permohonan pembaharuan pendaftaran produk perlu dilakukan setiap lima (5) tahun. Permohonan pembaharuan pendaftaran produk perlu dikemukakan oleh pemohon sekurang-kurangnya enam (6) bulan sebelum tarikh luput pendaftaran.

iv. Verifikasi Status Pendaftaran Produk bagi Aktiviti Penguatkuasaan

Di antara aktiviti Bahagian Penguatkuasa Farmasi adalah penguatkuasaan Peraturan Kawalan Dadah dan Kosmetik 1984. Produk-produk yang dirampas perlu disahkan status pendaftaran oleh pihak BPFK sebelum tindakan undang-undang dapat diambil.

iii. Pertukaran Pemegang Pendaftaran Produk

ii. Renewal of Product Registration

The application for renewal of a registered product has to be done every five (5) years. Application for renewal should be submitted at least six (6) months before the registration status of the product expires.

iv. Product Registration Status Verification for Enforcement Activities

Among the activities of the Pharmacy Enforcement Division is the enforcement of the Control of Drugs and Cosmetics Regulations 1984. The registration status seized products requires verification by NPCB before any legal action could be taken.

iii. Change of Product Registration Holder



Rajah 13 menunjukkan jumlah pertanyaan yang diterima untuk pengesahan status pendaftaran produk bagi tempoh 2012-2014.

v. Permohonan Tambahan Indikasi bagi Produk Berdaftar (Produk Entiti Kimia Baru dan Biologik sahaja)

Pada tahun 2014, permohonan tambahan indikasi yang dibentangkan untuk kelulusan oleh PBKD adalah 35 permohonan bagi produk entiti kimia baru dan 26 permohonan bagi produk biologik.

Figure 13 shows the number of requests received for the verification of product registration status for 2012-2014.

v. Additional Indication Applications for Registered Products (New Chemical Entities - NCE and Biologics only)

In 2014, there were 35 additional indication

applications for NCE products and 26 applications for biologics tabled in at DCA meetings for approval.



AKTIVITI PASCA PENDAFTARAN PRODUK PRODUCT POST-REGISTRATION ACTIVITIES

SURVEILANS & ADUAN PRODUK

Aktiviti surveilans dan pengendalian aduan produk dijalankan untuk memantau produk berdaftar/ kosmetik bernotifikasi di Malaysia bagi memastikan semua produk memenuhi piawaian kualiti dan keselamatan yang ditetapkan oleh Kementerian Kesihatan.

Persampelan Produk

Sejumlah 2,849 produk telah disampel di bawah Program Pengawasan Mutu Produk Berdaftar dan Kosmetik Bernotifikasi pada tahun 2014 (Rajah 1). Produk farmaseutikal disampel berdasarkan kriteria tertentu termasuk laporan kesan advers, aduan produk dan surveilans lepas.

Produk kosmetik yang disasarkan untuk persampelan termasuk produk berisiko tinggi seperti produk kegunaan bayi, produk untuk digunakan di sekitar mata atau membran mukus, serta produk pemutih kulit yang berpotensi dicampur palsu dengan bahan racun seperti hydroquinone.

SURVEILLANCE & PRODUCT COMPLAINTS

Market surveillance and handling of product complaints are in place to monitor registered medicinal products and notified cosmetics in Malaysia, ensuring that they comply with the quality and safety standards set by the Ministry of Health.

Product Sampling

A total of 2,849 products were sampled in 2014 under the Market Surveillance for Registered Products and Notified Cosmetics Programme (Figure 1). Pharmaceutical products are targeted based on certain criteria including adverse drug reaction reports, complaints, and surveillance history.

Cosmetics which are targeted for sampling included high-risk products such as baby products, products to be used around the eyes or mucous membranes, and skin-whitening products which could potentially be adulterated with poison substances such as hydroquinone.



0

1,000

500

1,500

2,000

2,500

3,000

3,500

4,000

2012

2013

2014

489123141

690

1,447

2,890

579

241

919

1,903

3,69250

562153

551

1,506

2,84977

Rajah 1: Bilangan Produk yang Disampel Mengikut Kategori (2012-2014)

Figure 1: Number of Products Sampled by Category (2012-2014)

BilanganNumbers



Supplemen Kesihatan / Health Supplement


Kosmetik /Cosmetic

Pemantauan Pematuhan Pelabelan Sejumlah 1,454 pemeriksaan label telah dijalankan ke atas produk-produk berdaftar dan kosmetik bernotifikasi untuk memastikan label/ sisip bungkusan mematuhi keperluan yang ditetapkan oleh PBKD dan garis panduan kosmetik (Jadual 1). Tindakan regulatori diambil sekiranya label produk tidak mematuhi keperluan tersebut. Kebanyakan produk yang tidak mematuhi keperluan pelabelan pada tahun 2014 terdiri daripada produk semulajadi dan kosmetik.

Jadual 1: Pemantauan Kepatuhan PelabelanTable 1: Monitoring of Labelling Compliance

Monitoring of Labelling Compliance

A total of 1,454 labelling checks were performed on registered products and notified cosmetics to ensure the labels/package inserts comply with the latest requirements specified by the DCA and cosmetic guidelines (Table 1). Regulatory action is taken if the product labels do not comply. The main products associated with labelling non-compliance in 2014 were cosmetics and natural products.

Kategori produk/Product Category

Lulus/Pass

Amaran/Warning

Panggilbalik /Recall

Pengkelasan Semula /

Reclassification

Jumlah/Total

Preskripsi/ Prescription (A)

376 42 5 - 423

Bukan Preskripsi/ Non-prescription (X)

121 27 - - 148

Supplemen Kesihatan/ Health Supplement (X/T)

67 18 5 - 90

Semulajadi/ Natural (T) 98 259 136 - 493

Kosmetik/ Cosmetics (K) 3 210 - 87 300

Jumlah/ Total 665 556 146 87 1,454



0

10

20

30

40

50

60

Tahap I / Degree Ih I / D Tahap II / Degree IIII / D

13

0 0 0 0 0 0 0 0 0

Tahap III / Degree IIIIII / D

10

2 2

52

14

Rajah 2: Kategori Produk yang Dipanggil Balik pada Tahun 2014

Figure 2: Category of Products That Were Recalled in 2014

Bila

ngan

Pro

duk

Num

ber o

f Pro

duct

s

Tahap Panggil Balik / Degree of Recall



Suplemen Kesihatan / Health Supplement


Kosmetik /Cosmetic

Pemantauan Kualiti Produk Produk-produk di pasaran yang disampel melalui aktiviti surveilans dihantar ke Pusat Kawalan Kualiti BPFK untuk pengujian makmal. Keputusan ujian untuk 2,262 produk telah diterima pada tahun 2014, di mana sebanyak 2,117 (93.5%) telah lulus ujian makmal manakala baki 147 (6.5%) gagal. Produk-produk yang gagal ujian makmal terdiri daripada 28 produk preskripsi, 6 produk bukan preskripsi, 12 supplemen kesihatan, 66 produk semulajadi, dan 35 kosmetik.

Tindakan Regulatori

Sekiranya sesuatu produk gagal ujian makmal, tindakan regulatori akan diambil berdasarkan tahap kegagalan dan risiko yang terlibat. Tindakan yang diambil termasuk pengeluaran surat amaran, arahan panggil balik produk, penggantungan atau pembatalan pendaftaran produk/ notifikasi kosmetik.

Sejumlah 93 arahan panggil balik telah dikeluarkan pada tahun 2014 disebabkan isu-isu kualiti (Rajah 2). Lebih daripada separuh (56%) produk yang dipanggil balik merupakan produk semulajadi, dengan punca seperti kegagalan ujian had mikrob, ujian logam berat, dan produk dicampur palsu.

Pada tahun 2014, BPFK telah mengeluarkan sembilan (9) amaran berkaitan kualiti produk, dan 20 amaran berkaitan isu dokumentasi. Sejumlah empat (4) produk berdaftar dan sembilan (9) kosmetik bernotifikasi telah didapati dicampur palsu, dan dicadangkan untuk pembatalan pendaftaran atau notifikasi kosmetik, seperti tersenarai di Jadual 3(a) dan (b). Senarai ini juga dipaparkan pada laman sesawang BPFK.

Product Quality Monitoring Products sampled through market surveillance are sent to the NPCB Centre for Quality Control for laboratory testing. A total of 2,262 product test results were received in 2014, of which 147 (6.5%) failed. Breakdown of the products which failed laboratory testing are as follows: 28 prescription products, 6 non-prescription items, 12 health supplements, 66 natural products, and 35 cosmetics.

Regulatory Action

When a product fails laboratory testing, regulatory action is taken based on the level of failure and risk associated. Actions taken may include issuance of warning letters, product recall, suspension or cancellation of product registration/ cosmetic notification.

A total of 93 recall directives were issued in 2014 due to quality issues (Figure 2). More than half the recalls (56%) involved natural products, for reasons such as failing laboratory tests on microbial limit, heavy metals, and adulteration.

In 2014, NPCB issued nine (9) warnings related to product quality and 20 warnings related to documentation. A total of four (4) registered products and nine (9) notified cosmetics were found to be adulterated and were tabled for cancellation of product registration or cosmetic notification, as in Table 3(a) and (b). This list is also published on the NPCB website.



Jadual 3(a): Senarai Produk Berdaftar Yang Dibatalkan Pada Tahun 2014 kerana Dicampur PalsuTable 3(a): List of Registered Products Cancelled Due to Adulteration in 2014

Jadual 3(b): Senarai Produk Kosmetik Yang Dibatalkan pada tahun 2014 kerana Dicampur PalsuTable 3(b): List of Cosmetics Cancelled Due to Adulteration in 2014

Bil./No.

Nama Produk/Product Name

No. Pendaftaran Produk/Product Registration No.

Bahan Campur Palsu yang dikesan/

Adulterant detected

1 Jingzhi Yingiao Jiedu Tablet 260 mg MAL06071213T Paracetamol

2 Minyak Kayu Merah Herbanika MAL20032056T Methyl salicylate

3 Bam Gamat Herbanika MAL20032053T Methyl salicylate

4 Leung Pui Kee Chi Kat Pills MAL19987460T Ephedrine

Bil./No.

Nama Produk/Product Name

No. Pendaftaran Produk/Product Registration No.

Bahan Campur Palsu yang dikesan/

Adulterant detected

1 AS Beauty Night Cream NOT101103172K Merkuri

2 AS Beauty Day Cream NOT101103272K Merkuri

3Golden Horse Herbal Milk Lotion-

GH507NOT120905457K Merkuri

4Golden Horse Bio Complex Cream-

GH903-2NOT120905465K Merkuri

5 Dermaceutic Spot Cream NOT101104772KHydroquinone dan

Tretinoin

6 Dermaceutic Spot Peel Cream NOT101104771KHydroquinone dan

Tretinoin

7 Dnars Magic Gold Foundation NOT111001084K Hydroquinone

8 Yellow Cream (Krim Ku-Neng) NOT120101719K Hydroquinone

9 Sf Protect & Perfect Day Cream NOT130604475K Merkuri

10 Hans Beauty Flawless Day Cream NOT130304286K Merkuri

11 Hans Beauty Flawless Night Cream NOT130304287K Merkuri

12 Hans Beauty Treatment Toner NOT130304284K Hydroquinone



Kerjasama Antarabangsa berkaitan Kualiti dan Keselamatan

Malaysia terlibat dalam perkongsian maklumat kualiti dan keselamatan produk ubat-ubatan, termasuk kosmetik, melalui ASEAN Post Marketing Alert System (PMAS) dan Pharmaceutical Inspection Cooperation Scheme (PIC/S) - Rapid Alert Notification System (RAS) bagi negara bukan ASEAN. BPFK merupakan penyelaras bagi PMAS.

Pada tahun 2014, sejumlah 1,076 makluman telah diterima melalui rangkaian PMAS yang melibatkan 1,209 produk, dengan 872 makluman (81.2%) disumbang oleh Malaysia. Melalui RAS, 49 makluman yang melibatkan 146 produk telah diterima, dan hasilnya tiga (3) produk telah dipanggil balik secara sukarela oleh pemegang pendaftaran produk.

Aduan Produk

Dalam tempoh masa sepuluh tahun yang lepas, bilangan aduan produk yang diterima telah meningkat sebanyak 79% (Rajah 3). Trend peningkatan yang ketara dapat diperhatikan pada tahun 2010 disebabkan peningkatan kesedaran di kalangan ahli profesional kesihatan dan orang awam berkaitan kualiti dan efikasi produk berdaftar yang terdapat di pasaran.

Pada tahun 2014, sejumlah 1,001 aduan telah diterima yang melibatkan 401 produk berdaftar, iaitu 731 aduan (73%) melibatkan produk preskripsi, 234 aduan (23%) untuk produk bukan preskripsi, 20 aduan (2%) untuk suplemen kesihatan dan 16 aduan (1.6%) untuk produk semulajadi. Bilangan aduan yang diterima mengikut kategori ditunjukkan dalam Rajah 4.

Merujuk kepada produk kosmetik, BPFK telah menerima sebanyak 54 aduan pada tahun 2014, kebanyakkannya melibatkan isu regulatori dan keselamatan, seperti produk tidak bernotifikasi atau dicampur palsu, dan kesan adverse yang dialami selepas penggunaan produk. Di antara aduan yang diterima, 22 (40.7%) melibatkan produk kosmetik bernotifikasi sementara baki 32 (59.3%) adalah untuk produk tidak bernotifikasi.

International Collaboration on Quality and Safety

Malaysia is involved in sharing information on quality and safety of medicinal products, including cosmetics, through the ASEAN Post Marketing Alert System (PMAS) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) - Rapid Alert Notification System (RAS) for non-ASEAN countries. NPCB is the coordinator for PMAS.

In 2014, there were a total of 1,076 alerts received via the PMAS network involving 1,209 products, with 872 alerts (81.2%) contributed by Malaysia. Through RAS, 49 alerts involving 146 products were received, resulting in the voluntary recall of three (3) products by respective registration holder.

Product Complaints

Over the last ten years, the number of product complaints received has steadily increased by 79% (Figure 3). A significant upward trend was noted in 2010 due to increasing awareness among both healthcare professionals and the public on quality and efficacy of registered products available in the market.

In 2014, a total of 1,001 complaints involving 401 registered products were received. These comprised of 731 complaints (73%) for prescription products, 234 (23%) for non-prescription products, 20 (2%) for health supplements and 16 (1.6%) for natural products. The number of complaints received according to category is shown in Figure 4.

With regards to cosmetic products, NPCB received a total of 54 complaints in 2014 which were mainly due to regulatory and safety issues, such as unnotified and/or adulterated products, and adverse reactions following use. Among the complaints received, 22 (40.7%) involved notified cosmetics, while 32 (59.3%) were for unnotified products.



Bila

ngan

adu

anNu

mbe

r or c

ompl

aint

s

0

200

400

600

800

1,000

1,200

2005

213

2006

268

2007

258

2008

448

2009

456

2010

723

2011

820

2012

964

2013

997

2014

1001

Rajah 3: Peratusan Produk Preskripsi Berdaftar Mengikut Sumber Negara Setakat 31.12.2014 Figure 3: Percentage of Registered Prescription Products Based on Source Country as of 31.12.2014

Kualiti / Quality

Bungkusan / Packaging

Pelabelan / Labelling

Lain-lain / Others

Efikasi / Efficacy

Rajah 4: Aduan Produk yang Diterima Mengikut Kategori (2014)

Figure 4: Product Complaints Received Based on Categories (2014)

2014

33%

40%

7%

6%

14%

2014

FARMAKOVIGILANS

Pelaporan Kesan Advers Ubat

BPFK berusaha menjamin keselamatan produk ubat-ubatan yang bardaftar di Malaysia, melalui pemantauan laporan kesan advers ubat (ADR), mengenal pasti dan menilai isu-isu keselamatan ubat peringkat tempatan dan antarabangsa, serta melalui latihan dan komunikasi risiko.

Terdapat peningkatan sebanyak 13.4% dalam jumlah laporan ADR yang diterima pada tahun 2014 berbanding tahun sebelumnya (Rajah 1). Pecahan mengikut kumpulan farmakologi dan kelas sistem organ WHO ditunjukkan di dalam Rajah 2 dan 3.

PHARMACOVIGILANCE

Monitoring of ADR Reports

The NPCB strives to ensure the safety of medicinal products registered in Malaysia, through monitoring of adverse drug reaction (ADR) reports, identification and review of local and international drug safety issues, training and risk communication.

There was a 13.4% increase in the total number of ADR reports received in 2014 as compared to the previous year (Figure 1). The breakdown by pharmacological group and WHO System Organ Class (SOC), are shown in Figures 2 and 3.



Bila

ngan

Lap

oran

No. o

f Rep

orts

0

3,000

6,000

9,000

12,000

15,000

20092009

214

5,6365,850

2010

1,529

5,5507,079

2011

3,183

6,2029,385

2012

1,903

8,19910,102

2013

1,795

9,67811,473

2014

1,080

11,92113,001

Rajah 1: Jumlah Laporan Kesan Adverse Ubat yang Diterima di Malaysia (2009-2014) Figure 1: Total Number of ADR Reports Received in Malaysia (2009-2014)

Laporan ADR (Tanpa AEFI) / ADR Reports (Without AEFI)

Laporan AEFI / AEFI Reports

0

500

1000

1500

2000

2500

Antiobesity Drugs 1Antivenoms 10

Cosmetics 13Health Supplements 14

Antirheumatics 17Antispasmodics 19

Dermatological Drugs 28Food 33

Anesthetics 41Minerals 52

Eye Preparations 55Corticosteroids 65

Antidepressants 66Immunosuppressive Agents 72

Antihistamines 77Contrast Media 91Antiasthmatics 97

Hormones 107Vitamins 117

Anticoagulants 135Antigout Drugs 140

Antiulcers 155Antiemetics 174

Traditional Medicines 175Antivirals 192

Antipsychotics 214Antituberculosis Drugs 273

Antiepileptics 366Antihyperlipidemics 451

Antidiabetics 559Antineoplastics 813

Others 841Vaccines 1,076

Analgesics 1,402Antiinfectives 2,517

Cardiovascular Drugs 2,565

Bilangan ProdukNumber of Products

Kum

pula

n Fa

rmak

olog

iPh

arm

acol

ogic

al G

roup

Rajah 2: Bilangan Produk yang Disyaki Menyebabkan Kesan Adverse Ubat mengikut Kumpulan Farmakologi (2014)

Figure 2: Number of Products Suspected to Cause Adverse Drug Reaction based on Pharmacological Group (2014)



0 1000

2000

3000

4000

5000

6000

Autonomic Nervous System Disorders 1Neonatal and Infancy Disorders 7

Male Reproductive Disorders 8Other Special Senses Disorders 10

Myo-, Endo-, Pericardial & Valve Disorders 15Neoplasms 16

Feotal Disorders 29Female Reproductive Disorders 35

Endocrine Disorders 37Resistance Mechanism Disorders 48Hearing and Vestibular Disorders 77

White Cell and Res Disorders 113Red Blood Cell Disorders 153

General Cardiovascular Disorders 175Vascular (Extracardiac) Disorders 210

Platelet, Bleeding & Clotting Disorders 275Heart rate and Rhythm Disorders 277

Metabolic and Nutritional Disorders 314Vision Disorders 383

Liver and Biliary System Disorders 484Psychiatric Disorders 511

Secondary Terms - Events 543Musculo-Skeletal System Disorders 586

Urinary System Disorders 559Application Site Disorders 1,315

Respiratory System Disorders 1,473Gastro-Intestinal System Disorders 2,123

Central & Peripheral Nervous System Disorders 2,504Body as a Whole - General Disorders 3,503

Skin and Appendages Disorders 5,924

Bilangan Kesan Advers UbatNumber of Adverse Drug Reactions

Kela

s Si

stem

Org

anSy

stem

Org

an C

lass Rajah 3:

Bilangan Kesan Advers Ubat mengikut Kelas Sistem Organ (2014)

Figure 3: Number of Adverse Drug Reactions by System Organ Class (2014)

Kesan Adverse Berikutan Pelalian

BPFK telah menerima 1,069 laporan kesan adverse berikutan pelalian (AEFI) pada tahun 2014. 908 (84.9%) daripadanya melibatkan vaksin Human Papilloma Virus (HPV) sejak pemantauan secara aktif dijalankan untuk vaksin ini. Melalui program ini, didapati majoriti kesan adverse yang dilaporkan adalah kesan adverse ringan dan pelalilan HPV di Malaysia adalah selamat. Edisi kedua Garispanduan Farmakovigilans Vaksin di Malaysia sedang dikemaskinikan. Pegawai BPFK juga terlibat dalam pengemaskinian dan penyemakan semula edisi kedua Guidelines for Adult Immunisation (dikemas kini pada Nov 2014).

Pengujian Produk Yang Disyaki Campur Palsu

BPFK juga menerima laporan ADR berserta sampel produk, biasanya untuk produk-produk tradisional, makanan dan kosmetik, yang dihantar oleh pengguna atau pengamal perubatan yang mengesyaki produk tersebut dicampur palsu. BPFK menjalankan ujian makmal bagi mengenal pasti bahan terlarang yang dikandungi, seperti steroid, antihistamin, ubat antiradang bukan steroid (NSAID) atau agen pelangsing.

Adverse Events Following Immunisation

The NPCB received 1,069 Adverse Events Following Immunisation (AEFI) reports in 2014. 908 (84.9%) of these reports involved the Human Papilloma Virus (HPV) vaccine as active surveillance is conducted for this vaccine. Through this programme, majority of the adverse events reported have been non-serious and HPV vaccination in Malaysia has been found to be safe.

The second edition of the Malaysian Guidelines on Pharmacovigilance of Vaccines is in the process of being updated. NPCB staff also contributed in revising and reviewing the Guidelines for Adult Immunisation, 2nd Edition (revised Nov 2014).

Testing of Suspected Adulterated Products

The NPCB receives ADR reports with samples of products, mainly for traditional medicines, food and cosmetics, sent in by consumers or healthcare professionals who suspect adulteration for these products. The NPCB conducts tests on these samples to identify suspected adulterants including steroids, antihistamines, NSAIDs or slimming agents.



Di antara laporan ADR yang dibentangkan semasa mesyuarat-mesyuarat MADRAC pada tahun 2014, sejumlah 93 produk telah dihantar untuk ujian makmal dan 31 (33%) didapati mengandungi bahan terlarang. Kesemua produk campur palsu ini adalah produk tradisional yang tidak berdaftar atau produk makanan, dan maklumat berkaitan penemuan ini dimajukan kepada Bahagian Penguatkuasaan Farmasi untuk tindakan lanjut.

Kualiti Laporan ADR Usaha juga diambil untuk meningkatkan kualiti laporan ADR yang diterima di Malaysia. World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring, Uppsala, Sweden menilai kualiti laporan dengan menggunakan sistem ‘Documentation Grading - Completeness Score’. Ini merupakan suatu skor antara 0 (dokumentasi tidak memuaskan) hingga 1 (dokumentasi lengkap), yang mengukur jumlah maklumat yang disertakan di dalam sesuatu laporan ADR. Malaysia telah memperoleh skor purata sebanyak 0.45 dari tahun 2010-2013, dan telah berjaya meningkatkan skor tersebut kepada 0.63 pada tahun 2014.

Laporan Suspected Unexpected Serious Adverse Reaction (SUSAR)

Sebanyak 3,700 laporan SUSAR telah diterima oleh PKPB pada tahun 2014 berbanding 6,005 laporan dan 3,742 laporan pada dua tahun sebelumnya. Penurunan jumlah laporan SUSAR pada tahun 2014 adalah disebabkan oleh pengemaskinian Standard Operating Procedure (SOP) dalaman dimana hanya laporan SUSAR yang lengkap sahaja akan diterima ke dalam pangkalan data PKPB. Laporan-laporan SUSAR yang diterima merangkumi kesemua kajian klinikal yang dijalankan di Malaysia yang memerlukan CTIL dan CTX. Sumber laporan-laporan ini adalah daripada tapak kajian di Malaysia atau tapak kajian di luar negara bagi kajian klinikal multinasional. Masa yang diambil dalam melaporkan SUSAR ini sentiasa dipantau oleh PKPB mengikut prinsip-prinsip Good Clinical Practice dan Malaysian Guideline for Safety Reporting of Investigational Products.

MADRAC

Jawatankuasa Penasihat Kesan Adverse Ubat Kebangsaan (MADRAC) telah ditubuhkan pada tahun 1987 di bawah PBKD untuk memainkan peranan dalam memantau profil keselamatan ubat-ubatan yang berdaftar di Malaysia. Ahli-ahli MADRAC

Among the ADR reports presented during MADRAC meetings in 2014, a total of 93 products were sent for laboratory testing and 31 (33%) were tested positive for various adulterants. These were all unregistered traditional products or products classified as food, and information on the adulterants detected was conveyed to the Pharmacy Enforcement Division for further action.

Quality of ADR Reports

Efforts are also being taken to increase the quality of ADR reports in Malaysia. The World Health Organisation (WHO) Collaborating Centre for

measures report quality using the ‘Documentation Grading - Completeness Score’ system. This is a score between 0 (poorly documented case) to 1 (well-documented), measuring the amount of information provided in a report. Malaysia obtained an average score of 0.45 from 2010 to 2013, and has successfully increased the score to 0.63 in 2014.

Suspected Unexpected Serious Adverse Reaction (SUSAR) Reports

reports were received in 2013 and 2012 respectively. There was a drop in 2014 due to a revamp on our internal Standard Operating Procedure (SOP) which

from either Malaysian or other international sites in

reported are monitored by CINP in accordance to the principles of Good Clinical Practice and Malaysian Guideline for Safety Reporting of Investigational Products.

MADRAC

The Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) was established in 1987 under the DCA to perform the function of monitoring safety profiles of drugs registered for use in Malaysia. MADRAC members for the 2013-2015 session



untuk sesi 2013-2015 terdiri daripada pakar-pakar perunding Kementerian Kesihatan Malaysia (KKM) dari pelbagai bidang kepakaran, ahli farmasi, ahli akademi dari universiti tempatan, dan wakil daripada beberapa pertubuhan profesional.

Semasa mesyuarat MADRAC yang diadakan dua bulan sekali, verifikasi causality dilakukan untuk semua laporan ADR tempatan, dan sebarang isu keselamatan ubat yang berkaitan akan dibincangkan supaya PBKD dapat dibekalkan dengan maklumat dan cadangan pengurangan risiko, jika perlu. Maklumat lanjut boleh diperoleh dengan merujuk kepada laporan tahunan Pusat Pemonitoran Kesan Advers Ubat Kebangsaan (portal.bpfk.gov.my).

Rajah 1 : Ahli-ahli dan sekretariat MADRACFigure 1 : MADRAC members and secretariat

Rajah 2-3 : Semasa mesyuaratFigure 2-3 : During the meeting

comprised of Ministry of Health consultants from various specialties, pharmacists, academicians from local universities and representatives from professional bodies.

During MADRAC meetings which are held once every two months, causality verifications are done for all local ADR reports and all pertinent drug safety issues are discussed to provide DCA with information and recommendations if required. Full details are available in the annual report of the National Centre for Adverse Drug Reactions Monitoring (portal.bpfk.gov.my).



Pemantauan Isu Keselamatan Ubat

Pada tahun 2014, sejumlah 76 isu keselamatan ubat telah dikenal pasti melalui penyaringan persekitaran. Setelah dikaji, 22 isu telah dibentangkan dalam mesyuarat MADRAC untuk mengenalpasti tindakan pengurangan risiko yang perlu diambil. Kebanyakan isu tersebut melibatkan tindakan pengemaskinian maklumat sisip bungkusan produk, contohnya mengawal indikasi atau menambah kontraindikasi. Tindakan regulatori bagi sepuluh (10) isu telah dicadangkan kepada PBKD. Hasilnya, direktif PBKD telah dikeluarkan untuk memastikan sisip bungkusan semua produk generik yang mengandungi bahan aktif terbabit dikemas kini dengan maklumat keselamatan berkenaan.

MADRAC juga mencadangkan pelaksanaan label amaran tambahan untuk ubat-ubat yang paling kerap menyebabkan kesan adverse kulit serius. Penggunaan label ini telah dilaksanakan di fasiliti Kementerian Kesihatan Malaysia (KKM) serta fasiliti kesihatan swasta.

Pemantauan Keselamatan Produk yang Baru Berdaftar

Produk-produk yang baru berdaftar seperti Entiti Kimia Baru (NCE) dan produk biologik diwajibkan mengemukakan Periodic Benefit-Risk Evaluation

(PBRERs/ PSURs) selama lima (5) tahun selepas pendaftaran. PBRER/ PSUR mengandungi maklumat profil keselamatan produk di negara-negara dimana ia didaftarkan, dan sebarang perubahan atau penemuan baru berkaitan keselamatan produk tersebut. Pada tahun 2014, sebanyak 160 PBRER/PSUR yang melibatkan 168 produk telah dinilai, seterusnya melibatkan kemas kini maklumat keselamatan dalam sisip bungkusan bagi 39 produk (23.2%).

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Pada tahun 2014, sejumlah 1,294 RiMUP telah dinilai untuk produk berdaftar yang boleh diadministrasi sendiri oleh pengguna. Daripada jumlah ini, 282 (22%) telah diluluskan dan dimuat naik pada laman sesawang BPFK untuk kegunaan pengguna atau ahli profesional kesihatan. Baki RIMUP yang dikemukakan masih di bawah penilaian. Langkah-langkah sewajarnya akan diambil untuk memastikan lebih banyak RiMUP dipaparkan untuk rujukan dan kegunaan pihak tersebut di atas.

Monitoring Drug Safety Issues

In 2014, a total of 76 drug safety issues were identified through environmental screening. Following review, 22 issues were presented at MADRAC meetings to determine the appropriate risk minimisation measures. The majority of these issues resulted in updates to the package insert safety information, such as tightening of indications or additional contraindications. Regulatory actions for ten (10) of these issues were proposed to the DCA, resulting in DCA directives issued to ensure package inserts of all generic products containing the affected active ingredients are updated with the required safety information.

MADRAC also proposed the implementation of auxiliary warning labels for the top drugs suspected to cause serious skin reactions. These labels have been implemented in Ministry of Health as well as private healthcare facilities.

Safety Monitoring of Newly Registered Products

Newly registered products such as New Chemical Entities (NCEs) and biological products are required to submit Periodic Benefit-Risk Evaluation Reports/

for the first five years post-registration. PBRERs/

profile in countries where it is registered, and any changes or new findings related to product safety. In

products were assessed, resulting in implementation of package insert changes for 39 products (23.2%) to ensure that they contain the latest safety information.

Consumer Medication Information Leaflets (RiMUP)

registered products were reviewed, with 282 (22%) approved to be uploaded on the NPCB website for use by consumers or healthcare professionals. The

are available for use by all parties mentioned above.



Kerjasama Dalam Bidang Penyelidikan

Institusi pengajian tinggi tempatan sering bekerjasama dengan BPFK untuk projek penyelidikan, termasuk untuk pelajar peringkat Sarjana dan PhD. Pada tahun 2014, pelajar-pelajar dari Universiti Malaya, Kolej Universiti Sains Perubatan Cyberjaya, dan Universiti Teknologi Malaysia (UiTM) telah menganalisis data daripada Pusat Pemonitoran Kesan Adverse Ubat Kebangsaan untuk projek kajian yang melibatkan topik ‘Pengesanan Isyarat Keselamatan’, ‘ADR Berkaitan Ubat Darah Tinggi’, ‘Kesan Adverse Anti-tetanus Toxoid’, ‘Drug-induced Blurred Vision’, ;ADR Berkaitan DPP-4 Inhibitors’, and ‘ADR Berkaitan Alopecia’.

KOSMETIK

Produk kosmetik di Malaysia dikawal di bawah Peraturan-peraturan Dadah dan Kosmetik 1984. Semua produk kosmetik perlu bernotifikasi dengan BPFK sebelum produk tersebut boleh dikilangkan dan dipasarkan di Malaysia. Pemegang notifikasi bertanggungjawab sepenuhnya untuk memastikan keselamatan, kualiti dan tuntutan produk mematuhi semua peraturan yang ditetapkan.

BPFK memantau kosmetik bernotifikasi secara aktif dan sistematik melalui Program Pengawasan Mutu Produk Kosmetik Bernotifikasi untuk memastikan produk mematuhi keperluan yang ditetapkan. Tindakan punitif seperti pembatalan notifikasi mungkin diambil ke atas pemegang notifikasi yang gagal mematuhi peraturan dan keperluan yang ditetapkan.

Notifikasi Kosmetik

Sehingga 31 Disember 2014, terdapat sebanyak 144,897 kosmetik bernotifikasi di Malaysia, di mana 14.3% adalah produk tempatan (20,569 produk). Tempoh sah notifikasi kosmetik adalah dua (2) tahun.

Pada tahun 2014, terdapat peningkatan sebanyak 12.2% berbanding tahun sebelumnya (Rajah 1). Penyaringan notifikasi produk kosmetik dijalankan

sebilangan produk mungkin memerlukan semakan lanjut oleh pegawai BPFK. Notifikasi produk akan ditolak sekiranya mengandungi bahan terlarang, bahan melebihi had dan syarat yang dibenarkan, ataupun di luar skop takrifan kosmetik (Rajah 2).

Research Collaboration

Local universities often collaborate with the NPCB for research projects, including for Masters and PhD

data from the National ADR Monitoring Centre for their research publications, involving the topics ‘Signal Detection’, ‘ADRs related to Antihypertensives’, ‘Adverse Events of Anti-tetanus Toxoid’, ‘Drug-induced Blurred Vision’, ‘ADRs Related to DPP-4 Inhibitors’, and ‘ADRs Related to Alopecia’.

COSMETICS

Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetics Regulations 1984. All cosmetic products must be notified with NPCB before the product can be manufactured and marketed in Malaysia. Notification holders are to take full responsibility to ensure that the safety, quality and claimed benefits of their products comply with all existing regulations.

NPCB monitors notified cosmetics systematically and actively through the Market Surveillance for Notified Cosmetics Program. Punitive action such as notification cancellation may be taken against notification holders who fail to comply with the stipulated regulations and requirements.

Cosmetic Notification As of 31 December 2014, there are a total of 144,897 notified cosmetics in Malaysia, of which local cosmetic products account for 14.3% (20,569 products). Notified cosmetics have a validity of two (2) years.

In 2014, there was a 12.2% increase in submissions for cosmetic notification as compared to the previous year (see Figure 1). Screening of notification submissions are done automatically via the Quest 3 system. However, some products may require further evaluation by NPCB officers. Notifications containing prohibited ingredients, ingredients that have exceeded the maximum allowable limit and conditions of use, or beyond the scope of cosmetics, will be rejected (Figure 2).



0

1,000

2,000

4,000

3,000

5,000

6,000

7,000

8,000

2012

2013

2014

66,913

69,925

78,465

Rajah 1: Bilangan Notifikasi Kosmetik yang Dikemukakan (2012-2014)

Figure 1: Number of Cosmetic Notifications Submitted (2012-2014)

Bil. Permohonan NotifikasiNumber of Notification Submissions

0

200

400

600

800

1,000

1,200

2014459

28

2013761

88

20121,015

37

Rajah 2: Penolakan Notifikasi Kosmetik (2012-2014)

Figure 2: Rejection of Cosmetic Notifications (2012-2014)

Bilangan Penolakan NotifikasiNumber of Notification Rejections

Formulasi produkProduct formulation

Bukan kosmetik Non-cosmetic

Aktiviti Surveilans Kosmetik di Pasaran

Aktiviti surveilans dijalankan ke atas produk kosmetik yang dipasarkan di Malaysia melalui penyaringan maklumat produk, ujian makmal ke atas sampel produk, pemantauan label, audit Product Information File (PIF), pemantauan iklan produk kosmetik, pengendalian aduan produk, dan penilaian tuntutan produk. [Sila rujuk kepada bahagian ‘Surveilans’ untuk maklumat lanjut berkaitan aktiviti-aktiviti ini].

Audit Product Information File (PIF)

BPFK menjalankan audit Product Information File (PIF) untuk memastikan pemegang notifikasi menyimpan maklumat terperinci berkaitan produk kosmetik, termasuk dokumen berkaitan, data kualiti bahan mentah dan produk siap, serta data keselamatan dan dokumen sokongan untuk tuntutan. Sebanyak 502 PIF telah diaudit pada tahun 2014, iaitu peningkatan sebanyak 57.9% berbanding tahun sebelumnya.

Market Surveillance of Cosmetics Market surveillance of cosmetic products is conducted through screening of product information, sampling for laboratory testing, label monitoring, audit on Product Information Files (PIFs), monitoring of cosmetic advertisements, handling of product complaints, and evaluation of claim substantiation. [Please refer to the section ‘Surveillance’ for further information on these activities.]

Product Information File (PIF) Audit The aim of Product Information Files (PIFs) audit is to ensure compliance of notification holders in keeping PIFs which contain detailed information of a notified cosmetic product, including administrative documents, quality data of raw material and finished product, as well as safety data and claimed benefits. A total of 502 PIFs were audited in 2014, showing a 57.9% increase as compared to the previous year.



Pemantauan Iklan Kosmetik BPFK telah meningkatkan pemantauan ke atas iklan kosmetik mulai tahun 2012, dan tindakan regulatori diambil ke atas iklan yang melampaui skop kosmetik, ataupun yang membuat tuntutan tidak berasas. Pada tahun 2014, sejumlah 723 iklan dari media cetak dan elektronik telah dipantau, dan tindakan diambil ke atas 287 (39.7%) iklan terlibat.

Selain itu, BPFK turut menerima 42 aduan berkaitan iklan kosmetik daripada syarikat-syarikat serta Bahagian Penguatkuasa Farmasi, yang melibatkan 65 produk. Tindakan telah diambil, di mana 50 produk telah diberikan surat amaran untuk mengeluarkan tuntutan-tuntutan yang melampaui skop kosmetik, 12 produk diarahkan untuk membuat pengkelasan semula kerana produk-produk tersebut bukan merupakan kosmetik, sementara tiga (3) produk diminta mengemukakan dokumen sokongan bagi tuntutan yang dibuat.

Pembatalan Notifikasi

Pembatalan notifikasi telah dijalankan ke atas 753 produk kosmetik pada tahun 2014 untuk pelbagai sebab (Rajah 3).

Monitoring of Cosmetic Advertisements

NPCB intensified monitoring of cosmetic advertisements starting 2012 and regulatory actions were taken on advertisements which are beyond the scope of cosmetics, or those with unsupported claims. In 2014, 723 advertisements from both printed and electronic media were monitored, with actions taken on 287 (39.7%) of these.

Meanwhile, NPCB also received 42 complaints on cosmetic advertisements from companies and the Pharmacy Enforcement Division, which involved 65 products. Action was taken on all the products involved, whereby 50 of the products were issued warning letters to remove claims which were made beyond the scope of cosmetics, 12 products required reclassification because they were non-cosmetics, and the remaining three (3) products were requested to provide documents for claim substantiation.

Notification Cancellation

Notification cancellations were carried out for 753 cosmetics in the year 2014 for various reasons (Figure 3).

Rajah 3: Sebab-sebab Pembatalan Notifikasi Kosmetik (2014)

Figure 3: Reasons for Notification Cancellations (2014)

2014417 (55.5%)

7 (0.9%)3 (0.4%)

320 (42.6%) 2014

2 (0.3%)2 (0.3%)

Lain-lain (Isu GMP, permintaan syarikat, atau bahan terlarang disenaraikan pada labelOthers (GMP issues, company request or banned substances declared on label

Bukan kosmetikNot cosmetic

Gagal ujian makmal (campur palsu)Failed lab test (adulteration)

Surat perlantikan kuasa tidak sahInvalid Letter of Authorisation

Nama produk sama dengan produk campur palsuSame product name as adulterated product

Penamatan pemegang notifikasiTermination of notification holder



Kerjasama dengan Bahagian Penguatkuasa Farmasi

BPFK sentiasa bekerjasama dengan Bahagian Penguatkuasa Farmasi dalam usaha mengurangkan permintaan dan penjualan produk kosmetik tidak bernotifikasi. BPFK telah menerima sebanyak 2,270 produk untuk pengesahan status notifikasi pada tahun 2014, iaitu peningkatan sebanyak 16.1% berbanding tahun 2013. Daripada 1,987 status notifikasi produk yang telah disahkan, 177 (8.9%) produk merupakan kosmetik yang bernotifikasi dan 92 (4.6%) bukan produk kosmetik. Baki 1,718 (86.5%) produk didapati tidak bernotifikasi dan tindakan undang-undang akan diambil terhadap produk-produk terlibat oleh Bahagian Penguatkuasa Farmasi.

Aktiviti dan Penglibatan Lain

BPFK turut terlibat dalam aktiviti lain berkaitan pengawalan produk kosmetik, contohnya mengadakan dialog dan perbincangan secara berkala dengan syarikat pengiklanan, serta menganjurkan seminar dan pameran untuk Program Kesedaran Pengguna dan Pencegahan. Aktiviti lain adalah seperti ditunjukkan pada Jadual 1.

Cooperation with the Pharmacy Enforcement Division

NPCB and the Pharmacy Enforcement Division work together with the aim of reducing demand for and sale of unnotified cosmetics. NPCB received 2,270 seized products for notification status verification in 2014, which is an increase of 16.1% compared to the previous year. Out of 1,987 products for which notification status was verified, 177 (8.9%) products were notified cosmetics and 92 (4.6%) products were non-cosmetics. The remaining 1,718 (86.5%) products were found to be unnotified and the list was forwarded to the Pharmacy Enforcement Division for their action.

Other Activities and Involvement

NPCB is also involved in other activities related to cosmetics regulation, such as holding regular dialogues and discussions with advertising companies, and organising seminars and exhibitions for Consumer Awareness & Prevention Programmes. Other activities are as shown in Table 1.

Jadual 1: Aktiviti/ Penglibatan Lain Berkaitan Pengawalan Kosmetik (2014)Table 1 : Other Activities and Involvement Related to Control of Cosmetics (2014)

Bil./No.

Aktiviti / PenglibatanActivities / Involvement

1

Penglibatan dalam mesyuarat di peringkat ASEAN iaitu mesyuarat ASEAN Cosmetic Committee dan ASEAN Cosmetic Scientific Body.(i) Mengusulkan mesyuarat untuk mengkaji semula kegunaan beberapa bahan dalam produk

kosmetik, iaitu methylisothiazolinone, nonoxynols, Papaver Rhoeas, dan Pueraria Mirifica;

(ii) Mengusulkan mesyuarat untuk mengkaji semula label amaran dalam Garis Panduan ASEAN Sunscreen Labeling.

Involvement in meetings at ASEAN level, namely the ASEAN Cosmetic Committee meeting and ASEAN Cosmetic Scientific Body meeting.(i) Proposed to review the use of several substances in cosmetic products which are

methylisothiazolinone, nonoxynols, Papaver Rhoeas, dan Pueraria Mirifica;(ii) Proposed to review the warning label in ASEAN Sunscreen Labeling Guideline.



Bil./No.

Aktiviti / PenglibatanActivities / Involvement

2

Kerjasama antara kementerian untuk melindungi kesihatan awam:(i) Kementerian Perdagangan Dalam Negeri, Koperasi dan Kepenggunaan- sebagai ahli

jawatankuasa untuk mengawal ‘perkhidmatan kosmetik dan kecantikan’ (ii) Kementerian Dalam Negeri (Lembaga Penapisan Filem)- pemantauan iklan kosmetik

Inter-ministerial cooperation in safeguarding public health:(i) Ministry of Domestic Trade, Co-Operatives and Consumerism- as a committee member to

regulate ‘cosmetic and beauty treatment services’(ii) Ministry of Home Affairs (Film Censorship Board)- monitoring cosmetic advertisements

3

Meningkatkan kemampuan perusahaan kecil dan sederhana (SME) dengan menganjurkan:(i) Seminar Kosmetik 2014 secara usaha sama dengan Persatuan Kosmetik, Dandanan Diri dan

Haruman Malaysia (CTFAM)(ii) Bengkel Penilaian Keselamatan Produk Kosmetik secara usaha sama dengan Persekutuan

Pengilang-pengilang Malaysia - Kumpulan Industri Kosmetik dan Dandanan Diri Malaysia (FMM-MCTIG)

(iii) seminar dan pameran untuk Program Transformasi Luar Bandar (RTC)

Enhancing capability of Small Medium Enterprises (SMEs) by organising:(i) Cosmetic Seminar 2014 in collaboration with the Cosmetic, Toiletry and Fragrance

Association Malaysia (CTFAM)(ii) Workshop on Safety Evaluation of Cosmetics in collaboration with the Federation of

Malaysian Manufacturers - Malaysian Cosmetics and Toiletries Industry Group (FMM-MCTIG)(iii) seminars and exhibitions for the Rural Transformation Programme (RTC)

4

Kerjasama berterusan dengan Persatuan Kosmetik Malaysia:(i) Jawatankuasa Kerja Teknikal Kosmetik (BPFK, CTFAM & FMM-MCTIG)(ii) Jawatankuasa Pakar Keselamatan Kosmetik (CoSEC)

On-going engagements with the Malaysian Cosmetic Association:(i) Cosmetic Technical Working Group (NPCB, CTFAM & FMM-MCTIG)(ii) Cosmetic Safety Expert Committee (CoSEC)



PENGUJIAN SAMPEL DAN PENILAIAN PROTOKOL & DATA VALIDASISAMPLE TESTING AND EVALUATION OF PROTOCOL & VALIDATION DATA

Pusat Kawalan Kualiti (PKK) bertanggungjawab menjalankan pengujian sampel dan penilaian dokumentasi data validasi berdasarkan standard regulatori global dan dilaksanakan oleh personel yang terlatih dan kompeten. Produk yang diuji adalah untuk tujuan pendaftaran bagi produk tradisional, pengawasan produk berdaftar dan juga produk komestik yang dinotifikasi dalam pasaran, kes-kes adverse drug reaction (ADR) & aduan serta sampel daripada penguatkuasa.

STATISTIK

The Centre for Quality Control (CQC) is responsible for product testing and evaluation of analytical method validation in accordance with global regulatory standard and these duties are carried out by trained and competent personnel. Product testing is carried out for the purposes of registration for traditional products, product surveillance for registered products and notified cosmetic products, adverse drug reaction (ADR) reporting & complaint and samples from enforcement.

STATISTICS

2,056 (63.22%)

Pendaftaran / Registration

Pengawasan / Surveillance

Aduan / Complaint

ADR / Adverse Drug Reaction

CPF / Enforcement

Lain-lain / Others

Rajah 1: Sampel Yang Diterima Mengikut Kategori

Figure 1: Samples Received According To Categories

2014

623 (19.16%)

70 (2.15%)

2014

278 (8.55%)

115 (3.54%)

110 (3.38%)



2,128 (61.03%)

Pendaftaran / Registration

Pengawasan / Surveillance

Aduan / Complaint


CPF / Enforcement

Lain-lain / Others

Rajah 2: Sampel Yang Diuji Mengikut Kategori

Figure 2: Samples Tested According To Categories

2014

692 (19.85%)

2014

32 (0.92%)

382 (10.95%)

145 (4.16%)

108 (3.10%)

0

50

100

150

200

300

250

62 5844

2012

2013

2014

Rajah 3: Bilangan Sampel Yang Gagal Ujian Untuk Tahun 2012 - 2014

Figure 3: Number Of Failed Samples For 2012 - 2014

Bila

ngan

Num

ber

PendaftaranRegistration

155132

155

PengawasanSurveillance

2512

36

AduanComplaint

15 2644


109

160

297

CPFEnforcement

13 7 3

Lain-lainOthers

0

50

100

150

200

300

250

0 044

Rajah 4: Bilangan Sampel Yang Gagal Ujian Mengikut Kategori Untuk Tahun 2014

Figure 4: Number Of Failed Samples By Category For 2014

Bila

ngan

Num

ber

PendaftaranRegistration

30 33

61

310

PengawasanSurveillance

154 2

160

AduanComplaint

0 041

3 0


0 0

289

8 0

CPFEnforcement

0 0 0 0 0

Lain-lainOthers




Kosmetik / Cosmetic

Veterinar / Veterinary



0

500

1,000

1,500

2,000

2012

2013

2014

799

992

1,404

130

195

353

Rajah 5: Bilangan Sampel Tradisional Yang Diuji Dan Dikesan Bahan Campurpalsu Untuk Tahun 2012 - 2014

Figure 5: Number Of Traditional Samples Tested And Found Adulterated For 2012 - 2014)

BilanganNumbers

Bilangan sampel yang dikesan bahan campurpalsuNumbers of adulterated samples

Bilangan sampel yang diujiNumbers of samples tested

0

5

10

15

20

25

9

45

Rajah 7: Bilangan Permohonan Vaccine Lot Release (VLR) diterima (Jul - Dis 2014)

Figure 7: Number of Vaccine Lot Release (VLR) application received (Jul - Dec 2014)

Bila

ngan

Num

ber

JulaiJuly

0

25

16

9

OgosAugust

0

11

45

SeptemberSeptember

2

14

4

7

OktoberOctober

3

16

4

10

NovemberNovember

2

6

03

DisemberDecember

3 TotalCombinationMonovalentPolyvalent

Rajah 6: Bahan-bahan campurpalsu yang dikesan dalam sampel tradisional untuk tahun 2014.Figure 6: List of adulterants detected in traditional samples for 2014.

Jenis bahan campurpalsu Adulterants

Sampel CPFCPF Sample

Sampel Pengawasan Surveillance Sample

Sampel Pendaftaran Registration sample

Ubat ED / ED Drugs 87% - -

Steroid / Steroids 7% 22% 1%

NSAIDS - 4% 1%

Antihistamin / Antihistamine 4% 17% -

Antidiabetik / Antidiabetics - 1% -

Agen pelangsing / Slimming agents

42% 3% 1%

Lain-lain / Others 7% 5% -



0

5

10

15

20

25

9 9

0

Rajah 8: Aktiviti Vaccine Lot Release (VLR) (Jul - Dis 2014)

Figure 8: Vaccine Lot Release (VLR) activity (Jul - Dec 2014)

Bila

ngan

Num

ber

JulaiJuly

25 25

1

OgosAugust

11 11

0

SeptemberSeptember

14 14

0

OktoberOctober

16

12

4

NovemberNovember

6 6

0

DisemberDecember

Keputusan yang bermaksud pelepasan separaResult indicates partial release

Bilangan permohonan VLR diterimaNumber of VLR application received

Bilangan konsainan vaksin diluluskanNumber of vaccine consignment released

Bilangan konsainan vaksin ditolakNumber of vaccine consignment rejected

Rajah 9: Peratus data validasi yang dinilai mengikut bulanFigure 9: Percentage of validation data assessed by month

BulanMonth

Jan Feb Mac Apr Mei Jun Jul Ogos Sep Okt Nov DisJumlah

Total

BilangandatadinilaiNumberof dataevaluated

53 26 67 44 45 28 63 74 89 103 60 59 711



AKTIVITI PEMBANGUNAN DAN VALIDASI METODOLOGI DEVELOPMENT AND METHODOLOGY VALIDATION ACTIVITIES

Bil./No.

Tajuk penyelidikanTitle of Research

StatusStatus

Status penerbitanPublication Status

1

Pengesanan dan penentuan Berberine, sebatian penanda negatif, dalam bahan mentah herba dan produk.

Detection and determination of Berberine, a negative marker compound, in herbal raw materials and products.

Selesai pembangunan dan validasi metodologi

Completed development and validation methodology

Tidak diterbitkan

Not Published

2

Pengesanan Aconitum alkaloid, Aconitine, dalam produk tradisional oleh kaedah LCMS.

Detection of Aconitum alkaloid, Aconitine, in traditional products by LCMS method.



Tidak diterbitkan

Not Published

3

Penentuan Glutathione dalam makanan tambahan kesihatan.

Determination of Gluthathione in health supplement.



Tidak diterbitkan

Not Published

4

Pembangunan kaedah untuk penentuan alfa & beta Asarone dalam produk tradisional yang mengandungi Acoruscalamus.

Method development for determination of alpha & beta Asarone in traditional products containing Acoruscalamus.



Tidak diterbitkan

Not Published



Bil./No.

Tajuk penyelidikanTitle of Research

StatusStatus

Status penerbitanPublication Status

5

Pembangunan kaedah untuk penentuan Metil Salisilat dalam produk tradisional. Method development for determination of Methyl Salicylate in traditional products.



Tidak diterbitkan

Not Published

6

Penentuan Vitamin E dalam minyak sawit daun menggunakan kaedah HPLC.

Determination of Vitamin E in palm oil leaves using HPLC method.



Telah diterbitkan di bawah projek Monograf Herba Malaysia

Published under Malaysia Herbal Monograph Project

Boleh diakses di:

Can be accessed:

http://www.globinmed.com/

7

Pengesahan kaedah HPLC: Pengesahan produk Misai Kucing menggunakan Sinensetin penanda kimia. Validation of HPLC method: Authentication of Misai Kucing products using Sinensetin chemical marker.

8

Pengesahan daun Kaduk dengan profil TLC dan pengesahan kehadiran Beta Sitosterol penanda kimia.

Authentication of Kaduk leaves by TLC profiling and confirmation of the presence of Beta Sitosterol chemical marker.

9

Pengesahan rizom Temulawak oleh profil TLC dan pengesahan kehadiran penanda kimia Xanthorrhizol.

Authentication of Temulawak rhizomes by TLC profiling and confirmation of

marker.

10

Pengesahan bahan mentah Tongkat Ali menggunakan penanda kimia Eurycomanone melalui kaedah HPLC.

Authentication of Tongkat Ali raw material using Eurycomanone chemical marker by HPLC method.



AKTIVITI PEMERIKSAANINSPECTION ACTIVITIES

Pusat Komplians dan Pelesenan (PKP) bertanggungjawab untuk menjalankan pemeriksaan Amalan Perkilangan Baik (APB) ke atas premis pengilang keluaran berdaftar dan kosmetik bernotifikasi serta memastikan pematuhan pengilang terhadap garispanduan APB semasa. PKP juga bekerjasama dengan Cawangan Penguatkuasa Farmasi (CPF) Negeri bagi memastikan pengimport dan pemborong keluaran berdaftar mematuhi garis panduan semasa.

Pemeriksaan melibatkan jenis rutin (berjadual dari awal tahun) dan jenis bukan rutin (mengikut permohonan syarikat melalui Borang BPFK 504). Kategori premis yang diperiksa termasuk farmaseutikal (racun dan bukan racun), tradisional, kosmetik dan lain-lain (termasuk veterinar, suplemen kesihatan dan bahan aktif farmaseutikal).

Sebanyak 360 pemeriksaan APB telah dijalankan pada tahun 2014. Daripada jumlah ini, bilangan pemeriksaan ke atas premis farmaseutikal, tradisional, kosmetik dan lain-lain adalah 68, 117, 133 dan 42 masing-masing. Antara 68 pemeriksaan premis farmaseutikal yang telah dijalankan, sebanyak 11 premis melibatkan pemeriksaan luar negara.

Sepanjang tahun 2014, pemeriksaan Amalan Pengedaran Baik (AEB) telah dijalankan ke atas 147 premis pengimport dan/ atau pemborong di sekitar Kuala Lumpur dan Selangor.

Centre of Compliance and Licensing (CCL) is responsible for the Good Manufacturing Practice (GMP) inspections on manufacturer of registered products and notified cosmetics to ensure their compliance towards the current GMP requirements. CCL, with assistance of the State Pharmacy Enforcement Division, is also responsible to ensure the adherence of importers and wholesalers to the current Good Distribution Practice (GDP) requirements.

The inspections are of 2 types, i.e. routine (scheduled at the beginning of the year) and non-routine (as per company’s application through BPFK Form 504). The category of premises covered varies from pharmaceutical (poison and over the counter), traditional, cosmetic and others (includes veterinary, health supplement and active pharmaceutical ingredient).

There were 360 GMP inspections conducted in year 2014. Of these, the number of inspections on pharmaceutical, traditional, cosmetic and other premises was 68, 117, 133 and 42 respectively. There were 11 overseas inspections conducted out of the 68 pharmaceutical premises inspected.

Throughout year 2014, Good Distribution Practice (GDP) inspections were conducted on 147 importer and/ or wholesaler premises within Kuala Lumpur and Selangor.



0

30

60

90

120

150

20122012

45

102119

33

Rajah 1: Bilangan Pemeriksaan APB Yang Telah Dijalankan Dari Tahun 2012 – 2014

Figure 1: Number of GMP Inspections Carried Out From Year 2012 – 2014

Jum

lah

Num

bers

20132013

64

10595

31

20142014

68

117133

42Farmaseutikal / Pharmaceutical

Tradisional / Traditional

Kosmetik / Cosmetic

Lain-lain / Others

Pusat Kajian Produk Baru (PKPB) bertanggungjawab menjalankan pemeriksaan ke atas premis berikut :

(BE) tempatan dan luar negarasponsor dan contract

research organisations (CRO)

klinikal

Mereka juga bertanggungjawab memastikan semua produk kajian yang digunakan ke atas subjek-subjek dalam percubaan klinikal dipantau keselamatannya.

1. PEMERIKSAAN GOOD LABORATORY PRACTICE (GLP)

BPFK telah menjalankan sebanyak tiga (3) pemeriksaan GLP pada tahun 2014.

Centre for Investigational New Product (CINP) is responsible in conducting inpections on the following premises:

bioequivalence (BE) center

organisations (CRO)

They are also responsible in ensuring the investigational products administered to subjects in clinical trial are monitored in terms of safety.

1. GOOD LABORATORY PRACTICE (GLP) INSPECTION

NPCB had conducted three (3) inspections in 2014.

Bil./No.

Jenis PemeriksaanTypes of Inspection

Fasiliti KajianTest Facility

TarikhDate

1Pemeriksaan Surveilans kedua

2nd SurveillanceMelaka Biotechnology

Corporation (MBC)4-6 March 2014

2Pemeriksaan Surveilans kedua

2nd SurveillanceInfo Kinetics Sdn. Bhd. 1-3 July 2014

3Pemeriksaan Surveilans pertama

1st Surveillance

Non-Clinical Research Facility, Institute of Medical

Research (IMR)17-19 November 2014



2. PEMERIKSAAN PUSAT KAJIAN BIOEKUIVALENS (BE)

BPFK bertanggungjawab untuk menjalankan pemeriksaan Pusat Kajian BE Tempatan dan Luar Negara untuk memastikan kajian BE yang dijalankan adalah mengikut keperluan regulatori di Malaysia dan garis panduan antarabangsa sebelum sesuatu produk generik didaftarkan di Malaysia. Ini adalah berdasarkan direktif yang dikeluarkan di bawah Peraturan 29, Peraturan Kawalan Dadah dan Kosmetik 1984, Bilangan 1 Tahun 2011. Pemeriksaan Pusat Kajian BE meliputi pemeriksaan fasiliti dan audit kajian bagi bahagian klinikal, bioanalitikal serta analisis farmakokinetik dan statistik bagi sesuatu kajian BE. Ini adalah untuk memastikan bahawa kajian BE yang dijalankan adalah mengikut keperluan regulatori, GCP dan prinsip-prinsip GLP yang berkaitan.

a. Pemeriksaan Pusat Kajian BE Tempatan

Pada tahun 2014, sebanyak tujuh (7) pemeriksaan telah dijalankan di pusat BE tempatan. Pemeriksaan tersebut terdiri daripada kajian pemeriksaan penuh, pemeriksaan tambahan tapak klinikal, pemeriksaan verifikasi dan lawatan infrastruktur pra pemeriksaan .

1. MyCRO Sdn. Bhd., UKM Medical Centre, Kuala Lumpur

(Tapak klinikal: Haematology Day Care Centre, UKM Medical Centre; bioanalytical site: MyCRO Sdn. Bhd., UKM Medical Centre)

2. Clinical Research Centre, Hospital Pulau Pinang, Pulau Pinang (Pusat Pengajian Sains Farmasi, USM)

3. Clinical Research Ward (CRW), Clinical Trial Unit, Hospital Ampang, Selangor (tapak klinikal) and BA/BE Laboratory Kompleks Eureka, USM (tapak bioanalitikal)

4. Regalia Records Management Sdn. Bhd.

Kontrak fasiliti arkib bagi Clinical Research Centre, Hospital Seberang Jaya on 16th April 2014 (verifikasi pertama) dan 30th May 2014 (verifikasi kedua). Pemeriksaan verifikasi ini dijalankan susulan penemuan pemeriksaan CRC Hospital Seberang Jaya pada 4th – 5th Jun 2013

a. Local BE Centre Inspection

In 2014, a total of seven (7) inspections were conducted at local BE centre. The inspections comprised of full inspection, additional clinical site inspection, verification inspection and pre inspection infrastructure visit.

Centre, Kuala Lumpur (Clinical site: Haematology Day

bioanalytical site: MyCRO Sdn. Bhd.,

2. Clinical Research Centre, Hospital Pulau Pinang, Pulau Pinang (Pusat Pengajian

3. Clinical Research Ward (CRW), Clinical

(Clinical Site) and BA/BE Laboratory

site) 4. Regalia Records Management Sdn.

Bhd. Contracted archive facility of Clinical

Research Centre, Hospital Seberang Jaya on 16th April 2014 (first verification) and 30th May 2014 (second verification). These verification inspections were conducted following finding arose from full inspection at CRC Hospital Seberang Jaya on 4th – 5th June 2013

2. INSPECTION ON BIOEQUIVALENCE (BE) CENTRE

NPCB is responsible for conducting inspections at Local and Foreign BE Centres to ensure that the BE studies are conducted according to the Malaysian regulatory requirements and international guidelines before the generic product is registered in Malaysia. This is in accordance with the directive issued under Regulation 29 of the Control of Drugs and Cosmetics Regulations (CDCR) 1984, Number 1 Year 2011. BE Centre inspection covers the facilities inspection and study audit for the clinical part, bioanalytical part as well as pharmacokinetic and statistical analyses of a BE study. This is to ensure that the BE studies are conducted in accordance with applicable regulatory requirements, GCP and applicable principles of GLP.



Pulau Pinang 6. Kuliah Farmasi, Universiti Islam

Antarabangsa Malaysia (UIAM) Kampus Kuantan, Pahang

b. Pemeriksaan Pusat Kajian BE Luar Negara

Pemeriksaan Pusat Kajian BE Luar Negara telah diteruskan pada tahun 2014 dan 14 pemeriksaan telah dijalankan.

Pemeriksaan penuh1. International Bio Service Co. Ltd.,

Bangkok, Thailand 2. PT. Clinisindo Laboratories, Jakarta,

Indonesia3. Accutest Research Laboratories (I) Pvt.

Ltd., Mumbai, India

5. Mithra Biotechnology Inc, New Taipei City, Taiwan

6. Auriga Research Ltd. & Arbro Pharmaceutical Ltd., New Delhi, India

7. Medica Innova Co, Bangkok, Thailand

India9. Bibi General Hospital & Cancer Centre,

Hyderabad, India10. Narayana Hrudayalaya Hospital,

Bangalore, India11. Curie Manavata Cancer Centre,

Mumbai, India12. Green City Hospital, Nagpur, India13. All Research Co. Ltd., Bangkok,

Thailand14. Manipal AcuNova Limited, India

3. PEMERIKSAAN JAWATANKUASA ETIKA

Pemeriksaan surveilans ke atas Jawatankuasa Etika yang berdaftar dengan PBKD telah dirancang untuk dijalankan pada tahun hadapan.

5. Questra Clinical Research Sdn Bhd, Pulau Pinang

Kuantan, Pahang

b. Foreign BE Centre Inspection

NPCB continued foreign BE centre inspections and had conducted 14 inspections in 2014.

Full Inspection 1. International Bio Service Co. Ltd.,

Bangkok, Thailand 2. PT. Clinisindo Laboratories, Jakarta,

Indonesia3. Accutest Research Laboratories (I) Pvt.

Ltd., Mumbai, India4. QPS Taipei, Taiwan 5. Mithra Biotechnology Inc, New Taipei

City, Taiwan 6. Auriga Research Ltd. & Arbro

Pharmaceutical Ltd., New Delhi, India7. Medica Innova Co, Bangkok, Thailand 8. Quest Life Sciences Pvt. Ltd., Chennai,

India9. Bibi General Hospital & Cancer Centre,

Hyderabad, India10. Narayana Hrudayalaya Hospital,

Bangalore, India11. Curie Manavata Cancer Centre,

Mumbai, India12. Green City Hospital, Nagpur, India13. All Research Co. Ltd., Bangkok,

Thailand14. Manipal AcuNova Limited, India

3. ETHICS COMMITTEE INSPECTION

NPCB have planned to conduct surveillance inspections for those Ethics Committees which are registered with DCA in next year.



4. PEMERIKSAAN TAPAK PENYELIDIKAN KLINIKAL

Pada tahun 2014, sebanyak tujuh (7) pemeriksaan telah dijalankan di Tapak Kajian Klinikal.

1. Hospital Serdang (No. Protokol: CSPP110A2408)2. Pusat Perubatan Universiti Malaya (No. Protokol: EFC 10743/GETGOAL)3. Pusat Perubatan Sunway (No. Protokol: A3921045)4. Hospital Sultanah Bahiyah (No. Protokol: SYR-322MET_303)5. Universiti Monash Malaysia (No. Protokol: SYR-322MET_303)6. Klink Kesihatan Greentown (No. Protokol: SYR-322MET_303)7. Hospital Universiti Sains Malaysia (No. Protokol: SYR-322MET_303)

4. CLINICAL TRIAL SITE INSPECTION

In 2014, a total of seven (7) inspections were conducted at clinical trial sites.

1. Serdang Hospital (Protocol no.: CSPP110A2408)

(Protocol no.: EFC 10743/GETGOAL)3. Sunway Medical Center (Protocol no.: A3921045)4. Sultanah Bahiyah Hospital (Protocol no.: SYR-322MET_303)

(Protocol no.: SYR-322MET_303)6. Greentown Health Clinic (Protocol no.: SYR-322MET_303)

(Protocol no.: SYR-322MET_303)



AKTIVITIPELESENANLICENSING ACTIVITIES

BPFK bertanggungjawab untuk pengeluaran lesen bagi premis pengilang, mengimport dan pemborong. Pada tahun 2014, Pusat Komplians dan Pelesenan telah mengeluarkan sebanyak 2058 lesen iaitu 247 Lesen Pengilang, 471 Lesen Mengimport dan 1296 Lesen Pemborong (Rujuk Rajah 1).

Sebanyak 604 senarai keluaran (tambahan) lesen keluaran berdaftar dan 478 sijil APB telah dikeluarkan pada tahun 2014 (Rujuk Rajah 2).

NPCB plays a role in the issuance of licenses to premises of manufacturer, importer and wholesaler. In the year 2014, the Centre for Compliance and Licensing has issued a total of 2058 licenses which comprise of 247 Manufacturer’s License, 471 Import License and 1296 Wholesaler’s License (Refer to Figure 1).

There were 604 additional product list for registered products along with 478 GMP certificates issued in year 2014 (Refer to Figure 2).

0

500

1,000

1,500

2,000

2,500

2014

2013

2012

247

471

1,296

2,014

272

429

2,025

278

410

1,8321,144

1,324

Rajah 1: Bilangan Lesen Dikeluarkan Berdasarkan Premis Pengilang, Mengimport dan Pemborong

Figure 1: Number of Licenses Issued According to Premises of Manufacturer, Importer and Wholesaler

BilanganNumbers

Pengilang / Manufacturer

Mengimport / Importer

Pemborong / Wholesaler



Pada tahun 2014, Pusat Kajian Produk Baru, BPFK telah menilai sebanyak 92 permohonan baru yang melibatkan produk farmaseutikal, produk biologikal, suplemen kesihatan dan lain-lain. Terdapat 428 pemohonan variasi yang telah diproses dalam tahun 2014.

Hasil daripada penilaian permohonan di atas, sebanyak 258 CTIL, 15 CTX dan 428 kelulusan permohonan variasi telah dikeluarkan seperti yang ditunjukkan di bawah.

In 2014, Centre for Investigational New Product, NPCB had evaluated 92 new applications of pharmaceutical, biological, health supplement products and others in Malaysia. A total of 428 application for variation had been processed in year 2014.

From the total of these completed evaluations, 258

had been approved as shown below.

Bila

ngan

Num

bers

0

100

300

200

400

500

600

700

800

2012

529564

2013

565507

2014

478

604

Rajah 2: Bilangan Sijil APB dan Senarai Keluaran Berdaftar (Tambahan), 2012-2014 Figure 2: Number of GMP Certificates and Additional Product List, 2012-2014

Sijil APB GMP Certificates

Senarai Keluaran Berdaftar(Tambahan)Additional Product List

Bila

ngan

Kel

ulus

anNu

mbe

r of A

ppro

vals

0

100

200

300

400

500

2012

282

15

213

2013

344

12

287

2014

258

15

428

Rajah 3: Kelulusan Lesen CTIL, CTX dan Variasi, 2012 - 2014 Figure 3: Approvals of CTIL, CTX and Variation, 2012 – 2014

Lesen Import Percubaan Klinikal (LIPK) Clinical Trial import Licence (CTIL)

Kebenaran Mengilang Clinical Trial Exemption (CTX)

Variasi Variation



PENYEBARANMAKLUMAT DAN AKTIVITI LATIHANINFORMATIONDISSEMINATION AND TRAINING ACTIVITIES

Sesi Dialog dengan Pihak Industri

BPFK sentiasa bekerjasama erat dengan pihak industri tempatan dan persatuan industri bagi memastikan keberkesanan sistem regulatori sedia ada. Sesi dialog bersama industri ini juga digunakan sebagai landasan penyebaran maklumat regulatori terkini. Sepanjang tahun 2014, BPFK telah menganjurkan 13 sesi dialog bersama pesatuan-persatuan.

Dialogues between NPCB and associations

NPCB works closely and collaborates with the local industry and the industry associations to further enhance the effectiveness of the current practices in the regulatory system. These dialogue sessions are used as a platform to ensure the industry is constantly updated with the current regulatory affairs. A total of 13 dialogue sessions with associations were conducted in 2014.

Jadual 1: Dialog di antara BPFK dengan Persatuan-persatuan pada tahun 2014Table 1 : Dialogues between NPCB and Associations in 2014

Bil./No.

Persatuan / IndustriAssociations / Industry

TarikhDate

1 22 January 2014

2 17 February 2014

3Malaysian Animal Health and Nutrition Industries Association (MAHNIA)

18 February 2014

4 Malaysian Organisation of Pharmaceutical Industries (MOPI) 25 March 2014



Penglibatan BPFK dalam aktiviti pameran sepanjang 2014

Selain berkerjasama dengan industry, BPFK sentiasa berusaha untuk mendidik pengamal kesihatan serta orang awam mengenai sistem regulatori ubat-ubatan dan isu-isu lain yang berkaitan di Malaysia. Ini penting untuk memastikan bahawa orang ramai memahami peranan dan usaha BPFK untuk melindungi orang awam dengan memastikan kualiti dan keselamatan ubat-ubat berdaftar di pasaran. Sepanjang 2014, BPFK telah mengambil bahagian dalam 10 pameran.

NPCB’s Participation in Exhibition Events in 2014

Apart from being in touch with the industry, NPCB strives to continuously educate health professionals and the public on the regulatory control system and other relevant issues in the country. This is to ensure the public understands NPCB’s role and effort to safeguard the public’s safety by ensuring the quality and safety of registered products in the market. Throughout 2014, NPCB has participated in 10 exhibitions.

5Persatuan Pengeluar Ubat Cina Malaysia / Chinese Medicine Manufacturers Association of Malaysia (PPUCM)

23 April 2014

6Persekutuan Persatuan-persatuan Tabib dan Perdagangan Ubat Tionghua Malaysia / Federation of Chinese Physicians and Medicine Dealers Association of Malaysia (FCPMDAM)

23 April 2014

7 6 May 2014

8 Pharmaceutical Association of Malaysia (PhAMA) 27 May 2014

9 Direct Selling Association of Malaysia (DSAM) 22 July 2014

10Malaysian Direct Distribution Association (MDDA) / Persatuan Edaran Terus Malaysia

22 July 2014

11 Malaysia Dietary Supplement Association (MADSA) 22 July 2014

12Persatuan Pengeluar-pengeluar Ubat Tradisional Melayu Malaysia (PURBATAMA)

4 November 2014

13Gabungan Pertubuhan Pengamal Perubatan Melayu Malaysia (GAPERA)

4 November 2014



Jadual 2 :Penglibatan BPFK dalam Pameran sepanjang 2014Table 2 : NPCB’s Participation in Exhibitions Events in 2014

Bil./No.

PameranExhibition

PenganjurOrganizer

LokasiLocation

TarikhDate

1

Exhibition in conjunction with the Deputy Minister of Health’s visit to the Pharmaceutical Services Division

Pharmaceutical Services Division, Ministry of Health

Malaysia

Serai Wangi Hall, Pharmaceutical Services Division, Selangor

9 January 2014

2 Cosmetic Seminar 2014The Cosmetic,

Toiletry & Fragrance Association (CTFA)

Sime Darby Convention Centre, Kuala Lumpur

18 – 19 February 2014

3PMPASKL Annual Scientific Congress 2014 for GPs

The Private Medical Practitioners

Association of Selangor and Kuala Lumpur (PMPASKL)

Holiday Inn, Glenmarie, Selangor

19 – 20 May 2014

4 Malaysia Herbal ExhibitionMinistry of Agriculture,

Malaysia

Putra WorldTrade Centre (PWTC), Kuala Lumpur

23 – 25 May 2014

5APHM International Healthcare Conference 2014

Association of Private Hospitals of Malaysia

(APHM)

Sunway Pyramid Convention Centre, Selangor

3 – 5 June 2014

6"Wacana Ubat-ubatan PPUM 2014" Program

Pharmacy Faculty, University Malaya Medical Centre

University Malaya Medical Centre, Kuala Lumpur

23 – 25 June 2014

7 Herbal Asia 2014Ministry of Agriculture,

MalaysiaMATRADE Convention Centre, Kuala Lumpur

9 – 11 October 2014

8

8th International Traditional and Complementary Medicine (INTRACOM) Conference

Traditional and Complementary

Medicine Division, Ministry of Health

Malaysia

Sunway Pyramid Convention Centre, Selangor

30 October – 2 November 2014

9Pharmacy Entrepreneurship Village and Animal Awareness Day

Pharmacy Faculty, Universiti Teknologi

MARA (UiTM)

Pharmacy Faculty, Universiti Teknologi MARA (UiTM), Selangor

14 - 15 November 2014

10Launching of “Do it Right” campaign

Pharmaniaga Bhd.Pharmaniaga Bhd., Selangor

19 November 2014



Rajah 1 : Pameran sempena lawatan Timbalan Menteri Kesihatan ke Bahagian Perkhidmatan Farmasi pada 9 Januari 2014Figure 1 : Exhibition in conjunction with the visit of the Deputy Minister of Health to the Pharmaceutical Services Division on

9 January 2014

Rajah 2 : Pameran sempena “Wacana Ubat-ubatan PPUM 2014 Program” di Pusat Perubatan Universiti Malaya

Rajah 3 : Pameran sempena “APHM International Healthcare Conference 2014” bertempat di Pusat Konvensyen Sunway Pyramid.

Figure 3 : Exhibition during “APHM International Healthcare Conference 2014” held at Sunway Pyramid Convention Centre



Lawatan ke BPFK

BPFK sentiasa mengalu-alukan pelawat tempatan mahupun antarabangsa dari universiti dan agensi kerajaan yang lain untuk memahami dengan lebih mendalam proses kerja BPFK. Ini secara tidak langsung dapat membantu proses pertukaran maklumat serta mengukuhkan kerjasama antara agensi.

Visitors to NPCB

NPCB welcomes local and international visitors from universities and other government agencies to learn and better understand our work processes. This will indirectly help the process of information exchange and strengthen cooperation between the agencies.

(a) Senarai Pelawat Tempatan ke BPFK List of Local Visitors to NPCB in 2014

Bil./No.

InstitusiInstitution

Objektif Lawatan /Skop lawatan

Purpose of Visit / Scope of study

TarikhDate

1 Johor Enforcement Division Medicine Regulatory Control 6 - 8 January 2014

2

Y.B. Dato’ Seri Dr. Hjilmi bin Yahaya (Deputy Minister of Health Malaysia)

Y.Bhg. Datuk Farida binti Mohd Ali(Secretary General, Ministry of Health)

Courtesy Visit 9 January 2014

3 1 Malaysia Call Centre (1MOCC)Study attachment of the

functions of NPCB13 & 16 January 2014

4 Universiti Sains Malaysia (USM) Academic Visit 13 February 2014

5Department of Islamic Affairs Negeri Sembilan (JHEAINS)

Product Classification 18 March 2014

6Ministry of International Trade and Industry (MITI)

Courtesy Visit 16 April 2014

7 University Malaya Medical Centre Microbiology Training 11 – 15 August 2014

8 Universiti Sains Malaysia (USM) Academic Visit 20 October 2014

9 KSKB Sultan Azlan Shah Attachment Training2 – 19 September 2014

10International Islamic International Malaysia (UIA)

Study attachment of the functions of NPCB

8 December 2014



Rajah 4 : Taklimat Pengenalan BPFK kepada pelajar Universiti Sains Malaysia (USM) pada 13 Februari 2014

Rajah 5 : Taklimat berkaitan Farmaseutikal Halal kepada pegawai daripada Pejabat Agama Islam Negeri Sembilan pada 18 Mac 2014

Figure 5 : Briefing on Halal Pharmaceutical to officers from Department of Islamic Affairs Negeri Sembilan on 18 March 2014



Bil./No.

InstitusiInstitution

Objektif Lawatan /Skop lawatanPurpose of Visit / Scope of study

TarikhDate

1World Health Organization (WHO)

WHO NRA Assessment on Vaccines 25-27 February 2014

2National Drug Authority, Uganda

Regulatory framework governing the operations of NPCB including the enforcement activities in relation to

medicine control in Malaysia

17 – 21 March 2014

3Pharmacy & Poison Board, Kenya

Control on Pharmaceutical, traditional & cosmetic products

24-28 March 2014

4Ministry of Health and Family Welfare, India

Courtesy Visit 27 March 2014

5National Medicine & Poison Board, Republic of Sudan

Attachment Training in: Notification of cosmetics, GMP & inspection of cosmetics and analysis of cosmetic

products

8 - 17 April 2014

6The Pharmaceuticals and Medical Devices Agency (PMDA), Japan


7Department of Health, Papua New Guinea


8

ARISE Representative along with participants from Cambodia, Loa PDR, Myanmar and Vietnam

ARISE Study Tour for CLMV on Development of Online E-Notification

System5 - 6 May 2014

9Ministry of Health, Republic of Botswana

Attachment training in the field of :- Registration of medicine- PMS activities- Testing facilities & related sub-

stances- Monitoring of sub-standard &

counterfeit medicine

12 – 16 May 2014

10The Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Second Courtesy Visit 22 May 2014

11Health Science Authority (HSA), Singapore

Working Group Meeting & 3rd Technical Bilateral Meeting between

NPCB and HSA14 - 15 August 2014

(b) Senarai Pelawat Antarabangsa ke BPFK pada tahun 2014 List of International Visitors to NPCB in 2014



Rajah 6 : “WHO NRA Assessment on Vaccines” yang telah dijalankan pada 25-27 Februari 2014Figure 6 : WHO NRA Assessment on Vaccines carried out on 25-27 February 2014

Rajah 7 : Kunjungan hormat oleh pegawai daripada Ministry of Health and Family Welfare, India ke BPFK pada 27 Mac 2014

Figure 7 : Courtesy Visit to NPCB by officers from Ministry of Health and Family Welfare, India on 27 March 2014



Pengurusan Pertanyaan

Unit Helpdesk di Pusat Pembangunan Organisasi memainkan peranan yang penting dalam mengendalikan pertanyaan oleh pengamal kesihatan, pihak industri dan orang awam. Pertanyaan diterima melalui pelbagai saluran seperti telefon, e-mel, faks/surat, serta pelanggan di kaunter.

Penerbitan

BPFK menerbitkan newsletter yang bertajuk Berita Ubat-ubatan (BUU) secara berkala sebagai media untuk penyebaran maklumat. Penerbitan ini mengandungi maklumat berkaitan acara dan mesyuarat regulatori, direktif regulatori yang baru serta ringkasan keratan akhbar berkaitan produk tradisional dan kosmetik untuk maklumat pengamal kesihatan dan orang awam. Penerbitan ini dimuat naik ke laman web rasmi BPFK dan boleh diakses oleh orang awam.

Handling of Inquiries

Development plays a substantial role in handling enquiries made by healthcare professionals, industry players and the general public. These enquiries are received via different channels.

Publications

As a mean of information dissemination, NPCB

regulatory events and meetings, updates of regulatory directives and summary of press releases regarding traditional dan cosmetic products for the information of health professionals as well as the public. These publications are uploaded onto NPCB’s official website and can be accessed by the public.

TelefonTelephone

EmelEmail

Pertanyaan KaunterWalk-in

4,377 607 1,133



Komunikasi Keselamatan Ubat

BPFK turut mewujudkan senarai mel elektronik untuk semua ahli profesional kesihatan, dalam usaha memastikan maklumat disebarkan dengan lebih cepat dan meluas. Pada masa terkini, lebih daripada 400 individu telah dimasukkan dalam senarai mel elektronik ini, termasuk doktor, ahli farmasi, jururawat, penolong pegawai perubatan dan penolong pegawai farmasi. Maklumat lanjut berkaitan terbitan-terbitan dan senarai mel ini boleh diperoleh daripada laman web BPFK, ataupun emel pertanyaan kepada [email protected] Selain daripada terbitan tersebut di atas, sebanyak 21 Direct Healthcare Professional Communications (DHPCs) telah diluluskan oleh BPFK untuk diedarkan pada tahun 2014. DHPC dikeluarkan oleh pemegang pendaftaran produk untuk menekankan perubahan yang penting pada maklumat sisip bungkusan, profil keselamatan, ataupun penggunaan sesuatu produk.

BPFK telah mengeluarkan empat (4) edisi Buletin MADRAC pada tahun 2014, dan lapan (8) edisi Reaksi Drug Safety News. Artikel dalam terbitan-terbitan ini menekankan isu-isu keselamatan ubat yang telah dibincangkan oleh MADRAC dan juga memberikan nasihat kepada ahli profesional kesihatan. Selain itu, laporan kes ADR dan isu-isu terkini yang melibatkan keselamatan ubat turut diterbitkan.

Drug Safety Communication

NPCB has established an electronic mailing list for all healthcare professionals in an effort to ensure wider and faster spread of the information. This mailing list currently consists of more than 400 individuals from various diciplines, including doctors, pharmacists, nurses, assistant medical officers and assistant pharmacists. Further information on our publications and mailing list may be obtained from the NPCB website, or by emailing your query to [email protected]

Besides the publications, a total of 21 Direct Healthcare Professional Communications (DHPCs) were approved by the NPCB for distribution in 2014. These were issued by the product registration holders to highlight important changes in the prescribing information, safety profile or use of a product.

The NPCB released four (4) issues of the MADRAC Bulletin in 2014, as well as eight (8) issues of Reaksi Drug Safety News. Articles in these publications highlight drug safety issues discussed by MADRAC along with advice to healthcare professionals, as well as present case reports and other latest issues.



Lima (5) Makluman Terkini Isu Keselamatan telah diedarkan pada tahun 2014 kepada semua fasiliti KKM serta pertubuhan ahli profesional kesihatan seperti Persatuan Perubatan Malaysia (MMA) dan Persatuan Farmasi Malaysia (MPS). Ini melibatkan produk erythropoietin stimulating agents, hydroxyethyl starches, strontium ranelate, dan produk kombinasi cyproterone acetate + ethinylestradiol (2mg/0.035mg).

Sejumlah lima (5) kenyataan akhbar telah disediakan berkaitan produk tradisional tidak berdaftar yang dilaporkan menyebabkan ADR berulang kali. Komunikasi berkaitan keselamatan ubat turut dilaksanakan melalui surat amaran atau pekeliling, dan maklum balas kepada pelapor ADR.

Garispanduan Pelaporan dan Pemantauan Keselamatan Ubat di Malaysia sedang dikemas kini untuk memberi panduan yang lebih jelas berkaitan semua aspek farmakovigilans di Malaysia kepada pihak-pihak yang terlibat.

Latihan Dalaman BPFK

Latihan berterusan amat penting bagi pegawai farmasi dan penolong pegawai farmasi bagi memastikan kakitangan BPFK sentiasa memperolehi maklumat yang terkini dalam bidang farmaseutikal dan bidang-bidang lain yang berkaitan. BPFK berpendapat bahawa keupayaan dan kepakaran warga kerja adalah elemen utama dalam merealisasikan matlamat institusi bagi memberikan perkhidmatan yang lebih baik kepada orang awam.

Pusat Pembangunan Organisasi bertanggungjawab untuk menyelaraskan latihan, seminar dan kursus di bawah program Continuous Professional Development (CPD). Pada tahun 2014, sebanyak 216 sesi CPD telah dianjurkan. Ini termasuk ceramah, seminar, bengkel dan Kelab Jurnal yang telah diadakan di BPFK mahupun di lokasi luar.

Five (5) early safety issue communications were distributed in 2014 to all Ministry of Health facilities as well as healthcare professional associations such as the Malaysian Medical Association and the Malaysian Pharmaceutical Society. These involved erythropoietin stimulating agents, hydroxyethyl starch products, strontium ranelate, and the combination product cyproterone acetate + ethinylestradiol (2mg/0.035mg).

A total of five (5) press releases were prepared regarding unregistered traditional products associated with recurrent ADR reports. Drug safety communication was also carried out through product alerts or circulars, and feedback to ADR reporters.

The Malaysian Drug Safety Reporting and Monitoring Guidelines are in the process of being updated to provide all stakeholders with a clearer guide on all aspects of pharmacovigilance in Malaysia.

NPCB’s Internal Training

Continuous training for pharmacist and assistant pharmacists is important in order to keep them updated on the latest information in regards to pharmaceuticals and other related fields. NPBC believes that member staff’s expertise and capability is the key element to achieve our goal to better serve the public.

The Centre for Organisational Development is responsible for coordinating rainings, seminars and courses for the staff as part of the Continuous Professional Development (CPD) Program. In the year 2014, a total of 216 CPD sessions were conducted. The sessions included educational talks, seminars, workshops and Journal Club sessions conducted both externally and in-house.



BENGKEL VACCINE LOT RELEASE

Bengkel Vaccine Lot Release anjuran bersama Biro Pengawalan Farmaseutikal Kebangsaan dan WHO Malaysia telah diadakan pada 23 - 27 Jun 2014 di Hotel Armada, Petaling Jaya dengan penceramah daripada Kementerian Kesihatan Awam, Thailand. Sejumlah 25 peserta daripada BPFK telah menghadiri bengkel ini.

Tujuan bengkel ini adalah untuk memberikan latihan kepada pegawai-pegawai daripada BPFK dalam aktiviti Vaccine Lot Release yang meliputi penilaian lot summary protocol, analisis statistik dan membuat keputusan.

WORKSHOP ON VACCINE LOT RELEASE

Workshop on Vaccine Lot Release was organized by National Pharmaceutical Control Bureau in collaboration with WHO Malaysia from 23rd – 27th June 2014 in Armada Hotel, Petaling Jaya with guest speakers from Ministry of Public Health, Thailand. A total of 25 participants from NPCB attended the workshop.

The objective of this workshop is to provide training to officers from NPCB on Vaccine Lot Release activity which includes lot summary protocol review, statistical analysis and decision making.



BengkelWorkshop: Hands-on High Performance Thin Layer Chromatography (HPTLC)

TarikhDate: 24 November 2014

TempatVenue:

Jemputan penceramah & fasilitatorInvited speaker & facilitator: Dr. Eike Reich, Director of CAMAG Laboratory

BengkelWorkshop: Transformation of Monograph to Pharmacopoeia & Materia Medica 2014

TarikhDate: 24 November 2014

TempatVenue: Hotel Armada, Petaling Jaya

Jemputan penceramah & fasilitatorInvited speaker & facilitator: Prof. Na Lin, Director & Professor, Research Centre of Chinese Medica Theory, Institute of Chinese Materia Medica, China Academy of Traditional Medical Sciences



WORKSHOP ON BIOEQUIVALENCE INSPECTION: CLINICAL AND BIOANALYTICAL ASPECTS (26-28 OGOS 2014)

BPFK telah mengadakan satu bengkel, Workshop on Bioequivalence Inspection: Clinical and Bioanalytical Aspects pada 26hb – 28hb Ogos 2014 di Kuala Lumpur Convention Centre, Kuala Lumpur. Penceramah jemputan bagi bengkel ini adalah Dr Arindam Dasgupta. Beliau merupakan seorang ahli farmakologi dari US Food and Drug Administration (US FDA). Seramai 50 orang peserta telah menyertai bengkel ini. Antaranya ialah pegawai dari BPFK, wakil dari pusat kajian bioekuivalen tempatan dan luar Negara seperti Mesir, Indonesia, Singapura, Taiwan, Thailand dan Vietnam.

WORKSHOP ON BIOEQUIVALENCE INSPECTION: CLINICAL AND BIOANALYTICAL ASPECTS (26-28 AUGUST 2014)

NPCB had successfully organized a Workshop on Bioequivalence Inspection: Clinical and Bioanalytical Aspects at Kuala Lumpur Convention Centre, Kuala Lumpur on 26th – 28th August 2014. The guest speaker was Dr Arindam Dasgupta, a pharmacologist from Center for Drug Evaluation and Research, US Food and Drug Administration (US FDA). A total of 50 participants, including officers from NPCB, representatives from local and oversea bioequivelance (BE) centres such as Egypt, Indonesia, Singapore, Taiwan, Thailand and Vietnam attended the 3-day workshop.



KURSUS AMALAN KLINIKAL BAIK (GCP)

Empat puluh lima kursus GCP yang melibatkan sebanyak 2174 orang peserta telah dianjurkan oleh Pusat Penyelidikan Klinikal, Kementerian Kesihatan Malaysia, institusi swasta dan universiti pada tahun 2014 di mana Pusat Kajian Produk Baru, BPFK memainkan peranan penting dalam memberi ceramah dan menyelaraskan peperiksaan GCP. Bermula pada tahun 2012, sijil untuk semua peserta yang lulus dalam peperiksaan GCP telah dikeluarkan oleh BPFK yang bertindak sebagai sekretariat kepada Jawatankuasa Penyelidikan Klinikal Kebangsaan (JPKK). Dengan ini, BPFK telah mengeluarkan sebanyak 1811 sijil GCP termasuk peserta yang lulus dalam peperiksaan berulang dalam tahun 2014.

GOOD CLINICAL PRACTICE (GCP) COURSE

Forty five GCP courses which involved 2174 participants had been organised by Clinical Research Centre, MOH, private institutions and universities in year 2014 where the Centre for Investigational New Product (CINP), NPCB played an important role in giving lectures and coordinating the GCP examinations. Starting from year 2012, the certificates for all participants who passed the GCP examination were issued by NPCB who acted as a secretariat to the National Committee for Clinical Research (NCCR). NPCB had issued a total of 1811 certificates which included re-sit participants in the year 2014.

Bila

ngan

Pes

erta

Num

ber o

f Par

ticip

ants

0

200

400

600

800

1,000

1,200

1,101

Bilangan Peserta Yang Lulus Kursus Amalan Baik (GCP) Tahun 2014 Number of Participants That Passed Good Clinical Practice (GCP) Examination in 2014

PenganjurOrganiser

727

346

Pusat Penyelidikan KlinikalClinical Research Centre

UniversitiUniversity

Institusi PersendirianPrivate Institution



Pengurusan kewangan dikendalikan oleh Pusat Pentadbiran yang juga bertanggungjawab dalam hal-hal pentadbiran am termasuk tugas-tugas lain yang bukan teknikal. Pusat Pentadbiran memastikan bahawa gaji bulanan serta tuntutan-tuntutan rasmi dibayar dalam tempoh yang ditetapkan serta mengawal peruntukan kewangan supaya sentiasa mencukupi bagi menjamin setiap aktiviti yang dirancang boleh dijalankan dengan jayanya.

Pada tahun 2014, BPFK telah menerima peruntukan sebanyak RM37,547,222.00 bagi bajet Mengurus dan RM502,000.00 bagi bajet Pembangunan.

The financial management is handled by the Administrative Centre which is also responsible for other general administrative duties including non-technical tasks. The Centre for Administration ensures that all emoluments and claims are paid within the specifed timeframe and ensures that the allocations of funds are sufficient for all planned activities to be carried out successfully.

In 2014, NCPB received an allocation of RM37,547,222.00 for Operating Budget and RM502,000.00 for Development Budget.

LAPORANKEWANGANFINANCIAL REPORT

Objek AmObject Code

KategoriCategory

PeruntukanAllocation

PerbelanjaanExpenditure

BakiBalance

RM % RM %

10000 EmolumenEmolument

24,494,700.00 27,652,050.44 112.89 (3,157,350.44) -12.89

20000Perkhidmatan &

BekalanService & Supply

12,919,496.00 10,332,883.57 79.98 2,586,612.43 20.02

30000 AsetAsset

130,026.00 120,509.00 92.68 9,517.00 7.31

40000

Pemberian & KenaanTetapGift and Fixed

Payment

3,000.00 0.00 0.00 3,000.00 100

JUMLAHTOTAL

37,547,222.00 38,105,443.01 101.49 (558,221.01) -1.49

BAJET MENGURUSOPERATING BUDGET



Objek AmObject Code

KategoriCategory

PeruntukanAllocation

PerbelanjaanExpenditure

BakiBalance

RM % RM %

94000

Pembangunan Monograph

Herbal Malaysia Malaysian Herbal

Monograph Development

210,000.00 209,650.00 99.83 350.00 0.17

00105Latihan Dalam Perkhidmatan

Inservice Training120,000.00 119,136.20 99.28 863.80 0.72

88888

Projek National Blue Ocean

Strategy (RTC) National Blue

Ocean Strategy Project

172,000.00 55,250.07 32.12 116,749.93 67.88

JUMLAHTOTAL

502,000.00 384,036.27 76.50 117,963.73 23.50

BAJET PEMBANGUNANDEVELOPMENT BUDGET

Kutipan hasil BPFK diterima melalui bayaran bagi pendaftaran produk, notifikasi kosmetik, pelesenan, perkhidmatan makmal dan bayaran-bayaran lain. Jumlah kutipan hasil pada tahun 2014 adalah sebanyak RM11,965,723.29.

NPCB obtained its revenue from various payments for product registration, cosmetic notifications, licensing, laboratory tests as well as others payments. The total revenue for 2014 is RM11,965,723.29.



KodCode

PerkaraItem

JumlahTotal(RM)

72199 Daftar Produk Kosmetik | Registration of Cosmetic Product 4,055,250.0

Daftar Ubat Baru | New Product Registration 2,236,800.00

Daftar Ubat Semula | Product Re-registration 2,729,550.00

Daftar Ubat | Product Registration 42,500.00

Perakuan Penjualan | Free Sale Certificate 265,000.00

Tukar Pemegang | Change of Holder 263,800.00

Pertukaran Tapak Kilang | Change of Site 80,500.00

Daftar Ubat Ekspot | Export Product Registration 99,000.00

73301 Jualan Aset | Selling of Asset 3,052.00

71999 Bayaran-bayaran Lain | Other Payments 25.15

71499 Lesen Impot Klinikal Percubaan | Clinical Trial Import License 134,000.00

72499 Lesen Pengilang | Manufacturer’s License 272,000.00

Lesen Mengimport | Import License 222,000.00

Lesen Pemborong | Wholesaler’s License 491,000.00

Invois BE | BE Invoice 253,169.16

Invois APB | GMP Invoice 768,126.98

Amalan Perkilangan Baik | Good Manufacturing Practice 4,000.00

Sijil APB | GMP Certificate 23,750.00

73999 Perkhidmatan Makmal | Laboratory Testing 14,000.00

Jualan Lain | Other Sales 8,200.00

JUMLAHTOTAL

11,965,723.29

KUTIPAN HASIL TAHUN 2014REVENUE FOR 2014



HALATUJUTHE WAY FORWARD

Sebagai agensi regulatori yang dipercayai untuk melindungi keselamatan orang ramai, BPFK sentiasa berusaha meningkatkan kawalan regulatori ubat-ubatan di pasaran:-

atas produk Cellular & Gene Therapy (termasuk produk biologik, stemcell & genetherapy) yang akan berkuat kuasa selepas rangka kerja dan garis panduan dimuktamadkan.

produk veterinar yang mengandungi dadah/bahan yang bertujuan digunakan atau boleh diguna; atau dituntut untuk tujuan perubatan, akan dikuatkuasakan.

Kawalan regulatori terhadap bahan aktif farmaseutikal (API) bagi pendaftaran Produk Generik mengandungi Racun Berjadual dalam bentuk dos parenteral telah bermula pada 1 Julai 2014 dan akan diikuti dengan bentuk dos oral bermula 1 Julai 2016 serta 1 Julai 2018 bagi bentuk dos lain. Pelaksanaan bagi produk berdaftar mengandungi Racun Berjadual yang sedia ada akan bermula dengan produk yang tamat tempoh pendaftaran pada 1 Januari 2020.

Untuk maju ke hadapan, BPFK sentiasa memastikan perkhidmatan kami adalah yang terbaik dengan mematuhi piawaian antarabangsa seperti ISO. Sistem Pengurusan Kualiti (ISO 9001) dipraktis dan dipertingkatkan setiap tahun dan tambahan skop akreditasi ISO 17025 setiap tahun membuktikan makmal kami adalah kompeten dari segi teknikal.

As the trusted regulatory authority to safeguard the public’s safety, NPCB constantly continues to strengthen the regulatory control of medicines in the market:-

Therapy Products (which includes Biologics, stemcells & genetherapy) which will take effect after the framework and guidelines are finalised.

import and manufacture veterinary products containing drug/ingredients to be used or capable, purported or claimed to be capable, for a medicinal purpose will be enforced.

Regulatory control of Active Pharmaceutical Ingredients (API) for new registration application of Generic Product containing Scheduled Poison in parenteral dosage form begun on 1 July 2014 and will be followed by oral dosage form beginning 1 July 2016 and 1 July 2018 for other dosage form. Implementation for existing registered products will begin for products expiring on 1 January 2020 onward.

To stay ahead, NPCB continues to ensure our services is at its best by abiding to international standards such as the ISO. The Quality Management System (ISO 9001) is maintained and improved every year and the expansion of accreditation scope of the ISO 17025 every year proves our laboratories are deemed to be technically competent.



Kami akan penambahkan skop akreditasi termasuk pengujian logam berat menggunakan Inductively Coupled Plasma Mass Spectrometry (ICPMS) dan Penentuan kandungan Hyroquinone menggunakan Gas Chromatography Mass Spectrometry (GCMS). Makmal kami juga terlibat dalam Program Ujian Proficiency yang dijalankan oleh WHO dan EC-ASEAN untuk memantau kompetensi makmal kami berbanding makmal antarabangsa yang lain.

BPFK juga bekerja keras bagi mengekalkan keahlian dalam Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) untuk setanding dengan agensi regulatori antarabangsa yang lain bagi memudahkan jalinan hubungan profesional dengan mereka.

BPFK juga berusaha untuk mengekalkan status “non-Organisation for Economic Cooperation and Development (OECD) member adhering to Mutual Acceptance Data (MAD) system in the Assessment of Chemicals on Good Laboratory Practice (GLP)”. Ini bagi memastikan semua data klinikal yang dihasilkan di Malaysia diterimapakai oleh negara ahli OECD yang lain, dan ini akan membantu merealisasikan matlamat Malaysia untuk menjadi salah satu hub kajian bukan klinikal di Asia Tenggara.

BPFK memberi keutamaan kepada kerjasama dengan agensi-agensi lain untuk belajar serta menyumbang kepada pertumbuhan aspek kesihatan global dan sektor regulatori perubatan. Oleh itu, BPFK sentiasa berusaha ke arah memperbanyakkan kerjasama dengan agensi-agensi tempatan dan antarabangsa menerusi Memorandum of Understanding (MoU) dan mesyuarat teknikal.

BPFK meneruskan hubungan kerja yang rapat dengan industri tempatan untuk menggalakkan pertumbuhan sektor farmaseutikal, tradisional dan supplemen kesihatan. Selain daripada rundingan teknikal dan latihan yang diberikan semasa program Pusat Transformasi Luar Bandar, BPFK juga bercadang untuk mengadakan lebih banyak dialog dan sesi perbincangan bersama pihak industri untuk meningkatkan pematuhan mereka terhadap pelbagai garis panduan dan pekeliling. Strategi ini juga akan membantu mengurangkan jurang antara BPFK dan pihak industri tempatan dengan matlamat meningkatan pengeluaran ubat-ubatan serta produk supplemen kesihatan, produk tradisional dan produk kosmetik yang berkualiti dan selamat.

We aim to extend our accreditation scope to include detection of heavy metals by using Inductively Coupled Plasma Mass Spectrometry (ICPMS) and Determination of Hydroquinone by using Gas Chromatography Mass Spectrometry (GCMS). Our laboratories also participate in Proficiency Testing Scheme conducted yearly by WHO and EC-ASEAN to monitor our performance in relation to other international laboratories.

NPCB works hard to maintain its memberships in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S) in order to be on par with other international regulators and facilitate a close professional relationship with them in the field of Good Manufacturing Practice.

NPCB also strive to maintain its non-Organisation for Economic Cooperation and Development (OECD) member adhering to Mutual Acceptance Data (MAD) system in the Assessment of Chemicals on Good Laboratory Practice (GLP). This is to ensure that all non-clinical data produced in GLP Compliant test facilities in Malaysia will be accepted in other member countries, and to contribute to the national interest i.e. Malaysia as one of the non-clinical hubs in Southeast Asia.

NPCB place a high priority on partnerships with other agencies to learn as well as contribute to the growth of the global healthcare and medicinal regulatory sector. Hence, NPCB is continually working towards having more collaboration with other local and international agencies through formal Memorandum

NPCB continues a close working relationship with the local industry to promote growth of the local pharmaceutical, traditional and health supplement sector. Apart from the technical consultation and training given during the on-going Rural Transformation Centre program, NPCB also plans to hold more dialogues and discussions with the local industry to increase their understanding and compliance towards various guidelines and circulars. This strategy will also assist in breaking the barrier between NPCB and the local industry with the objective of increased production of good quality and safe medicines, health supplements, traditional as well as cosmetic products.



Oleh kerana Malaysia terus mengambil bahagian secara aktif dalam rundingan Trans Pacific Partnership Agreement (TPPA), BPFK akan terus memberi input teknikal kepada para perunding bagi membolehkan mereka berunding bagi meningkatkan akses pasaran produk tempatan, dan pada masa yang sama, meningkatkan akses orang ramai kepada ubat-ubatan dengan harga yang berpatutan.

Pada masa yang sama, Malaysia juga giat mengambil bahagian dalam rundingan Malaysia-EFTA Economic Partnership Agreement (MEEPA) dan rundingan Malaysia-Europe Partnership and Cooperation Agreement (Malaysia-PCA EU) bagi meningkatkan manfaat dari segi capacity building dalam bidang regulatori untuk mengukuhkan lagi sistem regulatori farmaseutikal Malaysia.

Dengan aspirasi ini, BPFK akan terus maju ke hadapan dan menjadi agensi regulatori yang bertanggungjawab di Malaysia.

As Malaysia continues to actively participate in the Trans Pacific Partnership Agreement (TPPA) negotiation, NPCB will continue to provide technical input to our negotiators while they pursue to increase market access of local products and, at the same time, increase access to affordable medicine for the public.

Simultaneously, Malaysia is also actively participating in the negotiation of the Malaysian-European Free Trade Association (EFTA) Economic Partnership (MEEPA) and the Malaysia-European Agreements

improve the benefits in terms of capacity building in the field regulatory control to strengthen Malaysia’s pharmaceutical regulatory system.

With these aspirations, NPCB will further advance itself and continue to be the entrusted regulatory authority in Malaysia.


LAPORAN TAHUNAN

National Pharmaceutical Control Bureau (NPCB) Biro Pengawalan Farmaseutikal KebangsaanLot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia + 603-7883 5400 + 603-7956 2924www.bpfk.gov.my

2014Biro Pengawalan Farmaseutikal Kebangsaan

National Pharmaceutical Control Bureau

ANNUAL REPORT

WJD006566_Cover BPFK 2014.indd 1 11/30/15 4:17 PM

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