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STRUKTUR ORGANISASIORGANIZATIONAL STRUCTURE OF

BAHAGIAN PERKHIDMATAN FARMASIPHARMACEUTICAL DIVISION

KEMENTERIAN KESIHATAN MALAYSIAMINISTRY OF HEALTH

KETUA PENGARAH KESIHATAN

DIRECTOR GENERAL OF HEALTH

TIMBALAN KETUA PENGARAH KESIHATAN

(Penyelidikan & Sokongan Teknikal)

DEPUTYDIRECTOR GENERAL OF HEALTH(Research & Technical Support)

PENGARAHPERKHIDMATAN FARMASI

DIRECTOR OF PHARMACEUTICAL SERVICES

PENGARAHBPFK

DIRECTORNPCB

TIMBALANPENGARAH

(Perlesenan &Penguatkuasaan)

DEPUTY DIRECTOR(Licensing &Enforcement)

TIMBALANPENGARAH(Pengurusan

Farmasi)

DEPUTYDIRECTOR

(PharmaceuticalCare)

KETUA PEGAWAIFARMASI

(Hospital KualaLumpur)

CHIEF PHARMACIST(Kuala Lumpur

Hospital)

13 TIMBALANPENGARAH

KESIHATAN NEGERI(Farmasi)

13-STATE DEPUTYDIRECTORS OF

HEALTH(Pharmacy)

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PengarahDirector

Bhg. Penilaian &Keselamatan Produk

Product Evaluation &Safety Division

Bahagian APB& Pelesenan

GMP &LicensingDivision

Bhg. PembangunanOrganisasi &

Teknologi Maklumat

Org. Development& Info. Technology

Division

Bahagian Surveilans& Farmakovigilans

Surveillance &Pharmacovigilance

Division

BahagianPentadbiran

AdministrativeDivision

BahagianAnalisis Ubat

Drug Analysis Division

Unit Sekretariat

Secretariat Unit

Unit Racun

Poisons Unit

Unit Bukan Racun

Non-PoisonsUnit

Unit Ubat Tradisional

Traditional MedicinesUnit

Unit Entiti Kimia Baru

New Chemical EntityUnit

Unit Kosmetik

Cosmetics Unit

MakmalKimia

Farmaseutikal

PharmaceuticalChemistry Laboratory

MakmalMikrobiologi

Farmaseutikal

PharmaceuticalMicrobiologyLaboratory

MakmalFarmakologi/Toksikologi

Pharmacology/Toxicology Laboratory

MakmalTeknologi

Farmaseutikal

PharmaceuticalTechnology Laboratory

Unit PiawaiRujukan

Reference StandardsUnit

MakmalUbat

Tradisional

Traditional MedicinesLaboratory

CARTA ORGANISASIORGANIZATIONAL CHART

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAANNATIONAL PHARMACEUTICAL CONTROL BUREAU

Duduk (Kiri ke kanan): Tn. Hj. Mohd. Zin Che Awang (Pengarah BPFK), Dr. Anis Ahmad (Pengarah Perkhidmatan FarmasiKKM), Mr. Lai Lim Swee (Timbalan Pengarah Bhg. Analisis Ubat), En. Mohd. Nasir Hashim (Ketua Unit Piawai Rujukan)

Diri (Kiri ke kanan): En. Selvaraja Seeragam (Ketua Makmal Farmakologi), Pn. Rosnaini Kamaruddin (Peg. Hal EhwalAwam), Pn. Faridah Abd. Malek (Ketua Makmal Far. Teknologi), Pn. Abida Haq (Ketua Bhg. Surveilans), Pn. NapsahMahmud (Ketua Unit Tradisional), Cik Fudziah Ariffin (Ketua Unit Racun), Pn. Chuah Siew Khim (Ketua Bhg. POTM), Pn.Yogeswary Markandoo (Ketua Makmal Far. Kimia), Pn. Hasnah Ismail (Ketua Unit Sekretariat), Pn. Tan Lie Sie (Ketua UnitBukan Racun), Pn. Eishah Abd. Rahman (Ketua Bhg. APB), Pn. Rosnani Mhd. Yusoff (Ketua Bhg. Pentadbiran), Dr. SulaikahV.K. Moideen (Ketua Makmal Far. Mikrobiologi), En. Jaafar Lassa (Ketua Makmal Tradisional)

Duduk (Kiri ke kanan): Pn. Hasnah Ismail (Ketua Unit Sekretariat), Tn. Hj. Mohd. Zin Che Awang(Pengarah BPFK), Mr. Lai Lim Swee (Timbalan Pengarah Bhg. Analisis Ubat)

Diri (Kiri ke kanan): Pn. Rosnaini Kamaruddin (Peg. Hal Ehwal Awam), Pn. Abida Haq (Ketua Bhg.Surveilans), Pn. Chuah Siew Khim (Ketua Bhg. POTM), Pn. Eishah Abd. Rahman (Ketua Bhg. APB), Pn. Rosnani Mhd. Yusoff (Ketua Bhg. Pentadbiran)

PENGARAH BPFK DAN KETUA-KETUA BAHAGIAN

PENGARAH PERKHIDMATAN FARMASI KKMDAN PEGAWAI-PEGAWAI KANAN BPFK

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Senarai jawatan pada 31 Disember 2000List of posts as at 31 December 2000

Jawatan (Post)Bil. Nama Jawatan Gred Bil. Diisi KosongNo. Position Grade No. Filled Vacant

1. Pengarah BPFK C 1 1 0Director of NPCB

2. Pegawai Farmasi U1 2 2 0Pharmacist

3. Pegawai Farmasi U2 13 13 0Pharmacist

4. Pegawai Farmasi U3 50 37 13Pharmacist

5. Penolong Pegawai Perangkaan N6 1 1 0Assistant Statistic Officer

6. Pembantu Farmasi U7 8 7 1Pharmacy Assistant

7. Pembantu Farmasi U8 65 62 3Pharmacy Assistant

8. Pembantu Tadbir N7 1 1 0Administrative Assistant

9. Pembantu Tadbir (Kesetiausahaan) N7 1 0 1Administrative Assistant ( Secretary)

10. Pembantu Perpustakaan S7 1 1 0Library Assistant

11. Pembantu Tadbir N9 11 9 2Administrative Assistant

12. Pembantu Tadbir (Kesetiausahaan) N9 2 2 0Administrative Assistant (Secretary)

13. Pembantu Tadbir (Setor) N9 1 1 0Administrative Assistant (Store)

14. Operator Mesin Prosesan Data F9 2 1 1Data Processing Operator

15. Pembantu Tadbir Rendah N11 4 2 2Typist

16. Pembantu Tadbir Rendah (Operator N11 1 1 0Telefon)Administrative Assistant (Telephone Operator)

17. Pembantu Am Rendah N13 2 0 2General Assistant

18. Atendan Kesihatan U16 10 7 3Health Attendant

15. Pengawal Keselamatan KP10 3 1 2Security Guard

16. Pemandu Kenderaan Bermotor R10 3 2 1Driver

JUMLAH (Total) 182 151 31

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FALSAFAH ORGANISASI

WAWASANBiro Pengawalan Farmaseutikal Kebangsaan sebagaipusat kecemerlangan unggul dalam bidang regulatorifarmaseutikal demi menjamin kesihatan dankesejahteraan insan sejagat.

MISIBiro Pengawalan Farmaseutikal Kebangsaan akanmemastikan kualiti, keberkesanan dan keselamatankeluaran farmaseutikal melalui perlaksanaan undang-undang oleh tenaga kerja yang berketerampilan danusahasama strategik ke arah peningkatan statuskesihatan rakyat.

MATLAMATMemastikan bahawa bahan-bahan terapeutik yangdibenarkan di pasaran tempatan adalah selamat,berkesan dan bermutu, serta menentukan bahawakosmetik-kosmetik yang dibenarkan di pasaran adalahselamat dan bermutu.

STRATEGIMemastikan kecekapan dan keberkesanan organisasimelalui permodenan dan automasi sistem-sistempejabat, makmal dan pendaftaran, peninjauan sertapembaikan perkhidmatan secara regular.

Memperkukuhkan aktiviti penguatkuasaan undang-undang berkaitan.

Memastikan suasana kefahaman dua hala dankerjasama berterusan sentiasa wujud antara pihakpengawalan dengan sektor swasta melalui sessi dialogdan bimbingan.

Meningkatkan potensi serta kepakaran personel.

Mewujudkan satu kumpulan tenaga kerja yangberdedikasi dan penuh komitmen melalui motivasi,penghargaan serta ganjaran yang berpatutan.

Mempergiatkan aktiviti penyelidikan serta meningkatkankemudahan-kemudahan bagi tujuan tersebut.

Mewujudkan suatu suasana yang menggalakkankakitangan bekerja secara berpasukan dengan sikappenyayang, serta melaksanakan tugas masing-masingsecara profesional.

ORGANIZATIONAL PHILOSOPHY

VISIONThe National Pharmaceutical Control Bureau will be acentre of excellence in pharmaceutical regulatory mattersto ensure the health and well-being of mankind.

MISSIONThe National Pharmaceutical Control Bureau shall ensurethe quality, efficacy and safety of pharmaceuticalproducts through the implementation of the relevantlegislation by a competent workforce working together instrategic alliances towards improving the health of thepeople.

OBJECTIVETo ensure that therapeutic substances approved for thelocal market are safe, effective and of quality and also toensure that cosmetic products approved are safe and ofquality.

STRATEGYTo ensure organizational efficiency and effectivenessthrough modernisation and automation of the office,laboratory and registration systems and regular reviewand improvement of services.

To strengthen enforcement activities of the relatedlegislation.

To ensure continuous mutual understanding and co-operation between the regulatory body and the privatesector through dialogues and guidances.

To upgrade personnel potential and expertise.

To attain a dedicated and fully committed work forcethrough motivation, appreciation and appropriaterenumeration.

To strengthen research activities and upgrade facilities forsuch purposes.

To create a working environment conducive for thepersonnel to work as a team with a caring attitude whilstdischarging their duties in a professional manner.

MOTTOUTAMAKAN KUALITI, EFIKASI DAN KESELAMATAN

EMPHASIZE QUALITY, EFFICACY AND SAFETY

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PIAGAM PELANGGAN

A.KEWAJIPAN BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN TEMA PIAGAM

Ditujukan khas kepada setiap pelanggan yangberurusan dengan BPFK.

1. AM

1.1. KEMUDAHAN UNTUK PELANGGAN

(i) Setiap pelanggan biro boleh mendapat perkhidmatan sewajarnya.

(ii) Setiap pelanggan yang tergolong dalam keadaan yang memerlukan perhatian segera akan diberi layanan dengan segera.

1.2. TARAF PERKHIDMATAN

(i) Setiap pelanggan akan dilayan dengan baik, mesra, bertimbang rasa, hormat dan ikhlas.

(ii) Setiap pelanggan akan diberi perkhidmatan yang terbaik secara profesional.

1.3. MAKLUMAT PERKHIDMATAN

Setiap pelanggan boleh mendapat penjelasan dan nasihat mengenai perkhidmatan yang diberikan kepadanya.

2. AKTIVITI - PENDAFTARAN

2.1. Memastikan bahawa semua keluaran farmaseutikal yang berdaftar adalah selamat, berkesan dan berkualiti serta menentukan bahawa kosmetik-kosmetik yang berdaftar adalah selamat.

CLIENTS CHARTER

A. THE OBLIGATION OF THE NATIONAL PHARMACEUTICAL CONTROL BUREAU CHARTER THEME :

Exclusive concern for clients who deal with NPCB.

1. GENERAL

1.1. FACILITIES FOR CLIENTS

(i) Every client of the bureau shall receive the appropriate service.

(ii) Every client who requires immediate attention shall be served immediately.

1.2. STANDARD OF SERVICE

(i) Every client shall be treated with courtesy, understanding, respect and sincerity.

(ii) Every client shall be given the best possible professional service.

1.3. INFORMATION SERVICE

Every client shall be given explanation and advice on the services provided.

2. ACTIVITY - REGISTRATION

2.1. To ensure the safety, efficacy and quality of all registered pharmaceutical products and the safety of registered cosmetic products.

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2.2. Semua permohonan akan dinilai dengan adil dan saksama berlandaskan kepada peraturan-peraturan yang berkaitan.

2.3. Semua dokumen yang dikemukakan oleh pelanggan akan disimpan dalam keadaan selamat dan terkawal.

3. AKTIVITI - MAKMAL

3.1. Semua ujian makmal akan dijalankan dengan adil dan saksama mengikut peraturan-peraturan dan prosedur-prosedur yang berkaitan.

4. AKVITIVI - PENGUATKUASAAN DAN KOMPLIANS

4.1. Setiap tindakan penguatkuasaan ke atas mana-mana pelanggaran undang-undang yang dikuatkuasakan akan dilakukan dengan adil dan saksama tanpa dipengaruhi oleh apa-apa kepentingan dan prasangka.

4.2. Bersedia bekerjasama dengan agensi penguatkuasaan lain dalam perkara yang berkaitan dengan penguatkuasaan ubat-ubatan.

5. SETIAP PERMOHONAN YANG LENGKAP AKAN DIPROSES MENGIKUT JANGKAMASA BERIKUT

(i) Lesen Untuk Percubaan Klinikal - tidak lebih dari 3 bulan.

(ii) Lesen Untuk Pemborong, Pengilang, Pengimport - tidak lebih dari 3 bulan.

(iii) Lesen Baru Untuk Pemborong, Pengilang, Pengimport - tidak lebih dari 6 bulan.

2.2. All applications shall be evaluated fairly and with impartiality in accordance with the relevant regulations.

2.3. All documents forwarded by clients shall be kept in a secure and organized manner.

3. ACTIVITY - LABORATORY

3.1. All laboratory tests shall be carried out fairly and impartially in accordance with the relevant regulations and procedures.

4. ACTIVITY - ENFORCEMENT &COMPLIANCE

4.1. Every enforcement action on any offence under the law shall be carried out fairly and impartially without influence from whatsoever vested interest and prejudice.

4.2. Ever ready to co-operate with other enforcement agencies in matters related to drug enforcement.

5. EVERY COMPLETE APPLICATION SHALL BE PROCESSED IN ACCORDANCE TO THE FOLLOWING TIME-FRAME :

(i) Licence For Clinical Trial - Not more than 3 months.

(ii) Licence For Wholesalers, Manufacturers and Importers - Not more than 3 months.

(iii) New Licence For Wholesalers, Manufacturers and Importers - Not more than 6 months.

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(iv) Registration

Stage 1 - Not more than 6 weeks.

Stage 2 - Not more than 4 months.

Stage 3 - Generic - Not more than 6 months.

NCE - Not more than 12 months.

Additional Indications - Not more than 6months.

(v) GMP Inspection Report

Follow-up - Not more than 2 months.

New/Routine - Not more than 3 months.

(vi) Product Certificate

Medical Device - Not more than 2 weeks.

Pharmaceuticals - Not more than 1 month.

B. CLIENTS OBLIGATION

To enable this charter to be implemented effectively,clients are obliged to fulfill the following:-

(i) Comply with the requirements of the relevant legislation and regulations.

(ii) Use the facilities provided responsibly.

(iv) Pendaftaran.

Peringkat 1 - tidak lebih dari 6 minggu.

Peringkat 2 - tidak lebih dari 4 bulan.

Peringkat 3 - Generik - tidak lebih dari 6 bulan.

NCE - tidak lebih dari 12 bulan.

Tambahan Indikasi - tidak lebih dari 6bulan.

(v) Laporan Pemeriksaan APB.

Susulan - tidak lebih dari 2 bulan.

Baru/Rutin - tidak lebih dari 3 bulan.

(vi) Perakuan Keluaran.

Alat Perubatan - tidak lebih dari 2 minggu.

Farmaseutikal - tidak lebih dari 1 bulan.

B. KEWAJIPAN PELANGGAN

Bagi membolehkan piagam ini dilaksanakan denganberkesan, pelanggan adalah berkewajipan untuk :

(i) Mematuhi semua undang-undang dan peraturan-peraturan yang berkaitan.

(ii) Menggunakan kemudahan-kemudahan yang disediakan secara bertanggungjawab.

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RINGKASAN AKTIVITI BPFK

Aktiviti-aktiviti Biro Pengawalan Farmaseutikal Kebangsaan pada amnya termasuk :-

1. Menguatkuasakan skim pendaftaran ubat dan kosmetik melalui penilaian data teknikal, ujian makmal, penyelidikan dan maklumat yang diterima dari badan-badan antarabangsa.

2. Menjalankan ujian analisa, farmaseutik, mikrobiologi, farmakologi serta toksikologi ke atas ubat-ubatan dan kosmetik untuk menentukan mutu, keberkesanan dan keselamatan keluaran-keluaran tersebut.

3. Menguatkuasakan skim kawalan mutu ubat-ubatan di pasaran melalui penyampelan rambang dan menjalankan ujian-ujian analisa.

4. Menguatkuasakan skim pelesenan pengilang, pengimport, pemborong ubat-ubatan, termasuk skim pelesenan untuk percubaan klinikal.

5. Mendorong dan membantu pengilang-pengilang ubat tempatan untuk meningkatkan mutu pengilangan setaraf dengan Amalan Perkilangan Baik (Good Manufacturing Practice) yang disarankan oleh Pertubuhan Kesihatan Sedunia.

6. Menguruskan program pemonitoran kesan advers ubat dan menganggotai Program Pemonitoran Ubat Antarabangsa WHO.

7. Menguruskan skim panggilbalik ubat-ubat yang didapati atau dibuktikan merbahaya kepada pengguna.

SUMMARY OF NPCB ACTIVITIES

The activities of NPCB are :-

1. To implement the drug and cosmetic registration scheme through evaluation of technical data, laboratory analysis, research and information received from international agencies.

2. To carry out analytical, pharmaceutical, microbiological, pharmacological and toxicological tests on drugs and cosmetics to determine quality, efficacy and safety of such products.

3. To implement the regulatory scheme on quality of pharmaceutical products in the market through random sampling and carrying out analytical tests.

4. To implement the licensing scheme for pharmaceutical manufacturers, importers and wholesalers including a licensing scheme for clinical trials.

5. To encourage and assist local pharmaceutical manufacturers to upgrade manufacturing standards to levels equivalent to the requirements of Good Manufacturing Practice as recommended by the World Health Organisation (WHO).

6. To manage the Adverse Drug Reaction Monitoring Program and participate in the WHO International Adverse Drug Reaction Monitoring Program.

7. To manage the product recall scheme for pharmaceutical products which are found to be substandard or dangerous to consumers.

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8. Mengendalikan sistem pengumpulan dan penyebaran maklumat ubat-ubatan selaras dengan peranannya sebagai Pusat Maklumat Ubat Kebangsaan.

9. Menjalankan penyelidikan metodologi dan penyelidikan asas untuk tujuan menilai mutu, keberkesanan dan keselamatan ubat - ubatan/kosmetik.

10. Menubuhkan sistem pembentukan piawai rujukan untuk kegunaan negara ini dan negara jiran melalui skim kerjasama dalam bidang farmaseutikal di antara negara-negara ASEAN.

11. Menjalankan latihan bagi pegawai-pegawai farmasi, pegawai-pegawai profesional lain dan juga pegawai-pegawai separuh profesional yang ditempatkan di Institusi ini dari masa ke semasa melalui skim latihan tempatan atau skim kerjasama antarabangsa.

8. To manage the drug information collecting and disseminating system in line with itsrole as a national drug information centre.

9. To carry out research on methodology and basic research for the purpose of evaluating quality, efficacy and safety of drugs/cosmetics.

10. To establish a reference standard system for use in this country and also for neighbouring countries through a scheme of cooperation in the field of pharmaceuticals among ASEAN countries.

11. To carry out training for pharmaceutical officers, other professional and semi-professional officers who are placed in this institution from time to time through local training or international cooperational schemes.

BAHAGIAN PENTADBIRAN

Bahagian Pentadbiran adalah bertanggungjawab dalammenguruskan semua hal berhubung dengan kewangan,pentadbiran am, hasil dan tugas-tugas lain yang bukanbidang profesional.

OBJEKTIF Memastikan bahawa semua anggota menikmati

upahan gaji bulanan dan tuntutan-tuntutan rasmi dibayar dalam tempoh yang ditetapkan.

Segala keperluan asas dan yang penting diuruskansegera.

Urusan Perkhidmatan yang wajib dan perlu dikemaskinikan.

Mengawal peruntukan kewangan supaya sentiasa mencukupi bagi menjamin setiap aktiviti yang dirancang boleh mencapai objektif keseluruhannya.

KewanganMengurus pembayaran upahan dan gaji untuk 151anggota berjumlah RM4,573,315

Kutipan HasilKutipan hasil diterima daripada pelanggan untukbayaran Pendaftaran Ubat-Ubatan, Ujian Makmal,Lesen, Perkhidmatan Nasihat, Jualan Buku-bukuGarispanduan dan lain-lain. Jumlah kutipan hasilmengikut disiplin adalah seperti dibawah:-

ADMINISTRATIVE DIVISION

The Administrative Division is responsible for themanagement of all matters pertaining to finance,general administration and other non-professionaltasks.

OBJECTIVES To ensure all emoluments and claims are paid

within the stipulated time. To take immediate action on basic and urgent

matters. To constantly update compulsory records. To oversee that financial allocations are sufficient

and ensure that each planned program and activity meets its objective.

FinancePayment to 151 staff members is RM4,573,315

RevenueRevenue is collected from the public for DrugRegistration, Laboratory Tests, Licences, AdvisoryServices, Sale of Guideline Books and others. Thebreakdown of total revenue is as follows:-

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KUTIPAN HASIL (RM) SEHINGGA AKHIR TAHUN 2000REVENUE UNTIL END 0F 2000

Tahun Pendaftaran Lesen Makmal Pemeriksaan Bahan Cetak Lain-lain

Year Registration License Laboratory Inspection Printed OthersMaterials

1992 422,965 53,650 308,685 0 0 16,213

1993 759,284 91,951 686,690 4,920 4,920 7,621

1994 911,840 84,601 516,805 25,805 9,720 38,610

1995 381,120 99,200 965,110 22,600 52,806 1,520,836

1996 728,253 97,101 963,570 17,700 28,316 14,050

1997 878,050 105,750 797,555 8,800 37,602 28,019

1998 793,825 129,350 750,360 8,400 18,296 12,100

1999 959,405 158,350 484,860 14,350 39,605 18871

2000 1,111,440 152,100 502,620 6,500 28,340 27,193

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TINJAUAN BELANJAWAN / BUDGET PREVIEW

Peruntukan dan Perbelanjaan Mengurus BPFK Bagi Tahun 20002000 NPCB Operating Allocation and Expenditure

Kod Jenis Perbelanjaan Peruntukan (RM) Perbelanjaan BakiObjek Am

Allocation (RM) Expenditure BalanceObject Expenditure Asal Dipinda Perbelanjaancode Bersih (RM) % (RM) %

Original AmendedActual Expenditure(RM)

10000 Emolumen3,884,000 4,282,000 4,573,315 106.80 (291,315) -6.80

Emolument

20000 Perkhidmatan dan Bekalan 2,295,000 2,261,000 2,172,023 96.06 88,977 3.94

Services and Supply

30000 Aset (Harta Modal)

50,000 164,000 151,482 92.37 12,518 7.63Asset (Property)

Jumlah6,229,000 6,707,000 6,896,820 102.83 189,820 2.83

Total

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BAHAGIAN PENILAIAN DANKESELAMATAN PRODUK

OBJEKTIFUntuk memastikan semua keluaran berdaftar dinilaidari segi kualiti, keselamatan dan efikasi.

Untuk memberikan sokongan teknikal danpentadbiran dalam semua bidang yang berhubung dengan pendaftaran keluaran.

PENCAPAIANSejumlah 45,955 permohonan diterima dari tahun1985 sehingga 2000, dimana 13,972 (30.4 %) ubatracun, 9,963 (21.7 %) ubat bukan racun, 20,291(44.1 %) ubat tradisional dan 1,729 (3.8 %) kosmetik(Jadual 1). Jumlah permohonan telah meningkatdengan ketara dari 6,448 pada 1986 kepada20,257 pada 1992. Aliran yang sama dapatdiperhatikan pada 1992 hingga 1999, dimanajumlah permohonan meningkat sebanyak 53.2 %,kerana permohonan yang banyak untuk ubattradisional dan kosmetik. Walau bagaimanapun,pada tahun 2000 jumlah permohonan telah menurunsedikit bagi ubat racun, ubat bukan racun dankosmetik.

Sejumlah 24,902 keluaran telah didaftarkan sehingga2000, dimana 8,813 ( 35.4 % ) ialah ubat racun,6,072 (24.4 %) ubat bukan racun, 8,550 (34.3 %)ubat tradisional dan 1,467 (5.9 %) kosmetik (Jadual2). Jumlah keluaran yang didaftarkan menunjukkanpeningkatan bagi semua kategori.

Sehingga 2000, sejumlah 16,392 permohonan yangditolak dan ini meliputi kira-kira 35.7% dari jumlahpermohonan yang diterima.

PRODUCT EVALUATION AND SAFETY DIVISION

OBJECTIVESTo ensure that all registered products have beenevaluated for quality, safety and efficacy.

To provide technical and administrative support in allmatters pertaining to registration of products.

ACHIEVEMENTSA total of 45,955 applications were received from1985 to 2000, of which 13,972 (30.4 %) wereprescription drugs, 9,963 (21.7 %) OTC products,20,291 (44.1 %) traditional medicines and 1,729 (3.8%) cosmetics (Table 1). The number of applicationshad increased significantly, from 6,448 in 1986 to20,257 in 1992. A similar increasing trend wasobserved from 1992 to 1999, where the number ofapplications had gone up by almost 53.2 %, mainlydue to the enormous number of traditional medicinesand cosmetics applications. However, the totalapplication for registration of prescription drugs, OTCand cosmetic products has decreased significantly inyear 2000.

A total of 24,902 products had been registered by2000, of which 8,813 ( 35.4 % ) are prescriptiondrugs, 6,072 (24.4 %) OTCs, 8,550 (34.3 %)traditional medicines and 1,467 (5.9 %) cosmetics(Table 2). The number of products registered displaya increasing trends for all categories.

Up until 2000, a total of 16,392 applications hadbeen rejected and this represents approximately 35.7% of the total number of applications received.

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Jadual 1: Permohonan untuk pendaftaran, 1985 2000

Table 1 : Applications received for registration, 1985 2000

Tahun Ubat Ubat bukan Ubat Kosmetik Jumlah Totalracun racun Tradisional Tahunan Kumulatif

Year Prescription OTC Traditional Cosmeticsdrugs products medicines Annual Cumulative

1985 9 - - - 9 91986 6,439 - - - 6,439 6,4481987 824 56 - - 880 7,3281988 702 2,532 - - 3,234 10,5621989 664 2,750 - - 3,414 13,9761990 528 597 - - 1,125 15,1011991 481 305 - 42 828 15,9291992 150 60 3,973 145 4,328 20,2571993 376 111 7,059 51 7,597 27,8541994 400 168 4,080 31 4,679 32,5331995 440 239 288 58 1,025 33,5581996 617 671 415 130 1,833 35,3911997 532 635 668 123 1,958 37,3491998 587 606 938 277 2,408 39,7571999 796 789 1,347 610 3,542 43,2992000 427 444 1,523 262 2,656 45,955

Jumlah 13,972 9,963 20,291 1,729 45,955 45,955Total

Jadual 2 : Kumulatif keluaran yang didaftarkan ( 1991 2000 )

Table 2 : Cumulative number of products registered ( 1991 2000 )

Tahun Ubat Ubat bukan Ubat Kosmetik Jumlahracun racun Tradisional

Year Prescription OTC Traditional Cosmetics Totaldrugs products Medicines

1991 5,332 3,331 - - 8,6631992 5,862 3,743 - 14 9,6191993 6,131 3,867 5 109 10,1121994 6,444 3,954 57 149 10,6041995 6,691 4,023 339 183 11,2361996 7,027 4,237 1,852 292 13,4081997 7,525 4,830 4,347 476 17,1781998 8,187 5,415 7,819 664 22,0851999 8,792 5,942 7,966 1,235 23,9352000 8,813 6,072 8,550 1,467 24,902

Jumlah 8,813 6,072 8,550 1,467 24,902Total

19A N N U A L R E P O R T 2 0 0 0

Sehingga 2000, sejumlah 6,033 permohonan yangdibatalkan atau ditarik balik, dan ini meliputi 2,231(37.0 %) ubat racun, 1,029 (17.0 %) ubat bukanracun, 2,707 (44.9 %) ubat tradisional dan 66 (1.1 %)kosmetik (Jadual 4). Jumlah keluaran yangdibatalkan atau ditarik balik adalah 13.1 % daripadajumlah permohonan yang diterima.

Up until 2000, a total of 6,033 applications had beencancelled or withdrawn, which consists of 2,231 (37.0%) prescription drugs, 1,029 (17.0 %) OTCs,2,707 (44.9 %) traditional medicines and Cosmetics66 (1.1 %) (Table 4). The total number of productscancelled or withdrawn represents about 13.1 % of thetotal number of applications received.

Jadual 3 : Permohonan Kumulatif yang ditolak1986 2000

Table 3 : Cumulative applications rejected by the DCA, 1986 2000

Tahun Ubat Ubat bukan Ubat Kosmetik Jumlahracun racun Tradisional

Year Prescription OTC Traditional Cosmetics Totaldrugs products Medicines

1986 955 - - - 9551987 2,043 - - - 2,0431988 2,389 329 - - 2,7181989 2,889 1,083 - - 3,9721990 3,206 1,318 - - 4,5241991 3,495 1,585 - - 5,0801992 3,693 2,127 - 14 5,8341993 3,770 2,262 0 92 6,1241994 3,860 2,362 410 98 6,7301995 3,938 2,592 1,253 98 7,8811996 4,020 2,783 2,570 98 9,3731997 4,132 2,963 3,915 98 11,1081998 4,164 3,065 7,190 98 14,5171999 4,186 3,125 8,975 98 16,3842000 4,206 3,165 9,021 98 16,392

Jumlah 4,206 3,165 9,021 98 16,392Total

L A P O R A N T A H U N A N 2 0 0 020

Jumlah rayuan yang diterima telah menurun kepada32 pada tahun 2000 berbanding dengan 370 pada1999 dan 522 pada 1998.

Dari 1985 hingga 2000, sejumlah 1,062permohonan diterima untuk keluaran entiti kimia baru(Rajah 1). Daripada jumlah ini, 729 (68.6%) telahdiluluskan, 284 (26.7%) ditolak dan 49 (4.6%)tertangguh.

Tambahan indikasi bagi produk-produk yang telahberdaftar juga dinilai dan diluluskan oleh PBKD.Sebanyak 33 permohonan telah diterima bagi tahun1999 dan 27 pada tahun 2000.

Jumlah permohonan CTIL yang diterima telahmeningkat pada tahun 1999 dan 2000 berbandingdengan tahun 1997 dan 1998 (Rajah 2). Dari tahun1997 hingga 2000, sejumlah 102 permohonan CTILditerima.

The number of appeals received has decreasedsignificantly to 32 for the year 2000, as compared to370 in 1999 and 522 in 1998.

From 1985 to 2000, a total of 1,062 applicationswere received for products classified as new chemicalentities (Figure 1). Out of these, 729 (68.6 %) hadbeen approved, 284 (26.7 %) rejected and 49 (4.6 %)deferred.

New indications for registered products were alsoassessed and approved by the DCA. A total of 33applications were received in 1999 and 27 in the year2000.

The number of Clinical Trial Import License (CTIL)received has increased significantly in 1999 and 2000as compared to 1997 and 1998 (Figure 2). From1997 to 2000, a total of 102 applications of CTIL werereceived.

Jadual 4 : Permohonan yang dibatalkan /ditarik balik, 1989 2000Table 4 : Applications cancelled/withdrawn,

1989 2000

Tahun Ubat Ubat bukan Ubat Kosmetik Jumlah Totalracun racun tradisional Tahunan Kumulatif

Year Prescription OTC Traditional Cosmeticsdrugs products medicines Annual Cumulative

1989 166 0 - - 166 1661990 114 0 - - 114 2801991 103 37 - - 140 4201992 0 15 - - 15 4351993 6 0 0 - 6 4411994 9 28 0 - 37 4781995 39 59 0 - 98 5761996 59 62 0 - 121 6971997 62 76 0 - 138 8351998 0 23 595 - 618 1,4531999 1,367 609 1,613 66 3,655 5,1082000 306 120 499 - 925 6,033

Jumlah 2,231 1,029 2,707 66 6,033 6,033Total

21A N N U A L R E P O R T 2 0 0 0

Sebanyak 42.0 % (10,451) daripada jumlah keluaranyang didaftarkan adalah dikilangkan secaratempatan, sementara 58.0 % (14,465) adalahdiimport. Keluaran tempatan dan keluaran importyang didaftarkan dari 1991 sehingga 2000, mengikutkategori berlainan diilustrasikan pada Jadual 5.

About 42.0 % (10,451) of the total number of productsregistered are locally-manufactured, while 58.0 %(14,465) are imported. Locally-manufactured andimported products registered for the period between1991 to 2000, according to different categories, arecumulatively illustrated in Table 5.

1200

1000

800

600

400

200

0

Terima / Received

Lulus / Approved

Tolak / Rejected

Tangguh / Deferred

431 8 2 60 47 52 127 114 140 81 1062

188 48 34 48 36 37 87 61 129 61 729

101 30 35 7 18 11 39 15 19 9 284

0 0 3 8 1 0 4 11 11 11 49

85-91 1992 1993 1994 1995 1996 1997 1998 1999 2000 Total

Rajah 1: Status Pendaftaran Keluaran Entiti Kimia Baru 1985 2000Figure 1: Registration Status of New Chemical Entities 1985 2000

Rajah 2: Lesen Import Penyelidikan Klinikal 1997 2000Figure 2: Clinical Trial Import Licence (CTIL) 1997 2000

Bila

ng

an P

erm

oh

on

an

Nu

mb

er o

f A

pp

licat

ion

40

35

30

25

20

15

10

5

0

1997 1998 1999 2000

TAHUN / YEAR

10

18

36

38

L A P O R A N T A H U N A N 2 0 0 022

Semenjak 2000, peratusan nisbah antara produktempatan dan produk import untuk ubat racun adalah31:69 seperti data dalam Jadual 5. Bagi ubat bukanracun, peratusan keluaran tempatan adalah lebihtinggi seperti mana ditunjukkan dalam nisbah 51:49.Peratusan untuk ubat tradisional adalah 51:49,menunjukkan peratusan keluaran yang dikilangtempatan adalah lebih tinggi manakala peratusannisbah kosmetik pula adalah 15:85.

As of 2000, the percentage ratio between locallymanufactured and imported products for prescriptiondrugs is in the order of 31:69 as shown by data inTable 5. For OTC products the percentage of locallymanufactured products is slightly higher as indicatedby a ratio of 51:49. The percentage ratio fortraditional medicines is shown to be 51:49, indicatinga higher proportion of locally manufactured productswhereas the percentage ratio for cosmetics is 15:85.

Jadual 5 : Jumlah kumulatif produk tempatan dan produk import ( 1991 2000 )

Table 5 : Cumulative number of locally-manufactured and imported products registered (19912000)

Tahun Ubat Ubat Ubat Kosmetik Jumlahracun bukan tradisional

racunTempatan Import Tempatan Import Tempatan Import Tempatan Import Tempatan Import

Year Prescription OTC Traditional Cosmetics Totaldrugs products medicines

Local Import Local Import Local Import Local Import Local Import

1991 1,602 3,730 1,750 1,581 - - - - 3,352 5,3111992 1,760 4,102 1,983 1,760 - - 2 12 3,745 5,8741993 1,867 4,264 2,032 1,835 1 4 22 87 3,922 6,1901994 1,951 4,493 2,081 1,873 17 40 22 127 4,071 6,5431995 2,041 4,650 2,083 1,940 145 194 22 161 4,291 6,9451996 2,213 4,814 2,202 2,035 950 942 72 220 5,437 8,0111997 2,347 5,178 2,475 2,355 2,300 2,047 72 404 7,194 9,9841998 2,602 5,585 2,755 2,660 4,246 3,573 106 558 9,709 12,3761999 2,781 6,011 3,052 2,890 4,098 3,868 197 1,038 10,128 13,8072000 2,742 6,071 3,080 2,992 4,400 4,150 215 1,252 10,451 14,465

Jumlah 8,813 6,072 8,550 1,467 24,902Total

23A N N U A L R E P O R T 2 0 0 0

Merujuk kepada jumlah produk tempatan yangdidaftarkan (n = 10,451) seperti pada Jadual 5,2,742 (26.2 %) adalah ubat racun, 3,080 (29.5 %)ubat bukan racun, 4,400 (42.1 %) ubat tradisionaldan 215 (2.1%) kosmetik. Untuk produk import,berdasarkan kepada jumlah yang didaftarkan (n =14,465), 6,071 (42.0 %) adalah ubat racun, 2,992(20.7 %) ubat bukan racun, 4,150 (28.7 %) ubattradisional dan 1,252 (8.7 %) kosmetik (Rajah 3).

Pengeluaran sijil perakuan keluaran farmaseutikal[Certificates of Pharmaceutical Products (CPP)] dan sijilperakuan penjualan bebas [Certificates of Free Sale (CFS)]untuk alatan perubatan, untuk kebenaran mengeksport,telah bertambah sejak 1987 sehingga 1992. Sejumlah15,135 CPP dan 6,271 CFS telah dikeluarkan sejak 1999sehingga tahun 2000 (Rajah 4).

Based on the total number of locally-manufacturedproducts registered (n = 10,128) as presented in Table 5,2,781 (27.5 %) are prescription drugs, 3,052 (30.1 %)OTC products, 4,098 (40.5 %) traditional medicines and197 (1.9%) cosmetics. For imported products, based onthe total number registered (n = 13,807), 6,011 (45.1 %)are prescription drugs, 2,890 (21.5 %) OTC products,3,868 (28.9 %) traditional medicines and 1,038 (4.5 %)cosmetics (Figure 3).

Issuance of certificates of pharmaceutical products(CPP) and certificates of free sale (CFS) for medicaldevices, and export authorisation, had increasedsteadily since 1987 and 1992 respectively. A total of15,135 CPP and 6,271 CFS had been issued up tothe year 2000 (Figure 4 ).

Rajah 3: Produk Berdaftar Tempatan VS Import, 2000Figure 3: Registered Products Local VS Import, 2000

454035302520151050

26.2

42

29.5

20.7

8.7

28.7

42.1

2.1

Racun / Prescription Bukan racun / OTC Tradisional / Traditional Kosmetik / Cosmetic

Tempatan / Local Import / Import

Rajah 4: Pengeluaran Sijil Perakuan Keluaran Farmaseutikal danSijil Perakuan Penjualan Bebas 1987 2000

Figure 4: Issuance of Certificate of Pharmaceutical Product and Certificate of Free Sale, 1987 2000

2000

1500

1000

5000

0

CPP

CPS

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 Total

158 242 250 393 532 561 827 943 1502 1590 1865 2094 1700 2478 15135

192 257 263 278 372 652 864 1679 1719 6271

L A P O R A N T A H U N A N 2 0 0 024

10 negara pengeluar utama ialah China, AmerikaSyarikat, Australia, Germany, England, Indonesia,Thailand, Switzerland, India dan Perancis. Negara-negara ini meliputi lebih kurang 71.3 % (10,427)daripada jumlah keluaran import (14,629). Produkyang diimport dari negara-negara ASEAN sepertiIndonesia, Thailand, Singapura, dan Filipina meliputihampir 12.2 % (1,785).

5 negara pengeluar utama bagi keluaran ubat racun,ubat bukan racun, ubat tradisional dan kosmetikditunjukkan pada Rajah 5. Malaysia merupakanpengeluar utama keluaran ubat racun, ubat bukanracun dan ubat tradisional, sementara negaraGerman ialah pengeluar utama keluaran kosmetik.

The top 10 leading foreign sources include China,United States of America (USA), Australia, Germany,England, Indonesia, Thailand, Switzerland, India andFrance. Together they account for approximately 71.3% (10,427) of our total imports (14,629). Productsimported from neighbouring ASEAN countries, whichinclude Indonesia, Thailand, Singapore andPhilippines constitute nearly 12.2 % (1,785).

The 5 leading sources for prescription drugs, OTCproducts, traditional medicines and cosmetics areillustrated in Figure 5. Malaysia is the leadingsource for prescription drugs, OTCs and traditionalmedicines, while Germany is the leading source forcosmetics.

Rajah 5: Pengeluar Utama Produk Berdaftar, 2000Figure 5: Leading Sources for Registered Products, 2000

Malaysia

China

USA

Australia

England

Germany

Indonesia

Switzerland

5000

4500

4000

3500

3000

2500

2000

1500

1000

500

0

3174

144

4688

122404120

2586

RacunPrescription

Bukan RacunOTC

TradisionalTraditional

KosmetikCosmetic

25A N N U A L R E P O R T 2 0 0 0

BAHAGIAN APB DAN PELESENAN

OBJEKTIFObjektif utama bahagian ini ialah untuk memastikanpremis-premis pengilang keluaran farmaseutikal danubat-ubatan tradisional mematuhi keperluan AmalanPerkilangan Baik (APB). Bahagian ini jugabekerjasama dengan Unit Penguatkuasa FarmasiNegeri (UPFN) dalam memastikan premis pengimportdan pemborong mematuhi keperluan AmalanPenstoran Baik (ASB).

AKTIVITI-AKTIVITI YANG DIJALANKANBahagian ini menjalankan aktiviti-aktiviti sepertiberikut:

Memeriksa premis pengilang, pengimport dan pemborong keluaran-keluaran berdaftar.

Memproses permohonan dan mengeluarkan lesen pengilang, pengimport dan pemborong keluaran-keluaran berdaftar.

Mengeluarkan senarai tambahan keluaran-keluaran berdaftar.

Menilai pelan susun-atur premis pengilang keluaran berdaftar.

Memberi khidmat nasihat dan bimbingan kepada industri berkenaan dalam aspek APB, ASB dan pelesenan.

Menganjur kursus latihan APB untuk industri farmaseutikal dan tradisional serta pelawat-pelawat luar negara.

Mengadakan perbincangan teknikal dengan industri farmaseutikal untuk meningkatkan tahap APB premis pengilang tempatan.

Mengumpul maklumat berkaitan industri farmaseutikal dan tradisional.

Mengeluarkan Perakuan APB dan mengesahkan salinan dokumen-dokumen berkaitan lesen.

GMP AND LICENSING DIVISION

OBJECTIVESThe main objective of this division is to ensure thatpharmaceu t i ca l and t rad i t iona l medic inemanufacturing premises adhere to the requirement ofGood Manufacturing Practice (GMP). This divisionalso co-operates with the State Pharmacy EnforcementUnits to ensure that the premises of importers andwholesaler adhere to Good Storage Practice (GSP).

ACTIVITIESThis division carries out the following activities:

Inspection of premises for manufacturers, importers and wholesalers of registered products.

Processing of license application for manufacturers, importers and wholesalers of registered products.

Issuance of additional lists of registered products.

Evaluation of lay-out plans for manufacturing premises for registered products.

Advisory service to relevant industries on technical aspects regarding GMP, GSP and licensing.

Training course for pharmaceutical and traditional medicines industries and also overseas visitors.

Technical discussion with pharmaceutical industries to upgrade the GMP standard of local manufacturing premises.

Collection of information related to pharmaceutical and traditional industries.

Issuance of GMP certificates and endorsement of license related documents.

L A P O R A N T A H U N A N 2 0 0 026

PENCAPAIANPemeriksaan APB

Sebanyak 126 pemeriksaan APB telah dijalankanpada tahun 2000, berbanding 120 pada tahun 1999 dan 111 pada tahun 1998. Pemeriksaantersebut meliputi 25 premis pengilang keluaran racun,18 keluaran bukan racun, 76 ubat tradisional, 2 kosmetik dan 5 lain-lain. Pencapaian ini adalah 16.7% melebihi sasaran yang ditetapkandan menunjukkan peningkatan sebanyak 5.0%daripada jumlah pemeriksaan tahun 1999. Rajah 6menunjukkan statistik pemeriksaan APB bagi tahun1995 hingga 2000.

Penilaian Pelan Premis PengilangSejumlah 69 pelan susun-atur premis pengilang barudan sediada telah dinilai, termasuk 10 premispengilang keluarn racun, 8 keluaran bukan racun, 38 ubat tradisional, 9 kosmetik dan 4 lain-lain. Pencapaian ini telah meningkat 11.3% berbanding tahun 1999.

Status Perkembangan Premis BerlesenStatus perkembangan premis-premis pengilang,pengimport dan pemborong berlesen bagi tahun1987 hingga 2000 adalah seperti yang dipaparkandalam Rajah 7. Pada tahun 2000, jumlah pengilangberlesen ialah 208, pengimport 322 dan pemborong686, menjadikan jumlah besar keseluruhan adalah1,216.

ACHIEVEMENTSGMP Inspection

A total of 126 inspections were conducted in 2000 as compared with 120 in 1999 and 111 in 1998. These inspections included 25 premises for scheduled poison manufacturers, 18 non-scheduled poison, 76 traditional medicines, 2 cosmetics and 5 others. This achievement is 16.7% more than thetargeted output and it shows an increase of 5.0% performance output, as compared to the output for 1999. Figure 6 shows the number of GMP inspections carried out since 1995 until 2000.

Evaluation of Manufacturing PremisesLay-out Plans.A total of 69 lay-out plans for new and existingmanufacturing premises were evaluated, these include10 premises of scheduled poisons manufacturers, 8non-scheduled poison, 38 traditional medicines, 6cosmetics and 4 others. This shows an increase of11.3%, as compared to 1999.

Growth Status of Licensed Premises.Growth status of licensed premises for manufacturers,importers and wholesalers for the year 1997 until2000 are shown in Figure 7. In 2000, a total of1216 premises were licensed consisting of 208manufacturers, 322 importers and 686 licensedwholesalers.

Rajah 6: Pemeriksaan APB Premis Pengilang, 1995 2000Figure 6: GMP Inspections of Manufacturing Premises, 1995 2000

120

108

111

334

126

214

1995

1996

1997

1998

1999

2000

27A N N U A L R E P O R T 2 0 0 0

Senarai serta maklumat lengkap mengenai premis-premis berlesen boleh dicapai dan dilayari menerusilaman web BPFK (www.bpfk.gov.my).

Taburan Geografi Premis BerlesenTaburan geografi premis-premis berlesen bagi tahun2000 adalah seperti yang digambarkan dalamRajah 8. Negeri Selangor mempunyai premisberlesen yang paling banyak, diikuti oleh, WilayahPersekutuan (Kuala Lumpur) dan Pulau Pinangditempat ketiga.

List and detail information on licensed premises areavailable on the NPCB homepage atwww.bpfk.gov.my.

Geographical Distribution of LicensedPremises.Geographical distribution of licensed premises for theyear 2000 are illustrated in Figure 8. Selangorrecorded the highest number of licensed premises, followed by Wilayah Persekutuan (KualaLumpur) and Penang respectively.

Rajah 7: Bilangan Premis Berlesen, 1987 2000Figure 7: Number of Licensed Premises, 1987 2000

1400

1200

1000

800

600

400

200

0

Pengimport / Importer

Pengilang / Manufacturer

Pemborong / Wholesaler

Jumlah / Total

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

23 27 25 33 33 43 46 59 62 74 106 146 190 208

88 95 83 91 87 107 129 127 113 159 147 256 264 322

155 180 151 186 178 315 683 668 772 596 603 674 677 686

266 302 259 310 298 465 858 854 947 829 856 1076 1131 1216

Rajah 8: Taburan Geografi Premis Berlesen, 2000Figure 8: Geographical Distribution of Licensed Premises, 2000

Joh Ked Kel Mel NS Phg Prk Prs PP Sab Swk Sel Trg WP

31 21 9 14 3 0 17 2 27 0 4 63 0 17

14 4 1 3 2 0 9 0 23 2 9 153 0 102

53 16 39 23 13 29 69 1 65 96 104 99 27 52

98 41 49 40 18 29 95 3 115 98 117 315 27 171

350

300

250

200

150

100

50

0

Pengilang / Manufacturer

Pengimport / Importer

Pemborong / Wholesaler

Jumlah / Total

L A P O R A N T A H U N A N 2 0 0 028

Kategori Pengilang BerlesenKategori premis pengilang berlesen bagi tahun 2000adalah seperti yang dipaparkan dalam Rajah 9.Negeri Selangor mempunyai bilangan premis pengilang yang tertinggi, diikuti oleh Johor dan tempat ketiga Pulau Pinang.

Kadar Pertumbuhan Premis BerlesenKadar pertumbuhan premis berlesen adalah seperti yang digambarkan dalam Rajah 10. Bagi tahun 2000, pengimport menunjukkan kadar pertumbuhan yang paling tinggi berbanding pengilang dan pemborong. Pada keseluruhan kadarpertumbuhan yang dicatat ialah 7.5% berbanding5.8% pada tahun lepas.

Categories of Licensed ManufacturingPremises.Categories of licensed manufacturing premises for theyear 2000 are illustrated in Figure 9. Selangorrecorded the highest number of licensedmanufacturing premises, followed by Johore andPenang respectively.

Growth Rate of Licensed Premises.Growth rate of licensed premises are illustrated inFigure 10. In 2000, importers show the highestgrowth rate as compared to manufacturer andwholesaler. As a whole, overall growth rate wasrecorded to be 7.5% compared to 5.8% last year.

Rajah 9: Kategori Premis Berlesen, 2000Figure 9: Categories of Licensed Manufacturing Premises, 2000

Joh Ked Kel Mel NS Phg Prk Prs PP Sab Swk Sel Trg WP

10 4 1 3 1 0 6 0 13 0 0 31 0 5

31 21 9 14 3 0 17 2 27 0 3 63 0 17

1 0 0 0 0 0 0 0 1 0 0 0 0 1

20 17 8 11 2 0 11 2 13 0 3 32 0 11

70

60

50

40

30

20

10

0

Farmaseutikal / Pharmaceutical

Tradisional/ Traditional

Kosmetik / Cosmetic

Jumlah / Total

29

Khidmat NasihatBagi tahun 2000, sebanyak 210 khidmat nasihat telahdiberikan, berbanding 196 pada tahun 1999, 185pada tahun 1998 dan 140 pada tahun 1997.Daripada jumlah yang dicapai 32 adalah berkaitan APB keluaran racun, 9 bukan racun, 126 ubat tradisional, 12 kosmetik, dan 31 lain-lain. Statistik bagi tahun 1997 hingga 2000 adalah sepertiyang ditunjukkan dalam Rajah 11.

Advisory ServiceIn 2000, a total of 210 advisory service were givencompared to 196 in 1999, 185 in 1998 and 140 in1997. From the increased output, 32 of them wererelated to GMP scheduled poison, 9 non-scheduled poison, 126 traditional medicine, 12cosmetic and 31 others. Statistic for the year 1997until 2000 are illustrated in Figure 11.

1997 1998 1999 2000

250

200

150

100

50

0

Rajah 11: Khidmat Nasihat, 1997 2000Figure 11: Advisory Service, 1997 2000

185 196210

140

Rajah 10: Kadar Pertumbuhan Premis Berlesen, 1988 2000Figure 10: Growth Rate of Licensed Premises, 1988 2000

140

120

100

80

60

40

20

0

-20

-40

Pengilang / Manufacturer

Pengimport / Importer

Pemborong / Wholesaler

Jumlah / Total

88 89 90 91 92 93 94 95 96 97 98 99 0

17.4 -7.4 32 0 30.3 6.9 28.3 5.08 19.4 43.2 37.7 30.1 9.5

8 -12.6 9.6 -4.4 23 20.6 -1.55 -11 40.7 -7.6 74.1 3.1 22

16.1 -16.1 23.2 -4.3 77 116.8 2.2 15.6 -22.8 1.2 11.8 -0.9 1.3

13.5 -14.2 19.7 -3.9 56 84.5 -0.5 10.9 -12.5 3.3 15.7 5.8 7.5

A N N U A L R E P O R T 2 0 0 0

L A P O R A N T A H U N A N 2 0 0 030

PEMPROSESAN LESENLesen PengilangSebanyak 289 lesen pengilang telah diprosesberbanding 237 pada tahun 1999, 148 pada tahun1998 dan 100 pada tahun 1997. Daripada jumlahini, 30 adalah permohonan baru manakala 259 lagiadalah pembaharuan. Pencapaian ini adalahsebanyak 2.9 kali ganda melebihi sasaran yangditetapkan.

Lesen PengimportBagi lesen pengimport, sebanyak 424 permohonantelah diterima dan diproses. Daripada jumlah ini, 38adalah permohonan baru dan 386 pembaharuan.Bilangan permohonan didapati telah meningkatberbanding 305 pada tahun 1999, 255 pada tahun1998 dan 171 pada tahun 1997. Pencapaian ini jugaadalah 69.6% melebihi sasaran yang ditetapkan.

Lesen PemborongBilangan permohonan lesen pemborong yangdiproses adalah 728, dimana 86 adalah permohonanbaru dan 642 pembaharuan. Bilangan permohonanyang diproses telah menurun 26.1% berbandingtahun 1999.

LICENCE PROCESSING.Manufacturers License.A total of 289 manufacturers licenses were processedcompared to 237 in 1999, 148 in 1998 and 100 in1997. From this total number, 30 are new applicationswhereas the remaining 259 are renewals. Theperformance achieved is 2.9 times more than thetargeted output.

Importers License.A total of 424 applications were received andprocessed for importer license. From this total, 38applications are new applications and 386 arerenewal. The number of applications has increasedsignificantly, compared to 305 in 1999, 255 in 1998and 171 in 1997. The performance is 69.9% morethan the targeted output.

Wholesalers License.The number of applications processed for wholesalerslicense is 728, whereby 86 are new applications and642 renewals. The number of applications processedhas decreased by 26.1% as compared to 1999.

Rajah 12: Pemprosesan Lesen, 1995 2000Figure 12: Processing of Licenses, 1995 2000

2000

1999

1998

1997

1996

1995

0 500 1000 1500 2000

1995 1996 1997 1998 1999 2000

719 827 916 1108 1527 1441

544 596 642 705 985 728

113 159 171 255 305 424

62 72 103 148 237 289

Jumlah / Total

Pemborong / Wholesaler

Pengimport / Importer

Pengilang / Manufacturer

31A N N U A L R E P O R T 2 0 0 0

Senarai Tambahan Keluaran BerdaftarJumlah permohonan yang diproses pada tahun 2000adalah sebanyak 299 dan jumlah produk ialah1,228. Pada tahun 1999 jumlah permohonan adalahsebanyak 314 dan melibatkan 1,928 produk,berbanding 343 permohonan dan 1,844 produkpada tahun 1998. Rajah 13 menunjukkan statistikbagi pengeluaran senarai tambahan produk untuktahun 1998 hingga 2000.

Pertukaran Pemegang LesenBagi tahun 2000, sebanyak 22 pertukaran pemegangtelah diproses, dimana 4 adalah untuk pengilang, 6pengimport dan 12 pemborong. Bilangan yangdicapai telah menurun 53.2% berbanding tahun1999. Statistik bagi permohonan pertukaranpemegang bagi tahun 1997 hingga 2000 adalahseperti yang ditunjukkan dalan Rajah 14.

Additional Lists for Registered Products.The total number of applications that were processedin 2000 was 299 and these include 1228 newproducts. In 1999, the number of application was 314and it includes 1928 products compared with 343applications and 1844 products in 1998. Figure 13shows statistics for issuance of additional registeredproduct list for the year 1998 until 2000.

Change of License Holder.In 2000, a total of 22 applications for change oflicense holder were processed, whereby 4 weremanufacturers, 6 importers and 12 wholesalers. Theissuance has decreased by 53.2% as compared to1999. Statistics for change of license holder for theyear 1997 until 2000 are illustrated in Figure 14.

1997 1998 1999 2000

100

90

80

70

60

50

40

30

20

10

0

Rajah 14: Permohonan Pertukaran Pemegang, 1997 2000Figure 14: Application for Change of Holder, 1997 2000

PengilangManufacturer

PengimportImporter

PemborongWholesaler

JumlahTotal

56

34

47

27

11

9

23

13

64

14

8

12

1998 1999 2000

2500

2000

1500

1000

500

0

Rajah 13: Pengeluaran Senarai Tambahan Produk 1998 - 2000Figure 13: Issuance of Additional Registered Product List, 1998 2000

PermohonanApplication

ProdukProduct

314 299343

1844 1928

1228

L A P O R A N T A H U N A N 2 0 0 032

Perakuan APB Untuk Tujuan EksportPada tahun 2000 jumlah perakuan APB yangdikeluarkan adalah sebanyak 181, berbanding 101pada tahun 1999, 124 pada tahun 1998 dan 80pada tahun 1997. Perakuan ini adalah untuk negara-negara termasuk Vietnam, Hong Kong, Philippines,Brazil, Kemboja, Bahrain, Qatar, United ArabEmirates, Namibia, Peru, Myanmar, Indonesia,Singapura. Australia, Iraq, Oman, Poland, SaudiArabia, Barbados, Slovakia, Tanzania, Thailand,Taiwan, Bulgaria, Mesir, Venezuela, Denmark, Sudan,Jordan, Zambia, Ethiopia, Pakistan, Sri Lanka,Maldives, Kanada, Papua New Guinea, DominicanRepublic, Yemen, Kazakhstan, China, Honduras,Lithuania, Malta, India, Brunei Darussalam, Romaniadan Kenya.

Tindakan PunitifPihak Berkuasa Kawalan Dadah (PBKD) telahmenggantung sementara lesen pengilang bagi 4premis pada tahun 2000, berbanding 5 pada tahun1999, 3 pada tahun 1998 dan 6 pada tahun 1997.

GMP CertificationIn 2000, the total number of GMP certificates issuedwas 181, as compared with 101 in 1999, 124 in1998 and 80 in 1997. These certifications are forcountries such as Vietnam, Hong Kong, Philippines,Brazil, Cambodia, Bahrain, Qatar, United ArabEmirates, Namibia, Peru, Myanmar, Indonesia,Singapore. Australia, Iraq, Oman, Poland, SaudiArabia, Barbados, Slovakia, Tanzania, Thailand,Taiwan, Bulgaria, Egypt, Venezuela, Denmark, Sudan,Jordan, Zambia, Ethiopia, Pakistan, Sri Lanka,Maldives, Canada, Papua New Guinea, DominicanRepublic, Yemen, Kazakhstan, China, Honduras,Lithuania, Malta, India, Brunei Darussalam, Romaniaand Kenya.

Punitive ActionsThe DCA has temporarily suspended manufacturinglicenses for 4 premises in 2000, compared with 5 in1999, 3 in 1998 and 6 in 1997.

1997 1998 1999 2000

200

180

160

140

120

100

80

60

40

20

0

Rajah 15: Permohonan Perakuan Amalan Perkilangan Baik (APB), 1997 2000Figure 15: Application of Good Manufacturing Practice (GMP) Certificates, 1997 2000

80

124

101

181

33A N N U A L R E P O R T 2 0 0 0

TWG GMPKumpulan kerja teknikal (TWG) GMP telahmenganjurkan 5 bengkel latihan APB bercorak moduluntuk industri farmaseutikal tempatan. Bidang-bidangyang diliputi adalah seperti berikut:

Module 1 Quality assurance and GMP auditing.

Module 2 GMP documentation and records.

Module 3 GMPs for utilities and services.Module 4 Facility, materials and

environmental control.Module 5 GMPs for equipment, cleaning

and computerized systems.

Penubuhan Pusat IndustriFarmaseutikalPembinaan pusat tersebut yang merangkumi kawasankilang contoh, ruangan sumber maklumat danruangan untuk pameran telah dilaksanakan secaraberperingkat.

Permohonan Untuk Menjadi AhliPharmaceutical Inspection CooperationScheme (PIC/S)Dua orang pegawai BPFK telah mewakili Malaysiapada Mesyurat PIC/S 2000 yang diadakan diColmar, Perancis pada 24 Oktober 2000.Berdasarkan penilaian dokumentasi, PIC/S telahberpuas hati dengan maklumat-maklumat yangdikemukakan oleh Malaysia. PIC/S telah membuatkeputusan untuk menghantar delegasi seramai 6orang untuk menilai sistem pemeriksaan di Malaysiapada bulan Mac 2001. Penilai-penilai tersebut adalahdaripada Australia, Slovak Republik, United Kingdom,Switzerland dan Singapura.

Garis Panduan APB KosmetikDraf garispanduan tersebut telah dikemukakankepada Asean Consultative Committee for Standardsand Quality (ACCSQ) Cosmetic Product WorkingGroup untuk dipertimbangkan dan diterima-pakaisebagai Garis Panduan APB Kosmetik ASEAN.

Garis Panduan Fail Induk PengilangGaris panduan Edisi Kedua telah dicetak dan akandiedarkan kepada semua pengilang berlesen untukdilengkapkan dan dikemaskini.

TWG GMPThe GMP Technical Working Group (TWG) hasconducted five modular training workshops in GMP forlocal pharmaceutical industries. The following moduleswere carried out in 2000:

Module 1 Quality assurance and GMPauditing.

Module 2 GMP documentation and records.

Module 3 GMPs for utilities and services.Module 4 Facility, materials and

environmental control.Module 5 GMPs for equipment, cleaning

and computerized systems.

Establishment of PharmaceuticalIndustry Centre.The centre which includes a mock factory, informationcentre and exhibition course were developed phaseby phase.

Application of PIC/S Membership.Two officers from NPCB represented Malaysia for thePIC/S 2000 Meeting which was held in Colmar,France, in October 24, 2000. Based on thedocumentation evaluation, PIC/S was satisfied withthe information submitted by Malaysia. PIC/S hasdecided to send a delegation consisting of six auditorsto evaluate the inspection system in Malaysia, inMarch 2001. The auditors are from Australia, SlovakRepublic, United Kingdom, Switzerland andSingapore.

Cosmetic GMP Guidelines.The draft guideline was submitted to the ASEANConsultative Committee for Standards and Quality(ACCSQ) Cosmetic Product Working Group to beconsidered and adopted as the ASEAN Cosmetic GMPGuidelines.

Site Master File Guideline.The second edition of the Site Master File guidelineshave been printed and will be distributed to all thelicensed manufacturers for completion and updating.

L A P O R A N T A H U N A N 2 0 0 034

Pensijilan ISO 9002Bahagian ini juga telah menyediakan danmengemaskini prosedur-prosedur kualiti yangberkaitan dengan skop pemeriksaan dan pelesenan.Seramai 4 orang Pegawai Farmasi daripadabahagian ini terlibat dalam Jawatankuasa ISOTeknikal manakala 3 orang pula terlibat dalamkumpulan Audit Dalaman untuk bahagian-bahagianBPFK dan 2 daripada mereka adalah ketua kumpulan.Seorang Pegawai Farmasi juga telah dilantik untukmembantu Document Control Centre (DCC).

RANCANGAN UNTUK TAHUN 2001Usahasama Pemeriksaan APBUsahasama diantara BPFK dengan UPFN akan terusdipergiatkan untuk memantapkan Skim InspektoratKebangsaan dan meningkatkan pemantauan danpenguatkuasaan skim pelesenan, khususnya untukpremispengilang ubat tradisional. Satu jadualpemeriksaan premis pengilang tradisional akandisediakan untuk diagihkan kepada UPFN.

Pusat Industri Farmaseutikal Peruntukan tambahan akan dipohon untukmengubahsuai dan melengkapkan infrastrukturdengan kemudahan-kemudahan asas termasukperabot, peralatan pejabat dan lain-lain. Jawatan-jawatan baru juga akan dipohon.

Permohonan Untuk Menjadi Ahli PIC/SSatu sesi taklimat mengenai permohonan Malaysiauntuk menjadi ahli PIC/S akan dianjurkan oleh BPFKuntuk menyampaikan maklumat kepada pengilang-pengilang tempatan. Pemeriksaan latihan (mockaudit) juga akan diatur untuk meningkatkankecekapan.

Latihan APB Farmaseutikal BercorakModulProgram latihan APB bercorak modul untuk industrifarmaseutikal tempatan akan diadakan seperti yangdijadualkan pada bulan Februari, Mac, April dan Mei2001. Projek ini akan dikelolakan bersama denganMOPI dan Intertech Global Access Australia. Modul-modul tersebut adalah seperti berikut:

- process control manufacturing and packaging.- Process validation , plans and protocols.- Introduction to Good Laboratory Practices.- Staff development and GMP training.

ISO 9002 Certification.Several quality procedures regarding inspection andlicensing were prepared and updated. Four officersfrom this division are involved in the ISO TechnicalCommittee and three officers involved in InternalQuality Audit team for NPCB divisions and two ofthem are team leaders. An officer has also beenappointed to assist the Document Control Centre(DCC).

PLANS FOR YEAR 2001.GMP Inspection Co-operation.Co-operation between NPCB and State PharmacyEnforcement Units will be enhanced to strengthen theNational Inspectorate Scheme towards strengtheningthe monitoring and enforcement of the licensingscheme, especially for traditional medicinemanufacturing premises. A schedule on inspection oftraditional manufacturing premises will be preparedand distributed to the State Pharmacy EnforcementUnits.

Pharmaceutical Industry Centre.Additional budget will be needed for renovation andfurnishing the centre with basic facilities such asfurniture, office equipment and other miscellaneousitems.

Application of PIC/S Membership.A briefing session regarding Application of PIC/SMembership by Malaysia will be conducted by NPCBto deliver information to the local manufacturers. MockAudits will be conducted to provide training.

GMP Modular Training.GMP modular training programme for localpharmaceutical industry will be held as scheduled inFebruary, March, April and May, 2001. Thisprogramme will be jointly organized with MOPI andIntertech Global Access Australia. Modules to beconducted are as follows:

- process control manufacturing and packaging.- Process validation , plans and protocols.- Introduction to Good Laboratory Practices.- Staff development and GMP training.

35A N N U A L R E P O R T 2 0 0 0

Bengkel Dokumentasi APB UntukPengilang Ubat TradisionalBeberapa bengkel dalam aspek dokumentasi APBkhususnya untuk pengilang ubat tradisional akandianjurkan bersama dengan organisasi industriberkenaan. Bengkel-bengkel tersebut akan diadakanmengikut zon.

Harmonisasi Kosmetik ASEANBagi aspek APB, usaha-usaha gigih perludiselaraskan dengan industri kosmetik tempatan sertapihak-pihak berkuasa negara-negara ASEAN untukmewujudkan infrastruktur teknikal khususnyamengatur dan mengadakan latihan dalam bidangAPB, dibawah program ACCSQ (Cosmetic).

Harmonisasi Farmaseutikal ASEANMalaysia akan bekerjasama dengan negara-negaraASEAN dalam usaha mengharmonisasikan keperluanAPB semasa, selaras dengan garispanduanantarabangsa.

Asian Harmonisation Working Party(AHWP) untuk Peralatan PerubatanSatu jawatankuasa yang dikenali sebagai AsianHarmonisation Working Party (AHWP) telahditubuhkan untuk mengkaji dan mencadangkan cara-cara untuk mengharmonisasikan peraturan-peraturanmengenai peralatan perubatan di rantau Asia selarasdengan aliran global, serta kerjasama dengan GlobalHarmonization Task Force (GHTF) dan Apec. Malaysiatelah dilantik sebagai Naib Pengerusi 1 untuk AHWPTechnical Committee.

Pihak BPFK dengan kerjasama Association ofMalaysia Medical Industries (AMMI) bercadang untukmenganjurkan satu seminar kawalan regulatoriperalatan perubatan untuk memberi kesedaran danmaklumat kepada industri berkenaan.

Pelesenan Kosmetik dan KeluaranVeterinarBahagian ini akan berusaha kearah melaksanakankeperluan pelesenan untuk premis-premis kosmetikdan keluaran veterinari sepertimana yangdijadualkan sebagai susulan selepas pendaftarankeluaran-keluaran tersebut.

GMP Documentation Workshop forTraditional Medicine Manufacturer.Several GMP documentation workshops especially fortraditional medicine manufacturers will be held andjointly organized with relevant industry organization.The workshops will be conduct according to zones.

ASEAN Cosmetic Harmonization.With regards to GMP, the cosmetic industries andASEAN regulatory authorities need to work hand inhand to establish technical infrastructure especially inarranging and conducting training in GMP, under theACCSQ (Cosmetic).

ASEAN Pharmaceutical Harmonization.Malaysia will co-operate with other ASEAN countriestowards harmonization of current GMP requirements,in tandem with international guidelines.

Asian Harmonization Working Party(AHWP) for Medical Device.The Asian Harmonization Working Party (AHWP) wasestablished to analyze and propose methods toharmonize regulations on medical device in Asia, intandem with global trend, and also to co-operate withthe Global Harmonization Task Force (GHTF) andAPEC. Malaysia was appointed as Vice Chairman forAHWP Technical Committee.

The NPCB and Association of Malaysia MedicalIndustries (AMMI) will jointly organise a seminar onmedical device regulatory control to create awarenessand provide information to relevant industries.

Licensing of Cosmetic and VeterinaryProduct.This division will work towards implementation oflicensing for cosmetics and veterinary productpremises as scheduled, in tandem with productregistration.

L A P O R A N T A H U N A N 2 0 0 036

BAHAGIAN SURVEILANS DANFARMAKOVIGILANS

OBJEKTIFObjektif Bahagian Surveilans dan Farmakovigilansadalah untuk memastikan secara berterusan bahawasemua keluaran yang berdaftar dengan PihakBerkuasa Kawalan Dadah adalah selamat, berefikasidan memenuhi tahap kualiti yang diiktiraf.

PENCAPAIANSepanjang tahun 2000, program surveilans telahmenyaksikan peningkatan sebanyak 9.6% dalamjumlah persampelan keluaran untuk tujuan kajiankualiti berbanding pada tahun 1999 dan peningkatansebanyak 150.5% berbanding tahun 1998. Julat danbilangan sampel keluaran untuk tujuan surveilanstelah meningkat dengan adanya kerjasama pegawaiunit penguatkuasa farmasi negeri yang membantudalam pungutan sampel keluaran daripada premispemegang lesen di seluruh negara.

Jumlah laporan kesan advers ubat yang diterimapada tahun 2000 menurun sedikit iaitu sebanyak 792laporan berbanding 885 laporan pada tahun 1999.

Bilangan aduan keluaran bagi keluaran berdaftarmenurun pada tahun 2000 dengan jumlahkeseluruhan sebanyak 110 aduan berbanding 151laporan pada tahun sebelumnya. Ini mungkindisebabkan peningkatan dalam kualiti keluaran didalam pasaran yang menghasilkan penguranganaduan.

SURVEILLANCE &PHARMACOVIGILANCE DIVISION

OBJECTIVEThe objective of the Surveillance andPharmacovigilance Division continue is ensure thatproducts registered by the Drug Control Authority aresafe, efficacious and meet the established standards ofquality.

ACHIEVEMENTSDuring the year 2000, the surveillance program sawa 9.4% increase in the number of products sampled forquality testing as compared to 1999 and an increaseof 150.5% increase as compared to 1998. The rangeand number of products sampled for surveillance wasincreased through the assistance of the state pharmacyenforcements officers who supplemented the activitiesof the surveillance officers by collecting samples ofproducts from the premise of the registration holdersthroughout the country.

The number of adverse drug reactions reports receivedreduced slightly in 2000 as a total of 792 reports werereceived as compared to 885 in 1999.

The number of product complaints for registeredproducts dropped in 2000 with a total of 110complaints being received as compared to 151 in theprevious year. This could be attributed to the quality ofproducts in the market improving thus resulting infewer complaints.

2000

1500

1000

500

0

Bil. keluaran diujiNo. of products sampledBil. laporan ADR diterimaNo. of ADR reports receivedBil. aduan diterimaNo. of complaints received

1 2 3 4 5

531 602 714 1635 1789

530 602 603 875 792

55 97 111 151 110

Rajah 16: Aktiviti SurveilansFigure 16: Surveillance Activities

37A N N U A L R E P O R T 2 0 0 0

Surveilans1789 sampel keluaran berdaftar yang digunakan diMalaysia telah diambil dibawah program ini untuksurveilans. Namun begitu, disebabkan lebihan daritahun sebelumnya, sejumlah 2032 keluaran telahdihantar untuk ujian makmal dan keputusan 1726keluaran telah diterima. Analisis kadar kegagalankeluaran yang telah diuji berdasarkan kategorikeluaran ditunjukkan di dalam pada Rajah 17.

PanggilbalikArahan telah dikeluarkan untuk membuatpanggilbalik terhadap 120 kelompok keluaran dimana 13 adalah keluaran racun berjadual, 10persediaan bukan racun dan 97 keluaran tradisional.Manakala 28 keluaran lagi (19 racun; 7 OTC; 2 tradisional) telah dipanggilbalik secara sukarelaoleh pemegang pendaftaran keluaran berdasarkanaduan yang diterima terhadap keluaran tersebut.

SurveillanceSamples of 1789 products registered for use inMalaysia were taken through this program forsurveillance. However, due to a spillover from theprevious year, a total of 2032 products were actuallysent for laboratory testing and results were receivedfor 1726 products. An analysis of the failure rate ofproducts tested by category of products is shown inFigure 17.

RecallsInstructions were issued for the recall of 120 batches ofproducts of which 13 were products containingscheduled poisons, 10 were over-the-counterpreparations and 97 were traditional medicines. 28other products (19-poisons; 7-OTC; 2 -traditional)were recalled voluntarily by the product registrationholders mainly based on product complaints.

Rajah 17: Analisis Keputusan SurveilansFigure 17: Analysis of Surveillance Results

Racun (Poison)25 (1%)

Lain-lain(Other)

13%

LULUS (Pass)1493 (87%)

Bukan Racun(OTC)

35 (2%)

Tradisional (Traditional)173 (10%)

Jadual 6: Panggilbalik Keluaran Atas arahan + sukarela Table 6: (Product Recalls - Directive + voluntary)

TahunYear 1995 1996 1997 1998 1999 2000

JumlahTotal 35 37 32 93 148 148

KategoriCategory 35 20 93 32 17 99(A/X/T)

A=Racun (Poisons); X=OTC; T=Ubat Tradisional (Traditional Medicine)

L A P O R A N T A H U N A N 2 0 0 038

Tiada panggilbalik yang begitu serius yangmengkehendaki panggilbalik Paras I atau II. Semuapanggilbalik adalah panggilbalik Paras III i.edilakukan dalam tempoh 30 hari sehingga Tahap Biaitu sampai kepada pusat pengedaran.

Pemonitoran ADRDibawah program pemonitoran ADR, didapatiterdapat sedikit penurunan pada jumlah laporankesan advers ubat yang diterima pada tahun 2000berbanding tahun 1999.

Bilangan laporan yang diterima daripada pelbagainegeri ditunjukkan pada Rajah 19 dengan jumlahlaporan tertinggi yang dihantar adalah dari hospitalKuala Lumpur dan negeri Selangor.

There were no recalls which were serious enough towarrant a Degree I or Degree II recall. All recalls wereDegree III recalls i.e. carried out over period of 30days and were done up to Level B which is up to thepoint of distribution.

ADR Monitoring Under the ADR monitoring program, there was a slightdecrease in the number of adverse drug reactionreports received in 2000 as compared to 1999.

The reporting rate from the various states is as shownin Figure 19 with the highest number of reportsbeing submitted from the Kuala Lumpur GeneralHospital and from the state of Selangor.

Rajah 18: Bilangan aduan yang diterima oleh ADRFigure 18: Number of ADR reports receiver

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

900

800

700

600

500

400

300

200

100

010 38 40 44

150

216263

233

602

875

603

792

400

530

Rajah 19: Analysis ADRs berdasarkan negeriFigure 19: Analysis of ADRs by reporting states

120

100

80

60

40

20

0

Sela

ngor

K. L

umpu

r

Joho

r

Pera

k

Paha

ng

Sara

wak

Saba

h

N. S

embi

lan

P. Pi

nang

Tere

ngga

nu

Keda

h

Kela

ntan

Mel

aka

Labu

an

Perli

s

112 112

106

88

4743

4135 34

2924

19 17

83

39A N N U A L R E P O R T 2 0 0 0

Usaha telah dijalankan untuk menggalakkanpenglibatan daripada pelbagai bidang untukmempertingkatkan kadar laporan ADR di manasebelum ini banyak bergantung kepada doktor darisektor awam. Walaubagaimanapun, jumlah laporanADR oleh doktor dari hospital kerajaan menurunsedikit tetapi terdapat peningkatan ketara padajumlah laporan yang dikemukakan oleh ahli farmasi.Tiada perbezaan yang signifikan di dalampemonitoran ADR oleh industri farmaseutikal padatahun 2000 berbanding tahun 1999 (Rajah 20).

RANCANGAN UNTUK MASA DEPANBahagian Surveilans merancang untuk menstruktursemula Program Post-Market Surveilans di manaperatusan tertentu keluaran yang mewakili senaraikeluaran yang dikeluarkan oleh sesuatu pengeluarakan diambil untuk surveilans. Berdasarkan sistem ini,diharap lebih banyak keluaran akan dicakupi untuksurveilans di samping memberi profil tentangkedudukan pengeluar.

Satu sistem untuk surveilans bagi pemonitoran kesanadvers ubat telah dirancang di mana beberapa ubatakan dikenalpasti untuk surveilans secara intensif olehbahagian ini.

Efforts were made to encourage a multidisciplinaryapproach to improve the reporting rate of ADRswhich previously relied mainly on doctors in the publicsector. In 2000, there was a slight increase in thenumber of ADRs reported by doctors from the privatesector. Unfortunately, the number of ADRs reported bydoctors from government hospitals decreased slightlybut there was a marked decrease in the number ofreports submitted by pharmacists. There was nosignificant difference in the monitoring of ADRs by thepharmaceutical industry in 2000 as compared to1999 (Figure 20).

FUTURE PLANSThe surveillance division plans to restructure the Post-Market Surveillance Program whereby a certainpercentage of products which will be representative ofthe range of products manufactured by a particularmanufacturer will be taken for surveillance. It is hopedthat with this system, a wider range of products can becovered for surveillance whilst providing a profile ofthe standard of the manufacturer.

An improved system for surveillance of adversereaction monitoring is being planned whereby certaindrugs will be identified for intensive surveillance bythis division.

Rajah 20: Analisis PelaporFigure 20: Analysis of Reporters

Doktor Kerajaan / Government DoctorsPengawal Perubatan Swasta / Private Practitioners

Ahli Farmasi / Pharmacists

Industri / Industry

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

10 32 36 39 87 129 193 191 303 419 473 469 607 573

0 2 2 4 51 81 68 33 70 61 52 44 66 74

0 3 2 1 12 6 2 9 27 40 61 61 141 38

0 1 0 0 0 0 0 0 0 10 16 18 54 43

L A P O R A N T A H U N A N 2 0 0 040

BAHAGIAN ANALISIS UBAT

PENGAWALAN MUTU UBATBahagian Analisis Ubat (BAU) meneruskan perananyang efektif dalam kawalan kualiti produk yangmerupakan satu komponen penting dalam penilaianproduk farmaseutikal. Produk yang diterimamerangkumi produk untuk permohonan pendaftaran,pengawasan mutu ubat di pasaran ke atas keluaranberdaftar, kes-kes aduan untuk keluaran berdaftardan sampel dari penguatkuasaan. Ujian yangdijalankan meliputi ujian-ujian kimia, fizikal,mikrobiologi, farmakologi dan toksikologi, yangmerangkumi berbagai jenis ujian seperti ujianidentifikasi, berbagai jenis ujian had, penentuankandungan bahan dalam produk dan juga penelitiankepada pelbagai parameter prestasi dosis. Kriteriauntuk penerimaan keputusan ujian berasaskankepada farmakopia, spesifikasi dalaman atauhad/spesifikasi pengilang yang diluluskan.

PENCAPAIANPencapaian BAU bagi tahun 2000 adalahseperti berikut:

Beban KerjaSepanjang tahun 2000 BAU telah menguji sebanyak5,539 sampel (Rajah 21) dan menjalankan 34,153Ujian (Rajah 22). Berbanding dengan pencapaiandi tahun 1999, bilangan sampel yang diuji telahmeningkat sebanyak 20.9% sementara bilanganujian yang dilakukan meningkat sebanyak 25.4%.

DRUG ANALYSIS DIVISION

QUALITY CONTROLDrug Analysis Division (DAD) continues to play aneffective role in quality control assessment of productswhich constitute an important component ofpharmaceutical product evaluation. The productsreceived include samples submitted for registration,registered products submitted for post marketingsurveillance, complaint samples and enforcementsamples. The tests conducted include chemical,physical, microbiological, pharmacological andtoxicological, covering various types such asidentification tests, the various limit tests, quantitationof the content in the product and also assessing thevarious dosage performance parameters. Acceptancecriteria are based on pharmacopoeia, in-house orapproved manufacturers limits and specifications.

ACHIEVEMENTSThe achievements of DAD in 2000 aresummarized as follows

WorkloadThroughout the year 2000, DAD had analyzed a totalof 5,539 samples (Figure 21) which generated atotal of 34,153 tests (Figure 22). In comparison tothe achievements in 1999, the number of samplesanalyzed has increased by 20.9% while the number oftests done has increased by 25.4%.

Rajah 21: Bilangan Sampel DiujiFigure 21: Number of Samples Tested

12000

10000

8000

6000

4000

2000

0

4583

55396343 6623

4922

7141

11337

85177472

998710698

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

41A N N U A L R E P O R T 2 0 0 0

Jenis sampel yang diterima dijelaskan dalam Rajah23, perbandingan keluaran tradisional dan bukantradisional dinyatakan di Rajah 24 danperbandingan keluaran import dan tempatandigambarkan di Rajah 25.

Selain dari itu, penganalisaan terhadap keputusanujian menunjukkan bahawa 8.5% daripada jumlahujian telah gagal ujian makmal (Rujuk Rajah 26)

The types of samples received are illustrated in Figure23, comparison between traditional and non-traditional samples indicted in Figure 24 andcomparison between imported and locallymanufactured samples illustrated in Figure 25.

Additional analysis of the test results has shown that8.5% of the tests done had failed laboratory tests(Refer to Figure 26).

Rajah 22: Bilangan Ujian DijalankanFigure 22: Number of Tests Done

40000

35000

30000

25000

20000

15000

10000

5000

0

2327925949

19776

3258635017

27236

34153

2371024519

28370 28649

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

Rajah 23: Jenis Sampel DiterimaFigure 23: Types of Samples Received

(5%)Unit PenguatkuasaFarmasi & Lain-lain

Pharmacy EnforcementUnit & Others

(62%)PengawasanSurveillance

(29%)PendaftaranRegistration

(4%)Aduan

Complaint

Rajah 24: Perbandingan Sampel Ubat Tradisional Dengan Sampel LainFigure 24: Traditional Medicine Versus Other Samples

(48%)Sampel Ubat Tradisional

Traditional Medicine Samples

(52%)Lain-Lain

Others

Rajah 25: Perbandingan Keluaran Import dan TempatanFigure 25: Imported Versus Local Samples

(55%)Sampel Keluaran Tempatan

Local Samples

(45%)Sampel Keluaran Import

Imported Samples

L A P O R A N T A H U N A N 2 0 0 042

Kos penganalisaan yang diterima juga telahmeningkat sebanyak 5.6% dengan pungutansebanyak RM 528,536.75 untuk tahun 2000

Penilaian tatacara dan protokol ujianSebanyak 730 protokol penganalisaan telah diterimapada tahun 2000. Terdapat penurunan sebanyak25.8% jika dibandingkan dengan bilangan protokolpada tahun 1999. Ini mencerminkan penurunanterhadap permohonan pendaftaran untuk keluaran difasa 1 dan 2. Namun begitu penilaian protokol ditahun 2000 dapat dijalankan dengan lebih berkesanapabila 98.8% penilaian protokol dapat diselesaikankurang dari 1 bulan (dibandingkan dengan 78.6%pada tahun 1999)

Menjalankan Pemeriksaan AmalanPerkilangan BaikSebelas pemeriksaan Amalan Perkilangan Baik (APB)untuk aspek mengenai Amalan Baik Makmal telahdilakukan ke atas premis pengilang farmaseutikaltempatan di tahun 2000 dan ini adalah lebih rendahdari bilangan yang dilaporkan pada tahun 1999(empat belas pemeriksaan).

Buat kali ketiganya seorang pemeriksa dari BAU telahmenjalankan pemeriksaan premis di luar negeriapabila En Jaafar telah menjalankan pemeriksaan keatas pengilang keluaran tradisional di Taiwan.

The collection of analytical fees had been increased by5.6% with RM 528,536.75 collected for the year2000.

The evaluation of analytical protocols730 analytical protocols were received in 2000. Thefigure showed a decrease of 25.3% when compared tothe number received in 1999. This reflects a decreasein the applications for registration of products in phase1 and phase 2 of the registration exercise. Howeverthe protocol evaluation for the year 2000 were able tobe effectively evaluated with 98.8% protocolevaluation completed in less that 1 month (comparedto 78.6% in the year 1999)

Good Manufacturing Practice(GMP) Inspection Eleven GMP inspections for Good Laboratory Practiceaspect were conducted on local pharmaceuticalmanufacturing premise in the year 2000 and this waslower than the number reported in 1999 (fourteeninspections)

For the third time DAD was involved in overseaspremise inspections when En. Jaafar was inspecting atraditional manufacturer in Taiwan.

Rajah 26: Perbandingan Ujian Lulus dan Gagal PenganalisaanFigure 26: Number of Tests Passed versus Failing Analysis

(91.5%)Bilangan Ujian Yang LulusPenganalisaan

Number of TestsWhich Passes Analysis

(8.5%)Bilangan Ujian Yang Gagal

PenganalisaanNumber of Tests

Which Fails Analysis

43A N N U A L R E P O R T 2 0 0 0

Piawai Rujukan Pada tahun 2000 sejumlah 237 vial piawai rujukan(ASEAN/BPFK) telah dibekalkan kepada jabatankerajaan dan ini merupakan peningkatan kepadajumlah pada tahun 1999 (198 vial). Selain dari ituterdapat peningkatan untuk jumlah piawai yang dijualkepada industri tempatan (446 vial pada tahun 2000berbanding dengan 329 vial pada tahun 1999)

Latihan Yang Dikendalikan Oleh BAU Mengendalikan kursus 5 hari dalam bidang kawalanmutu untuk pengeluar ubat tradisional tempatan yangberminat untuk mendapatkan pengetahuan "hands-on" dalam pengujian ubat tradisional. Seramai 12peserta telah menghadiri kursus tersebut yang telahdiadakan 2 kali iaitu dari 22 hingga 26 Mei 2000dan dari 5 hingga 9 Jun 2000.

Anggota BAU juga telah memberikan latihan 1minggu kepada Pelajar Farmasi UKM (tahun 3) pada3 hingga 8 April dan 20 hingga 25 Mac 2000. Selaindari itu empat peserta dari JKN Sarawak (En Stephenak Moses, Puan Lau Choon Eng, Encik Hasnan bEyong dan Puan Josephine Wong Ding Chee) telahdiberi latihan kawalan kualiti.

Latihan Untuk Kakitangan Satu seminar untuk Pembantu Farmasi telah diadakanpada 10 hingga 11 Oktober 2000 di BPFK. Seminarlain yang turut diadakan di BPFK untuk PembantuFarmasi termasuk "Laboratory Quality ManagementSystem of Measuring Instrument Seminar" yangdiadakan pada 23 March 2000, seminar mengenai"Safety in Use of Chemicals" yang diadakan pada 30hingga 31 Oktober 2000 dan kursus "Fundamental ofUV/Rf" yang diadakan pada 22 November 2000.Selain dari itu satu seminar mengenai "Culture media"telah diaturkan pada 5 April 2000 untuk semuakakitangan Mikrobiologi Farmaseutikal.

Reference StandardsIn year 2000 a total of 237 reference standards(ASEAN/NPCB) were supplied to governmentdepartments and this figure reflects an increase to thenumber reported in 1999 (198 vial). There was anincrease in the standards sold locally (446 vialcompared to 329 vial in 1999).

Trainings conducted by DAD andcooperation with the industryA 5-day hands-on training course in quality control oftraditional medicines was conducted for the localindustry. A total of 24 participants attended thetraining which has held twice from 22nd to 26th Mayand 5th to 9th Jun 2000.

UKMs third year students received a one weektraining from DAD staff from 3rd to 8th April and 20thto 25th Mac 2000. Four participants from JKNSarawak (En Stephen ak Moses, Puan Lau Choon Eng,Encik Hasnan b Eyong and Puan Josephine Wing DingChee) were given quality control training.

DAD had formed two working groups with the localpharmaceutical industry. Laboratory technical workinggroup was formed to deal with issues pertaining tolaboratory matters and had their first meeting held on27th November 2000. Meanwhile another workinggroup was formed to deal with matters pertaining toreference standard and the first meeting was held on21st November 2000.

Training for DAD staffA seminar for Pharmacy Assistants was held on 10thto 11th October 2000 in BPFK. Other seminars held inBPFK for Pharmacy Assistants include "LaboratoryQuality Management System of MeasuringInstruments", seminar on "safety in use of chemicals"and "fundamentals of UV/RF" which were held on23rd Mac 2000, 30th to 31st October 2000 and22nd November 2000 respectively. A seminar on"culture media" was arranged for the staff ofPharmaceutical Microbiology Laboratory on 5th April2000.

L A P O R A N T A H U N A N 2 0 0 044

Ahli baru BAUBAU telah mengalu-alukan kedatangan 3 orangpembantu farmasi baru iaitu Puan Ong Pei Pei, CikIsma Zairika bt Zainol dan Cik Malliga a/p Kalidas

Pematuhan ISO 9000Semua unit di BAU memandang serius pematuhanISO dengan menyediakan dokumen yang berkaitandengan prosedur pemprosesan kerja dan pengurusanmakmal mengikut standard dan masa yangditetapkan.

Mesyuarat Di luar Negeri En Lai Lim Swee telah menghadiri "18th Meeting of theASEAN Working Group on Technical Cooperation inPharmaceuticals" pada 30 Oktober 2000 hingga 1November 2000 dan beliau telah membentangkanlaporan aktiviti mengenai "Training Centre forStrengthening of Quality Assurance and Non-Pharmacopoeial Analytical Methods in Malaysia".

RANCANGAN UNTUK MASA DEPANBAU akan sentiasa bersedia untuk menghadapicabaran baru bagi melengkapkan dan meningkatkankeupayaan agar dapat terlibat secara aktif dan efektifdalam melaksanakan fasa-fasa pendaftaran yangberikutnya. Rancangan yang dijadualkan untuk tahun2001 adalah seperti berikut:

a) Meneruskan kursus kawalan mutu untuk pengeluar ubat tradisional tempat