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  1. NPRA Publications
  2. Safety Alerts
  3. Application Forms
  4. Industry
  5. Professional
  6. Public
  7. Online Statistic
  8. Sebut Harga
  • General Forms :
    Document Name PDF MS Word
    BPFK 001: Borang Penyerahan Permohonan Download -
    NPRA 300.1: Borang Pengkelasan Produk (digunakan mulai 1 Jan 2016) Download Download
    BPFK 399: Sampel Untuk Ujian Kualiti Keluaran Penilaian Ringkas Download -
    BPFK 400.003: Checklist Penyerahan Permohonan Pendaftaran (Unit Bioteknologi) Download -
    BPFK 403: Peraturan-peraturan kawalan dadah dan kosmetik 1984 sampel untuk ujian kualiti Download -
    BPFK 416.4: Application For Variation Of Registered Traditional And Health Supplement Products - Download
    NPRA 418.5: Borang Laporan Aduan Produk yang Berdaftar dengan PBKD Download -
    NPRA 420: Reporting Notified Cosmetic Products Download -
    BPFK 430.5(3): Borang Statement of Acceptance as Product Registration Holder Download Download
    BPFK 438.1 (T): Permohonan Bagi Produk Tradisional Untuk Tujuan Eksport Sahaja (FEO) Download -
    BPFK 438.1: Permohonan Bagi Pendaftaran Keluaran-Keluaran Untuk Tujuan Eksport Sahaja - Download
    BPFK 439AF: Borang Laporan Pertukaran Pemegang Lesen (Ahli Farmasi) Bagi Lesen Pengilang, Pemborong & Mengimport Download -
    BPFK 505: Set Up for Biological Based Product Manufacturing Facility Letter of Intent - Download
    Borang Permohonan Sijil Indikasi dan Sijil Deklarasi Download
  • Veterinary Forms:

    Document Name PDF MS Word
    Borang BPFK-438.1 (V) : Application Form for Veterinary Product For Export Only - Download
    BPFK-414.4:Permohonan Perakuan Penjualan Bebas Untuk Keluaran-Keluaran Veterinar Download -
    Borang BPFK-438.1 (V) : Application Form for Veterinary Product For Export Only Download -
  • GLP Forms:
    Document Name PDF MS Word
    200-103- Application for Good Laboratory Practice (GLP) Certification Download _
    300-101-Application Form for NPRA GLP Compliance Programme Download Download
  • Clinical Trial  Forms:
    Document Name PDF MS Word MS Excel
    PKPB/300/303 (Version 02) Borang Permohonan Variasi Lesen Import Percubaan Klinikal/ Kebenaran -
    PKPB/300/302 (Version 01) Borang Permohonan Kebenaran Mengilang Produk-produk Tidak Berdaftar -
    PKPB/300/301 (Version 03) Borang Permohonan Lesen Import Percubaan Klinikal -
    PKPB/300/290 (Version 00) CTILCTX Protocol Deviation Template - -
    PKPB/300/521 Borang Permohonan Pemeriksaan untuk Program Komplians BPFK bagi Pusat Kajian Bioekuivalens (Dalam Negara) - -
    PKPB/300/531 Borang Permohonan Pemeriksaan untuk Program Komplians BPFK bagi Pusat Kajian Bioekuivalens (Luar Negara) - -
    PKPB/300/546 Borang Pendaftaran dan Pemeriksaan Jawatankuasa Etika _
    PKPB/300/551 Borang Permohonan Penilaian Laporan Pemeriksaan Pusat Kajian BE bagi Pendaftaran Produk -
    PKPB/300/552 Borang Permohonan Penilaian Laporan Pemeriksaan Pusat Kajian BE Bagi Notifikasi Kajian -
    PKPB/300/561 Permohonan Untuk Notifikasi bagi Kajian Bioekuivalens (BE) yang Tidak Memerlukan Lesen Import Percubaan Klinikal / Kebenaran Mengilang Oleh Penaja Atau Pusat Kajian BE -
  • Compliance and Licensing Forms:
    Document Name PDF MS Word
    Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar -
    BPFK 501: Foreign GMP Inspection Application Form


  • Vaccine Lot Release Forms:


    Document Name PDF MS Word
    Application Form Vaccine Lot Release version 3
  • Laboratory & Quality Control Forms:


    Document Name PDF
    Borang Permohonan Pengiktirafan Makmal Swasta Download
  • Plasma Products Lot Release Forms:

    Document Name PDF MS Word
    Application form for Plasma Products Lot Release version 2



ACHIEVEMENT OF NPCB’S CLIENTS’ CHARTER FOR YEAR 2016 (JANUARY – DECEMBER)

 

No.

Our Promise

Target

Achieve Expectation

Below Expectation

Total

Number

Percentage

Number

Percentage

1.

To evaluate application for registration of:

        Prescription Drugs

210 working days

123

73.65%

44

26.35%

167

        Non-prescription Drugs

210 working days

31

100%

0

-

31

        New Drugs and Biologicals

245 working days

93

98.9%

1

1.06%

94

2.

To evaluate application for registration of traditional products containing:

         Single active ingredient

116 working days

164

85.8%

27

15.5%

191

        2 or more active ingredients

136 working days

352

83.0%

72

17.0%

424

To evaluate application for registration of health supplements containing:

         Single active ingredient

116 working days

78

100%

0

-

78

         2 or more active ingredients

136 working days

158

98.75%

2

1.25%

160

3.

To evaluate application for registration of non-prescription drugs (as stated in  Table V Drug Registration Guidance Document) containing:

         Single active ingredient

116 working days

6

100%

0

-

6

         2 or more active ingredients

136 working days

6

100%

0

-

6

4.

Issuance of Cosmetic Notification

1 working day

63,821

100%

0

-

63,821

5.

Certificate of Free Sale (CFS) for Cosmetics

15 working days

2,470

100%

0

-

2,470

6.

Decision on application for change of registration holder

45 working days

333

100%

0

-

333

7.

 Certificate of Pharmaceutical Product (CPP)

15 working days

2,323

100%

0

-

2,323

8.

Certificate of Free Sale (CFS)

15 working days

35

100%

0

-

35

7.

Decision on application for change of manufacturing site

60 working days

490

88.9%

61

11.1%

551

9.

Issuance of manufacturer's,

wholesaler's and importer's license

4 working days

1,698

93.9%

110

6.1%

1,808

10.

Evaluation of Import License Application for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) :

      For products involving Phase 1 study, biological products, Cell & Gene Therapy Products (CGTPs) and herbal products

45 working days

58

100%

0

-

58

      For products other than stated above

30 working days

129

100%

0

-

129

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