Application Forms and Checklist

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Document Name PDF MS Word Updated

Application For Biopharmaceutics Classification System (BCS) Biowaiver

 Download  Download Sep-18

Application For A Biowaiver: Additional Strength

 Download  Download Sep-18

Bioequivalence Study Report Submission Checklist

 Download  Download Sep-18

PKPB/F-521 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Dalam Negara)

 -  Download May-19

PKPB/F-531 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara)

- Download May-19

PKPB/F-551 Borang Permohonan Penilaian Laporan Pemeriksaan Pusat Kajian BE bagi Pendaftaran Produk

Download Download May-19

PKPB/F-552 Borang Permohonan Penilaian Laporan Pemeriksaan Pusat Kajian BE Bagi Notifikasi Kajian

Download Download May-19

PKPB/F-561 Permohonan Untuk Notifikasi bagi Kajian Bioekuivalens (BE) yang Tidak Memerlukan Lesen Import Percubaan Klinikal / Kebenaran Mengilang Oleh Penaja Atau Pusat Kajian BE

Download Download May-19

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 21 August 2019, 09:55:47.
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