Application Forms and Checklist

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Checklist for submission of section P9 (Quest 3+ system)   

Application For Biopharmaceutics Classification System (BCS) Biowaiver

 Download  Download Dec-2021

Application For A Biowaiver: Additional Strength

 Download  Download Dec-2021

Bioequivalence Study Report Submission Checklist

 Download  Download Dec-2021

Guide on How to Upload the BE Study Report and Other Relevant Documents in QUEST 3+ System Under Section P9

Download - Dec-2021
Application form for BE centre inspection

BEEC/F-003 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Dalam Negara) 

 - Download July-2020

BEEC/F-004 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara)

- Download July-2020
Application form for evaluation on the need for BE study inspection   

BEEC/F-017 Borang Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE

- Download July-2020

BEEC/F-017-L1 Maklumat Penilaian Penentuan Keperluan Pemeriksaan Kajian BE

- Download July-2020

BEEC/F-018 Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE

Download - July-2020

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 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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