Application Forms and Checklist

User Rating: 4 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Inactive
 

 

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

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

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, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

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.

Mobile Web :

Site Last Modified

  • Last Modified: Wednesday 05 August 2020, 14:19:12.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language