Bioequivalence

Guidelines on Bioequivalence

Malaysia has fully adopted ASEAN guideline since March 2015 and it is the most current guide for the conduct of bioequivalence studies. This guideline is adopted from the Guideline on the Investigation of Bioequivalence” (European Medicines Agency, London, 20 January 2010, CPMP/EWP/QWP/1401/98 Rev 1) with some adaptation for ASEAN application.

ASEAN Guideline for the Conduct of Bioequivalence Studies, Revision 1, Draft 4_ FINAL, March 2015

This guideline is to be read in conjunction with all relevant directives, circulars and updates regarding bioavailability and bioequivalence studies.

In addition, other relevant and latest international guidelines e.g. by EMA, USFDA, ICH should also be referred to complement the ASEAN Guidelines.

Bioequivalence Guidelines

ASEAN Guideline, Malaysian Guidance on Bioequivalence 

BE Studies Centres

BE Centres that are listed in Bioequivalence Centre Compliance Programme, NPRA 

Application Forms and Checklist

Application For Biopharmaceutics Classification System (BCS) Biowaiver, Application For A Biowaiver: Additional Strength & Bioequivalence Study Report Submission Checklist

Generic Product List For BE Studies

Biowaivers

Generic Products That May Be Considered For Biowaiver

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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