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, 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 Guideline.
BE Studies Centres
BE Centres that are listed in Bioequivalence Centre Compliance Programme, NPRA
BE Studies Centres
Application Forms and Checklist
Application For Biopharmaceutics Classification System (BCS) Biowaiver,
Application For A Biowaiver: Additional Strength & Bioequivalence Study Report Submission Checklist
Application Forms and Checklist
Generic Product List For BE Studies
Generic Product List For BE Studies
Biowaivers
Generic Products That May Be Considered For Biowaiver
Biowaivers
BE Test
test BE
BE BAru
BE Studies Centres
BE Centres that are listed in Bioequivalence Centre Compliance Programme, NPRA
BE Studies Centres
Application Forms and Checklist
Application For Biopharmaceutics Classification System (BCS) Biowaiver,
Application For A Biowaiver: Additional Strength & Bioequivalence Study Report Submission Checklist
Application Forms and Checklist
Generic Product List For BE Studies
Generic Product List For BE Studies
Biowaivers
Generic Products That May Be Considered For Biowaiver
Biowaivers
BE Test
test BE
BE BAru
