International Generic Drug Regulators Unveil New Biowaiver Assessment Template

Posted 01 March 2017 By Zachary Brennan


Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members.

IGDRP, which is made up of regulators from all over the world including the US Food and Drug Administration, Health Canada, European Medicines Agency and China Food and Drug Administration, among others, created its Bioequivalence Working Group,  as there are often differing requirements for biowaivers.

Biowaivers, or waivers of in vivo bioequivalence studies, are a priority of IGDRP, which notes: "The application of scientifically based waivers to bioequivalence studies, which would normally be required to demonstrate the therapeutic equivalence of a generic and reference product, is important to avoid unnecessary testing in human subjects, reduce generic development costs and provide for a more efficient regulatory review process."

Formed in May 2013, the Biowaivers Working Group is looking to establish a common set of conditions for granting biowaivers as well as the possible expanded application of waivers.

"The Members of the Working Group envisage that this BCS Biowaiver Assessment Report template will also be of benefit to applicants and the broader regulatory community," IGDRP added.

BCS Biowaiver Assessment Report Template

Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template (PDF version 1)

Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template (Word version 1)

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Categories: Generic drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, FDA, EMA, Health Canada, CFDA, WHO

Tags: IGDRP, biowaivers, Biopharmaceutics Classification System

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