M9 Biowaivers Guidance Nearly Harmonised During ICH Meeting
Experts came close to harmonizing draft ICH M9 guidance on biowaivers, which allow in-vitro in lieu of in-vivo bioequivalence testing under certain circumstances. Final guidance is expected soon, Drug Information Association annual meeting told.
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An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.
European drug companies have expressed concern over region-specific requirements variations permitted in an ICH guideline that proposes a harmonized approach to granting waivers for in vivo bioequivalence studies.
The International Council for Harmonisation has issued draft guidance specifying the supportive data needed to classify a drug substance under the Biopharmaceutics Classification System and for biowaiver applications.