ICH Consults On Harmonized Criteria For Bioequivalence Study Waivers
The International Council for Harmonisation has issued draft guidance specifying the supportive data needed to classify a drug substance under the Biopharmaceutics Classification System and for biowaiver applications.
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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.
ICH outlines an ambitious work plan to harmonize the disparate requirements for biowaivers among regulators worldwide; New concept paper and business plan highlight areas of disagreement.
While FDA took a big leap forward by waiving bioequivalence studies for BCS Class 3 drugs and aligning biowaiver rules with the EU, there is still work that needs to be done to harmonize solubility and permeability criteria. Until these differences are resolved, pharmaceutical manufacturers may still need to perform separate studies in getting biowaivers approved in these to jurisdictions. This issue is taking on more prominence now as ICH is looking into harmonizing biowaiver requirements worldwide.