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Despite Progress, More Work Needed To Harmonize FDA and EMA Criteria For Biowaivers

 
• By Joanne S. Eglovitch

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.

FDA’s guidance last year waiving bioequivalence testing requirements for highly soluble and low permeable drugs did much to harmonize these exemptions with the European Medicines Agency but more work is needed to resolve differing requirements for solubility, dissolution and permeability. Until then, pharmaceutical manufacturers may still need to submit separate biowaiver requests and conduct separate studies in the US and the EU.

Speakers at the 2nd annual meeting of the Global Bioequivalence Harmonization Initiative (GBHI) in Rockville, Md., on Sept. 14 noted...

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