And Japan? [BE/BA News]

posted by ElMaestro  – Denmark, 2019-12-04 14:43 (501 d 20:15 ago) – Posting: # 20923
Views: 3,232


» A: The guideline focuses on BCS-based biowaiver principles to be applied for bioequivalence purposes provided they are supported by a sound scientific rationale. The provision in the guideline that accommodates exceptions to existing regulations that do not permit BCS-based biowaivers for generic product applications, at this time, does not disqualify implementation of these harmonized technical requirements to demonstrate BCS based biowaivers for other product applications unless explicitly stated.

I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??

Pass or fail!

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