And Japan? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-12-04 11:42 (604 d 09:24 ago) – Posting: # 20918
Views: 3,658

Hi Ohlbe,

» Now it is, along with a Q&A.

THX! Added to the collection. I guess, the following (in the Q&A) was a concession to Japan for not accepting biowaivers.

Q: Why does the guideline allow for regional differences in applications for BCS-based biowaivers for generic products?
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.


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