And Japan? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-12-04 11:42  – Posting: # 20918
Views: 544

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.


Cheers,
Helmut Schütz
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