Bioequivalence and Bioavailability Forum • And Japan?

And Japan? [BE/BA News]

posted by Helmut – Vienna, Austria, 2019-12-04 12:42 (1597 d 23:55 ago) – Posting: # 20918
Views: 5,590

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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Helmut Schütz

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Complete thread:

ICH M13 Helmut 2019-11-27 19:08
- ICH M13 ElMaestro 2019-11-27 21:42
  - ICH pushed by GBHI? Helmut 2019-11-28 12:37
    - ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
      - “Lively” discussions Helmut 2019-11-28 14:23
        
        M9 step 4 now published Ohlbe 2019-12-04 11:26
        
        And Japan?Helmut 2019-12-04 11:42
        
        And Japan? ElMaestro 2019-12-04 14:43
        
        ? business as usual Helmut 2019-12-04 15:42