Bioequivalence and Bioavailability Forum

And Japan? [BE/BA News]

posted by ElMaestro  – Denmark, 2019-12-04 15:43 (1603 d 14:42 ago) – Posting: # 20923
Views: 5,591

Wow,

❝ 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." ??

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