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Helmut
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Vienna, Austria,
2018-07-16 14:49

Posting: # 19065
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 ICH M9 Draft [BE/BA News]

Dear all,

on 27 June the ICH released the draft guideline

Biopharmaceutics Classification System-based Biowaivers (M9, step 2).

Public consultation is planned for August 2018 and adoption of the final guideline in May 2019.

I’m wondering how this guideline was developed where one of the founding members of ICH (Japan) does not accept BCS-based biowaivers at all… :confused:

Cheers,
Helmut Schütz
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