WHO Draft on BCS-based Biowaivers [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-08-29 13:18 (103 d 22:37 ago) – Posting: # 23708
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Dear all,

the WHO published a draft working document for public consultation last July. Sorry that I discovered it that late (THX to Susana Al­meida of Medicines for Europe). It contradicts partly ICH M9 of Nov 2019

Comments should be submitted by 31 August 2023.

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