ICH M9 Draft [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2018-07-16 14:49 (1198 d 20:31 ago) – Posting: # 19065
Views: 1,801

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:


Edit: Deadline for comments:
ANVISA, Brazil - Deadline for comments by 28 January 2019
EC, Europe - Deadline for comments by 6 February 2019
Health Canada, Canada - Deadline for comments by 4 November 2018
HSA, Singapore - Deadline for comments by 26 October 2018
MFDS, Republic of Korea- Deadline for comments by 31 December 2018
MHLW/PMDA, Japan - Deadline for comments by 29 January 2019
NMPA, China - Deadline for comments by 30 November 2018
Swissmedic, Switzerland - Refers to EC, Europe consultation
TFDA, Chinese Taipei - Deadline for comments by 31 October 2018

Dif-tor heh smusma 🖖
Helmut Schütz
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