Helmut ★★★ Vienna, Austria, 2018-07-16 16:49 (2082 d 20:59 ago) Posting: # 19065 Views: 2,253 |
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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… 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 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |