ICH M13 [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-11-27 19:08 (508 d 20:44 ago) – Posting: # 20878
Views: 4,437

Dear all,

The International Council for Harmonisation (ICH) met in Singapore from 16 – 20 November 2019, bringing together over 450 participants from ICH’s sixteen Members and thirty-two Observers. The meeting saw the convening of fourteen ICH Working Groups, which included six new Working Groups who met to progress work on recently approved new topic proposals…

From today’s press release:

Agreement on new ICH harmonisation activities
The Assembly revisited two new topic proposals which it had supported in principle at the last ICH biannual meeting in June 2019. This included the new topic proposal on Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13) and a proposal for the revision of the ICH Q9 Guideline on Quality Risk Management. The Assembly approved the Concept Paper Outlines for both topics, with the revision of ICH Q9 to have a delayed start time in view of other ongoing quality work, while a new Working Group would be established without delay to initiate work on finalising the concept paper and business plan for the M13 topic.

(my emphasis)

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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