Bioequivalence and Bioavailability Forum • ICH M13

ICH M13 [BE/BA News]

posted by Helmut – Vienna, Austria, 2019-11-27 20:08 (1783 d 10:51 ago) – Posting: # 20878
Views: 8,342

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)

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Complete thread:

ICH M13Helmut 2019-11-27 19:08 [BE/BA News]
- ICH M13 ElMaestro 2019-11-27 21:42
  - ICH pushed by GBHI? Helmut 2019-11-28 12:37
    - ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
      - “Lively” discussions Helmut 2019-11-28 14:23
        
        M9 step 4 now published Ohlbe 2019-12-04 11:26
        
        And Japan? Helmut 2019-12-04 11:42
        
        And Japan? ElMaestro 2019-12-04 14:43
        
        ? business as usual Helmut 2019-12-04 15:42