ICH Project Workshop on ICH M13A Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms"
April 24, 2023
The ICH M13 Expert Working Group (EWG) has been working on the development of a guideline for bioequivalence of immediate-release oral solid preparations. As a result, the draft ICH M13A Guideline was published on the ICH official website and public comments on the draft ICH M13A "Bioequivalence of Immediate Release Oral Solid Drugs" were accepted in Japan on March 22, 2023. The public comment period for the draft guideline has started on March 22, 2023.
In order to promote understanding of the draft guideline and to support the collection of public comments, a briefing session on the draft ICH M13A Guideline Workshops was recently held.
The program and other details of the briefing can be found on the PMDA website.