ICH Project Workshop on ICH M13B Guideline (Draft) "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver"
March 21, 2025.
The ICH M13 Expert Working Group (EWG) has been working on the development of guidelines for bioequivalence of immediate-release oral solid dosage forms, and M13A reached Step 4 on July 23, 2024. Now, the draft ICH M13B guideline has reached Step 2 as of March 13, 2025, and has been published on the official ICH website. In Japan, a call for public comments on the draft ICH M13B "Bioequivalence of Immediate Release Oral Solid Dosage Forms - Additional Content Biowaiver" is scheduled to be launched.
In order to promote understanding of the draft guideline and to support the collection of public comments, we will hold a Draft ICH M13B Guideline Workshops.
The program and other details of the briefing can be found on the PMDA website.