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 continuing its deliberations toward the development of guidelines on bioequivalence for immediate-release oral solid dosage forms.As a result, on December 20, Reiwa 4, the draft ICH M13A guideline reached Step 2 and was published on the official ICH website. In Japan, on March 22, Reiwa 5, the ICH M13A"Bioequivalence of Immediate-Release Oral Solid Dosage Forms" (Draft) in Japan.
We recently held Guideline Workshops on the draft ICH M13A guideline to promote understanding of this draft guideline and to support the collection of public comments.
Details regarding the program and other information for this briefing session are available on the PMDA website.