ICH Project Workshop on ICH E21 "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials (Draft)"
July 9, 2025
The ICH E21 Expert Working Group (EWG) has been continuing its deliberations toward the development of guidelines regarding the inclusion of pregnant and lactating women in clinical trials.
As a result, on May 14, 2025, the draft ICH E21 guideline reached Step 2 and was published on the official ICH website.In Japan as well, the call for public comments on the ICH E21 “Inclusion of pregnant and breastfeeding individuals in clinical trials (Draft)” began on July 1, 2025.
To promote understanding of this draft guideline and support the collection of public comments, we will be hosting video Guideline Workshops on the ICH E21 draft guideline.
Details regarding this briefing session are available on the PMDA website.