ICH Project Workshop on ICH E21 "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials (Draft)"
July 09, 2025.
The ICH E21 Expert Working Group (EWG) has been working on the development of guidelines for the inclusion of pregnant and lactating women in clinical trials.
As a result, the draft ICH E21 guideline reached Step 2 as of May 14, 2025 and was published on the official ICH website. In Japan, the call for public comments on ICH E21 Inclusion of pregnant and breastfeeding individuals in clinical trials (draft) was launched on July 1, 2025.
In order to promote understanding of the draft guideline and to support the collection of public comments, PMDA will hold ICH E21 Draft Guideline Workshops in the form of video distribution.
The details of this briefing can be viewed on the PMDA Website.