ICH Project ICH E21 Inclusion of pregnant and breastfeeding individuals in clinical trials (draft)
July 09, 2025
The ICH E21 Expert Working Group (EWG) has been studying to develop a guideline on the inclusion of pregnant women 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 also launched on July 1, 2025.
In order to promote understanding of the draft guideline and to support the collection of public comments, a Guideline Workshops on ICH E21 will be held in the form of a video streaming.
The details of this briefing can be viewed on the PMDA Website.