ICH Project ICH E11A "Extrapolation in Pediatric Drug Development" Draft Guideline Workshops
June 10, 2022
The ICH E11A Expert Working Group (EWG) has been working on the development of a guideline for Pediatric Extrapolation. As a result, the draft ICH E11A Guideline reached Step 2 on April 4, 2012, and was published on the ICH official website. In Japan, the call for public comments on ICH E11A: "Guidelines for Pediatric Extrapolation" (draft) began on May 26, 2022.
In light of the above background, a briefing session on the ICH E11A draft guideline was held to promote understanding of the draft guideline and to support the collection of public comments.
Please refer to PMDA Website for the program and other details of this briefing session.