Drug Evaluation Committee
Symposium on Pediatric Drug Development to be held on March 17, 2026
Symposium on Pediatric Drug Development "Envisioning the Future of Pediatric Drug Development: Challenges in the New Era Brought about by the Revision of the Pharmaceutical Affairs Agency Law
February 03, 2026
The revision of the Pharmaceutical Affairs Law last year made it an "obligation of effort" for pharmaceutical companies to formulate development plans for pediatric drugs, and the law will come into effect in May of this year. The environment surrounding pediatric drug development in Japan is currently at a major turning point.
Internationally, the ICH E11A "Pediatric Extrapolation" guideline has reached the ICH agreement (Step 4) in 2024, which provides a comprehensive framework for extrapolation in pediatric drug development.
In light of these major developments in the promotion of pediatric drug development, the Subcommittee will hold a symposium under the theme of "Envisioning the Future of Pediatric Drug Development: Challenges in the New Era Brought about by the Revision of the Pharmaceutical Affairs Law".
The first part of the symposium will focus on the latest regulatory systems and measures to promote pediatric drug development and the efforts of regulatory authorities, proposals from academia, and recent examples of pediatric extrapolation strategies and flexible submission data packages. In the second part, focusing on the burden of blood collection, one of the important issues in pediatric clinical trials, the actual situation and problems of blood collection in pediatric patients, issues from the viewpoint of medical institutions, and specific examples of problems related to blood collection in pediatric clinical trials and measures taken by pharmaceutical companies will be shared, and effective improvement measures will be discussed based on these examples.
We hope that this symposium will be an opportunity to take advantage of the major changes in the Pharmaceutical Affairs Law, and to take a new step toward the promotion of pediatric drug development and improved access to medical care for children, through collaboration between industry, government, and academia.
Date: Tuesday, March 17, 2026, 13:00-17:00
Format: Webinar (YouTube)