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
Apr 02, 2026.
Slides of presentations by each speaker at the 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 Act" held on March 17, 2026 are now available.
In the first part of the symposium, the MHLW and PMDA introduced their efforts to promote pediatric drug development, while academia provided an overview of the MHLW-designated studies conducted in the three years from FY2023 to FY2025 and shared their recommendations, and the JPMA (Pediatric Drug Development Task Force) provided an overview of the ICH E11A Guidelines and a report on pediatric extrapolation strategies and case studies. The Pharmaceutical Manufacturers Association of Japan (PMAJ) presented an overview of the ICH E11A guidelines, pediatric extrapolation strategies and case studies.
In the second part, focusing on the burden of blood collection, one of the important issues in pediatric clinical trials, issues from the perspective of companies and medical institutions, actual cases of problems occurring in pediatric clinical trials, and measures taken by companies were shared.
We hope that the recent revision of the Pharmaceutical Affairs Law to make it mandatory to establish a pediatric drug development plan will help participants deepen their understanding of the importance of pediatric drug development.
- Program
- 1-1_Pediatric Drug Development Promotion Efforts in the Pharmaceutical Affairs System (Ministry of Health, Labour and Welfare)
- 1-2_PMDA's efforts to promote pediatric drug development
- 1-3_Summary and Recommendations of the MHLW-Designated Research Program "Research for Proposing New Review Criteria for the Early Realization of Drugs for Pediatric Cancer and Rare or Intractable Pediatric Diseases
- 1-4_Strategy for Development of Pediatric Drugs in Japan and Survey Report of Pediatric Extrapolation Cases
- 2-1_Issues in Pediatric Clinical Trials -Blood Sampling in Pediatric Clinical Trials
- 2-2_Burden of blood collection in pediatric clinical trials from the company's perspective
- 2-3_Difficulties in Blood Collection in Pediatric Patients and Challenges in Clinical Trials -From Investigator Site CRC's Perspective
- 2-4_Issues of Blood Collection in Pediatric Clinical Trials and the Countermeasures of Each Company