This WG organizes the points at issues over pediatric drugs and investigate the measures for expediting the review as well as encouraging their development through the exchange of information with overseas relevant organizations.
（Activity period:：From November, 2011）
Activities
- Encourage industries and investigators to develop medicinal products for children
- Strengthen collaboration with foreign regulatory agencies for development of pediatric medicines
- Studying and organizing past reviews and cases of consultations
- Exchanging views with domestic stakeholders (medical institutions, industry groups)
Pediatric Cluster
- PMDA has agreed on the Pediatric Cluster Terms of Reference (ToR) between US.FDA, EMA, HC and TGA in the context of regulatory cooperation and transparency:
(Note) MHLW/PMDA and US.FDA, EMA, HC and TGA have concluded a confidentiality arrangement (Confidentiality Arrangement) to exchange views on pharmaceutical regulatory systems.
- Based on the ToR, PMDA has exchanged opinions and strengthened mutual understanding concerning pediatric drug development.
US.FDA: the United States Food and Drug Administration
EMA: the European Medicines Agency
HC: Health Canada
TGA: Therapeutic Goods Administration of Australia.
The activities conducted over the last five years.
Presentations
The Japan Agency for Medical Research and Development (AMED) Project for Promotion of Training Biostatistician (The University of Tokyo) and Biostatistics Division, Center for Research Administration and Support, National Cancer Center co-organized seminar “Toward resolving issues in clinical trials aimed at pediatric drug development”, Tokyo, Japan, December 2023
First Exchange Meeting on Facilitating R&D and Scientific Supervision for Pediatric Drugs in China, Web, June 2022
Joint EFGCP/DIA Conference “Better Medicines for Children”, Web, October 2021
Publications
2022
- Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases
Carla Epps, MD, MPH1 ・ Ralph Bax, MD, MA2 ・ Alysha Croker, PhD3 ・ Dionna Green, MD, FCP1 ・ Andrea Gropman, MD, FAAP, FACMG, FANA4 ・ Agnes V. Klein, MD3 ・ Hannah Landry, MSc3 ・ Anne Pariser, MD5 ・ Marc Rosenman, MD6 ・Michiyo Sakiyama, MD7 ・ Junko Sato, PhD7 ・ Kuntal Sen, MD4 ・ Monique Stone, MBBS, FRACP, MD8 ・Fumi Takeuchi, MD, PhD7 ・ Jonathan M. Davis, MD9
Therapeutic Innovation and Regulatory Science 56: 964-975
Related Notification
Related links
- International Collaboration/ Pediatric Cluster（U.S. FDA）
- Cluster activities（EMA）