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Pediatric Drugs WG
About this WG
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.
Our Task
- 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)
Established
November, 2011
Members
Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Pharmacovigilance I to II
Office of Regulatory Science Coordination
Past Presentations (Last 5 years)
| date | Presentation Title | Place |
|---|---|---|
| June 2022 | Pediatric Drug Development in Japan | First Exchange Meeting on Facilitating R&D and Scientific Supervision for Pediatric Drugs in China, Web |
| October 2021 | Paediatric Drug Development in Japan and International Regulatory Collaboration | Joint EFGCP/DIA Conference “Better Medicines for Children”, Web |
| September 2020 | Review of Pharmaceutical Products for Children | 17th Annual Meeting DIA Japan 2020, Web |
| September 2020 | ICH E11 and Pediatric Drug Development | 17th Annual Meeting DIA Japan 2020, Web |
| November 2019 | Promotion of Pediatric Drug Development by Industry, Government and Academia – What Has Changed, What Has Been Done and What Is Necessary for the Further Progress? From the perspective of the PMDA | 16th Annual Meeting, DIA Japan 2019, Tokyo, Japan |