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)

• Pediatric Drug Development in Japan

First Exchange Meeting on Facilitating R&D and Scientific Supervision for Pediatric Drugs in China, Web, June 2022

 

• Paediatric Drug Development in Japan and International Regulatory Collaboration

Joint EFGCP/DIA Conference “Better Medicines for Children”, Web, October 2021

 

• 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, September 2020

 

• 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, November 2019