Projects across Multi-offices in PMDA examine cross-sectional issues on PMDA’s review services and post-marketing safety measures as issues related to Regulatory Science.
Cross-Sectional Project Team
In order to resolve these issues, a cross-sectional project team is established for each project with the goal of publishing concept or developing guidelines.
Project Team in Progress
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Project team for Consideration of Guiding Principles for AI Utilization
This project team aims to develop and publish a set of guiding principles on the appropriate use of AI in the lifecycle management of medical products, including accountability, transparency, and the appropriate handling of data and personal information. The activity period of the team is from May 2026.
Completed Project Team
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Project team for Consideration of Inquiries Concerning Pediatric Drugs Development Program
This project team considered policy of inquiries concerning pediatric drugs development program in consultation service and approval review of a new drug development for adults. The activity period of the team was from October 2024 to July 2025.- "Initiatives to Promote Pediatric Drug Development" has been published.
Initiatives to Promote Pediatric Drug Development [229KB]
(March 21, 2025 PMDA/CPE Notification No. 1618・PMDA/CRS Notification No. 15)
- "Initiatives to Promote Pediatric Drug Development" has been published.
Opinion Exchange Working Group
Opinion Exchange Working Groups (WGs) are established to exchange opinions on cross-sectional issues on PMDA’s review services and post-marketing safety measures as issues related to Regulatory Science. The Working Groups collect and analyze cases related to the issues, share and disseminate information, and exchange opinions with overseas regulatory authorities and stakeholders from industry, government and academia.
Working Groups in Progress
Click the WG name to view the activities.
AI Action WG / Companion Diagnostics WG / Multi-Regional Clinical Trials WG
Orphan Drugs WG / Patient Centricity WG / Pediatric Drugs WG
Completed Working Groups
Fiscal Year 2024
Cardiovascular Risk Evaluation WG / ICH Q12 WG
Innovative Manufacturing Technology WG / Medical Device International Affairs WG
Nanomedicine Initiative WG / Omix WG / RWD WG
Before Fiscal Year 2024
Clinical Innovation Network WG (Reorganised to RWD WG)
Induced pluripotent stem cells (iPSC) WG
Innovative Statistical Strategies for New Drug Development
Microdose Trials Project / Post-approval Manufacturing Changes Project
QbD Assessment Project