Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

Orphan Drugs WG

About this WG

This WG looks into issues pertaining to the development and application review of orphan drugs, and makes proposals for supportive measures to facilitate the orphan drug development.


December, 2011


Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Review Management
Office of Regulatory Science Coordination



EC: European Commission
EMA: European Medicines Agency
FDA: US Food and Drug Administration

Related Notification

January 16, 2024
PSB/PED Notification No. 0116-1・PSB/MDED Notification No. 0116-1

January 16, 2024
Administrative Notice


Past Presentations (Last 5 years)

19th DIA Japan Annual Meeting 2022, Tokyo, Japan, October 2022


9th Joint Conference of Taiwan and Japan on Medical Products Regulation (Web), October 2021


4th India-Japan Medical Products Regulation symposium 2019, Tokyo, Japan, February 2020


16th DIA Japan Annual Meeting 2019, Tokyo, Japan, November 2019


Past Presentation (Related to PMDA-sponsored/co-sponsored workshop)

Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop, UK, March 2014


Related links