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.
（Activity period:：From December, 2011）
Activities
Cooperative relationships between MHLW/PMDA and EC/EMA
- Set up the cooperative pilot program arrangement (Pilot Terms of Reference: ToR[146KB]) of orphan medicines under the cooperative relationships between MHLW/PMDA and EC/EMA.
(Note) MHLW/PMDA and EC/EMA have concluded a confidentiality arrangement (Confidentiality Arrangement) to exchange views on pharmaceutical regulatory systems.
- Based on ToR, exchanged opinions and strengthened mutual understanding concerning orphan drug designation systems.
EC: European Commission
EMA: European Medicines Agency
The activities conducted over the last five years.
Presentations
20th DIA Japan Annual Meeting 2023, Tokyo, Japan, November 2023
DIA China 2023 Annual Meeting, Suzhou, China (Web), June 2023
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
Publications
2021
- Orphan drug designation and development in Japan: 25 years of experience and assessment
Ken Sakushima, Hiroshi Takeda, Yoko Aoi
Nat Rev Drug Discov. 2021; 20(12): 893-4
Related Notification
Related links
- Overview of Orphan Drug/Medical Device Designation System (Ministry of Health, Labour and Welfare (MHLW) website)
- Orphan Products Development Support Program (National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) website)