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.
Established
December, 2011
Members
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
Activities
- Set up the cooperative pilot program arrangement (Pilot Terms of Reference: ToR) 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.
- Jointly held the following workshop on 10 March 2014;
Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop
EC: European Commission
EMA: European Medicines Agency
FDA: US Food and Drug Administration
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
15th DIA Japan Annual Meeting 2018, Tokyo, Japan, November 2018
Past Presentation (Related to PMDA-sponsored/co-sponsored workshop)
Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop, UK, March 2014
Related links
- Overview of Orphan Drug/Medical Device Designation System (Ministry of Health, Labour and Welfare (MHLW) website)
- Orphan Products Development Support Program (National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN) website)