The purpose of this WG is to deal with regulatory issues related to Real World Data (RWD) such as utilization of patient registry data and medical information databases. The WG contributes to clarify general principles on RWD utilization and data reliability ranging from development through post-marketing surveillance of drugs and medical devices, etc.
(Activity period:：From April, 2021 to September, 2024)
Activities
- Publicize the MHLW notifications on RWD utilization in Japan and overseas.
- Extract potential issues with implementing the notifications.
- Announce results of the WG’s activity (e.g., organizing examples of regulatory use of RWD, or facilitating RWD utilization) in Japan and overseas.