RWD WG

Activities

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.

• 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.

Established

April, 2021

Members

Office of New Drug I-V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Medical Devices I-II
Office of Standards and Compliance for Medical Devices
Office of Manufacturing Quality and Vigilance for Medical Devices
Office of Non-clinical and Clinical Compliance
Office of Medical Informatics and Epidemiology
Office of Advanced Evaluation with Electronic Data
Office of Pharmacovigilance I-II
Office of International Programs
Office of Research Promotion

Related Notification