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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 to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Medical Devices I to 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 I
Office of Medical Informatics and Science
Office of Pharmacovigilance I to II
Office of International Programs
Office of Regulatory Science Coordination
Related Notification
| Date | Notification No. | Title |
|---|---|---|
| March 31, 2014 | - | Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases |
| June 9, 2017 | PSEHB/PED Notification No.0609-8 PSEHB/SD Notification No.0609-4 |
Basic principles on the utilization oh health information databases for Post-Marketing Surveillance of Medical Products |
| October 26, 2017 | Ordinance of MHLW No.116 | Amendment of Ministerial Ordinance on Good Post-marketing Study Practice for Drugs |
| January 23, 2018 | - | Contents and format of a study protocol for Post-marketing Database Study |
| February 21, 2018 | PSEHB/PED Notification No.0221-1 | Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs |
| December 19, 2018 | PSEHB/MDED Notification No.1219-4 | Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices |
| March 14, 2019 | PSEHB/PED Notification No.0314-4 PSEHB/SD Notification No.0314-4 | Procedures for Developing Post-marketing Study Plan (originaly published as “Procedures for Developing Post-marketing Study Plan” by PMDA in January 2018) |
|
June 19, 2019
(abolished)
|
Administrative Notice | Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs |
| March 23, 2020 | PSEHB/MDED Notification No.0323-4 | Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products |
| July 31, 2020 | PMDA/CRS Notification No.0731002 PMDA/CPE Notification No.0731002 |
Basic principles in conducting a validation study of outcome definitions used for post-marketing database study |
| Mar.23.2021 | PSEHB/PED Notification No.0323-1 PSEHB/MDED Notification No.0323-1 |
Basic Principles on Utilization of Registry for Applications |
| March 23, 2021 | PSEHB/PED Notification No.0323-2 PSEHB/MDED Notification No.0323-2 |
Points to consider for Ensuring the Reliability in Utilization of Registry Data for Applications |
| September 14, 2022 | Administrative Notice | Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Drugs |
| March 31, 2023 | Administrative Notice | Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products |