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.
1) "Basic principles on Utilization of Registry for Applications" (PSEHB/PED Notification No.0323-1, PSEHB/MDED Notification No.0323-1 by the Directors of the Pharmaceutical Evaluation Division and the Medical Device Evaluation Division, MHLW, dated Mar. 23, 2021)
2) "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"(Administrative Notice by the Director of the Pharmaceutical Evaluation Division, MHLW, dated Sep. 14, 2022)
3) "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" (Administrative Notice by the Director of the Medical Device Evaluation Division, MHLW, dated Mar. 31)
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
March 31, 2023
Administrative Notice
September 14, 2022
Administrative Notice
March 23, 2021
PSEHB/PED Notification No.0323-2・PSEHB/MDED Notification No.0323-2
March 23, 2021
PSEHB/PED Notification No.0323-1・PSEHB/MDED Notification No.0323-1
- Basic principles in conducting a validation study of outcome definitions used for post-marketing database study
July 31, 2020
PMDA/CRS Notification No.0731002・PMDA/CPE Notification No.0731002
March 23, 2020
PSEHB/MDED Notification No.0323-4
June 19, 2019 (abolished)
Administrative Notice
- Procedures for Developing Post-marketing Study Plan (originaly published as “Procedures for Developing Post-marketing Study Plan[308KB]” by PMDA in January 2018)
March 14, 2019
PSEHB/PED Notification No.0314-4・PSEHB/SD Notification No.0314-4
December 19, 2018
PSEHB/MDED Notification No.1219-4
February 21, 2018
PSEHB/PED Notification No.0221-1
- Contents and format of a study protocol for Post-marketing Database Study
January 23, 2018
- Amendment of Ministerial Ordinance on Good Post-marketing Study Practice for Drugs
October 26, 2017
Ordinance of MHLW No.116
- Basic principles on the utilization oh health information databases for Post-Marketing Surveillance of Medical Products
June 09, 2017
PSEHB/PED Notification No.0609-8・PSEHB/SD Notification No.0609-4
March 31, 2014