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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.


April, 2021


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

Date Notification No. Title
Mar.31.2014 - Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases
Jun.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
Oct.26.2017 Ordinance of MHLW No.116 Amendment of Ministerial Ordinance on Good Post-marketing Study Practice for Drugs
Jan.23.2018 - Contents and format of a study protocol for Post-marketing Database Study
Feb.21.2018 PSEHB/PED Notification No.0221-1 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs
Dec.19.2018 PSEHB/MDED Notification No.1219-4 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices
Mar.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)
Jun.19.2019 Administrative Notice Questions and Answers (Q&A) on Points to Consider for  Ensuring the Reliability of Post-marketing Database Study for Drugs
Mar.23.2020 PSEHB/MDED Notification No.0323-4 Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products
Jul.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
Mar.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
Sep.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


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