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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

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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RWD WG
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