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.
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
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 |