We would like to ask for your continued understanding and support of PMDA. Director of Center for Regulatory Science 3 December 2024 Pharmaceuticals and Medical Devices Agency Emiko Kondo The Pharmaceuticals and Medical Devices Agency (PMDA) is an administrative agency that primarily provides services in three main areas : Approval Reviews, Post-marketing Safety Measures, and Relief Services for Adverse Health Effects caused by drugs, medical devices, and regenerative medical products (See the PMDA website page for details). In order to improve the quality of these services, the agency is engaged in regulatory science research activities and related initiatives. The PMDA's Fifth Mid-Term Plan, which began in FY2024, has the goal of further promoting regulatory science research and related activities, including proactive dissemination of regulatory science-related information. This report summarizes PMDA’s regulatory science-related activities with some details. This is the first report, and will be released every year in the future. Since FY 2024, PMDA has published “Early Considerations”, which serve as reference information to promote the practical application of innovations such as new technologies and the development of innovative drugs. Additionally, PMDA has released YouTube videos in which PMDA staff explained their published papers. The PMDA will continue to work for further enhancing the contents of this report. We hope that this report is a useful source of information in understanding PMDA's regulatory science-related activities. 1. Regulatory Science Activity Report
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