Drug Evaluation Committee Data Linkage Initiative - Data Linkage Based on Overseas Regulations (Phase 2 Activity Report)
November 2025
In Europe and the United States, discussions are underway among all stakeholders—including industry, government, academia, and standards development organizations such as CDISC and HL7—to promote the implementation of direct integration of electronic health record data in clinical trials from a broad and high-level perspective. In Japan, however, there continues to be a lack of sufficient forums for discussion among all stakeholders.
In light of this situation, the “Data Integration Concept Study Group”—a consortium involving various stakeholders—launched its second phase of activities in 2024, following the first phase that began in 2020.In the second phase, representatives from medical institutions (4 institutions), IT-related companies (including electronic medical record vendors) (6 companies), pharmaceutical companies (6 companies),one CRO, and volunteers from the Japan Pharmaceutical Manufacturers Association. Based on their understanding and analysis of relevant overseas laws and regulations, they identified the requirements necessary for data linked from EHRs in clinical trials to be accepted in international regulatory submissions and compiled recommendations for the necessary measures in Japan into a proposal document.In addition to the main recommendation document, please make use of the following three attachments as appropriate.
Attachment 1: Overview of research materials on European and U.S. laws and regulations(Excel files summarizing key points are attached to each overview)
Appendix 2: Reference Materials: Examples of Domestic Data Integration Initiatives
Appendix 3: Glossary of Terms
We hope that these recommendations will serve as a starting point for the more effective utilization of well-organized electronic medical record data from Japanese medical institutions in clinical trials and clinical research.
- Data Linkage Initiative - Data Linkage Based on Overseas Regulations (Phase 2 Activity Report)
- Appendix 1: Overview of Research Materials on Legal Regulations in Europe and the United States
- Appendix 2: Reference Materials: Examples of Domestic Data Integration Initiatives
- Appendix 3: List of Definitions
*Each slide in Appendix 1 contains an embedded Excel icon that links to a document summarizing the key points of each reference. Please open Appendix 1 in Adobe and click the embedded Excel icon.