Drug Evaluation Committee Data Linkage Initiative - Data Linkage Based on Overseas Regulations (Report on Phase II Activities)

Data Science Subcommittee

November 2025

In Europe and the U.S., in order to directly link electronic medical record data in clinical trials, discussions are underway to promote implementation from a broad and high perspective across all stakeholders, including standards development organizations (CDISC, HL7) in addition to industry, government, and academia, but in Japan, there continues to be insufficient opportunities for discussion among all stakeholders In Japan, however, there are still not enough opportunities for stakeholders as a whole to discuss the issues.
In light of this situation, the consortium activity "Data Linkage Concept Study Group," in which each stakeholder participates, launched its second phase activities in 2024, following the first phase activities started in 2020. In the second phase of activities, volunteers from medical institutions (4 institutions), IT-related companies (including electronic medical record vendors) (6 companies), pharmaceutical companies (6 companies), CRO (1 company), and the Japan Pharmaceutical Manufacturers Association (JPMA) will participate to identify the requirements for data linked from electronic medical records in clinical trials to be accepted in international pharmaceutical applications based on the results of understanding and analyzing relevant overseas laws and regulations. Based on the results of their understanding and analysis of relevant overseas laws and regulations, they identified the requirements for data linked from electronic medical records in clinical trials to be accepted in international regulatory applications, and compiled a proposal for necessary measures in Japan. In addition to the main body of the proposal, the following three appendices should be used as appropriate.
Attachment 1: Summary of each survey document including laws and regulations in Europe and the U.S. (Excel file with important items organized in each summary is attached)
Attachment 2: Reference material: Examples of data linkage efforts in Japan
Attachment 3: List of definitions of terms
We hope this proposal will serve as a starting point for effectively utilizing electronic medical record data of Japanese medical institutions in clinical trials and clinical research. We hope that this proposal will be one of the starting points for effective use of electronic medical record data of Japanese medical institutions in clinical trials and clinical research.

Each slide in Attachment 1 has an embedded Excel icon that provides a "link to a document that organizes the important items in each document. Please open Attachment 1 in Adobe and click on the embedded Excel icon.

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