Characteristics and Future Perspectives of Available Electronic Health Record Databases in Japan

The global use of real-world data (RWD) for drug approval and post-marketing surveillance has increased significantly. During 2023 and 2024, the US Food and Drug Administration issued industry guidance, and the European Medicines Agency released real-world evidence framework reports to support regulatory decision making. In Japan, the Pharmaceuticals and Medical Devices Agency promotes the use of RWD, with collective efforts from the government and related industries. This report focuses on electronic health record (EHR) databases in Japan, aiming to (1) organize the characteristics of data generated from such databases, and (2) identify the challenges when using EHR databases for regulatory decision making. This report conducted an internet-based Google search using the keywords 'electronic medical record database' with the condition that the results include any of the keywords 'Japan' or 'real-world data'. Online interviews were conducted with representatives from eight EHR database companies identified as being utilized in Japan, focusing on the characteristics of each EHR database, challenges in their utilization, and future perspectives. The characteristics and limitations of current EHR databases were summarized; they offer broad coverage in terms of patient backgrounds and easier access to clinical laboratory values but are unable to track patients who transfer between hospitals due to lack of data linkage, and there may be loss of information during data abstraction. Data collection methods were mostly retrospective. Critically, there is no overall standardization between the EHR databases. Currently, EHR studies are primarily observational to verify efficacy and safety in real clinical practice and are gradually being used for post-marketing surveillance to support regulatory decision making in Japan. Addressing operational, technical, and methodological challenges in using EHR databases for regulatory approval applications requires efforts from multiple stakeholders, including industry, academia, and government.