Drug Evaluation Committee Comparison of Guidance Related to RWD/RWE Utilization in Japan and the U.S.
Clinical Evaluation Subcommittee
May 2025
The Japan Committee on Drug Evaluation (JCIA) has been working on a comparison of guidance issued by the FDA and the U.S. in relation to the use of real-world data (RWD) in drug development in Japan and the U.S. The team's research focuses on the differences in the issuance of guidance as a factor in this situation. The team compared and examined the content of guidance issued by the FDA and PMDA related to RWD/Real World Evidence (RWE) in the context of regulatory submissions.
We hope that this deliverable will help stakeholders promoting RWD policies and projects, as well as pharmaceutical companies utilizing RWD, to deepen their understanding of the Japanese and U.S. guidance and contribute to discussions on the use of RWD/RWE in regulatory filings.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Clinical Evaluation Subcommittee, Continuing Issues Response Team 9
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