Drug Evaluation Committee Comparison of Guidance Related to RWD/RWE Utilization in Japan and the U.S.
Clinical Evaluation Subcommittee
May 2025
The Japan Pharmaceutical Manufacturers Association (JPMA) has been working with the FDA and the U.S. Food and Drug Administration (FDA) on the use of real-world data (RWD) in drug development in recent years. 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 in RWD policies and projects, as well as pharmaceutical companies utilizing RWD, deepen their understanding of the guidance in Japan and the U.S. and contribute to discussions on the use of RWD/RWE in regulatory filings.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Clinical Evaluation Subcommittee Continuing Issues Response Team 9