Drug Evaluation Committee Translation: RWD-related FDA Guidance
Medical Information DBTF
November 2024
This document was prepared based on the translation of guidance provided by the AMED Nakamura Group "Research on the Utilization of Medical Information Databases, etc. to Contribute to Clinical Outcome Evaluation and Other Regulatory Procedures in the Approval Process of Drugs", with the cooperation of the JPMA's Medical Information DB Utilization Promotion TF ST2 members, who reviewed the translation. We would like to thank Dr. Ishizuka, Dr. Ohba, Dr. Ishiguro, and Dr. Nakamura for providing the translations.
ST2 is working to promote the use of real-world data and is working with the FDA guidance "Submitting documents using real-world data and real- The translations of the FDA guidance "Submitting documents using real-world data and real- world evidence to FDA for drugs and biologics" and "Considerations for the use of RWD and RWE to Support Regulatory Decision-Making for Drug and Biological The translations of "RWD/RWE and real-world evidence to FDA for drugs and biologics" and "Considerations for the use of RWD and RWE to Support Regulatory Decision-Making for Drug and Biological Products" are expected to improve understanding of the use of RWD/RWE in US regulatory applications and to be helpful for use in Japan.
Published November 2024
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
TF ST2 for Promotion of Utilization of Medical Information DB