Drug Evaluation Committee Consideration of Pseudonym Processing Techniques when Creating Processed Pseudonym Information, etc.
December 2024
In recent years, there has been growing attention on advancing and streamlining clinical development through the secondary use of real-world data from Japan and abroad, as well as data from past clinical trials of similar drugs.The Reiwa 5 amendment to the Next-Generation Medical Infrastructure Act (Amended Next-Generation Medical Infrastructure Act) established a framework for utilizing pseudonymized medical information—which has less stringent processing standards than anonymized data—thereby enabling medical information to be used in a wider range of research.Pseudonymization is not only easier to perform than anonymization but also results in less information loss during the processing, so it is expected to enhance the usefulness of the data. In addition to providing an overview of the Amended Next-Generation Medical Infrastructure Act, this report examines—based on international reports—the design objectives, pseudonymization policies, and pseudonymization techniques required when a certified user obtains pseudonymized medical information from a certified creator for the purpose of pharmaceutical regulatory applications.We hope this report will contribute to the future utilization of pseudonymized information.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, Data Science Subcommittee, FY2023 Continuing Task Force 2