Drug Evaluation Committee Q&A on "Points to Consider Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data
Clinical Evaluation Subcommittee
April 2023
In the development of pharmaceutical products, it is necessary to handle a wide variety of information, including data collected in clinical trials and real world data (RWD), which includes personal information in various forms. We have studied various issues related to the protection of such personal information, and in April 2022, we published " Points to Keep in Mind Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data " on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
In addition, we have compiled concerns regarding the handling of personal information at the practitioner level and prepared a Q&A (this document) as a supplement to the above published material.
We hope that this document will serve as a reference for companies in their drug development activities.
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