Drug Evaluation Committee Points to Consider Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data
Clinical Evaluation Subcommittee
April 2022
Clinical trial data and RWD contain a lot of information related to individuals. As awareness of the need to protect personal information grows around the world, pharmaceutical companies need to give due consideration to the handling of such information from both legal and ethical perspectives.
In clinical trials, the Pharmaceutical Affairs Law and GCP mandate the preservation of subject confidentiality, while the Act on the Protection of Personal Information (Act on the Protection of Personal Information) exists as a general law.
The Personal Information Protection Law was revised in 2015 and newly stipulates the handling of acquisition and provision to third parties of personal information requiring special consideration, restrictions on provision of personal data to third parties in foreign countries, and anonymized processed information.
In addition, the 2020 Amendment Law and the 2021 Amendment Law (in part) went into effect on April 1, 2012, strengthening restrictions on the provision of personal data to third parties in foreign countries and newly establishing the concept of pseudonymized information.
Against this background, the Clinical Evaluation Subcommittee, Special Project 3, has examined various issues related to the protection of personal information in drug development and compiled them into a deliverable.
We hope that this document will be of some help in appropriately protecting personal information in the course of drug development and other operations.