Drug Evaluation Committee Q&A on the Clinical Research Act, Enforcement Regulations of the Clinical Research Act, and Related Notices, etc. (January 5, 2026)
Medical Affairs Subcommittee
January 2026
Based on the promulgation and enforcement of the Clinical Research Act and the Enforcement Regulations of the Clinical Research Act, the JPMA Drug Evaluation Committee has been studying the issues raised by the Special Study Group and the MA Subcommittee in the TF, and has prepared "Q&A on the Clinical Research Act, Enforcement Regulations of the Clinical Research Act and related Notifications, etc." (JPMA Q&A) to answer questions that the JPMA received and to provide points to note and how companies should handle such issues. The JPMA website (HP) has published these Q&A twice, in November 2018 and August 2019.
Subsequently, the review and revision of the Clinical Research Act after 5 years of its enforcement was proceeded, and a relatively major revision of the law was made in June 2024, followed by the revision of the ministerial ordinance in February 2025, and the enforcement notice and Q&A were issued in May 2025, which came into effect on May 31, 2025.
Therefore, the JPMA MA Subcommittee TF9 (Issues for Consideration: Company Responses to the Clinical Research Act and the Pharmaceutical Affairs Law (Post-Marketing Clinical Trials Not Involving Reexamination, Reevaluation, etc.)) has decided to integrate and update the two JPMA Q&As based on the content of the revisions and publish them on the JPMA website in January 2026.
We hope that JPMA member companies will take appropriate measures in clinical research to which the Clinical Research Act applies, based on this JPMA Q&A in addition to the relevant laws, regulations, enforcement rules, and related notices.
A list of the background and changes is also available for your reference.