Drug Evaluation Committee Q&A, 5th Edition, Regarding “Registration of Clinical Trial Status and Other Information” (Pharmaceutical and Medical Devices Administration Notice No. 0831-9, August 31, Reiwa 2)
July 2026
Following the issuance of “Regarding the Registration of Clinical Trial Status(Pharmaceutical and Medical Devices Administration Notice No. 0326-3, March 26, Heisei 30),” the first edition of the Q&A on “Registration of Clinical Trial Status, etc.” was prepared in 2018 to address any uncertainties companies might have regarding the registration of clinical trial information.Subsequently, based on the results of a survey on clinical trial information registration conducted among member companies of the Clinical Evaluation Subcommittee of the Drug Evaluation Committee, and in light of the mandatory disclosure of clinical trials in 2022 and the issuance of “Regarding the Registration of Clinical Trial Status, etc. (Drug Evaluation Committee Notice No. 0831-9,August 31, Reiwa 2), and the migration of registration data from the Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) to the Clinical Research Submission and Disclosure System (jRCT) in 2023, we have revised the Q&A to its fourth edition.
This time, based on the results of discussions held in 2024 by the Expert Committee on the Future Direction of jRCT and in light of the jRCT enhancements implemented in March 2026, we have revised the Q&A to Version 5 (hereinafter referred to as “this Q&A”).We would like to express our gratitude to the staff of the Research and Development Policy Division, Bureau of Medical Policy, Ministry of Health, Labor and Welfare, for their guidance in the preparation of this Q&A.
We hope that this Q&A will facilitate the registration process and improve patient access to clinical trial information by providing up-to-date information on clinical trial information registration.
These Q&As consist of the Q&As regarding jRCT registration and an appendix (List of jRCT Registration Items).