Drug Evaluation Committee Q&As on "Registration of Clinical Trials (No. 9 of 0831 issued by the Pharmaceutical Affairs Agency, August 31, 2020)" (Pharmaceutical Affairs Agency of Japan, Version 4)
Clinical Evaluation Subcommittee
February 2024
With the issuance of "On the Registration of Clinical Trial Implementation Status, etc. (Pharmaceutical Affairs Council of Japan, No. 0326-3, March 26, 2008)," Q&A on "On the Registration of Clinical Trial Implementation Status, etc." 1st edition was prepared in 2018 to resolve doubts about the registration of clinical trial information at each company. Subsequently, the Q&A was revised based on the results of a questionnaire survey on the registration of clinical trial information conducted among member companies of the Clinical Evaluation Committee of the Drug Evaluation Committee, and furthermore, with the publication of clinical trials becoming mandatory in 2022 and the issuance of the "Registration of Clinical Trial Implementation Status, etc. (Pharmaceutical Affairs Agency, No. 0831, August 31, 2020)," the third edition of the Q&A was created. The third edition of the Q&A has been prepared.
The Q&A has now been revised to the fourth edition (hereafter referred to as the "Q&A") following the transfer of registration data from the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI) to the Japan Registry of Clinical Trials (jRCT) on March 6, 2023. In preparing this Q&A, we would like to express our sincere appreciation for the guidance provided by the Research and Development Promotion Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare, and the National Institute of Health Sciences (NIHS).
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.
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