Drug Evaluation Committee jRCT/Japic CTI registration item comparison table is available.
Clinical Evaluation Subcommittee
Regarding the registration of the status of clinical trials, etc., to the Registration Center for Clinical Trial Information (*) in Japan, the Ministry of Health, Labour and Welfare (MHLW) has been promoting the appropriate disclosure of clinical trial information in its Director's Notice "Registration of Clinical Trial Status". Recently, in light of the mandatory publication of clinical trials under the enforcement regulations of the revised Pharmaceutical Affairs Law, the notice was revised (August 31, 2020, Pharmaceutical Affairs Bureau Notification No. 0831-9) to ensure further transparency and revitalization of clinical trials, and the domestic clinical trial information registration centers were unified into jRCT. In order to facilitate the smooth start of use of jRCT by pharmaceutical companies, a table comparing jRCT/JapicCTI registration items has been prepared and is now available to the public.
- *Clinical Trial Information Registration Center: Website with information on clinical trials and other research (viewable by the public)