Drug Evaluation Committee Q&As on "Registration of Clinical Trials" (Pharmaceutical Affairs Bureau, No. 0831, August 31, 2020) 3rd Edition
Clinical Evaluation Subcommittee
With the issuance of "On the Registration of Clinical Trial Implementation Status (Pharmaceutical Affairs Council of Japan, No. 0326-3, March 26, 2008)," Q&A Version 1 regarding "Registration of Clinical Trial Implementation Status, etc." was prepared on September 21, 2018 to resolve any doubts regarding the registration of clinical trial information at each company. Subsequently, a questionnaire regarding the registration of clinical trial information was sent to JPMA participating companies, and the second edition of the Q&A was revised on February 28, 2020, based on the results of the questionnaire.
The "Ministerial Ordinance Concerning the Establishment of Relevant Ministerial Ordinances in Connection with the Enforcement of the Law Concerning Partial Amendment to the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Related Matters (Revised Ministerial Ordinance) (Ordinance of the Ministry of Health, Labour and Welfare No. 155 of 2020)" newly established Article 272-2 (Disclosure of Information) of the Enforcement Regulations of the Pharmaceutical Affairs Act, making the publication of clinical trial information mandatory. The Q&As have been revised as the third edition in accordance with the new regulation and the "Registration of Clinical Trials" (Ministry of Health, Labour and Welfare Ordinance No. 155 of 2020) issued by the Ministry of Health, Labour and Welfare.
This Q&A is intended to provide the latest information on the registration of clinical trial information, and we hope that it will be useful for the smooth implementation of registration operations.