Guidance for Providing Information on Clinical Trials for Patients and the General Public, 3rd Edition
Drug Evaluation Committee
November 2023
In November 2008, the Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee formulated the "Guidelines for Providing Information on Clinical Trials for the Recruitment of Subjects <Revised Version>" (hereinafter referred to as the "Previous Guidelines"), which was provided to member companies and put into operation.
Subsequently, in response to the requirements for the provision of information on clinical trials by pharmaceutical companies in "Handling of Provision of Information on Clinical Trials" (January 24, 2023, Pharmaceutical Affairs Bureau, AIST No. 0124-1), the JPMA established the "Guidelines for Provision of Information on Clinical Trials" in June 2023 to ensure transparency in the implementation of clinical trials and to improve patient access to clinical trials. In June 2023, the Pharmaceutical Manufacturers Association of Japan (PMAJ) issued the "Basic Policy on the Handling of Information Provision for Clinical Trials" (hereinafter referred to as the "Basic Policy") to ensure transparency in the conduct of clinical trials and improve patient access.
This time, we have reviewed the old guidelines and prepared new guidelines for the provision of information on clinical trials conducted by pharmaceutical companies, etc., as "Guidelines for the Provision of Information on Clinical Trials for Patients and the General Public, Third Edition" (hereinafter referred to as "the Guidelines"). Since this guideline includes information on clinical trials provided at the time of subject recruitment, the "Basic Concept" and the "Old Guideline" will be abolished with the issuance of this guideline.
（2026Year5 May Addition）
「 Handling of Information Provision Concerning Clinical Trials, etc.」（ March 20228Year3 March30 January 20220330 No.1 No.。 The "Handling of Provision of Information for Clinical Trials, etc." (March 30, 2026, Pharmaceutical Affairs Bureau AIMA No. 0330-1; hereinafter referred to as "this notice"), "Q&A on Handling of Provision of Information for Clinical Trials, etc." (March 30, 2008, administrative communication), and "Q&A on Provision of Information for Clinical Trials, etc. by Patient Organizations, etc." (March 30, 2026, administrative communication) were issued, and "Handling of Provision of Information for Clinical Trials" (January 24, 2023, Pharmaceutical Affairs Bureau AIMA No. 0124-1; hereinafter referred to as "this notice") was issued. In accordance with the repeal of the "Q&A on Provision of Information to Clinical Trials, etc." (Office Announcement, March 30, 2026) and the "Handling of Provision of Information for Clinical Trials" (January 24, 2023, Pharmaceutical Affairs Bureau, AIST No. 0124-1), the "Guidelines" are hereby repealed.
Please refer to the following for the handling of information provision related to clinical trials, etc. based on the new notification and Q&A.