Drug Evaluation Committee Explanation of "Handling of Provision of Information for Clinical Trials, etc." and Q&A
May 2026
In November 2023, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) formulated the "Guidelines for Provision of Information on Clinical Trials for Patients and the Public (Version 3)" (hereinafter referred to as the "Old Guidelines"), which was provided to member companies and has been in operation.
At this time, we would like to inform you of the、「 Handling of Provision of Information Pertaining to Clinical Trials, etc.」（ 20388 Year3 March30 Date: Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare0330 No.1 No.。 The "Handling of Provision of Information on Clinical Trials, etc." (Pharmaceuticals and Medical Devices Agency Announcement No. 0330-1, March 30, 2026; hereafter "this notice"), "Q&A on Handling of Provision of Information on Clinical Trials, etc." and "Q&A on Provision of Information on Clinical Trials, etc. by Patient Groups, etc." (March 30, 2026, Office Communication. Explanation of "Handling of Provision of Information on Clinical Trials, etc." and "Q&A on Provision of Information on Clinical Trials, etc. by Patient Groups, etc." (Office Communication dated March 30, 2026; hereinafter referred to as "Q&A")," (hereinafter referred to as "this Explanation") has been prepared. With the issuance of this Explanation, the "Old Manual" is abolished.
Explanation of "Handling of Provision of Information for Clinical Trials, etc." and Q&A
Briefings on this notice, the Q&A, and this Explanation are currently available on YouTube. (Available for a limited time until December 31, 2026)
Click here to watch the briefing session on the handling of information disclosure related to clinical trials, etc., and to view the presentation materials.
For a limited time, we are accepting questions regarding this notice, the Q&A, this Explanation, and the briefing materials (until July 31, 2026). If you have any questions, please submit them using this form. If you have multiple questions, please submit a separate form for each question. Answers will be posted collectively on this page after the question submission period ends.
For your reference
- “Handling of Information Provision Related to Clinical Trials, etc.” (Reiwa 8, March 30; Pharmaceutical and Narcotics Supervision Bureau Notice No. 0330-1)
- “Regarding the Q&A on the Provision of Information Related to Clinical Trials, etc.” (Administrative Notice, March 30, Reiwa 8)
- “Q&A Regarding the Provision of Information on Clinical Trials, etc., by Patient Organizations, etc.” (Administrative Notice, March 30, Reiwa 8)