Drug Evaluation Committee Explanation of "Handling of Provision of Information for Clinical Trials, etc." and Q&A

Clinical Evaluation Subcommittee

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

Explanation of the Notice, Q&A, and this Explanation will be available on YouTube. See below for details.

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