Basic Policy on the Handling of Information Provision Related to Clinical Trials
Drug Evaluation Committee
November 2023
In response to the requirements for the provision of clinical trial information by pharmaceutical companies, etc. in "Handling of Provision of Information pertaining to Clinical Trials" (January 24, 2023, Pharmaceutical Affairs Bureau, AIST No. 0124-1), the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) has issued "Guidelines for Provision of Information pertaining to Clinical Trials" to ensure transparency in the conduct of clinical trials and to improve patient access to clinical trials. Basic Policy on the Handling of Provision of Information on Clinical Trials" (hereinafter referred to as "this document").
Subsequently, the position and content of the "Guidelines for Provision of Information for Recruitment of Subjects for Clinical Trials <Revised Version>" (Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, November 2008) were reviewed, and the "Guidelines for Provision of Information for Clinical Trials for Patients and the General Public, Third Edition" (Japan Pharmaceutical Manufacturers Association, November 2023) including the content of this document was newly prepared. The "Guidelines for Providing Information on Clinical Trials to Patients and the Public" (November 2023, Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation) has been newly prepared.
In the future, please refer to "Guidelines for Provision of Information on Clinical Trials for Patients and the General Public, Third Edition" for basic ideas on how to handle the provision of information on clinical trials.