Drug Evaluation Committee Declarations, Guidelines, Guidance, and Practice Statements
Data Integrity Declaration - Our Declaration
Clinical Trial Ecosystem Business Industry Statement
Electronic Acquisition of Clinical Trial Data
Guidelines and Guidelines for Conducting Clinical Trials, etc.
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Items to be considered when conducting clinical trials that collect genomic samples in drug development
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation - Guidelines for Providing Information for Recruitment of Subjects for Clinical Trials <Revised Version> (Japanese only)
- Agreement on the Provision and Transfer of Control Drugs Japan Pharmaceutical Manufacturers Association
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Promotion of DX that contributes to the improvement of the drug development environment
Joint Statement: Council for the Promotion of Clinical Research at National Universities / Committee on Drug Evaluation, Japan Pharmaceutical Manufacturers Association
Implementation guidelines and guidelines regarding the disclosure of clinical trial information
Basic Policy on MA/MSL Activities
The basic concept regarding MA/MSL activities in member companies is presented (2019.4.1).
Guidelines for Clinical Research
- Guidelines for Supporting Investigator-Initiated Clinical Research Using Ethical Drugs (Revised October 12, 2020)
- Guidelines for Collaborative Clinical Research Using Ethical Drugs (enacted May 10, 2024)
- Pharmaceutical Association of Japan Guideline on Clinical Research Using Ethical Drugs (May 10, 2024)
- Pharmaceutical Association of Japan Guideline for Clinical Research Using Ethical Drugs, etc. Explanatory Material (May 10, 2024)