Drug Evaluation Committee: Declarations, Guidelines, Guidance Documents, and Implementation Guidelines
Data Integrity Declaration—Our Declaration—
Clinical Trial Ecosystem Initiative: Industry Statement
Electronic Collection of Clinical Trial Data
Guidelines and Procedures for Conducting Clinical Trials
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Considerations for Conducting Clinical Trials Involving the Collection of Genomic Samples in Drug Development
, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association - Guidelines for Providing Information to Recruit Subjects for Clinical Trials <Revised Edition>
- Agreement on the Provision and Transfer of Comparator Drugs; Japan Pharmaceutical Manufacturers Association
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Promoting Digital Transformation (DX) to Improve the Pharmaceutical Development Environment
Joint Statement: National University Clinical Research Promotion Council / Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association
Implementation Guidelines and Guidelines on the Disclosure of Clinical Trial Information
Basic Principles Regarding MA/MSL Activities
This document presents the basic principles regarding MA/MSL activities at member companies (April 1, 2019).
- Basic Principles Regarding Medical Affairs (MA) Activities (256KB)
- (Reference Material) Consensus Statement on Medical Affairs Activities (94KB)
- Basic Principles Regarding Medical Science Liaison (MSL) Activities (262 KB)
- (Reference Material) Consensus Statement on Medical Science Liaison Activities (102 KB)
Guidelines on Clinical Research
- Guidelines on Support for Investigator-Initiated Clinical Research Using Prescription Drugs and Other Products (Revised October 12, 2020)
- Guidelines on Collaborative Clinical Research Using Prescription Drugs and Other Products (Enacted May 10, 2024)
- JPMA: Comparison Table for Guidelines on Clinical Research Using Prescription Drugs and Other Products (May 10, 2024)
- JPMA Guidelines on Clinical Research Using Prescription Drugs and Other Products: Explanatory Materials (May 10, 2024)