Drug Evaluation Committee
In order to promote pharmaceutical research, development, post-marketing safety and proper use, and medical affairs activities, the Drug Evaluation Committee examines technologies and regulations in each of these activities, makes policy recommendations, and conducts educational activities.
Announcements and Updates
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Drug Evaluation Committee
The 148th Annual Meeting of the Drug Evaluation Committee" is now available.
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Drug Evaluation Committee
Asian eCTD / Gateway System Information" is posted.
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Drug Evaluation Committee
The "Results of Questionnaire on Information Provision Activities at the Time of Precautions for Use Revision" is now available.
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Drug Evaluation Committee
Review of the 10 years since the introduction of the RMP system from the standpoint of the pharmaceutical industry" is now available.
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Drug Evaluation Committee
eCTD v4 Implementation Promotion Symposium Lecture Slides (JPMA Presentation)" is now available.
Contents of the Drug Evaluation Committee
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Implementation Plan
The implementation plan for this fiscal year is posted.
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Implementation Structure and Active Task Forces
The system for implementing committee activities to resolve issues and the task forces that are currently active are posted.
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Deliverables of the Drug Evaluation Committee
Reports and recommendations for improvement, etc., examined by the committee and each specialized subcommittee are posted.
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Receipt of questions regarding clinical trials or GCP at Clinical Trial 119
Questions regarding clinical trials and GCP are accepted from medical institutions, CROs, SMOs, and pharmaceutical companies.
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Drug Evaluation Committee Symposium
Information and materials on symposiums and general meetings held by the Drug Evaluation Committee are available.
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Drug Evaluation Committee Declarations, Guidelines, Guidance, and Practice Statements
Guidance, guidelines, and policies established based on the Declaration and voluntary standards in the activities of the Drug Evaluation Committee are posted.
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Pharmaceutical Association of Japan PV Navi
The Green Book and other PV-related "guidance" are posted by category.
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Drug Evaluation Committee YouTube/X
Official account of the Drug Evaluation Committee. It introduces information on the activities of the Drug Evaluation Committee, including videos created by the Committee and recordings of symposiums it has hosted.
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Communication from the Drug Evaluation Committee
The site also provides information on the activities of the Drug Evaluation Committee.