Drug Evaluation Committee
In order to promote pharmaceutical research, development, post-marketing safety measures/appropriate use, and medical affairs activities, the committee examines technologies and regulations in each of these activities, makes policy recommendations, and conducts educational activities.
Notices and Updates
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Drug Evaluation Committee
We have posted the presentation slides titled “Reflections on the Impact of the Study Group on the Future of Pharmaceutical Regulations on Post-Marketing Surveys and Other Activities” (July 11, 2026, 28th Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information).
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Drug Evaluation Committee
We have posted the “Q&A, 5th Edition, Regarding ‘Registration of Clinical Trial Status, etc.’ (Pharmaceutical and Medical Devices Safety and Evaluation Division Notice No. 0831-9, August 31, Reiwa 2).”
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Drug Evaluation Committee
We have published an article titled “The Revised Next-Generation Medical Infrastructure Act and Post-Marketing Drug Safety Surveillance: Required Actions for Pharmaceutical Companies.”
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Drug Evaluation Committee
We have posted an article titled “JPMA’s Perspective on the FDA Roadmap and Related Matters.”
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Drug Evaluation Committee
"The Potential for Bioequivalence Evaluation Using Physiological Drug Absorption Models: The Current Status and Future Prospects of Virtual BE" has been published.
Contents of 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 structure of the committee's activities for solving problems and the task forces in action are posted.
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Deliverables of Drug Evaluation Committee
Reports and recommendations for improvement, etc., examined by the committee and each specialized subcommittee are posted.
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Acceptance of questions about clinical trials or GCP on Clinical Trials 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 symposia and Assembly meetings held by the Drug Evaluation Committee are available.
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Drug Evaluation Committee Declaration, Guideline, Guidance, and Implementation Guidance
Guidance, guidelines, and policies established based on the Declaration and Voluntary Standards in the activities of the Drug Evaluation Committee are posted here.
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JPMA PV Navi
The Green Book and other PV-related "guidance" are posted by category.
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Drug Evaluation Committee YouTube/X
The 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 Drug Evaluation Committee
The Drug Evaluation Committee's official account.
