Regulatory Affairs Committee
The committee studies and examines various issues in the operation of the Pharmaceuticals and Medical Devices Act system and various pharmaceutical regulatory matters related to drug approval screening and safety measures, etc., and makes policy recommendations on various pharmaceutical administration matters, such as improving the efficiency of corporate activities and expediting approval screening, from the standpoint of R&D-oriented pharmaceutical companies.
Announcements and Updates
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Regulatory Affairs Committee
Report on the Results of the Questionnaire Survey on the Review Status of New Pharmaceuticals and New Biologics at the Pharmaceuticals and Medical Devices Agency -January 2025 Survey-" is now available.
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Regulatory Affairs Committee
The 15th Annual Meeting of the Regulatory Science Society of Japan (RSCJ)" is now available.
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Regulatory Affairs Committee
The article "Toward the Era of Co-Creation" <4> by Dr. Kashiwatani, Chairperson of the Pharmaceutical Affairs Committee, was published in Nikkan Yakugyo.
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Regulatory Affairs Committee
A report on the "Joint Meeting of the Drug Evaluation Committee and the Pharmaceutical Affairs Committee in 2025" is available.
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Regulatory Affairs Committee
The 14th Annual Meeting of the Regulatory Science Society of Japan" is now available.
Contents of the Pharmaceutical Affairs Committee
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Implementation Plan
The implementation plan for this fiscal year is posted.
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Symposium
Documents of symposiums, workshops, etc. related to pharmaceutical affairs are posted.
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Deliverables
Publications of the Regulatory Affairs Committee are posted.
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Information from the Pharmaceutical Affairs Committee
Announcements from the Regulatory Affairs Committee are posted.