Regulatory Affairs Committee
The committee investigates and examines various issues related to the operation of the Pharmaceuticals and Medical Devices Act system and various pharmaceutical regulations pertaining 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.
Notices and Updates
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Regulatory Affairs Committee
Report on Results of Questionnaire Survey on Companies' Current Perceptions of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency (February 2026)" is posted.
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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 available.
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Regulatory Affairs Committee
The report of "The 15th Annual Meeting of the Regulatory Science Society of Japan" is now available.
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Regulatory Affairs Committee
The article "Toward the Era of Co-Creation" <4> by Chairperson Kashitani was published in Nikkan Yakugyo.
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Regulatory Affairs Committee
Report on "FY2025 Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee" is now available.
Regulatory Affairs Committee Contents
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Implementation Plan
The implementation plan for this fiscal year is posted.
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Symposium
Materials on pharmaceutical affairs-related symposiums and workshops, etc. are posted.
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Deliverables
The deliverables of the Regulatory Affairs Committee are posted.
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Announcement from Regulatory Affairs Committee
Announcements from the Regulatory Affairs Committee are posted.