Cover key Japan regulatory topics on drugs, medical devices and ATMPs

Key Topics on Japan Regulatory Affairs (Drugs, Medical Devices, ATMPs)

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2024.09.16

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Key Topics on Japan Regulatory Affairs (Drugs, Medical Devices, ATMPs)

Recent Posts

Notification of necessity for Japanese data when applying for drug approval (dated October 23, 2024)

Overview of Japanese Phase I Trials

Gate Opening Summit for Innovative Drug Discovery (on July 30, 2024), and Strategic Goal and Action Plan for Improving Drug Discovery Capabilities to Support Early Availability of Innovative Drug

Notification of Use Results Survey and Administrative Notice (dated July 18, 2024)

Japanese Website: “Basics of Medical Program Development”

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Changes in the timing of new drug approvals/drug price listings in Japan (from January 2025)

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US approval of self-administered nasal influenza vaccine (September 20, 2024)

Drugs: Pilot of change procedures for moderate risk changes of manufacturing method (from September 27, 2024)

Overview of Japanese Phase I Trials

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Key Topics on Japan Regulatory Affairs (Drugs, Medical Devices, ATMPs)

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