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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Definition of “New Drug” in Japan and its standard pre-market review process by PMDA/MHLW

Starting September 6, 2024, a trial scheme has been implemented, where submission of documents in English for new drug a...
2024.09.17
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Recent Posts

Notification of necessity for Japanese data when applying for drug approval (dated October 23, 2024)
2024.11.11
Overview of Japanese Phase I Trials
2024.10.08
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
2024.10.06
Notification of Use Results Survey and Administrative Notice (dated July 18, 2024)
2024.10.05
Japanese Website: “Basics of Medical Program Development”
2024.10.02

Popular Articles

Changes in the timing of new drug approvals/drug price listings in Japan (from January 2025)
2024.09.232024.11.10
The Roles of the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)
2024.09.29
US approval of self-administered nasal influenza vaccine (September 20, 2024)
2024.09.23
Drugs: Pilot of change procedures for moderate risk changes of manufacturing method (from September 27, 2024)
2024.10.01
Overview of Japanese Phase I Trials
2024.10.08

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