Basic Period from new drug application to drug price listing in Japan
The period from application for approval of a new drug to its drug price listing (market launch) in Japan is very easy t...
Basic
Basic Basic The Roles of the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)
The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) play major r...
Basic PMDA Consultation Services: Consultations and Pre-consultation meetings
PMDA offers many types of consultations related to the development of drugs, medical devices and ATMPs (clinical trials,...
Basic 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...