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...
2024-09
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,...
ATMPs Brief review: Akuugo injection for intracerebral implantation (SanBio), results of Drug Committee on June 20, 2024
Akuugo injection for intracerebral implantation is a Japan origin ATMP with intended use for improvement of chronic moto...
Drugs Changes in the timing of new drug approvals/drug price listings in Japan (from January 2025)
The timing of drug approval is an important factor that affects the outlook for development schedules (application timin...
Drugs US approval of self-administered nasal influenza vaccine (September 20, 2024)
On September 20, 2024, the US FDA approved the first self-administered nasal influenza vaccine. (FDA press release) This...
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...
Drugs Submission of documents in English for new drug approval applications (trial scheme, from September 6, 2024)
An administrative notice entitled "Submitting documents to be attached in the application for approval of new ethical dr...