Drugs Notification of necessity for Japanese data when applying for drug approval (dated October 23, 2024)
On October 23, 2024, a notification was issued outlining the necessity of Japanese data when applying for drug approval....
Drugs Drugs Overview of Japanese Phase I Trials
In order to advance discussions related to drug regulations with the aim of eliminating drug lag/drug loss and strengthe...
Drugs 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
The Gate Opening Summit for Innovative Drug Discovery was held in Japan on July 30, 2024. At this time, the Strategic Go...
Drugs Notification of Use Results Survey and Administrative Notice (dated July 18, 2024)
In order to advance discussions related to pharmaceutical regulations with the aim of eliminating drug lag/drug loss and...
Medical Devices Japanese Website: “Basics of Medical Program Development”
The Japan Association for Advancement of Medical Equipment has launched a website called "The Basics of Medical Program ...
Drugs Drugs: Pilot of change procedures for moderate risk changes of manufacturing method (from September 27, 2024)
On September 27, 2024, the "Pilot of Change Procedures for Moderate Risk Changes of Manufacturing Method" (Notification ...
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 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...