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...
PMDA
Drugs 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...
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,...
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...