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...
approval application
Drugs 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 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...