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....
drug loss
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 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 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...