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 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...
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...
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...