GMP

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 ...

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...