Drug Committee

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...

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...