pre-consultation meeting

PMDA Consultation Services: Consultations and Pre-consultation meetings

PMDA offers many types of consultations related to the development of drugs, medical devices and ATMPs (clinical trials,...

BasicDrugs, Medical Devices, ATMPs

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...