Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
Prior Assessment System Is One Step Forward to Quicker NDA Review
The PMDA (Pharmaceuticals and Medical Devices Agency) introduced a “prior assessment consultation system”on a trial basis in 2009. Under this system, preclinical and early clinical data are submitted to and reviewed by the PMDA before an NDA is formally submitted.…
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COMMENTARY
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