Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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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