Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Sets 6-Month Target for All SaMD Products under Priority Review
The Pharmaceuticals and Medical Devices Agency (PMDA) aims to complete its reviews for all software as a medical device (SaMD) products on the priority pathway within six months under its new mid-term plan starting this April. The PMDA presented a…
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