Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
The Japanese government enforced its emergency approval system on May 20 upon the promulgation of the amended Pharmaceuticals and Medical Devices (PMD) Law, opening the way for regulators to green-light certain drugs and vaccines based on “presumed” efficacy. The amended…
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