Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
A Japanese health ministry panel on December 3 roughly endorsed an outline of an emergency authorization system that would grant approval for drugs and medical devices based on “presumed efficacy” as long as safety is “confirmed.” The Ministry of Health,…
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