Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
The Ministry of Health, Labor and Welfare (MHLW) plans to propose an emergency authorization system that would grant approval for products with a good benefit-risk balance based on their “presumed efficacy” as long as their safety is “confirmed.” According to…
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