Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Unveils Planned Framework for Conditional Early Approval Scheme
The Ministry of Health, Labor and Welfare (MHLW) on September 28 presented a planned framework for an envisioned “conditional early approval system,” which would apply to treatments for serious diseases for which confirmatory clinical studies are difficult to conduct. Under…
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