Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Proposes New Approval Framework Incorporating Conditional OK, Sakigake Scheme
With an eye to an amendment of the Pharmaceuticals and Medical Devices (PMD) Law, the health ministry on October 18 proposed the creation of a new approval framework with solid legal backing that incorporates the current conditional early approval system…
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REGULATORY
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