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 “Institutionalization” of Conditional Approval, Sakigake Schemes
With an eye on an amendment of the Pharmaceuticals and Medical Devices (PMD) Law, the health ministry has proposed the “institutionalization” of its conditional early approval system and sakigake fast-track designation scheme under the law in order to give them…
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