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 Creating Legal Provision on RWD-Only Drug Submissions
The Ministry of Health, Labor and Welfare (MHLW) has proposed stipulating in the Pharmaceuticals and Medical Devices (PMD) Act that it is possible to file for regulatory approval of drugs based on real-world clinical data alone. The proposal was made…
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