Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Outlines Envisaged Cases of Regulatory Submissions without Japanese Data, Covering Rare Disease Drugs
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on October 23 spelling out cases in which drug makers can file regulatory applications for rare disease treatments without conducting clinical trials in Japanese patients. The notification sorted out…
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