Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Eases Rule on Regulatory Submissions for Combination Therapies
The Ministry of Health, Labor and Welfare (MHLW) has relaxed the rules on regulatory filings for combination therapies, effective May 31, now allowing companies to omit applications for combined drugs, with the submission of a label update notification required instead.…
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REGULATORY
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