Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Updates Q&A on Use of Registry Data in Drug Applications
Japan’s Ministry of Health, Labor and Welfare (MHLW) has updated its Q&A guidance on the use of registry and medical database data in drug approval and re-examination applications. The revised guidance, issued on March 30, incorporates insights from the ministry’s…
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