Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Revises Q&A on Nitrosamine Self-Inspections, OKs Use of Interim Control Limit
The Ministry of Health, Labor and Welfare (MHLW) has issued an administrative communication that partially revises its Q&A on self-inspections conducted by drug manufacturers regarding the risks of nitrosamine impurities in their products. When nitrosamines exceeding acceptable levels are detected,…
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