Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Issues Guidance to Thwart Distribution of Drugs with Unacceptable Nitrosamine Levels
Japan’s Ministry of Health, Labor and Welfare (MHLW) has issued a guidance regarding regulatory procedures for measures to manage the risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals. The goal is to prevent products with nitrosamine impurities above acceptable intake…
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