Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Weighs Adoption of EMA Approach for Nitrosamine Impurities Risk Assessment
Earlier this month, European regulatory authorities issued a new assessment method to gauge the carcinogenic risks of nitrosamines detected in pharmaceutical products. Japan is considering following suit to also adopt this approach, which might eventually become the gold standard among…
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