Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Adopts New Evaluation Method for Nitrosamine Impurities Risks
Japan has adopted a new method issued by European regulators for the assessment of carcinogenic risks posed by nitrosamines detected in pharmaceutical products, called Carcinogenic Potency Categorization Approach (CPCA). In a Q&A letter updated on August 4 for nitrosamine self-inspections,…
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