The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
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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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