For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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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