Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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