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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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





