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Home » EMA Considers Ways to Evaluate Non-Genotoxic Drug Impurities
EMA Considers Ways to Evaluate Non-Genotoxic Drug Impurities
Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment.