FDA and EMA Publish Guidance on Nitrosamines

The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals.

The FDA’s guidance, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA.

The EMA has updated its June 2020 marketing authorization materials on nitrosamine impurities with a Q & A document that focuses on manufacturers having “appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, to improve their manufacturing processes.”

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