European Medicines Agency Revises Nitrosamine Impurity Guidelines for Drugs

The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products. The revisions include higher acceptable intake limits for certain nitrosamines and an extended implementation period for CPCA under specific conditions. Marketing authorization holders are reminded of their responsibility to ensure drug quality, safety, and efficacy, requiring risk evaluation, confirmatory testing, and updated marketing authorizations.