EMA Gives Drugmakers Six Months to Assess Products for Nitrosamines

The European Medicines Agency ordered drug companies to review their products within the next six months for contamination with nitrosamines.

Marketing authorization holders need to evaluate their drugs for the presence of nitrosamines and test all at-risk products — and quickly report any impurities to regulators, the agency said.

Drugmakers should review all approved medicines containing APIs, including generics and OTCs, but should prioritize evaluations and confirmatory testing using a risk-based approach. For example, drugs with higher daily doses or ones for chronic use may warrant priority.