EMA Lays Out Plans for Testing for Nitrosamine Impurities

Regulatory NewsRegulatory News | 28 October 2019 |  By 

As potentially cancer-causing impurities have been identified in some blood pressure and heartburn medicines, the European Medicines Agency (EMA) is outlining a three-step process whereby manufacturers can identify and control nitrosamine impurities, including N-nitrosodimethylamine (NDMA).

EMA on Monday released new templates for manufacturers to complete as part of their risk evaluations and confirmatory testing. By 26 April 2020, EMA is calling on companies to conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome and fill out either the template indicating “no risk identified” or “risk identified.”

The agency also says manufacturers should perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and report confirmed presence of nitrosamines as soon as possible via the appropriate template.

“EMA plans to complete this exercise by 26 September 2022. This timeline should be shortened in case of findings indicating higher risk to public health and that may require further risk minimisation measures,” the agency said.

The third step in the process would be for a company to apply for any necessary changes to its manufacturing process.

EMA also recently updated its question and answer document on nitrosamines to include the currently identified root causes for the presence of nitrosamines.

The updates from EMA comes as recalls of ranitidine and sartan medicines continue in the EU and US.

Nitrosamine impurities overview


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