European Authorities Continue Work to Prevent and Manage Nitrosamine Impurities

Pharmaceutical Technology Editors

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

According to a March 3, 2020 press release from the European Medicines Agency (EMA), European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

In a review by EMA’s human medicines committee (CHMP), the evidence on how N-nitrosodimethylamine (NDMA) was present in some batches of ranitidine is being considered. Additionally, authorities across the region are in the process of assessing the impact of recent tests that found NDMA in some batches of metformin medicines in the EU. Further results from these tests are being awaited and patients are advised to continue to take their medicine as prescribed.

Evidence is being gathered in an ongoing procedure that is aimed at providing guidance to companies on how to deal with nitrosamine impurities in medicines, and opinions from experts across the region are also being considered. This procedure, which began in September 2019, has led to the implementation of measures to evaluate and mitigate the risk of nitrosamines across the EU.

Furthermore, EU authorities are conducting an exercise to determine what lessons can be learned from the presence of nitrosamines in sartans. Recommendations from this group are in the process of being finalized.

Source: EMA