Nitrosamines: Risk Evaluation Required by the European Medicines Agency (EMA)

On September 19th 2019, the European Medicines Agency (EMA) notified all Marketing Authorisation Holders (MAHs) to evaluate the risk of the presence of nitrosamine impurities in human medicinal products. This is the latest step in the increasing pressure to the pharmaceutical, and indirectly to API companies, regarding the potential presence of these genotoxic impurities.

The hottest subject regarding compliance was triggered in July 2018, when EMA started reviewing medicines containing Valsartan, after the presence of N-nitrosodimethylamine (NDMA) was detected; later last year, US FDA also issued a communication on the same issue. Later last year, EMA recommended, companies manufacturing sartan medicines, to review their products and processes to prevent the presence of nitrosamines.

With the new requirement of the EMA, the risk evaluation for all products should be concluded within 6 months of the publication of the notification.

This represents an enormous task for pharmaceutical companies with the added difficulty to obtain the necessary information from their API suppliers regarding the details of the manufacturing processes.

TDV, with its extensive experience pharmaceutical and chemical processes since 1997, is currently providing to its customers, customised assistance to facilitate the fulfilment of the EMA requirement in the published due date. From the approach and methodology for the systematic risk evaluation to the detailed chemical assessment of synthetic steps and manufacturing details of the API, TDV can provide high value and efficient methodology to comply with the current EMA expectation.

TDV services related to the risk evaluation of nitrosamines in pharmaceutical products include:

If you are interested in more information, please email us.