In 2018, certain types of nitrosamines (N‑nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA)) were detected in a number of active substances used in the treatment of hypertension and in related medicines. Nitrosamines are known as possible carcinogens for humans: only very low amounts are acceptable according to current regulatory requirements (ICH M7 “cohort of concern”). Their detection requires highly sensitive analytical methods. As clarified by the European Medicines Agency (EMA), their presence in active substances may be linked to several factors, such as processing conditions, accidental introduction due to cross-contamination (due to processes running in parallel on the same production lines), recovery procedures for solvents, or also from degradation of the substance.

In line with its mandate to promote and protect public health in Europe by ensuring access to good quality medicines and healthcare, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been working actively at various levels to address the presence of nitrosamines in active substances and medicines and regularly informing all stakeholders, from national authorities to manufacturers, on the state of the works and on initiatives taken.

The EDQM has been co-operating continually with regulatory authorities at national, international and EU level and has regularly published updates on its website.

Details of EDQM initiatives concerning nitrosamine contamination can be found below.