Europe – Lessons learnt from presence of N-nitrosamine impurities in sartan medicines

In June 2020, the European Medicines Regulatory Network published a report on lessons learnt from the presence of N-nitrosamines in sartan medicines (also known as angiotensin II receptor antagonists). The report sets out a number of recommendations for strengthening the regulatory framework in order to reduce the potential of N-nitrosamines and other impurities being present in human medicines in the future and to support the regulatory network’s preparedness for managing similar cases of unexpected impurities should they occur in the future.
A summary of the recommendations with the assigned responsible party and indicative implementation timelines is provided below…