EMA Report Added on 29 July 2025: 'Response to nitrosamine impurities' section - which includes a report summarising the scientific and regulatory milestones since the discovery of nitrosamine impurities
A report is available outlining the the European medicines regulatory network’s response to nitrosamine impurities in human medicines.
The report summarises the scientific and regulatory milestones since the discovery of nitrosamine impurities in 2018. These impurities were detected in a group of cardiovascular medicines known as 'sartans' and later also in other medicines.
The report:
- highlights key scientific reviews, including Article 31 reviews of sartans and ranitidine and Article 5(3) review for all human medicines under Regulation (EC) No 726/2004;
- describes the regulatory framework that manages nitrosamine impurities;
- presents advances in scientific knowledge on quality and safety of nitrosamines;
- details the harmonised approach implemented in the EU to protect patients and ensure medicine availability;
- and describes Network's collaboration with international partners, industry, healthcare professionals and patients to ensure the continued safety and availability of medicines. [EMA]
