EMA/HMA: Nitrosamine Report published

At the end of July 2025, the report 'Nitrosamine impurities in human medicines - The response of the European Medicines Regulatory Network' was published on the website of the EMA (European Medicines Agency). It was published jointly with the HMA (Heads of Medicines Agencies) and provides an overview of the EMRN's (European Medicines Regulatory Network) response about nitrosamines.

The report contains the following chapters:

Executive summary
1. Introduction
2. CHMP scientific assessments
2.1. Article 31 reviews for sartans and ranitidine
       Sartans
       Lessons learnt from presence of N-nitrosamine impurities in sartan medicines
       Ranitidine
2.2. Article 5(3) review for all human medicines
3. Overview of developed approaches
3.1. Procedural
3.1.1. EMRN governance for implementation of the Article 5(3) CHMP opinion
3.1.2. Call for review to MAHs
3.1.3. Guidance for MAHs
3.1.4. Nitrosamine case assessment workflow
3.2. Safety
3.3. Quality
3.4. Market surveillance
3.5. Medicine shortages and availability issues
4. Engagement and communication with stakeholders and international partners
4.1. Industry, health care professionals and patients
4.2. Collaboration with international partners
5. Areas for future development
6. Conclusions
7. References

In addition to looking at nitrosamine levels in sartans and ranitidine, which was the initial focus, section 2.2 covers all relevant other medicines.

Please see the EMA website for the full report, 'Nitrosamine impurities in human medicines - The response of the European Medicines Regulatory Network'.