EMA strengthens control of nitrosamines in medicines
In recent years, the detection of impurities in medicines has gained significant attention from health authorities, particularly after the identification of nitrosamines, potentially carcinogenic compounds that can form during the manufacturing process of certain drugs.
In response to this risk, the European Medicines Agency (EMA) has published new guidelines aimed at improving the detection and control of theses substances. These measures seek to protect public health and minimize the risks associated with the consumption of contaminated medicines.
Why are nitrosamines in medicines a concern?
Nitrosamines are chemical substances classified as probable human carcinogens, according to toxicological studies. Their information can be caused by multiple factors, such as the interaction of certain ingredients, contamination of reagents, or contact with materials containing nitrites or secondary amines.
The EMA has pointed out documented cases in active substances such as sartans, ranitidine, and metformin, which have led to mass product recalls worldwide. This situation has prompted authorities to demand stricter controls.
Key updates in EMA guidelines
The new EMA recommendations affect both active substance manufacturers and marketing authorization holders. Some of the most relevant changes include:
- Comprehensive risk assessment: Manufacturers must thoroughly review their synthesis and production processes to identify potential sources of nitrosamine formation.
- Advanced analytical methods: The use of validated, sensitive analytical techniques aligned with ICH guidelines is now required.
- Immediate notification obligation: If nitrosamines are detected above the permitted limits, laboratories must immediately notify the competent authorities and submit an analysis of the impact on the quality and safety of the medicine.
A coordinated global approach
The EMA’s strategy aligns with similar actions taken by international agencies such as the FDA (USA) and the PMDA (Japan). The common goal is to harmonize criteria, raise quality standards, and prevent future incidents that could compromise patient safety.
Although this stricter control of impurities in the pharmaceutical industry involves technical and economic effort, the public health benefits are unquestionable. Effective prevention of nitrosamine contamination protects both the patient and the reputation of the sector.
