The European Medicines Agency (EMA) requests Marketing Authorization Holders to perform a Risk Assessment for the presence of Nitrosamines in all Chemically Synthesized API’s.
Nitrosamines are classified as probable human carcinogens. Due to findings in multiple medicines since July 2018, EMA recently published an urgent request (see press release of 26/09/2019). As a precautionary measure, all Marketing Authorization Holders are asked to review their manufacturing processes and evaluate the presence of nitrosamines in their medicinal product.
This evaluation should be performed for every concerned medicine within 6 months.
Ardena can help you performing the nitrosamine risk assessment for any synthesized API to stay compliant and to keep ensuring the safety of the patients.
We would be pleased to make an appointment to present our solutions on this matter.