How to comply with FDA and EMA regulations
Nitrosamines are classified as probable human carcinogens. Due to findings in multiple medicines since July 2018, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) request Marketing Authorization Holders to review all chemical medicines for the possible presence of nitrosamines, and test products at risk.
After the publication of the assessment report in July 2020, the EMA has included biological medicines to the scope of this review.
As a first step, the nitrosamine risk assessment should be performed
- Before 31 March 2021 for chemical medicines
- Before 1 July 2021 for biological medicines.
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Ardena can support you to perform the nitrosamine risk assessments to stay compliant and guarantee the safety of the patients.