In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in blood pressure medicines known as ‘sartans’. This led to some product recalls and strict new manufacturing requirements for sartans, based on a regulatory review. As a result, since September 2019 marketing authorisation holders were requested to review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.
The call for review was extended to biological active substances in July 2020, as an outcome of CHMP’s opinion. To allow marketing authorisation holders enough time to implement the opinion, the European medicines regulatory network agreed new deadlines:
- Step 1 (Risk evaluation):
- 31 March 2021 for chemical medicines;
- 1 July 2021 for biological medicines.
- Step 2 (Confirmatory testing):
- Confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and report confirmed presence of nitrosamines as soon as possible.
- Step 3 (Update marketing authorisations):
- 26 September 2022 for chemical medicines;
- 1 July 2023 for biological medicines.