EMA Issues Final Opinion on Nitrosamines

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines, it was revealed in a July 9, 2020 press release.

Companies will now be required to have appropriate control strategies in place that will prevent or limit the presence of nitrosamines, and, where necessary, improve the manufacturing processes. Additionally, companies will be expected to evaluate the risk of nitrosamines being present in medicines and will need to perform appropriate tests if a risk is identified.

CHMP’s opinion follows a request from EMA’s executive director that is in line with a procedure described in Article 5(3) of Regulation (EC) No 726/2004. Close collaboration between EMA and national authorities, the European Directorate for the Quality of Medicines and Healthcare, and international partner agencies was involved in drawing up the requirements. Authorities across the European Union will work together to ensure that the measures are taken for all medicines, irrespective of how they were authorized.

A dedicated webpage on EMA’s site will soon feature detailed information for companies, including timelines, according to the release. For now, the agency has specified that companies should follow current instructions.

Source: EMA