Biologicals Join List Of EU Medicines Requiring Nitrosamine Evaluation

Although biological medicines carry a very low risk of being contaminated by nitrosamine impurities, the EMA says the possibility cannot be ruled out.

Nitrosodimethylamine
Nitrosamines are classified as probable human carcinogens • Source: Shutterstock

The European Medicines Agency has directed sponsors of new and existing biological medicines to review their products for the presence of possible nitrosamine impurities, as is already required for medicines containing chemically synthesized active substances.

In addition, all drug sponsors are being asked to initiate new measures – such as developing appropriate control strategies and...

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