Nitrosamines: the latest position
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
The European Medicines Agency (EMA) initially proposed a risk-based approach for assessing the potential for contamination of medicinal compounds with nitrosamines, with an original deadline of 31 March 2021 for medicines containing chemically synthesised active pharmaceutical ingredients (APIs) and 01 July 2021 for biological APIs.1 If a risk was identified, the applicant was mandated to initiate confirmatory testing and feedback the outcomes as soon as possible. If testing confirmed the presence of nitrosamine contamination, the applicant was required to implement risk mitigation activities and submit variations to the Marketing Authorisation Application (MAA). The revised timelines are 26 September 2022 and 01 July 2023, for medicines containing chemically synthesised APIs or biological APIs, respectively.2