Published on Feb 24, 2025
A lot has happened in the past month alone which will impact the nitrosamine space for years to come.
New molecule classes
Since 2023, there has been a difference between the cohort of concern spoken of in guidance documents and that which has been controlled by regulatory agencies. Recently, that gap has narrowed, significantly. EMA recently announced limits for a number of pseudonitrosamines, further broadening the scope of action that must be taken by an industry still playing catch-up. Industry needs to ensure these compound classes are correctly designated in their risk assessments and act accordingly.
Argument for updates limits
Separately, perhaps the most important paper to date on the subject was published by Ponting, et al., “Control of N-nitrosamine impurities in drug products: Progressing the CPCA framework and supporting the derivation of robust compound-specific acceptable intakes.” In this paper, the authors share convincing data that the current CPCA limits are quite conservative and are due for revision. Suggestions are put forward to revise the process for establishing all acceptable intakes which would greatly increase the regulatory limits while taking a more realistic stance on patient safety.
Reaction
How both industry and regulators continue to evolve this topic will be critical in the coming months and years. It is more important than ever to further these conversations and stay abreast of each update as large-scale changes continue.
Join us as we discuss these topics and more during our in-depth nitrosamines webinar.
Published on Feb 24, 2025 by Jason Brown