EMA Updates Nitrosamine Q&A with New Substances and Revised Data

The European Medicines Agency and CMDh have updated their Nitrosamine Q&A document, which provides guidance to marketing authorisation holders on managing nitrosamine impurities in human medicines.

The document includes three appendices, with Appendix 1—developed by the Non-clinical Working Party (NcWP)—listing acceptable intake (AI) limits based on the Carcinogenic Potency Categorisation Approach (CPCA). In March 2026, several new substances were added to this appendix, while existing entries were revised. Updates are clearly marked for easy identification.

Newly included compounds feature various nitrosamine impurities linked to pharmaceutical substances, while updated entries reflect revised toxicological data and intake limits.

All appendices, including Annexes 2 and 3, along with the full Q&A document, are available on the EMA website under the “Questions and answers” section, supporting regulatory compliance and risk assessment efforts in the pharmaceutical industry.

01-04-2026