GMP topical


EMA: Update of Q&A on Nitrosamine Impurities

EMA: Update of Q&A on Nitrosamine Impurities

After only ten days, the European Medicines Agency (EMA) published yet another revised version of the Q&A on nitrosamine impurities for marketing authorisation holders on 12 October 2023. With revision 19, Annexes 2 and 3, among others, were removed from the document and are now available as separate Appendices.

The answer to question 10 "What limits apply to nitrosamines in medicinal products?" has been updated to allow reference to other sources for CPCA categorization:

“If the nitrosamine is not included in Appendix 1, MAH/MA applicants can also refer to a CPCA category from another source e.g. CPCA categories published by other regulatory authorities, but this will need confirmation to allow control of the substance at the level corresponding to that category.”

In addition, the references to the guideline ICH M7(R1) "Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk" were changed to ICH M7(R2). The guideline came into force on 30 September 2023 and deals with the evaluation of impurities.


EMA: Website on nitrosamine impurities

EMA: Q&A for marketing authorisation holders/applicants on nitrosamine impurities

Appendix 2; Appendix 3