EMA: Updated Q&A on Nitrosamines 2024
The EMA has updated its Q&A document on nitrosamine impurities in human medicinal products. In collaboration with the Heads of Medicines Agencies (HMA) responses to six questions were revised. Specifically, EMA updated one answer to reflect its position on the acceptability of the Ames test and another to clarify responsibilities concerning active substance master files and the certification of suitability.
Five responses were modified to "clarify expectations for risk assessments, confirmatory testing, and dossier requirements for products where nitrosamine impurities can be controlled according to ICH Q3A/B limits." These ICH principles guide the control of nitrosamine impurities.
"For products where nitrosamine impurities can be controlled according to ICH Q3A/B principles, see Q&A 10, confirmatory testing is generally not needed if the risk can be sufficiently mitigated based on scientific considerations that demonstrate the relevant ICH Q3A/B thresholds will not be exceeded," EMA stated.
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