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EMA – Public consultation on the Draft reflection paper on the qualification of non-mutagenic impurities

This reflection paper replaces a previous draft version (Reflection paper on the qualification of non-genotoxic impurities: EMA/CHMP/SWP/545588/2017). The focus of this reflection paper is to provide alternative strategies to qualify novel impurities or to qualify higher levels of impurities that were previously qualified at a lower level. It considers that the level of concern for impurities may vary depending on many factors that determine how much data is needed, ranging from none to compound-specific experimental data.

This reflection paper addresses the qualification of NMI, meaning the acceptability of certain levels of NMI from a safety perspective. It does not consider the acceptability of impurity levels from a quality perspective.

The deadline for comments is 30 April. Templates and other open consultations can be found on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (25 mars 2025). EMA – Public consultation on the Draft reflection paper on the qualification of non-mutagenic impurities. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/13kgd


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