The document “Reflection paper on the qualification of non-mutagenic impurities” (EMA/CHMP/543397/2024), currently under public consultation until April 30, 2025, addresses the safety assessment of non-mutagenic impurities (NMI).
The main objective of this document is to complement existing guidelines, such as ICH Q3A and ICH Q3B, by providing alternative strategies to qualify new impurities or higher levels of previously qualified impurities at lower levels. This is particularly relevant when data from (non)clinical development with active substance batches are not considered sufficient for the qualification of NMIs.
A distinctive feature of this document is its emphasis on non-animal-based approaches, which can provide more specific information on the compound compared to animal studies using active substance batches containing low levels of impurities. This approach aligns with the internationally recognized 3R principles (Replacement, Reduction, Refinement).
For further details and to access the full document, please visit the official EMA website:
Reflection paper on qualification of non-mutagenic impurities