EMA: Draft for Qualification of Non-Mutagenic Impurities

The EMA has published for consultation a reflection paper on the qualification of non-mutagenic impurities (NMI).

This reflection paper considers the safety evaluation of NMI in chemically synthesised pharmaceuticals and is intended to establish a framework to facilitate future discussions among stakeholders. Qualification of NMI may be required when data from the regular (non-)clinical development with the API batches is not considered sufficient.

The aim of this paper is to complement currently available guidelines addressing qualification of NMI such as ICH Q3A and ICH Q3B. The reflection paper discusses different non-animal approaches, which may provide more compound-specific information than animal studies with API batches containing the impurities at low levels.

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 consultation will close on 30 April 2025.

Source:

EMA: Reflection paper on the qualification of non-mutagenic impurities – Draft