As I examined the recently published EMA 3-year Work plan for the non-clinical domain, I wanted to share a few of the Nitrosamine related highlights plan for 2023
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Facilitate access and knowledge to in silico/QSAR applications for assessment of mutagenic
impurities (e.g. nitrosamines). There is a need to harmonize approaches in this area in the EU
with proper training of non-clinical assessors. [short-term] -
Continuous support of Committees and active participation in international fora related to
genotoxic impurities (including nitrosamines). [long-term] -
Organise 1-2 meetings with interested parties on nitrosamines [Stakeholder activities - European level]
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Co-operation with international regulators on nitrosamines [Communication activities - International level]