GMP topical

27.03.2024

Nitrosamines: EMA updates Appendix 3 of the Q&A

Nitrosamines: EMA updates Appendix 3 of the Q&A

Appendix 3 of the EMA’s Nitrosamine Q&A has been updated. The Appendix deals with the enhanced Ames test conditions for N-nitrosamines.


A checklist for the information required for the enhanced Ames test has been added to provide a summary of the conditions used and results obtained.

Source:

EMA: What's new


 

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