Guidance Document - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Impurities in New Drug Substances - ICH Topic Q3A(R2) (English, HTML)

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Publisher-reported update

2023-12-02

This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. It is not intended to apply to new drug substances used during the clinical research stage of development.

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