Description

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.

Resources

Name	Format	Description	Link
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)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/evaluation-recommendation-pharmacopoeial-texts-use-regions-topic-health-canada-2010.html
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)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/qualite/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-presence-impuretes-nouvelles-substances.html

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