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)

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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Champ	Valeur
Dernière modification	avril 17, 2026, 21:40 (TU)
Créé le	avril 17, 2026, 21:40 (TU)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2017-05-18 00:00:00
open_canada_keywords	{"fr": ["document d'orientation", "lignes directrices à l'intention des fabricants", "virus de l'immunodéficience humaine", "VIH", "tests de diagnostic rapide", "TDR", "point de service", "autotest"], "en": ["guidance document", "ICH technical requirements", "pharmaceuticals for human-use", "impurities in new-drug-substances", "ICH Topic Q3A(R2)"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	L'International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (l'ICH): Présence d'impuretés dans les nouvelles substances médicamenteuses ICH thème Q3A(R2)
update_frequency	as_needed