Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals

To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.

Données et ressources

Info additionnelle

Champ Valeur
Dernière modification avril 17, 2026, 21:46 (TU)
Créé le avril 17, 2026, 21:46 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2009-03-12 00:00:00
open_canada_keywords {"fr": ["document d'orientation", "exigences techniques de qualité", "chimie et fabrication", "applications d'essais cliniques", "CTA", "produits pharmaceutiques"], "en": ["guidance document", "quality technical requirements", "chemistry and manufacturing", "clinical trial applications", "CTAs", "Pharmaceuticals"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice en matière de qualité (chimie et fabrication) : demandes d'essais cliniques (DEC) pour les produits pharmaceutiques
update_frequency as_needed