Description

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.

Resources

Name	Format	Description	Link
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/quality-chemistry-manufacturing-guidance-clinical-trial-applications-pharmaceuticals.html#a11
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/templates/quality-overall-summary-chemical-entities-clinical-trial-application-phase-1.html
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/templates/quality-overall-summary-chemical-entities-clinical-trial-application-phase-2.html
Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/templates/quality-overall-summary-chemical-entities-clinical-trial-applications-phase-3.html
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/revisee-ligne-directrice-matiere-qualite-chimie-fabrication-demandes-essais-cliniques-produits-pharmaceutiques.html#a11
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/modeles/sommaire-global-qualite-entites-chimiques-demande-essai-clinique-phase-1.html
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/modeles/sommaire-global-qualite-entites-chimiques-demande-essai-clinique-phase-2.html
Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/modeles/sommaire-global-qualite-entites-chimiques-demandes-essai-clinique-phase-3.html

Tags

Topics

Categories