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

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. 2021-06-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentquality technical requirementschemistry and manufacturingclinical trial applicationsCTAsPharmaceuticals Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for PharmaceuticalsHTML 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 Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for PharmaceuticalsHTML 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/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 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/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 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/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/templates/quality-overall-summary-chemical-entities-clinical-trial-applications-phase-3.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

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.

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