Description

Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing.

Resources

Name	Format	Description	Link
Clinical Trial Applications for Biologics and Radiopharmaceuticals	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/biologics-radiopharmaceuticals.html
Clinical Trial Applications for Biologics and Radiopharmaceuticals	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/biologiques-radiopharmaceutiques.html

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