Description

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.

Resources

Name	Format	Description	Link
Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/guidance-document-preparation-clinical-trial-applications-use-cell-therapy-products-humans.html#a1a
Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/ligne-directrice-preparation-demandes-essais-cliniques-utilisation-produits-therapie-cellulaire-humains.html#a1a

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