Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans 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. 2021-06-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safety guidance document clinical trial applications sponsors cell therapy products cell therapy products in humans federal regulatory requirements Food and Drug Regulations 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
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.
English publication HTML