Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans

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 Safetyguidance documentclinical trial applicationssponsorscell therapy productscell therapy productsin humansfederal regulatory requirementsFood and Drug Regulations Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in HumansHTML 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 HumansHTML 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.

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