What is the regulatory framework governing stem cell-based therapies in Canada?
In Canada, review and approval of clinical trials involving therapeutic products, including stem cell based products, are the responsibility of the Health Products and Food Branch (HPFB) of Health Canada under the authority of the Food and Drugs Act (FDA) (1985). Within the HPFB, clinical trials that involve pharmaceutical “drugs” and “medical devices” fall under the authority of the Therapeutic Product Directorate (TPD), while clinical trials involving biological drugs or “biologics” are the responsibility of the Biologics and Genetic Therapies Directorate (BGTD). According to Schedule D of the FDA, “biologics” include blood and blood products, cells and tissues, gene therapies and radiopharmaceutical products. Anyone wishing to conduct a clinical trial must submit a Clinical Trial Application (CTA) under Part C, Division 5 of the Food and Drug Regulations. Also under the FDA, in 2007 the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) came
