With respect to human research, xenotransplants, the live cells, tissues and organs from animal sources, are considered therapeutic products, drugs or medical devices, and are subject to the requirements of the Food and Drugs Act and the Food and Drug Regulations or the Medical Devices Regulations.
Pursuant to these regulations, sponsors of human clinical trials involving xenotransplants would be required to submit an application to Health Canada for approval before a clinical trial may proceed. The clinical trial review and approval process conducted by Health Canada applies to all clinical trials involving xenografts, cellular, tissue or whole organ, in Canada, regardless of who the research is conducted by, for example, hospital, university or pharmaceutical company.
On March 29, 1999, Health Canada issued a notice to hospitals on the clinical use of viable animal cells, tissues or organs to treat patients, notifying hospitals that any studies involving xenotransplants could only be conducted under the auspices of an authorized clinical trial.
To date, no requests for clinical trials involving xenotransplantation have been received or approved by Health Canada.