Efficient Regulatory Assessment

Health Canada’s Key Role

In Canada, including in Quebec, Health Canada is the federal authority responsible for regulating clinical trials involving drugs, biologics, medical devices, and natural health products. Its responsibilities include authorizing commercial releases, monitoring adverse effects, managing recalls and inspections, as well as regulating the purchase and use of these products.

Sponsors that submit an initial application or change in protocol generally receive regulatory approval within 30 days. This efficiency is based on a clear political commitment that demonstrates Canada’s willingness to make clinical research a strategic priority and favour fast approval of the trials in the country.