The Therapeutic Products Directorate (TPD) of Health Canada uses these regulations to ensure that pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality. Clinical trials involving drugs must meet the requirements set out in these regulations.
These regulations provide a regulatory framework under which all research studies involving the use of natural health products (NHPs) fall. These regulations are designed to ensure that NHPs are safe effective, and of high quality.
The Medical Devices Regulations govern the use of medical devices for use in research. Any research studies involving medical devices must comply with these regulations.