Staff Services / Research Ethics / Research Ethics Board / National Regulations

Health Canada’s Initiative to Modernize Clinical Trial Regulations

• At the 2021 REB retreat, a Health Canada representative presented on Health Canada’s plans to modernize clinical trial regulations. These are the slides from the presentation.

Health Canada overview of the Part, C Division 5 Regulations and associated guidance documents

• 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.

Natural Health Product Regulations and links to associated guidance documents

• 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.

Medical Devices Regulations and links to associated guidance documents

• 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.