1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Canada in relation to the Decentralized Clinical Trials (“DCTs”) with medicinal products.

Health Canada (HC) is the Regulatory Authority in Canada, responsible for administering, developing, and enforcing acts and regulations as part of the legislation. This federal government department consults with the Canadian public industry, non-governmental organizations, and other interest parties in the development of regulations that have a direct impact on the health and safety of Canadians. 

The requirements for conducting clinical trials in Canada are contained under the Food and Drugs Act RSC, 1985 (“F&D Act”) and Division 5 of the Food and Drug Regulations CRC, c870 (“F&D Reg”).