1. Executive Summary

Health Canada administers, develops, and enforces 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.

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

The requirements for clinical trials in Canada are contained in the Food and Drugs Act RSC, 1985, and Food and Drug Regulations CRC, c870.

The Government of Canada issued temporary interim orders (“IOs”) on 23 May 2020, and again on 3 May 2021, to provide flexibility in order to enable the conduct of clinical trials on medical devices and drugs related to Covid-19 during the pandemic. The application of the IOs, and lessons learned from trials conducted during the Covid-19 pandemic, helped Health Canada develop its proposed Clinical Trials Regulatory Modernization Initiative (“Modernization Initiative”). Part of this initiative was an invitation to national stakeholders, during Spring/Summer 2021, to comment in writing on a consultation paper and participate in interactive webinars. The responses received informed Health Canada’s Regulatory Innovation Agenda for Health Products. One of the key aspects of this initiative is to modernize the regulation of clinical trials in Canada, particularly DCTs. The findings of the initiative are contained in a report entitled “What We Heard: Consultation on Clinical Trials Regulatory Modernization Initiative (Spring and Summer 2021)” (“The Consultation Report”). Suggestions were submitted on how to improve the clinical trials framework, which includes the need for further clarification on technological requirements used to support DCTs.

Furthermore, the Canadian Institutes of Health Research (“CIHR”), Canada’s federal funding agency for health research, announced the launch of a Clinical Trials Fund (“CTF”) on 22 June 2022 as part of Canada’s Biomanufacturing and Life Sciences Strategy, a CAD $2.2 bn investment to develop Canada’s clinical trial infrastructure and ensure it is prepared to deal with any future pandemics.

The Modernization Initiative, to refine policy and develop regulations to modernize Canada’s clinical trial framework, is currently underway. Its progress may be monitored via a website entitled “Forward Regulatory Plan 2022-2024: Modernization of the Regulation of Clinical Trials”.