Forward Regulatory Plan 2021-2023: Regulatory Proposal to Transition the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Title of Regulatory Initiative

Regulatory Proposal to Transition the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Enabling Act

Food and Drugs Act

Description

On May 23, 2020, the Minister of Health signed the Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19.  While the Interim Order is set to expire one year from when it was made, Health Canada intends to maintain the flexibilities and regulatory oversight provided by the Interim Order until at least fall 2021. By then, Health Canada proposes to bring forward new regulations or regulatory amendments to the Food and Drug Regulations in order to ensure that the authorizations, obligations, and oversight provided under the Interim Order continue uninterrupted beyond fall 2021.

The Interim Order introduces regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently and to facilitate broader patient participation across the country. The Interim Order also:

New regulations or regulatory amendments are being proposed in order to ensure that the authorizations, obligations and oversight made possible by the Interim Order continue uninterrupted, for a period of time, after expiry of the Interim Order to address the ongoing COVID-19 health care emergency.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation plan.

The proposed regulatory changes will continue to align Health Canada’s emergency provisions with global best practices with respect to providing a regulatory framework that is as efficient as possible for clinical trials for products to diagnose, treat or prevent COVID-19.

Potential impacts on Canadians, including businesses

The proposed regulatory changes are anticipated to allow sponsors of clinical trials for COVID-19 related drugs and medical devices authorized under the Interim Order to continue to be able to conduct these clinical trials, while maintaining the associated obligations and oversight.

This will ensure that these clinical trials can continue without disruption to allow potential treatments to be available to Canadians.

Consultations

Technical consultations on this proposal were completed in fall 2020. Information gathered from the consultations held in spring 2020 for the Interim Order were also used to inform this proposal.

Monthly engagement sessions on clinical trial oversight and implementation in Canada are being led by Health Canada with participation from the Canadian Institute of Health Research, the Canadian Association of Research Ethics Boards, and the Research Ethics Boards that frequently review clinical trials in Canada.

Through this initiative, policy makers, regulators, funders and oversight bodies will collaborate and share information on clinical trials. Further, the Interim Order will continue to be presented at ad hoc and planned external stakeholder engagement sessions (e.g., Canadian Association of Professionals in Regulatory Affairs).

Due to the fact that the Interim Order is only temporary in nature, an expedited regulatory development process is anticipated.

Policy consultations and stakeholder engagement on the proposed transition measures were held in fall 2020.

Health Canada will seek an exemption from pre-publication in the Canada Gazette, Part I.

The publication of the regulatory proposal in the Canada Gazette, Part II, is expected by fall 2021.

Further information

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

Consult Health Canada's acts and regulations web page for:

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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