Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations (Modernization of the Regulation of Clinical Trials)

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations, Naturel Health Products Regulations and the Medical Devices Regulations (Modernization of the Regulation of Clinical Trials)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Food and Drug Regulations,Natural Health Products Regulations and Medical Devices Regulations to modernize the regulation of clinical trials conducted in Canada.

Specifically, the proposed amendments would: (1) ensure that Canada remains an attractive place to conduct clinical trials while continuing to uphold high standards for protecting the health and safety of participants; (2) introduce a coherent risk-based approach to the regulation of clinical trials in Canada; (3) afford greater flexibility in the safe development of innovative therapies and products, and innovative clinical trial designs; (4) streamline regulatory processes toward greater efficiency and clarity; and, (5) align with international best practices regarding clinical trial oversight and public access to information.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.

This regulatory initiative is associated with Health Canada's stock review plan.

Regulatory cooperation efforts (domestic and international)

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

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States and European Union.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to health and biosciences and agri-food stakeholders involved in the conduct of clinical trials in Canada.

It is anticipated that this regulatory proposal would improve clarity, predictability and transparency around the regulation of clinical trials for businesses, academics and Canadians. Improved agility of the regulatory framework is expected to benefit researchers and industry by better accommodating innovative, non-conventional clinical trial designs; this in turn could benefit Canadians by improving access to clinical trials. The application of a risk based approach would help reduce regulatory burden for some clinical trials conducted on marketed products.

Canadian participants in trials would benefit from improved safety monitoring. Health care professionals would be able to apply for investigational testing of medical devices (without going through a manufacturer). As well, the agri-food business would be able to conduct clinical trials for infant formula and other foods for a special dietary purpose within Canada.

Consultations

Stakeholder engagement and consultation was undertaken in 2019.

Additional engagement was undertaken in 2020 related to the Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19 that has similar regulatory approaches to those in this proposal.

In spring 2021, Health Canada launched two related and parallel consultations to seek stakeholder feedback on 1) the modernization of the clinical trial framework for drugs, devices and natural health products; and 2) the design and development of regulations that would enable the authorization and conduct of human clinical trials in Canada on Foods for a Special Dietary Purpose.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022 and last 70 days.

Further information

Related information can be found on:

Regulatory innovation for health products: Modernizing clinical trial regulations

Agile regulations for advanced therapeutic products and clinical trials

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Clinical Trials Modernization: Consultation Paper

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: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

June 2019

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

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada’s implementation of government-wide regulatory management initiatives

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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