Forward Regulatory Plan 2021-2023: Modernization of the Regulation of Clinical Trials

Title of Regulatory Initiative

Modernization of the Regulation of Clinical Trials

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to amend sections of the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations.

The proposed regulatory amendments would: introduce a coherent risk-based approach; afford greater flexibility in the safe development of innovative therapies and products; streamline processes toward greater efficiency and clarity; and, align with international best practices regarding 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 proposal intends to better align Health Canada’s clinical trials framework across its business lines (human drug clinical trials, medical device investigational testing, non-prescription drugs and natural health product clinical trials, and clinical trials for foods for a special dietary purpose), and better align Canada with global best practices regarding oversight and public access to information on clinical trials.

Potential impacts on Canadians, including businesses

Industry and academics would benefit from flexible, clear and predictable regulatory requirements, and streamlined approaches. Regulatory burden would be reduced for low-risk clinical trials, facilitating patient access to more trials.

There would be greater public access to information on clinical trials and Canadian participants in trials would benefit from improved safety monitoring.

Healthcare professionals would be able to apply for investigational testing of medical devices (without going through a manufacturer).

The agri-food industry would be able to conduct clinical trials for infant formula and, other food for a special dietary purpose, within Canada.

Consultations

Prior to consultation on the broader regulatory proposal for all business lines, as described below, Health Canada undertook a targeted consultation with key stakeholders on potential regulatory improvements for investigational testing authorities (for medical devices). The consultation period closed in fall 2019.

In addition, Health Canada released a discussion paper: “Agile regulations for advanced therapeutic products and clinical trials” in July 2019. The consultation period closed in September 2019.

Health Canada continues to engage a range of stakeholders to validate and inform early policy thinking.

In Spring 2021, Health Canada intends to publish two related and parallel consultation papers 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.

During the COVID-19 pandemic, Health Canada further engaged stakeholders in introducing temporary regulations to expand access to clinical trials for COVID-19. The Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19 has similar agile approaches to those in this proposal. Stakeholder feedback on these temporary regulations will also help inform the policy approach.

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 spring 2022.

Further information

Related information on clinical trials for drugs can be found on Health Canada’s website, including a June 2019 Notice to Stakeholders on an interpretive guidance on the Investigational Use of Marketed Drugs in Clinical Trials.

Related information on investigational testing of medical devices can be found on Health Canada’s website.

Related information on clinical trials for natural health products can be found on Health Canada’s website.

Related information on clinical trials for food for a special dietary purpose is in development.

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 Plan

June 7, 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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