Forward Regulatory Plan 2019-2021: 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 Product 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; 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, experimental studies of veterinary drugs, and food clinical trials), 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 will be greater public access to information on clinical trials and Canadian participants in trials will benefit from improved safety monitoring. 

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

The agri-food industry will be able to conduct clinical trials for infant formula and, for other products such as food for special dietary use, within Canada.  

Consultations

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 2021 and last 70 days.

Prior to consultation on the broader regulatory proposal for all business lines, as described above, Canadians will have the opportunity to provide comments on the regulatory improvements proposed for investigational testing authorities (for medical devices) outlined in a Notice of Intent that will be published in June 2019.

Further information

Related information on clinical trials for drugs can be found on Health Canada’s website.

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.

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
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

May 27, 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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