Forward Regulatory Plan 2023-2025: Regulations Amending the Food and Drug Regulations (Agile: Access for Underrepresented Populations)

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations (Agile: Access for Underrepresented Populations)

Enabling Act

Food and Drugs Act


Health Canada is proposing amendments to the Food and Drug Regulations that would support the department in ensuring that individuals in Canada have access to information that supports informed decision making regarding their treatment options.

The proposed amendments would include a focus on drug submission requirements to improve the data that Health Canada receives with respect to subpopulations in Canada, such as pediatric populations.

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 the European Union.

Potential impacts on people in Canada, including businesses

The proposed amendments would apply to businesses that apply for a drug authorization under Part C (Drugs), Division 8 (New Drugs) of the Food and Drug Regulations. It is anticipated that the proposal would improve the understanding of the benefit risk profiles of a drug in underrepresented populations in Canada, result in more accurate prescribing information and facilitate the appropriate communication of risks to individuals in Canada.


Stakeholder engagement and consultation on the main components of this regulatory package have been ongoing since development of Health Canada's Pediatric Drug Action Plan began in 2019.

People in Canada 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 2024.

Further information

Additional information on this proposal may 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

Date the regulatory initiative was first included in the Forward Regulatory

April 2023.

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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