Forward Regulatory Plan 2023-2025: Access for Underrepresented Populations
Title of Regulatory Initiative
Access for Underrepresented Populations
Enabling Act
Description
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 part of the Comprehensive Economic and Trade Agreement Regulatory Cooperation Forum workplan.
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.
Consultations
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.
In June 2023, Health Canada launched a 60 day consultation on a draft guidance document on submitting pediatric studies and pediatric development plans with the intention of launching a policy pilot in fall 2023. The objectives of this pilot are to encourage sponsors to submit safety and efficacy information for drugs expected to be used in pediatric populations in a timely manner and to provide more information on the safety, efficacy and dosage of drugs used in pediatric populations to health practitioners, patients and the families of patients. The department will review the comments received and adjust the policy as needed prior to undertaking the pilot. The information gained from the pilot will be used to inform this regulatory proposal.
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
Email: lrm.consultations-mlr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory
April 2023.
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:
Page details
- Date modified: