Forward Regulatory Plan 2023-2025: Regulations Amending the Food and Drug Regulations (Agile Licensing: Precision Regulation and Use of Foreign Decisions)
Title of Regulatory Initiative
Regulations Amending the Food and Drug Regulations (Agile Licensing: Precision Regulation and Use of Foreign Decisions)
Health Canada is proposing to provide the Minister with the authorities necessary to prioritize certain health products and foods, taking into account what is most relevant and beneficial to people in Canada and the Canadian health care system, such as access to needed products and the risk/benefit profile of the product. This may include the ability to increase international regulatory cooperation and rely on a decision from a trusted foreign regulator.
This regulatory initiative was identified by Health Canada in the Agri-food and Aquaculture Sector Regulatory Review Roadmap and the 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.
Potential impacts on people in Canada, including businesses
The proposal would be expected to prioritize safety, facilitate access to important health products or foods that are not readily available in Canada, including new and innovative products.
Stakeholder engagement and consultation have been ongoing since 2017, including as part of Health Canada's response to the COVID-19 pandemic.
Further policy consultations will occur with a view to bring forward the new authorities in spring 2024.
Related information can be found on:
Additional information can be requested from the departmental contact.
Departmental contact information
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
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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