Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations (Use of Foreign Decisions Pathway)
Title of Regulatory Initiative
Regulations Amending the Food and Drug Regulations (Use of Foreign Decisions Pathway)
Enabling Act
Description
Health Canada is proposing amendments to the Food and Drug Regulations to create a streamlined application pathway that allows manufacturers of certain drugs that address an unmet medical need to rely on the authorization of a trusted foreign regulator.
The proposed amendments would facilitate access to certain drugs (human and veterinary) that address an unmet medical need.
This regulatory initiative aligns with the Government's commitment to provide more timely access to drugs and devices through the Regulatory Review of Drugs and Devices.
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.
Additional notes:
To ensure regulatory consistency, this initiative has been incorporated into the Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs) initiative.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on Canadians, including businesses
The proposed amendments would apply to businesses seeking authorization to sell drugs that address an unmet medical need in Canada.
It is anticipated that the proposal would reduce authorization costs providing an incentive for manufacturers to bring their product to the Canadian market. This in turn, would facilitate access to medically necessary drugs that are not readily available to Canadians. The proposed amendments would also create a pathway that would enable access by veterinarians, animal owners and food producers to minor use, minor species veterinary drugs that have not come to the Canadian market.
Consultations
Stakeholder engagement and consultation have been ongoing since 2017, including as part of the Health Canada's emergency regulatory response to the COVID-19 pandemic.
Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, as part of future phases of Agile Regulations for Licensing Drugs.
Further information
Related information can be found on:
Use of foreign reviews and decisions
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: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
April 2018
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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