Forward Regulatory Plan 2023-2025: Precision Regulating

Title of Regulatory Initiative

Precision Regulating

Enabling Act

Food and Drugs Act

Description

Health Canada is exploring instruments that would help address market gaps and vulnerabilities with precise tools to support the availability of health products and food, such as infant formula and other food for a special dietary purpose. This would enable Health Canada to rely on decisions of trusted foreign regulatory authorities, where appropriate, or to temporarily waive regulatory requirements to address market issues. These authorities would be carefully crafted to respect the health and safety requirements of the Food and Drugs Act and its associated regulations, ensuring that health products and food remain safe and effective while ensuring that people in Canada have access to the products they need.

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 prioritize safety, facilitate access to important health products or food that are not readily available in Canada, including new and innovative products.

Consultations

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.

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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