Forward Regulatory Plan 2023-2025: Regulations Amending Certain Regulations Made Under the Food and Drugs Act Regulations (Agile Licensing)
Title of Regulatory Initiative
Regulations Amending Certain Regulations Made Under the Food and Drugs Act Regulations (Agile Licensing)
Enabling Act
Description
Health Canada is proposing amendments to the Food and Drug Regulations and to the Medical Devices Regulations to enable the implementation of an agile, modern licensing scheme for drugs (prescription and over-the-counter) and medical devices in Canada. These amendments aim to enhance safety and ensure appropriate oversight while also supporting innovation.
The amendments will:
- Implement agile regulations that support timely access to innovative drugs and medical devices;
- Enable regulatory oversight based on risk and evolving evidence;
- Harmonize and align internationally; and
- Improve transparency about the risks, benefits and uncertainties of drugs and medical devices.
This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap and the Agri-food and Aquaculture Regulatory Review Roadmap.
This regulatory initiative is associated with Health Canada's Regulatory Stock Review Plan.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
The amendments will better align Health Canada requirements with those of other jurisdictions, such as the United States and European Union.
Potential impacts on people in Canada, including businesses
The amendments apply to health and biosciences industries (human and veterinary) conducting business in Canada.
Health Canada expects potential impacts to include improved risk-based regulation of drugs and medical devices, both before and after they are on the market; increased support for better decision-making by patients, health care practitioners and provinces/territories; and increased encouragement for businesses to bring innovative, safe, high-quality drugs and medical devices to the Canadian market.
Consultations
Health Canada published a Notice of Intent in July 2021 proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.
Stakeholder engagement and consultation on aspects of this initiative took place in 2020 and 2021 in the context of the Interim Orders related to COVID-19, the associated transition regulations that have certain components with similar regulatory approaches to those in this proposal.
Health Canada pre-published the proposed changes in the Canada Gazette, Part I, on December 17, 2022, with a 130-day public comment period.
Health Canada plans to publish the amended regulations in the Canada Gazette, Part II, in spring 2024.
Further information
Related information can be found on:
Improving the regulatory review of drugs and devices
Regulatory innovation for health products: Agile licensing for drugs
Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders
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
June 2019
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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