Forward Regulatory Plan 2019-2021: Regulations amending the Food and Drug Regulations, Part C, and the Medical Devices Regulations (Flexible Lifecycle-Based Licensing for Drugs and Medical Devices)
Title of Regulatory Initiative
Regulations amending the Food and Drug Regulations, Part C, and the Medical Devices Regulations (Flexible Lifecycle-Based Licensing for Drugs and Medical Devices)
Food and Drugs Act
Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to implement an adaptive, modern licensing scheme to effectively regulate pharmaceuticals, biologics, radiopharmaceuticals, veterinary drugs and medical devices throughout their life-cycles.
The initiative is intended to address stakeholder comments that the current licensing system for most health products is rigid and hard to understand.
Specifically, the ability to place terms and conditions on product approvals will be enabled, such that information could be further gathered and other measures implemented post-market and used to adjust a licence as appropriate. This approach would complement other authorities gained through amendments to the Food and Drugs Act introduced in 2014 to support more strategic, risk-based decision-making in the authorization of products and oversight of drugs and medical devices throughout their life-cycles.
This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap and the Agri-food and Aquaculture Sector Regulatory Review Roadmap.
This regulatory initiative is associated with Health Canada’s stock review plan.
Regulatory cooperation efforts (domestic and international)
It is anticipated that the eventual implementation of a life-cycle approach will create better alignment with international jurisdictions, such as the U.S. and the European Union, who already take this approach to the licensing of health products.
Potential impacts on Canadians, including businesses
This proposal would impact the following key stakeholders: industry and their associations, patient and consumer groups, health professionals and their associations, researchers, and, animal owners including agricultural producers.
This proposal would support a more life-cycle based approach to the authorization of drugs and medical devices. It would allow for efficient response to changes in what is known about the product’s risks and benefits and the real-world evidence gathered in the post-market experience, ultimately optimizing the benefits and risks of a product as new data is generated.
Industry would benefit from a clear, streamlined approach that will provide greater flexibility in the licensing of products. They would have the ability to rely on more of a balance between pre-market and post-market evidence.
The Department intends to engage with key stakeholders throughout 2020 and 2021 as it develops this proposal. Further details will be made available once plans are finalized.
Canadians will have the opportunity to provide comments on the regulatory proposal for the Food and Drug Regulations during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2021 and last 70 days.
Canadians will have the opportunity to provide comments on the regulatory proposal for the Medical Devices Regulations during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2022 and last 70 days.
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
June 7, 2019
Consult Health Canada’s acts and regulations web page for:
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- 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:
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