Forward Regulatory Plan 2023-2025: Modernizing the Drug Establishment Licensing (DEL) Framework
Title of Regulatory Initiative
Modernizing the Drug Establishment Licensing (DEL) Framework
Enabling Act
Description
Health Canada is planning to advance Modernizing the Drug Establishment Licensing Framework in two phases.
Phase I - The amendments to the Food and Drug Regulations will:
- Establish a regulatory framework for recalls of drugs ordered by the Minister and clarify reporting obligations for industry for voluntary recalls in a manner that is consistent with existing policy;
- Address outdated references in the Drug Establishment Licence (DEL) framework to other regulatory authorities who participate in mutual recognition agreements (MRAs) with Canada and replace the outdated references with a list incorporated by reference on an ambulatory basis within the Regulations and housed on the Government of Canada website;
- Offer conditional exemptions from the requirements related to finished product testing for certain biologics (e.g. gene and cell therapies) and radiopharmaceuticals in cases where alternative risk mitigation measures and safety controls have been implemented; and
- Clarify that direct shipment to a person other than an importer (typically a healthcare provider) is permitted for certain biologics and radiopharmaceuticals.
Phase II - The proposed amendments would reduce burden associated with annual licence review and modernize provisions related to the use of compliance and enforcement tools, such as terms and conditions and suspensions. It would introduce less prescriptive and more flexible provisions that would maintain appropriate oversight of regulated activities conducted in Canada.
This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap. This regulatory initiative is associated with Health Canada's Regulatory Stock Review Plan.
Note: For regulatory consistency, Phase I amendments to the Food and Drug Regulations will proceed jointly with the Phase I amendments to the Medical Devices Regulations that are part of the Modernizing the Medical Device Establishment Licensing (MDEL) Framework initiative.Regulatory cooperation efforts (domestic and international)
The Phase I amendments related to the Food and Drug Regulations will enhance Canada’s regulatory alignment with the United States, the European Union, the United Kingdom, Australia, and Switzerland.
The amendments for drug recalls will support Canada’s international responsibilities by improving clarity around the reporting obligations for industry, specifically clarifying the timelines for industry to comply with the regulations.
The amended regulations regarding finished product testing will allow importers and distributors to rely on the results from release testing conducted by the foreign fabricator and will be more closely aligned with advanced therapeutic product frameworks in the United States and the European Union
The collaborative work between Canada and its international partners through MRAs is a key driver for these proposed amendments and modernizing the table of designated regulatory authorities would support clear and accurate regulations for DEL holders.
Potential impacts on people in Canada, including businesses
Phase I amendments will strengthen Health Canada’s oversight over drug recalls and contribute to the safety and quality of Canada’s drug supply. By clearly outlining the jurisdictions for which Canada has a MRA and providing conditional exemptions around finished product testing, industry may be better positioned to provide expanded access to certain drugs.
Consultations
Drug and medical device establishment licence holders were consulted between April and June 2019.
On December 11, 2021, Health Canada published a Notice of Intent in Canada Gazette, Part I for a 60-day consultation period.
Phase 1: Health Canada pre-published the proposed changes to the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) in the Canada Gazette, Part I on April 15, 2023 for a 75-day public comment period. The comment period closed on June 29, 2023. Comments were received from 46 respondents during the comment period, including individuals, businesses, and associations. Comments were generally supportive of the proposed amendments, which included changes to both the Food and Drug Regulations and Medical Devices Regulations. For the Food and Drug Regulations, stakeholders were generally supportive of the amendments, but some concerns were expressed about the 24-hour recall reporting requirement for drugs, and conditional exemptions from aspects of finished product testing. Health Canada is taking these comments into consideration in preparing the proposal for final publication.
Health Canada plans to publish the amended regulations in the Canada Gazette, Part II in spring 2024.
Further information
Related information on the DEL framework can be found on Health Canada’s website.
Additional information can be requested from the departmental contact.
Departmental contact information
Stephanie Mangan
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Telephone: 343-550-4584
Email: prsd-questionsdspr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
February 2021
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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