Forward Regulatory Plan 2022-2024: Modernizing the Drug Establishment Licensing (DEL) Framework

Title of Regulatory Initiative

Modernizing the Drug Establishment Licensing (DEL) Framework

Enabling Act

Food and Drugs Act

Description

Health Canada is planning to advance Modernizing the Medical Device Establishment Licensing Frameworks in two phases.

Phase I is targeting fall 2022. The proposed amendments would include components respecting DEL, good manufacturing practices, and recall reporting to take a more agile, risk-based approach to compliance and enforcement oversight for drugs and reduce regulatory and operational burden. The proposed amendments for drugs would:

Phase II is targeting fall 2023. 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 under the 'Establishment licensing scheme for drugs and medical devices' and 'Recall reporting expectation' section.

This regulatory initiative is associated with Health Canada's stock review plan.

Note: This amendment was previously a component of 'Modernizing Drug and Medical Establishment Licensing Frameworks- Amendments to the Food and Drug Regulations and Medical Devices Regulations' and 'Recall of Therapeutic Products' but has now been separated into its own initiative.

Regulatory cooperation efforts (domestic and international)

This proposal would support international harmonization with regulatory partners.

Potential impacts on Canadians, including businesses

It is anticipated that the proposal would improve regulatory decision-making efficiency and predictability in relation to DEL, allowing an opportunity for industry stakeholders to streamline compliance programs accordingly.

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.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022.

The Modernizing Drug Establishment Licensing Phase II package is targeting pre-publication of amendments to the Food and Drug Regulations in Canada Gazette, Part I, in fall 2023.

Further information

Related information on drug establishment licensing framework (DEL) can be found on Health Canada’s website.

Additional information can be requested from the departmental contact.

Departmental contact information

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 343-540-8524
Email: prsd-questionsdspr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory

February 2021

Consult Health Canada's acts and regulations web page for:

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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