Forward Regulatory Plan 2021-2023: Modernizing Compliance and Enforcement Oversight for Drugs (establishment licensing, good manufacturing practices, and recalls)

Title of Regulatory Initiative

Modernizing Compliance and Enforcement Oversight for Drugs (establishment licensing, good manufacturing practices, and recalls)

Enabling Act

Food and Drugs Act

Description

Proposed amendments to the Food and Drug Regulations would streamline requirements for drug establishment licence applications and introduce flexible and risk-based elements to the licensing framework. 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.

Amendments to the Food and Drug Regulations would also introduce requirements for persons responsible for drug recalls. 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 align Canadian requirements for drug recalls with the United States (U.S.), which would support regulatory harmonization under the Canada-U.S. Regulatory Cooperation Council.

Potential impacts on Canadians, including businesses

This proposal is expected to increase regulatory decision-making efficiency and predictability in relation to drug establishment licences, allowing an opportunity for industry stakeholders to streamline their compliance programs accordingly.

Consultations

DEL and medical device establishment licence (MDEL) holders were broadly surveyed between April and June 2019.

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 spring 2022.

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: hc.prsd-questionsdspr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory

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:

• Federal regulatory management and modernization
• Learn more about regulatory cooperation

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

• Consulting with Canadians
• Canada Gazette