Forward Regulatory Plan 2021-2023: Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions)

Enabling Act

Food and Drugs Act

Description

Through amendments to the Food and Drug Regulations, Health Canada proposes to implement an agile, modern licensing scheme for prescription drugs and over-the-counter drugs (OTCs). These regulatory changes will improve and maintain safety while helping to support economic growth.

Improved and maintained safety will be achieved by:

  • Introducing regulatory tools to manage on-market risks and uncertainties (e.g., terms and conditions, risk management plans, etc.);
  • Introducing more targeted enforcement powers (e.g., suspension and revocation), and;
  • Creating formal transparency requirements to disclose information about the risks, benefits and uncertainties of drugs.

Support for economic growth will be achieved by:

  • Removing outdated requirements; creating technology-neutral regulations (e.g., references to faxes);
  • Increasing harmonization and alignment with international regulators;
  • Enabling a lower-cost market authorization pathway for lower-risk drugs.

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.

Note: These amendments were previously a component of ‘Regulations amending the Food and Drug Regulations – Part C, and the Medical Devices Regulations (Flexible Lifecycle-based Licensing for Drugs and Medical Devices’ but has now been separated into its own initiative).

Regulatory cooperation efforts (domestic and international)

It is anticipated that the implementation of agile, modern licensing for drugs will create better alignment with international jurisdictions, such as the United States and the European Union.

The use of foreign decisions pathways are based on the confidence that exists between Health Canada and other specified foreign regulators as a result of collaboration, harmonization and other regulatory confidence-building activities. They will also promote trade and further alignment with other jurisdictions and ensure that Canadians have access to innovative products.

The proposed regulatory changes to link the regulatory obligations placed on industry with the risks and uncertainties of the drug – both before and after it goes on the market (Self-Care Framework Phase 2) aligns with international best practices in Australia, Europe and the United States.

Potential impacts on Canadians, including businesses

This proposal would affect the following key stakeholders: industry and its associations; patients, consumers, and groups that represent them; provinces and territories; health professionals and their associations; researchers; and, animal owners including agricultural producers.

To improve and maintain safety, agile licensing for drugs proposes to improve the risk-based regulation of drugs, both before and after they are on the market and; support better decision-making by patients, healthcare practitioners, and provinces and territories.

To help support economic growth, agile licensing for drugs proposes to reduce pre- and on-market costs for OTC drugs and; encourage businesses to bring innovative, safe, high-quality drugs on to the Canadian market.

A modernized set of regulations will allow Health Canada to become a more efficient and responsive regulator. This will allow for increased and faster access to safe and effective new drugs for Canadians. These regulations will also enhance Health Canada’s ability to monitor the safety of drugs once they are on the market and respond in a timely manner when safety issues arise thus better protecting the safety of Canadians.

Consultations

Health Canada has conducted consultations on this regulatory initiative and its components, and the Department intends to continue engaging with key stakeholders in 2021.

Further details will be made available once plans are finalized. Stakeholders have also been consulted to inform a proposed interim regulatory approach for the authorization of drugs and vaccines for COVID-19. The interim regulatory proposal would allow Health Canada to test many of the agile ways of regulating envisioned in this permanent proposal, and will inform future approaches.

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

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: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

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:

  • 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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