Forward Regulatory Plan 2021-2023: Regulations Amending the Food and Drug Regulations - Use of Foreign Decisions (UFD) Pathway

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations - Use of Foreign Decisions (UFD) Pathway

Enabling Act

Food and Drugs Act

Description

Through a streamlined application pathway that allows manufacturers to rely on the authorization of a trusted foreign regulator, Health Canada is aiming to facilitate access to certain drugs that address an unmet medical need.

This pathway would be suitable for drugs that have not yet received market authorization for the Canadian market. It would be used for a sub-set of drugs that have been authorized by specified foreign regulators, have an adequate amount of post-market experience, and meet internationally established food safety standards for certain veterinary drugs.

For human drugs, this pathway could be used for prescription drugs such as those on the Special Access Program (SAP) or those listed on the Urgent Public Health Needs (UPHN) List.

For drugs for veterinary use, it intends to address stakeholder comments suggesting that the regulatory framework creates a barrier that has led to a lack of veterinary drugs for use in minor species (e.g., farmed fish, sheep) and to treat rare and life-threatening conditions in major species (e.g., cattle, chickens). This pathway could be used for such drugs currently accessed via the Emergency Drug Release (EDR) Program.

Proposed amendments would allow the Minister to issue an authorization without conducting a comprehensive review of clinical, non-clinical, chemistry and manufacturing data, as the review has been conducted by the listed foreign regulators.

These amendments will be incorporated into the Agile Licensing for Drugs regulatory package 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).

This regulatory proposal reflects several key commitments:

  • It aligns with the Government’s commitment to provide more timely access to drugs and devices through the Regulatory Review of Drugs and Devices initiative.

This regulatory initiative was identified by Health Canada in the Agri-food and Aquaculture Sector Regulatory Review Roadmap and the Health and Biosciences Sector Regulatory Review Roadmap

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

Regulatory cooperation efforts (domestic and international)

The Use of Foreign Decisions pathway is based on the confidence that exists between Health Canada and other foreign regulators as a result of collaboration, harmonization and other regulatory confidence building activities.

Potential impacts on Canadians, including businesses

The Use of Foreign Decisions (UFD) pathway would allow manufacturers of drugs for human use that meet specified criteria to rely on the decision of a trusted foreign regulator when applying for market authorization in Canada. By doing so, this pathway will reduce authorization costs thereby providing an incentive for manufacturers to bring their product to market. This in turn, will facilitate access to medically necessary drugs that are not readily available to Canadians.

This regulatory proposal will also create a pathway that will enable access by animal owners and food producers to minor use, minor species veterinary drugs which have not come to the Canadian market.

Consultations

Health Canada has engaged in targeted consultations between December 2017 and September 2018.

Stakeholders have recently been engaged in the context of Health Canada’s interim regulatory response to the COVID-19 pandemic.

Some of the temporary measures in place allow Health Canada to leverage foreign decisions in authorizing health products for COVID-19. Learnings and stakeholder feedback will help inform the policy approach for this proposal.

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

April 1, 2018

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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