Forward Regulatory Plan 2019-2021: Regulations Amending the Food and Drug Regulations - Use of Foreign Decisions Pathway

Title of Regulatory Initiative

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

Enabling Act

Food and Drugs Act

Description

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

Health Canada is aiming to facilitate access to prescription drugs for human and veterinary use by creating an alternate pathway, with eligibility requirements, for the authorization of drugs that meet an unmet medical need for Canadians or their animals. The use of foreign decisions would permit the approval of 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.

This pathway would be suitable for drugs that have not been brought to market in Canada, and could include drugs for human use on the Special Access Programme (SAP) or drugs for veterinary use on the Emergency Drug Release (EDR) Programme and drugs listed on the Urgent Public Health Needs (UPHN) List.

Proposed amendments to the Food and Drug Regulations would allow the Minister to issue a Notice of Compliance without conducting a comprehensive review of clinical data, as the review has been conducted by the listed foreign regulators.

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 regulatory initiative was identified by Health Canada in the Agri-food and Aquaculture Sectoral 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 is 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.

Potential impacts on Canadians, including businesses

The Use of Foreign Decisions (UFD) pathway will allow manufacturers of drugs for human use to submit drug submissions in Canada basing their submissions on foreign decisions and with a reduced cost thereby providing an incentive for manufacturers to bring their product to market if criteria are met. 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 yet due to economic reasons for drug companies.

Consultations

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

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 2021 and last 70 days.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
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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