Forward Regulatory Plan 2022-2024: Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Food and Drug Regulations to establish pharmaceutical equivalence between generic products with certain different physical or chemical forms of the medicinal ingredient as compared to the Canadian Reference Product. They would also clarify that, for drugs regulated under Part C, Division 8 of the Food and Drug Regulations, the medicinal ingredient is the form of the medicinal ingredient in the dosage form of the drug.

Specifically, the proposed amendments would: (1) create greater alignment and convergence with the practices of other international regulatory authorities; (2) provide predictability for manufacturers with respect to the requirements of the Abbreviated New Drug Submission pathway; and, (3) improve transparency for Canadians on the medicinal ingredients in their medications.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States and European Union.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to the manufacturers of drug products regulated under Part C, Division 8 of the Food and Drug Regulations.

It is anticipated that this regulatory proposal would provide Canadians with earlier access to a wider range of lower cost generic medicines through the codification and further refinement of its policy.

Consultations

Stakeholder engagement and consultation has been ongoing since 2017.

Health Canada pre-published the proposed changes in the Canada Gazette, Part I, on March 30, 2019, for a 70-day comment period.

Health Canada plans to publish the proposed changes in the Canada Gazette, Part II, in fall 2022.

Further information

Related information can be found on:

Notice of Intent - Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology

Draft Guidance Document: Generic Drug Equivalence: Medicinal Ingredients

Draft Guidance Document: Identifying and Labelling Medicinal Ingredients in New Drug Products

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 number: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 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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