Forward Regulatory Plan 2019-2021: Regulations amending the Food and Drug Regulations for Improved Access to Generic Drugs

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations for Improved Access to Generic Drugs

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to amend the Food and Drug Regulations around establishing pharmaceutical equivalence between generic products with different physical or chemical forms of the active moiety as compared to the Canadian Reference Product (CRP). In doing so, Health Canada aims to create greater alignment and convergence with the practices of other major regulatory jurisdictions and to standardize its use with those applied internationally.

Regulatory cooperation efforts (domestic and international)

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

This regulatory proposal could create alignment and convergence with the practices of other jurisdictions such as the United States Food and Drug Administration (FDA) and the European Union (EU) European Medicines Agency (EMA).

Potential impacts on Canadians, including businesses

This initiative is expected to provide Canadians with earlier access to a wider range of low cost generic medicines and to align Canada's approach to generic drug variations with other international regulatory authorities.

The initiative would allow generic drug manufacturers to file different salts as generic drug submissions.

Consultations

From June to October 2017, Health Canada consulted on a Notice of Intent - Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology. The Notice of Intent outlined possible changes to the Regulations with respect to the establishment of equivalence between a proposed generic drug product and the CRP.

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 2019 and last 70 days.

Further information

A guidance document on implementation of the regulatory proposal will be posted to the Health Canada website in spring 2019.

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 number: 613-946-6586
Email address: 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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