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
Food and Drugs Act
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 therapeutically active component 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.
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.
A regulatory proposal was pre-published in the Canada Gazette, Part I on March 30, 2019 for a 70 day comment period.The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2020.
The draft guidance documents Identifying and Labelling Medicinal Ingredients and Generic Drug Equivalence: Medicinal Ingredients which outline the implementation of the regulatory proposal, were posted to the Health Canada website for a 70 day consultation in spring 2019.
Additional information can be requested from the Departmental contact.
Departmental contact information
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Telephone number: 613-946-6586
Email address: firstname.lastname@example.org
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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