Forward Regulatory Plan 2021-2023: 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
Proposed amendments to the Food and Drug Regulations would establish pharmaceutical equivalence between generic products with certain different physical or chemical forms of the medicinal ingredient 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 international regulatory authorities that allow these differences in the form of the medicinal ingredient. For all drugs regulated under Division 8, the amendments will provide predictability for manufacturers filing drug submissions, as well as outline the requirements for labelling of the medicinal ingredient to ensure transparency for consumers.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation plan.
This regulatory proposal better aligns Health Canada requirements with the requirements of other jurisdictions such as the United States Food and Drug Administration and the European Union European Medicines Agency.
Potential impacts on Canadians, including businesses
This initiative is expected to provide Canadians with earlier access to a wider range of lower cost generic medicines by better aligning Canada's approach with other international regulatory authorities that allow certain differences of the medicinal ingredient.
The initiative would allow generic drug manufacturers to file different salts of the medicinal ingredient 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.
A regulatory proposal was pre-published in the Canada Gazette, Part I, on March 30, 2019, for 70 day comment period.
The draft companion guidance documents Identifying and Labelling Medicinal Ingredients and Generic Drug Equivalence: Medicinal Ingredients, which outline recommendations relating to the implementation of the regulatory proposal, were posted to the Health Canada website for a 70 day consultation in spring 2019.
The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2021.
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 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
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