Forward Regulatory Plan 2021-2023: Regulations amending the Food and Drug Regulations for Environmental Risk Assessment and Management of Ingredients in Drugs
Title of Regulatory Initiative
Regulations amending the Food and Drug Regulations for Environmental Risk Assessment and Management of Ingredients in Drugs
Enabling Act
Food and Drugs Act
Description
Health Canada is considering proposed amendments to the Food and Drug Regulations to modernize the current environmental and indirect human health risk assessments (and management of those risks) for ingredients used in drugs that are required under the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Chemicals and Polymers) and (Organisms).
Health Canada is currently assessing different options to achieve this objective. Before proceeding with any potential regulatory approach, Health Canada will follow regular consultation procedures, including publication of draft regulations in Canada Gazette, Part I.
Regulatory cooperation efforts (domestic and international)
Health Canada intends to align with other key regulatory agencies where possible (i.e., United States' Food and Drug Administration, European Medicines Agency).
Potential impacts on Canadians, including businesses
Preliminary analysis indicates that the Canadian and international pharmaceutical industry would be impacted by increased notification and data requirements.
The full extent of the impact is being assessed by Health Canada through the cost benefit analysis that will be published with the regulatory proposal in Canada Gazette, Part I.
Consultations
In fall 2018, stakeholders were asked for input on a cost-benefit analysis survey. The feedback obtained from the consultation informed policy positions, which were presented to stakeholders during targeted consultations. As a result, stakeholders were asked for additional feedback through a follow-up cost-benefit analysis survey which closed at the end of summer 2019. The responses are currently being analyzed.
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 fall 2021.
Further information
Additional information can be requested from the departmental contact.
Departmental contact
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
Consult Health Canada's acts and regulations web page for:
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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:
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