Forward Regulatory Plan 2019-2021: Regulations amending the Food and Drug Regulations for Environmental Risk Assessment of Active Ingredients in Drugs
Title of Regulatory Initiative
Regulations amending the Food and Drug Regulations for Environmental Risk Assessment of Active Ingredients in Drugs
Food and Drugs Act
Health Canada is proposing to modernize the environmental risk assessment of drugs by creating a notification and assessment regime in the Food and Drug Regulations.
The new regime would replace the current environmental and indirect human health risk assessments for active ingredients used in drugs that is required under the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Chemicals and Polymers) and (Organisms).
The proposal would also tailor environmental data requirements to the type of drug being assessed and also require data that would allow the Department to better understand the potential environmental and indirect human health effects of drugs.
Regulatory cooperation efforts (domestic and international)
Health Canada is aligning 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 will be assessed by Health Canada through the assessment of the Cost Benefit Analysis Survey responses which will be received by the end of summer 2019.
In fall 2018, stakeholders were asked for feedback 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 was launched in July 2019.
Canadians will also 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 2020 and last 70 days.
Additional information can be requested from the Departmental contact.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Telephone number: 613-946-6586
Date the regulatory initiative was first included in the Forward Regulatory Plan
April 1, 2018
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