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

Enabling Act

Food and Drugs Act

Description

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 is being assessed by Health Canada through the assessment of the Cost Benefit Analysis Survey responses provided by stakeholders in fall 2018.

Consultations

In 2018 the regulatory proposal was presented to stakeholders during targeted consultations. Stakeholders were also asked for feedback on a cost benefit analysis survey in fall 2018.

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 2020 and last 70 days.

Further information

Further information is available on the Health Canada website. Questions regarding this initiative can be sent to hc.ear-ree.sc@canada.ca.

Additional information can be requested from the Departmental contact.

Departmental contact

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:

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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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