Summary of precision regulating ministerial authorities
On this page
About these authorities
Amendments to the Food and Drugs Act (FDA) give the Minister additional authorities to develop tailored regulatory solutions so that people in Canada have access to safe, effective, high-quality products.
With these additional authorities, the Minister has the ability to:
- put in place supplementary rules for certain therapeutic products to protect against potential health risks or adverse effects
- put in place targeted exemptions from specific regulatory requirements for therapeutic products or food, adding conditions where needed
- rely on information or decisions from select regulatory authorities to satisfy specific regulatory requirements for therapeutic products or food
How the authorities will be used
These authorities are not meant to displace the normal functioning of the FDA and its associated regulations or the use of existing enforcement tools when needed. Rather, they make it possible for Health Canada to create targeted regulatory measures, for example, to help address supply disruptions, areas of unmet need, or emerging health or safety issues or priorities.
Under the supplementary rules authority, the Minister can establish additional rules to prevent, manage or control the risk of:
- injury to health that may result from the use, other than the intended use, of a therapeutic product or class of therapeutic products
- the promotion for a use, other than the intended use, of a therapeutic product or class of therapeutic products
- a therapeutic product or class of therapeutic products being made appealing for use beyond its intended use or
- adverse effects that the intended or unintended use of a drug or class of drugs for an animal of a particular species may present to humans, animals of a different species or the environment
To make an order under the exemption or reliance authorities, the Minister must believe, on reasonable grounds, that 2 legislated preconditions have been met:
- The order is necessary for a health or safety purpose or is otherwise in the public interest.
- The order being applied is unlikely to result in either unacceptable health, safety or, if applicable, environmental risks, or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.
Openness and transparency
Ministerial orders are a type of regulation. As with the development of any regulation, when we develop ministerial orders under these authorities, we will:
- be transparent
- consult with relevant parties
- maintain high scientific and regulatory standards
The guide to these authorities provides further information to stakeholders and the public.
Guide to the precision regulating authorities under the Food and Drugs Act
Contact us
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Email: hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca