Guide to precision regulating authorities under the Food and Drugs Act: Decision of foreign regulatory authority
On this page
Section 30.06
The following subsections of the Food and Drugs Act (FDA) set out the decision of foreign regulatory authority (reliance authority).
Section 2, definition of foreign regulatory authority:
"A government agency or other entity outside Canada that controls the manufacture, use or sale of therapeutic products or foods, within its jurisdiction."
Subsection 30.06(1), the authority to make a deeming (reliance) order:
"Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, deem that specified requirements of this Act or the regulations are met (in respect of a therapeutic product or food that belongs to a class specified in the order) on the basis of a decision of, or any information or document produced by, a foreign regulatory authority in respect of that therapeutic product or food."
Subsection 30.06(2), the preconditions required before making an order:
"The Minister may make the order only if the Minister believes on reasonable grounds that:
- (a) it is necessary for a health or safety purpose or is otherwise in the public interest and
- (b) having regard to its benefits and conditions, it is unlikely to result in
- (i) unacceptable health, safety or, if applicable, environmental risks or
- (ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks"
Subsection 30.06(3), the authority to impose conditions:
"The Minister may, in the order, impose any conditions that the Minister considers necessary."
Subsection 30.06(4), the obligation to comply with conditions:
"Any person to whom a condition applies must comply with that condition."
Subsection 30.06(5), clarifications:
"For greater certainty,
- (a) the requirements referred to in subsection (1) include requirements imposed on the Minister
- (b) the Minister may rely on a portion of a decision of, or a portion of any document or information produced by, a foreign regulatory authority and
- (c) nothing in this section is intended to limit the Minister's ability to consider information, documents or other material obtained, directly or indirectly, from a foreign regulatory authority."
Scope of the reliance authority
Orders under the reliance authority
The reliance authority under section 30.06 of the FDA applies to a:
- class of therapeutic products or
- class of foods
Reliance orders cannot be made for cosmetics.
The class of therapeutic products or foods depends on the situation at hand and is determined when the order is being developed.
Only the Minister may make, amend or revoke a reliance order under section 30.06 of the FDA. These activities cannot be delegated to officials.
The reliance authority allows the Minister to make an order deeming that specified requirements in the FDA or its regulations have been met for a class of therapeutic products or foods specified in the order. This deeming (or reliance) is based on information from or decisions (in full or in part) made by select foreign regulatory authorities. The Minister may set out conditions in the order that have to be met for the order to apply.
When carrying out their regulatory responsibilities, Health Canada and, as applicable, the Canadian Food Inspection Agency (CFIA) regularly collaborate with and consider information from foreign regulatory authorities. As paragraph 30.06(5)(c) of the FDA indicates, the reliance authority does not limit the ability of Health Canada or CFIA to conduct these collaborative activities in the absence of a reliance order. Collaboration can involve, for example, work-sharing activities, collaborative reviews as well as considering information from other regulators. Along with this type of existing collaboration, the reliance authority further enables us, in limited circumstances that are clearly laid out in the ministerial order, to rely on information from or decisions made by select foreign regulatory authorities.
The foreign regulatory authorities on whose decisions or information the Minister can rely on will be specific to each reliance order. They will also be based on an assessment of whether the regulatory regimes for the products in question are aligned.
Legislative preconditions
The Minister can only use this authority if there are reasonable grounds to believe the following:
- The order is necessary for a health or safety purpose or is otherwise in the public interest and
- Having regard to the benefits and conditions of the order, the use of the decision, information or document is unlikely to result in:
- unacceptable health, safety or, if applicable, environmental risks or
- an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks
These legislative preconditions, set out in subsection 30.06(2) of the FDA, are meant to be flexible enough to accommodate situations where tailoring the regulatory approach is necessary for health or safety or is in the public interest.
Process for making a reliance order
If we determine that a reliance order under these authorities is the best option to address the issue at hand, officials must ensure that the legislative preconditions have been met. They will also conduct the necessary analysis to support the order being developed.
Consultation
We will consult with relevant stakeholders and health system partners during the development of a reliance order. These consultations may take different forms depending on such things as the number of stakeholders and partners who are affected or the urgency of the situation.
Publication
Reliance orders are subject to both the Statutory Instruments Act and the Cabinet Directive on Regulation and are published in the Canada Gazette, Part II.
A class reliance order may include:
- the class of therapeutic products or class of foods subject to the order, as applicable
- the specific provisions of the FDA or regulations deemed to be met (based on the information from or decision made by select foreign regulatory authorities)
- the names of the select foreign regulatory authorities on whose information or decisions the Minister can rely on and
- any applicable conditions
Where necessary, supporting information such as guidance or procedures will be developed and published.
After a reliance order is made
Once an order is made, officials will assess over time whether it should remain or be updated, repealed or incorporated into our regulations of general application. An example would be to adapt to an evolving situation.
Refer to the Definitions and interpretations page for definitions on food, Minister, Ministerial order and therapeutic product.
Page details
- Date modified: