What is the Ministerial Reliance Order?
The Ministerial Reliance Order allows Health Canada to rely on decisions and assessments from comparable foreign regulatory authorities for certain drug submissions, streamlining the review process for eligible drugs listed in the Incorporated by Reference (IbR) document.
Ministerial Reliance Order – Summary
The Ministerial Reliance Order, which came into force on July 15, 2026, allows Health Canada to rely on decisions and scientific assessments from trusted foreign regulatory authorities when reviewing certain human and veterinary drug submissions. The objective is to reduce duplication, improve review efficiency, and accelerate access to eligible medicines while maintaining Canada’s standards for safety, efficacy, and quality. While this Order is a welcome development for stakeholders seeking market authorization under Division 8 (New Drugs), it does not extend to Division 1 applicants whose products are not classified as New Drugs, leaving them unable to benefit from the reliance pathway.
Key features:
- Applies only to eligible classes of drugs identified in an Incorporated by Reference (IbR) List and only where specified foreign regulators are recognized.
- Health Canada may “deem” portions of the review complete by relying on a comparable foreign regulator’s assessment of:
- Clinical data
- Non-clinical data
- Chemistry and manufacturing information
- Three reliance pathways are available:
- General deeming (foreign approval already granted)
- 120-day filing (Canadian submission filed within 120 days of the foreign submission)
- Joint review (Health Canada collaborates with foreign regulators during review)
- Sponsors must demonstrate that the Canadian product is essentially the same as the foreign product (e.g., medicinal ingredient, strength, dosage form, route of administration, and conditions of use), or justify any differences.
Expected benefits:
- Faster access to eligible medicines in Canada.
- Reduced regulatory burden and duplication for both industry and Health Canada.
- Better use of Health Canada’s scientific resources by focusing on areas where Canadian review adds the greatest value.
The full order may be found here
