On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance Order and (ii) clinical trial modernization (see our previous article).
The proposed Ministerial Reliance Order (Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs) aims to help encourage earlier availability of drugs to the Canadian market by allowing Health Canada to review certain parts of a drug submission for new drugs more efficiently by relying on decisions and documents made by foreign trusted regulators (referred to in the proposed Reliance Order as foreign regulatory authorities, FRAs).
The proposed Reliance Order contemplates a list incorporated by reference, the List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents (IbR List), which would set out the classes of drugs and FRAs that would be within the scope of the Reliance Order. The proposed Reliance Order does not include any proposed classes of drugs or FRAs.
The statutory and regulatory framework for the proposed Reliance Order
Section 30.06(1) of the Food and Drugs Act grants the deeming authority for the Reliance Order:
“… 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.”
Section 30.06(2) permits the making of such 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”.
Section C.08.004 of the Food and Drug Regulations (FDR) requires the Minister to issue a notice of compliance (NOC) if, after completing an examination of a new drug submission (NDS) or abbreviated new drug submission (ANDS) or supplement to either, the submission complies with the applicable sections of the FDR.
Details of the proposed Reliance Order
Deeming under the Reliance Order – If all the requirements in the Order have been met, the requirements under section C.08.004 of the FDR for the Minister to examine certain chemistry and manufacturing, non-clinical and/or clinical information in the submission would be deemed to have taken place on the basis of a decision, or documents produced, by an FRA. The manufacturer would still need to submit a full drug submission in accordance with the existing requirements in the FDR, as well as information demonstrating that they meet all requirements in the Order for deeming to occur.
Categories – There are three proposed deeming categories:
(i) Deeming where there is already an authorized foreign drug (for NDSs (s. 2), ANDSs (s. 5), and SNDSs and SANDSs (s. 7) only).
(ii) Deeming where there is a submission filed within 120 days after which an application is filed for a foreign drug, after the foreign drug is authorized (for non-comparative NDSs (s. 3) and SNDSs (s. 8) only). To encourage earlier filing of submissions, a manufacturer could file a submission with Health Canada within 120 days of the application filing for a foreign drug, allowing manufacturers to leverage an anticipated positive FRA decision.
(iii) Joint reviews (for NDSs (s. 4) only). Where a joint review is being conducted by Health Canada with one or more FRAs on the IbR List, the Order would deem a part of the examination required of the Minister complete on the basis of documents prepared by the FRA(s).
Requirements – For all three categories, the requirements include:
(i) the manufacturer must indicate that it seeks to have the section C.08.004 requirement deemed to be met in respect of non-clinical, clinical and/or chemistry and manufacturing information;
(ii) the manufacturer must provide the Minister with information that demonstrates:
- that the drug belongs to a class of drugs identified on the IbR List,
- that the drug has been authorized for sale by an FRA on the IbR List that relates to the class,
- that the drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
- that the conditions of use for the drug fall within the conditions of use for the foreign drug, and
- any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness.
The Regulatory Impact Analysis Statement (RIAS) indicates that the decision to add an FRA to the IbR List would consider several factors, including similarity to Canadian requirements and standards, a history of collaboration with Health Canada, and a history of conducting thorough reviews consistent with Health Canada’s standards. Examples of classes of drugs that could be added to the IbR List include drugs that include pediatric conditions of use that are not currently authorized in Canada.
Post-market measures – After an NOC is issued for the drug, the Order would require that the manufacturer notify Health Canada as post-market measures are fulfilled in relation to the authorization of the foreign drug (e.g., where there were confirmatory trials required by a foreign jurisdiction).
Intellectual property considerations – As explained in the RIAS, the intellectual property protections that are available on submitting an NDS or SNDS that results in an NOC (i.e., data protection, protection under the Patented Medicines (Notice of Compliance) Regulations, and protection under the Certificate of Supplementary Protection regime) remain available, irrespective of the proposed Order. Further, the intellectual property regimes would apply to comparative submissions including ANDSs for generic drugs and NDSs for biosimilar drugs, and supplements thereto, irrespective of the proposed Order.
Comments on the proposed Order may be provided until February 28, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.