Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs: SOR/2026-162

Canada Gazette, Part II, Volume 160, Number 14

Registration
SOR/2026-162 July 7, 2026

FOOD AND DRUGS ACT

Whereas the Minister of Health believes on reasonable grounds that the annexed Order is necessary for a health or safety purpose or is otherwise in the public interest;

And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and conditions, the annexed Order 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;

Therefore, the Minister of Health makes the annexed Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs under section 30.06footnote a of the Food and Drugs Actfootnote b.

Ottawa, July 7, 2026

Marjorie Michel
Minister of Health

TABLE OF PROVISIONS

Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

Interpretation

1 Definitions

New Drug Submissions

Abbreviated New Drug Submissions

5 Deeming — already authorized foreign drug

Supplements

Condition

9 Provision of information

Coming into Force

10 Publication

Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

Interpretation

Definitions

1 (1) The following definitions apply in this Order.

abbreviated new drug submission
means an abbreviated new drug submission filed under section C.08.002.1 of the Regulations. (présentation abrégée de drogue nouvelle)
corresponding foreign drug,
in respect of the drug that is the subject of a new drug submission, an abbreviated new drug submission or a supplement to either such submission, means
  • (a) the foreign drug referred to in subparagraph 2(1)(c)(i), clause 3(2)(b)(ii)(A), subparagraph 5(1)(c)(i), subparagraph 6(1)(c)(i) or clause 7(2)(b)(ii)(A), as the case may be; and
  • (b) any other foreign drug that meets the following criteria:
    • (i) in the case of a new drug submission or an abbreviated new drug submission,
      • (A) it belongs to the class of drugs to which the drug that is the subject of the submission belongs,
      • (B) it has the same strength, dosage form, route of administration and medicinal ingredient as that drug, and
      • (C) it has conditions of use that fall within the conditions of use of that drug, and
    • (ii) in the case of a supplement to a new drug submission or to an abbreviated new drug submission,
      • (A) it belongs to the class of drugs to which the drug that is the subject of the supplement belongs,
      • (B) it has the same strength, dosage form, route of administration and medicinal ingredient as that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement, and
      • (C) it has conditions of use that fall within the conditions of use of that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement. (drogue Ă©trangère correspondante)
drug
means a new drug but does not include a public health emergency drug. (drogue)
List
means the document entitled List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents, published by the Government of Canada on its website, as amended from time to time. (Liste)
new drug submission
means a new drug submission filed under section C.08.002 of the Regulations. (présentation de drogue nouvelle)
notice of compliance
means a notice of compliance issued under section C.08.004 of the Regulations. (avis de conformitĂ©)
post-market measure
means any measure that a foreign regulatory authority provides for in respect of a foreign drug for any of the following purposes:
  • (a) optimizing the benefits and managing the risks associated with the foreign drug;
  • (b) managing significant uncertainties relating to those benefits and risks;
  • (c) collecting information to enable the continuous assessment of those benefits and risks, the identification of any changes to them and the management of the uncertainties. (mesure après la mise en marchĂ©)
Regulations
means the Food and Drug Regulations. (Règlement)
supplement
means a supplement filed under section C.08.003 of the Regulations. (supplĂ©ment)

Words and expressions

(2) Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in Part A or C of the Regulations, as applicable.

Interpretation — information

(3) Unless the context otherwise requires, in this Order a reference to information includes a reference to material.

New Drug Submissions

Deeming — already authorized foreign drug

2 (1) Subject to subsections (2) and (3), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met, in respect of the drug that is the subject of the submission, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

Scope of deeming

(2) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met under this section only in respect of any set of information that the manufacturer indicates under paragraph (1)(b).

Exception

(3) Despite subsection (2), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under clause (1)(c)(iv)(A).

Non-application — joint review

(4) Paragraph (1)(f) does not apply if the decision of the foreign regulatory authority to authorize the sale of the foreign drug

Deeming — application filed for foreign drug

3 (1) This section does not apply to a manufacturer that seeks a notice of compliance in respect of a new drug submission on the basis of a direct or indirect comparison between the drug that is the subject of the submission and another drug that is authorized to be sold in Canada.

Requirements for deeming

(2) Subject to subsections (3) and (4), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met, in respect of the drug that is the subject of the submission, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

Scope of deeming

(3) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met under this section only in respect of all of the sets of information referred to in clauses (2)(b)(i)(A) to (C).

Exception

(4) Despite subsection (3), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under subclause (2)(c)(i)(D)(I).

Non-application — joint review

(5) Paragraph (2)(e) does not apply if the decision of the foreign regulatory authority to authorize the sale of the foreign drug

Deeming — joint review involving Minister

4 (1) This section does not apply to a manufacturer that seeks a notice of compliance in respect of a new drug submission on the basis of a direct or indirect comparison between the drug that is the subject of the submission and another drug that is authorized to be sold in Canada.

Requirements for deeming

(2) Subject to subsections (3) to (5), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met, in respect of the drug that is the subject of the submission, on the basis of a document referred to in paragraph (e) produced in the context of a joint review if the following requirements are met:

Scope of deeming

(3) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a new drug submission is deemed to be met under this section only in respect of the portion referred to in paragraph (2)(b) that is addressed by the document referred to in paragraph (2)(e).

Exception

(4) Despite subsection (3), the requirement in subsection C.08.004(3) of the Regulations that the Minister complete an examination of a new drug submission is not deemed to be met under this section in respect of the portion referred to in paragraph (2)(b) that is addressed by the document referred to in paragraph (2)(e) if the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations based on the document.

Exception

(5) Despite subsection (3), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under clause (2)(f)(iii)(A).

Abbreviated New Drug Submissions

Deeming — already authorized foreign drug

5 (1) Subject to subsections (2) and (3), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of an abbreviated new drug submission is deemed to be met, in respect of the drug that is the subject of the submission, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

Scope of deeming

(2) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of an abbreviated new drug submission is deemed to be met under this section only in respect of any set of information that the manufacturer indicates under paragraph (1)(b).

Exception

(3) Despite subsection (2), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under clause (1)(c)(iv)(A).

Non-application — joint review

(4) Paragraph (1)(f) does not apply if the decision of the foreign regulatory authority to authorize the sale of the foreign drug

Supplements

Deeming — already authorized foreign drug

6 (1) Subject to subsections (2) and (3), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement to a new drug submission or to an abbreviated new drug submission is deemed to be met, in respect of the drug that is the subject of the supplement, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

Scope of deeming

(2) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement is deemed to be met under this section only in respect of the portion referred to in paragraph (1)(b).

Exception

(3) Despite subsection (2), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under clause (1)(c)(iv)(A).

Non-application — joint review

(4) Paragraph (1)(f) does not apply if the decision of the foreign regulatory authority to authorize the sale of the foreign drug

Deeming — application filed for foreign drug

7 (1) This section does not apply to a manufacturer that seeks a notice of compliance in respect of a supplement to a new drug submission on the basis of a direct or indirect comparison between the drug that is the subject of the supplement and another drug that is authorized to be sold in Canada.

Requirements for deeming

(2) Subject to subsections (3) and (4), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement to a new drug submission is deemed to be met, in respect of the drug that is the subject of the supplement, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

Scope of deeming

(3) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement is deemed to be met under this section only in respect of the portion referred to in subparagraph (2)(b)(i).

Exception

(4) Despite subsection (3), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under subclause (2)(c)(i)(D)(I).

Non-application — joint review

(5) Paragraph (2)(e) does not apply if the decision of the foreign regulatory authority to authorize the sale of the foreign drug

Deeming — joint review involving Minister

8 (1) This section does not apply to a manufacturer that seeks a notice of compliance in respect of a supplement to a new drug submission on the basis of a direct or indirect comparison between the drug that is the subject of the supplement and another drug that is authorized to be sold in Canada.

Requirements for deeming

(2) Subject to subsections (3) to (5), the requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement to a new drug submission is deemed to be met, in respect of the drug that is the subject of the supplement, on the basis of a document referred to in paragraph (e) produced in the context of a joint review if the following requirements are met:

Scope of deeming

(3) The requirement in subsection C.08.004(1) or (3) of the Regulations, as the case may be, that the Minister complete an examination of a supplement is deemed to be met under this section only in respect of the portion referred to in paragraph (2)(b) that is addressed by the document referred to in paragraph (2)(e).

Exception

(4) Despite subsection (3), the requirement in subsection C.08.004(3) of the Regulations that the Minister complete an examination of a supplement is not deemed to be met under this section in respect of the portion referred to in paragraph (2)(b) that is addressed by the document referred to in paragraph (2)(e) if the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations based on the document.

Exception

(5) Despite subsection (3), the applicable requirement referred to in that subsection is not deemed to be met under this section in respect of information that is related to any difference identified under clause (2)(f)(iii)(A).

Condition

Provision of information

9 A manufacturer — that has indicated to the Minister that it seeks the applicable requirement in section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission, an abbreviated new drug submission or a supplement to either such submission to be deemed to be met under this Order with respect to certain information in the submission or supplement — must provide the Minister, on request, with any additional information to demonstrate that the applicable requirements of this Order are met.

Coming into Force

Publication

10 This Order comes into force on the day on which it is published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Executive summary

Issues: To sell a new drug in Canada, a manufacturer must file a drug submission and have the information on its safety, efficacy and quality examined and authorized by the Minister of Health (the Minister). These examinations are resource intensive and the challenges they present are compounded by an increase in the number and complexity of submissions over many years. In addition, there have been challenges meeting the growing demand for access to certain drugs on the Canadian market. These gaps are, in part, attributable to business decisions made in the face of Canada’s relatively small share of the global market.

Drug submission requirements and the approach to drug evaluations are largely harmonized globally across leading regulatory authorities. Health Canada (the Department) has a long history of cooperation with its international counterparts and organizations with engagement ranging from information sharing to work-sharing, to multilateral harmonization initiatives (e.g. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH]). Despite Health Canada having competitive review timelines and its continued efforts towards greater international alignment, stakeholders have raised concerns about the time it takes to get a product to market in Canada. Recognizing that Health Canada authorization is one step in the process of getting a drug to patients — a process that also health technology assessments and reimbursement decisions by provinces and territories — the Department has taken significant steps in recent years to reduce gaps in market access to drugs through a number of initiatives. While these initiatives have contributed to narrowing that access gap, there is still more to be done.

Description: The Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order) will deem the requirement for the Minister to examine specified information and material in a submission or supplement for a new drug to have been met based on decisions of, or documents produced by, certain foreign regulatory authorities (FRAs). So that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it sets out requirements that will need to be met. These requirements include that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that 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. Information in the submission or supplement relating to those differences will be examined by the Minister along with other aspects of the submission or supplement unique to the Canadian market (e.g. labelling). Where the Minister considers that the differences could potentially negatively impact the safety or effectiveness of the drug, deeming will not apply for that portion of the submission or supplement and a full examination of it will take place.

Rationale: As one component of the Government of Canada’s broader Red Tape Review commitment, the proposed Order could help support increased and more timely access to drugs in Canada by facilitating more efficient reviews of drug submissions and supplements and enabling greater international collaboration, including in joint reviews while maintaining the safety, effectiveness and quality of these products. It would build upon the work that Health Canada has undertaken with other leading regulators over the years to increase collaboration and harmonize and align international standards and submission requirements. It is part of the evolution of Health Canada as a leading regulatory authority among other regulatory authorities with like-minded high standards to drug regulation.

Taking a regulatory approach to modify the manner in which the Minister may examine a submission or supplement for a new drug by leveraging international collaboration and reliance will allow Health Canada to shorten review times and refocus resources, as needed. This will enable the Department to address the increasing volume and complexity of drug submissions overall, as one way of further supporting the health and safety of Canadians and the public interest.

The Order is estimated to result in a quantifiable net benefit to industry of $18,075 per submission where deeming applies, based on estimated costs of $9,600 per submission and estimated savings of $27,675 per submission. Given the built-in flexibilities of the Order, including that the classes of drugs and FRAs on the IbR List may vary over time, the expected number of eligible submissions requesting deeming in the future cannot be robustly estimated at this time. As a result, where possible, estimated costs and benefits are presented on a per-submission basis, with other impacts described qualitatively.

Issues

To sell a new drug in Canada, a manufacturer must file a drug submission and the information and materialfootnote 1 on its safety, efficacy and quality must be examined by the Minister of Health (the Minister). The Minister will authorize the drug by issuing a notice of compliance (NOC) and drug identification number if they are satisfied that the submission contains sufficient information to demonstrate the safety and effectiveness of the drug.

These examinations are resource intensive and the challenges they present are compounded by an increase in the number and complexity of submissions made to Health Canada over many years. There have also been challenges meeting the growing demand for access to certain drugs on the Canadian market. These gaps are, in part, attributable to manufacturers’ business decisions made in the face of Canada’s relatively small share of the global market.

Drug submission requirements and approach to drug evaluations are largely harmonized globally across leading regulatory authorities. Health Canada has a long history of cooperation with its international counterparts and organizations with engagement ranging from information sharing to work-sharing, to multilateral harmonization initiatives (e.g. ICH). Despite having competitive review timelines at Health Canada and its continued efforts towards greater international alignment, stakeholders have raised concerns about the time it takes to get a product to market in Canada.

Recognizing that Health Canada authorization is one step in the process of getting a drug to patients — a process that also involves federal pricing oversight, health technology assessments, and reimbursement decisions by provinces and territories — the Department has taken steps to reduce gaps in market access in recent years through a number of initiatives to meet the realities of a changing landscape. These initiatives have contributed to narrowing that access gap but there is still more to be done. Health Canada must continue evolving to meet these challenges by further strengthening its agility and efficiency as a regulator through risk-based and innovative approaches and increased collaboration with comparable international regulatory partners while maintaining sovereign decision-making authority.

A regulatory approach, which modifies the manner in which the Minister may examine a submissionfootnote 2 for a new drug by leveraging international collaboration and reliance, could help narrow the gap in product availability and could contribute to more timely access to products on the Canadian market. Such an approach provides the Minister with an additional and effective tool for the efficient review and authorization of submissions without compromising the safety, efficacy and quality of new drugs on the Canadian market. Further, the Order would build upon work that Health Canada has undertaken with other leading regulators over the years to increase collaboration and harmonize and align international standards and requirements. And it is thus part of the evolution of Health Canada as a leading regulatory authority among other regulatory authorities with like-minded high standards to drug regulation. In addition, it will allow Health Canada to refocus resources as needed. This will enable the Department to address the increasing volume and complexity of drug submissions overall as one way of further supporting the health and safety of Canadians and the public interest.

Objective

On July 9, 2025, the Government of Canada launched a Red Tape Review (RTR) across the federal regulatory system. The review is intended to eliminate outdated or unnecessary rules and streamline the delivery of regulatory decisions. The RTR builds upon work already completed in recent years to modernize regulations and seeks to further streamline rules and reduce the burden on both regulated parties and the government.

Under RTR, international alignment and reduction of trade barriers is a key commitment, including to help achieve more timely access to products on the Canadian market.

There has been an increasing drive internationally for greater collaboration and reliance amongst regulators to share scientific expertise, improve efficiencies and streamline processes for the pharmaceutical industry through greater harmonization or convergence of regulatory and submission requirements, standards and practices amongst regulators. For example, regulators have worked towards achieving greater harmonization worldwide through ICH, with the intent of ensuring that safe, effective and high quality medicines are developed and registered in the most resource-efficient manner. A number of collaborative frameworks have also been developed, such as the International Coalition of Medicines Regulatory Authorities (ICMRA), which provides a global architecture to support enhanced communication, information sharing and crisis response, and to address regulatory science issues. Leveraging this shared global expertise typically results in a more rapid, efficient, and cost-effective process and allows a regulator to make strategic choices regarding where they focus their resources based on where they are most needed.

In this context, the Order seeks to strengthen and expand the use of expertise, information, documents and decisions from FRAs. This would support the longer-term goal of increased collaboration, and ultimately, increase access to drugs for Canadians. More specifically, it would

As one component of the Government of Canada’s broader RTR commitment, the Order could help encourage increased and more timely access to drugs for human and animal use on the Canadian market by facilitating more efficient reviews of drug submissions and by enabling greater international collaboration, including through joint reviews and reliance on regulatory partners while rigorously maintaining the safety, effectiveness and quality of these products. Health Canada will retain the ability to make a positive or negative decision to authorize a drug on the basis of information examined by the Minister.

Currently, Health Canada meets its service standard over 95% of the time for drugs regulated under Division 8. This has remained consistent over the past five years despite a sharp increase in demand. Furthermore, in 2024, Health Canada’s median review time for priority drug submissions was 223 days, ranking first amongst comparable international regulators. Health Canada is committed to increasing the number of drugs available in Canada and the speed with which they are available. This Order is an important tool that will contribute to this goal, and is expected to further reduce review timelines. There are a number of factors that will influence the time for reviews, such as the number of submissions under review, the extent of reliance used for a submission, and other jurisdictions’ timelines. We anticipate that by the end of the 2028, some submissions will have up to 40% shorter review timelines.footnote 3

Description

Health Canada uses its existing authorities under the Food and Drugs Act and FDR to consider information, documents or other material obtained from other regulatory authorities in its examination of submissions for new drugs. To further support and increase the Department’s use of reliance on FRAs, the Order will, where the requirements of the Order are met, deem parts of the Minister’s examination to have been completed on the basis of an FRA’s decision or document(s) under the following three scenarios:

In providing for deeming in these three circumstances, the Order accounts for differences in what the deeming will be based on (i.e. decisions versus documents) and the time at which information demonstrating that all requirements of the Order are met can be provided to the Minister.

Nothing in the Order limits the Minister’s existing ability to consider information, documents or other material obtained from FRAs in the context of the review of drug submissions outside the deeming context. For example, the Minister may consider foreign review reports or inspection reports obtained from FRAs in their examination of a drug submission.

Scope

The Order will apply to certain specified classes of new drugs for human and animal use regulated under Part C, Division 8 of the FDR. These classes will be set out in a list incorporated by reference in the Order. Further, the Order only allows for deeming in relation to certain types of submissions made under Division 8 of the FDR, specifically:

The Order does not extend to extraordinary use new drug submissions, nor their supplements. In addition, the Order does not apply in relation to emergency/alternate pathways (i.e. Special Access Program, Emergency Drug Release for veterinary drugs, or public health emergency drugs). For clarity, the Order could apply to drug submissions that are filed for drugs previously requested under the Special Access Program and the Emergency Drug Release Program.

The filing requirements for submissions under the FDR are not affected by this Order (i.e. all submission requirements under the FDR must still be met where deeming is requested). In addition, once an NOC is issued, all post-market requirements will apply to the drug to which the Order applied, as they do for any drug authorized in Canada.

Documents incorporated by reference

The List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents (IbR List) will set out the classes of drugs and FRAs that are within the scope of the Order. An ambulatory IbR List will indicate the classes of drugs that are eligible for deeming. This ambulatory approach provides for flexibility and allows updates to be made as needed and more rapidly, while considering the health and safety risks involved in managing the IbR list. These classes of drugs may be further refined by certain qualifiers (e.g. uses/indications, target populations, dosage forms, modes of action). FRAs will also be set out in the IbR List (listed FRA) in relation to the applicable class of drugs.

The decision to add an FRA for a class of drugs on the IbR list will take into account several factors. These could include whether

Where relevant, Health Canada may also examine FRA-specific factors that help mitigate unacceptable health and safety risks associated with a specific class of drugs.

Before adding a class of drugs or FRA to the IbR List under this Order, an assessment will be done to determine whether the addition is necessary for a health or safety purpose, or is otherwise in the public interest, and whether it is unlikely to result in unacceptable risks or uncertainties to health, safety or, if applicable, the environment, based on the Order’s benefits and conditions. When appropriate, the decision to add a class of drugs to the IbR List would take into account the potential impact on Canadian manufacturers.

In keeping with the structure of the Order, the IbR List will consist of multiple parts to account for the different submission types and divisions for the general deeming, 120-day and joint review options. The IbR List will be further divided with sub-divisions for supplemental submissions, as they could pertain to either an NDS or ANDS. Structuring the IbR List with separate parts, divisions and sub-divisions for each of these elements took into account that the assessment of whether an addition to a section of the IbR List is necessary for a health or safety purpose, or is otherwise in the public interest, and whether it is unlikely to result in acceptable risks or uncertainties to health, safety or the environment could vary depending on the deeming option and type of submission.

As is standard practice, the Department will consult on any proposed changes to the IbR List to ensure an informed decision is made. The Department will also publish updates on the Government of Canada website in conformity with the Health Canada Incorporation by Reference Policy.

Operation of the Order

The Order sets out the three following scenarios under which deeming may take place: General Deeming, 120-day Filing and Joint Reviews. Each option is self-contained.

To help ensure that the Order does not result in unacceptable risks or uncertainties to health, safety or, if applicable, the environment and taking into account its benefits and conditions, the Order sets out requirements that need to be met for deeming to occur. For example, one requirement is for the manufacturer to demonstrate that the drug proposed for sale in Canada has the same strength, dosage form, route of administration and medicinal ingredient(s) as the foreign drug. In addition, in the case of General Deeming and 120-day Filing, the Order requires that the decision of the FRA to authorize the drug not have been based on their own use of reliance, with the exception of a decision that was based on an FRA’s joint review with other FRAs listed for that class of drug on the IbR List.

The manufacturer will need to submit a drug submission that is compliant with all existing filing requirements in the FDR, as well as information to meet all requirements in the Order for deeming to occur, such as having provided

For greater certainty, in the case where the manufacturer seeks a narrower authorization in Canada in comparison to a foreign drug (e.g. only proposes the use of the Canadian drug for some of the conditions of use authorized for the foreign drug), only the information that is relevant to the Canadian drug submission needs to be filed with Health Canada.

Given the health and safety purpose of this Order, it is understood that the authorization for the sale of the foreign drug must be valid and must not be subject to a cancellation or suspension when the deeming occurs under the Order.

Health Canada will request foreign review reports, where available, or other information from a manufacturer to enable and support the Department’s examination, namely of the risk management plan (RMP) and the labelling, including the product monograph for a drug.

In the cases of General Deeming and 120-day Filing, a manufacturer must also identify whether an application for a corresponding foreign drug was withdrawn from review with, or refused by an FRA listed on the same part of the IbR List as the class of drug subject to the submission. This is required where that information is in the possession of the manufacturer, or they have immediate access to it. A corresponding foreign drug refers to the foreign drug, as well as any other foreign drugs

Where there has been a withdrawal or refusal of an application for a corresponding foreign drug, the manufacturer is required to provide information that demonstrates that the reasons for the withdrawal or refusal would not impact the safety or effectiveness of the proposed Canadian drug. In the case of a refusal, the manufacturer must also provide the text of that decision. Where there has been a withdrawal or refusal that could impact safety or effectiveness, deeming would not apply for that submission.

These requirements account for differences in decisions about such corresponding foreign drugs amongst regulators to help ensure that the Order does not introduce unacceptable risks or uncertainties respecting health or safety in Canada. Reference to the manufacturer in Canada possessing or having immediate access to the requested information means that information on the corresponding foreign drug is sought where there is a relationship between the manufacturer in Canada and the company that sought market authorization in the other jurisdiction (e.g. a licensing agreement).

The Minister’s issuance of a notice of deficiency or non-compliance under C.08.004(1)(b) or refusal under C.08.004(3)(b) of the FDR is representative of the Department’s identification of safety and effectiveness issues with a drug submission. As a result, where a prior submission filed by the manufacturer for the same drug was withdrawn after having received such a notice or was previously refused under the FDR, a new submission filed by the same manufacturer for the same drug may not be eligible for deeming under the Order.

Each of the options under the Order explicitly sets out specific sets of information for which the examination could be deemed. Certain options require the manufacturer to identify any of the sets of information in the submission where they would have the Minister’s examination deemed to have been completed on the basis of a decision by a listed FRA on the applicable section of the IbR List.

Conversely, there are also certain FDR requirements specific to the Canadian context of the submission that the Minister will always examine, including the following with respect to a drug proposed for sale in Canada:

Notably, these submission requirements that will always be examined by the Minister are not explicitly referred to in the Order, as they do not fall within chemistry and manufacturing (C&M), non-clinical or clinical information that could be deemed and are therefore always subject to review by Health Canada. While the RMP package will not be deemed, Health Canada will consider information and documents developed by FRAs in the context of its review (e.g. an RMP approved by the European Medicines Agency). The Minister’s focus will be on the examination of components of the RMP that are relevant to the Canadian population.

To provide further clarity on which aspects of the Minister’s examination could be deemed complete, the Order references the submission requirements under the FDR that correspond with C&M,footnote 4 non-clinicalfootnote 5 and clinicalfootnote 6 information. Some submission requirements have been linked to more than one set of information in recognition of their cross-cutting nature. Further clarity on how each submission requirement pertains to C&M, clinical and non-clinical information will be provided in guidance.

Once all requirements in the Order have been met, the FDR requirement for the Minister to examine certain C&M, non-clinical and/or clinical information in the submission, as applicable, will be deemed to have taken place on the basis of a decision, or documents produced, by an FRA.

The Department will be transparent about which drug submissions are approved using deeming.

Differences between a drug submitted for authorization in Canada and a foreign drug

To be eligible under the Order, a drug submitted for authorization in Canada is required to have the same medicinal ingredient(s), strength, dosage form and route of administration as the foreign drug. In addition, conditions of use for the drug must fall within those authorized for the foreign drug.

However, the Order will allow for deeming where there are certain additional differences between the drug filed in Canada and the authorized foreign drug. For example, the Order may still apply if there are differences in the C&M of the drug in Canada when compared to the foreign drug. These differences could include, for example, those that are considered level 3 changes in Health Canada’s Guidance Document — Post-Notice of Compliance Changes: Quality Guidance for pharmaceutical drugs for human use. The Order may still apply if there are clinical differences between the drug submitted for authorization in Canada and the foreign drug, for example, new clinical information that has the potential to improve the management of risk/harm to users (e.g. a new drug interaction).

To account for these potential differences, the Order requires that the manufacturer describe all differences between the drug submitted in Canada and the foreign drug with respect to the components of the submission that the manufacturer seeks to have deemed, and demonstrate that these differences will not impact the safety or effectiveness of the drug if the Minister were to issue an NOC. If the differences could potentially impact the safety or effectiveness of the drug, deeming will not operate for that component of the submission. Note that even if deeming can occur for a component of the submission, because the FRA will not have reviewed any relevant differences to the drug, Health Canada will examine all information relating to these differences.

More information on differences and how they will impact the application of the Order will be provided by the Department in guidance.

Post-market measures

The Order requires the manufacturer to identify and describe any post-market measures provided for by the FRA in relation to the authorization of the foreign drug, related to the portion of the submission for which deeming is proposed. Post-market measures are any measures that an FRA provides for to optimize the benefits or manage risks or significant uncertainties associated with the foreign drug. They may also be used to provide for the collection of information enabling continued assessment of the benefits and risks associated with the foreign drug, identification of changes to them and the management of uncertainties. Where post-market measures provided for by the FRA have been included in the RMP of the submission in Canada, they do not need to be described in the information supporting the requirements under the Order, because Health Canada will always conduct a full review of the RMP package submitted in Canada. Examples of post-market measures provided for by an FRA that Health Canada would need to be informed of may include confirmatory trials, registries and controlled access or distribution programs where they are not included in the Canadian RMP.

On April 1, 2027, the authority to impose Terms and Conditions (T&Cs) for all drugs regulated under the FDR, introduced under Agile Licensing, will come into force. After that date, Health Canada can use the T&Cs authority on a case-by-case basis, to impose or amend T&Cs for a broader class of drugs authorized in Canada. In the deeming context, this could potentially include the imposition of T&Cs that are equivalent to post-market measures set by the FRA, or imposing T&Cs to require the Canadian manufacturer to notify Health Canada, as post-market studies in the FRA are fulfilled.

Existing authorities and operational mechanisms will continue to support oversight prior to the coming into force of Agile T&C authorities.

Additional information

In some cases, a manufacturer who seeks deeming for their submission will have to provide additional information, at the Minister’s request, to demonstrate that the applicable requirements of the Order are met (e.g. that differences between the foreign drug and proposed Canadian drug would not impact safety or effectiveness).

Intellectual property considerations

The IP protections that are available on submitting an NDS or SNDS that results in a NOC (i.e. data protection under section C.08.004.1 of the FDR, protection under the Patented Medicines (Notice of Compliance) Regulations, and protection under the Certificate of Supplementary Protection regime) remain available, irrespective of the Order.

Under the ANDS and NDS pathways of the FDR, manufacturers of subsequent entry drugs (generic and biosimilar drugs) can seek an NOC based on demonstrated similarity to an approved reference drug (for example in the case of generic drugs, a Canadian reference product as defined in section C.08.001.1 of the FDR). This is done by filing a comparative submission that relies, in part, on the previously approved evidence of safety and effectiveness regarding the reference drug. The IP regimes apply to comparative submissions, including their supplements, filed under the FDR, irrespective of the Order.

Deeming options
General deeming

Where the manufacturer would like to leverage the decision made by an FRA to authorize a foreign drug that belongs to a class of drugs in Division 1 of the applicable part of the IbR List, the Order provides the manufacturer with the option to request deeming of the Minister’s examination of any of the following sets of safety and effectiveness information relating to a new drug:

This provides for flexibility where a manufacturer can request that any or all of these sets of information within a submission could be deemed for an NDS, ANDS or their supplements.

120-Day filing

To enable earlier processing and screening of a submission of a drug that belongs to Division 2 of the applicable part of the IbR List, a manufacturer will have the option of filing certain NDSs and SNDSs with Health Canada within 120 days of the foreign filing for a foreign drug. This will allow manufacturers to leverage an anticipated positive FRA decision for the examination of non-comparative NDSs and SNDSs. This approach is intended to encourage earlier filing of submissions for innovator drugs in Canada to reduce the submission gap relative to the U.S. Food and Drug Administration and European Medicines Agency.

To help facilitate the review of a drug submission after the FRA decision to authorize the foreign drug, this part of the Order only applies to NDSs, where C&M, as well as non-clinical and clinical information, is deemed. Taking into account that an SNDS may not always contain information related to all three sets of information (clinical, non-clinical and/or C&M), the 120-day option will deem all portions of the sets of information that are included in the supplement.

The manufacturer will need to provide certain information when they file their submission in Canada, such as proof of filing in Canada within 120 days after filing an application to sell the foreign drug with the FRA and a demonstration that the Canadian drug would have the same strength, dosage form, route of administration and medicinal ingredients as the foreign drug, and that its proposed conditions of use fall within those of the foreign drug.

After the FRA authorizes the sale of the foreign drug, the manufacturer will need to provide additional documents required under the Order to Health Canada, such as information demonstrating that the foreign drug is authorized by the FRA and the labels most recently approved by the FRA in connection with the foreign drug. After the FRA authorized the foreign drug, the manufacturer will also need to provide the Minister with information about differences between the drug and foreign drug with respect to clinical, non-clinical and C&M information in the submission that would be deemed, as well as whether the drug was withdrawn or refused by another FRA in the intervening time between Health Canada submission and FRA final decision.

Joint reviews

Where a joint review is being conducted by Health Canada with one or more FRAs on Division 3 of Part 1 of the IbR List for an NDS or Division 3 of Part 3 of the IbR List for an SNDS, the Order will deem a part of the examination required of the Minister complete on the basis of documents (e.g. review reports) prepared by the FRA(s), enabling the Department to more fully leverage reviews conducted in collaboration with its regulatory partners. This part of the Order has been drafted with the intent of minimizing any impacts on the manner in which joint reviews are already conducted by Health Canada.

The Order includes an option for deeming aspects of the Minister’s examination for non-comparative NDSs and SNDSs in the context of joint reviews. The Order will allow for the deeming of the Minister’s examination of the portions of C&M, non-clinical and clinical information included in the submission that relate to an FRA’s review report.

To be able to benefit from the Order for a submission subject to joint review, the manufacturer will be required to demonstrate that certain requirements are met, including that their drug is part of a class identified on the applicable part of the IbR List and whether there are any differences between the drug subject to the submission filed with the Minister in comparison to the foreign drug related to the portions of the submission being deemed. The manufacturer must also demonstrate that these differences would not impact the drug’s safety or effectiveness if an NOC were to be issued.

While the Order does not make reference to post-market measures under the joint review option, the Minister will communicate with the FRAs during the course of review, including for the purposes of facilitating the Minister’s consideration of whether a T&C may be imposed on an authorization or amended.

In the context of a joint review, the submission is under review by two or more regulatory authorities at the same time and deeming occurs on the basis of documents produced by the participating FRAs. There is a possibility that the conclusions in the document produced by the FRA identify a safety or effectiveness issue. Where there is such a conclusion in a document produced by an FRA, deeming of the Minister’s examination of the relevant portions of the submission will occur and could lead to the issuance of a notice of non-compliance or a notice of deficiency under paragraph C.08.004(1)(b). If the manufacturer amends this portion of its submission in response to the notice of non-compliance or notice of deficiency, the Order specifies that that part of the amended submission will not be subject to deeming under subsection C.08.004(3). This allows the manufacturer to have an opportunity to be heard by the Minister before a final decision is issued in Canada, where the conclusions of the FRA document identify safety or effectiveness issues. As a result, this part of the amended submission will be reviewed by the Minister for the purpose of making a decision on NOC issuance under C.08.004(3).

Even after the Order is made, Health Canada will still conduct joint reviews and consider information, documents or other material obtained from an FRA in circumstances where deeming will not take place. As mentioned above, nothing in the Order limits the Minister’s ability to consider information, documents or other material obtained from an FRA outside the deeming context. Furthermore, some joint reviews would not meet the requirements for deeming, for example where

Opportunities to collaborate for the purposes of information sharing and learning will continue to exist, even when deeming is not possible.

Regulatory development

Consultation

Previous consultations

Consultations were undertaken with Health Technology Assessment organizations (HTAs), the pan-Canadian Pharmaceutical Alliance (pCPA) and key national stakeholder organizations to obtain efficient and informal feedback on the design and technical aspects of the proposed approach for the Order prior to its publication in Canada Gazette, Part I (CGI). At the time, industry stakeholders were asked to complete a cost-benefit survey. Stakeholders had mixed reactions to Health Canada’s proposal, with support for increased efficiency and the need for access, while cautioning about the possible impact on the domestic industry. Stakeholders also emphasized the importance of maintaining a robust review capacity within the Department and raised the need for clarity in guidance and the IbR List.

Prepublication in the Canada Gazette, Part I

Stakeholder feedback was requested following prepublication of the Regulatory Impact Analysis Statement and the Order in CGI. The 84-day consultation ran from December 20, 2025, to March 14, 2026.

The Department received comments from 120 stakeholders, including companies, industry associations, veterinary groups, health system partners, associations representing health care professionals and patients, academics, and individuals. Meetings were also held upon request with health system partners, industry associations, pharmaceutical companies and patient advocacy organizations. These meetings were used to provide an overview of the proposal and answer any questions stakeholders had about the proposed Order. All feedback received was considered and, where appropriate, amendments were made to the Order.

The majority of stakeholders were supportive of the Order, while some expressed the need to take a more cautious approach. Stakeholders expressed particular support for the Department’s efforts to improve access to drugs in Canada, leverage reviews conducted by international partners, and reduce red tape. Stakeholders also emphasized the need for Health Canada to maintain, and where necessary, strengthen scientific capacity, using the Order to shift, and not reduce resources. Concerns were also raised about the perceived inconsistency of the Order with broader government priorities related to strengthening Canada’s sovereignty and advancing domestic economic interests and the need to ensure that reliance-based regulatory decisions do not create downstream misalignment or delays (e.g. to health technology assessments and reimbursement decisions). Overarching concerns were raised around the potential for Health Canada’s loss of expertise or credibility, the level of discretion provided to manufacturers through the Order, potential use of the Order to seek authorization without intention to sell in Canada, and potential impacts on clinical trials and existing review policies of the Department (e.g. priority reviews, NOC with conditions). Response: Health Canada acknowledges the concerns raised. It is not the intent of the Order to be utilized to reduce resources, but rather refocus them to where they are most needed. The Government of Canada is focused on building a stronger, more resilient, and competitive economy, including supporting a sustainable domestic life sciences sector and improving security of supply for Canadians. Advancing efforts to reduce unnecessary regulatory burden and improve the efficiency and responsiveness of the regulatory system is one measure that supports these broader objectives.

The proposed Reliance Order is intended to support more agile, risk-based regulatory oversight by enabling Health Canada to better leverage decisions or documents from comparable international regulators for appropriate products. This approach is expected to reduce duplication, improve efficiency, and allow regulatory resources to be more effectively focused on higher-risk and more complex submissions, while continuing to uphold Health Canada’s requirements for safety, efficacy, and quality.

Health Canada recognizes stakeholder interest in ensuring that reliance approaches do not create unintended consequences for companies investing in Canada. The Department continues to work closely with federal partners, including Innovation, Science and Economic Development Canada (ISED) and Global Affairs Canada, as part of broader government efforts to strengthen Canada’s life sciences ecosystem, support domestic manufacturing and innovation, and enhance supply chain resilience.

This work is further supported through the recently established Pharmaceutical and Life Sciences Sector Task Force, a joint initiative led by Health Canada and ISED. As outlined in the Government of Canada’s announcement, the Task Force will explore “innovative, made-in-Canada solutions that enhance competitiveness, and long-term growth to support reliable and sustainable access to pharmaceutical products in Canada.” The Task Force will help inform the Government’s approach to strengthening Canada’s life sciences ecosystem while improving timely access to medicines.

Health Canada will continue to engage stakeholders as reliance policies are implemented to monitor impacts, assess operational considerations, and ensure approaches remain aligned with Canada’s health, economic, and supply resilience objectives.

While the Order would deem parts of the Minister’s examination complete where all requirements under the Order are met, Health Canada would always examine information in the submission relating to differences between the foreign drug and proposed Canadian drug related to the part of the submission that the manufacturer seeks to have deemed along with other aspects of the submission that are specific to the Canadian context, such as the RMP and label. The Minister will retain the ability to make a positive or negative NOC issuance decision under the FDR on the basis of information examined by Health Canada, where other parts of the examination are deemed complete. The Department will continue work to help ensure that drugs sold in Canada are safe and effective. As the Department gains experience with the Order, it will monitor for any unintended impacts and make adjustments as needed.

Unless otherwise indicated, the analysis below is based on the feedback provided by stakeholders who made specific comments on the substantive components of the Order.

Scope

Comment: Several stakeholders recommended expansion of the scope of the Order to also include drugs regulated only under Division 1 of the FDR. A few patient groups and an individual recommended extending the Order to public health emergency drugs and drugs that could avail themselves of emergency/alternate pathways under the FDR. One stakeholder did not agree with the exclusion of extraordinary use drugs, and another asked for reasons for their exclusion. One organization also expressed interest in advanced therapeutics being included within the scope of the Order. Veterinary stakeholders recommended that Health Canada and other government agencies expand the Order in future phases to include additional product categories beyond pharmaceuticals (i.e. veterinary health products, feed and water additives, vaccines, parasiticides and pesticides, and livestock feeds). On the other hand, some individuals raised concerns that the proposed scope of the Order may be overly broad and could result in near-automatic application to most submissions. Response: Given that this is the first use of the reliance authority under section 30.06 of the FDA, Health Canada will monitor outcomes with the use of deeming for eligible NDSs, ANDSs and their supplements filed under Part C, Division 8 of the FDR. However, the Department intends to take a stepwise approach and populate the IbR List in consultation with the Canadian industry while taking into account health and safety needs, or the public interest, as well as the likelihood that their inclusion in such an Order could introduce unacceptable risks or uncertainties to health, safety or the environment.

IbR List

Comment: Industry stakeholders representing innovators, veterinary groups and a subset of generic companies noted that the examples of classes of drugs provided in the CGI publication were too narrow, and recommended a broader approach be taken to achieve the stated objectives. At the same time, some stakeholders, predominantly representing the domestic generic industry, advocated for either a narrow focus that takes into account impact on domestic manufacturers of generics or a gradual approach that minimizes impact on the domestic industry. A few anonymous individuals raised concerns about the IbR List for joint reviews, with one recommending the ability to refer to individual drugs rather than classes, and another indicating that implementation of an IbR List for joint reviews may be more onerous than the current process for Access reviews. Response: Given that the reliance authority under the Food and Drugs Act applies to classes of therapeutic products or foods, the IbR List must refer to classes of drugs. Health Canada will monitor outcomes with the use of deeming for eligible submissions and amend the IbR List from time to time as appropriate, taking into account health and safety needs, or the public interest, as well as the likelihood that their inclusion in such an Order could introduce unacceptable risks or uncertainties to health, safety or the environment. The intent for joint reviews is to have minimal impact on the existing procedures under Access reviews. While an IbR List will be used for the joint review option, there is flexibility in how many classes will be listed in the corresponding section of the IbR List.

Operation of the Order

Foreign authorizations and format of submissions

Comment: Some stakeholders representing the generic industry asked that the Order account for IP holds and tentative authorizations where patents or exclusivities prevent authorization of the foreign drug by the FRA. They also asked that foreign authorization not be interpreted as final approval, as some FRAs have national level approvals limiting market authorizations. Response: To ensure that the Order does not result in potential risks or uncertainties to health and safety, Health Canada will not accept FRA IP holds and tentative authorizations as decisions for which deeming can occur under the Order, taking into account that these are not official authorizations that permit sale of the foreign drug by an FRA, and could therefore be subject to change (e.g. national bodies may impose risk mitigation measures). For the General Deeming and 120-day options, the Order requires that the manufacturer demonstrate that the sale of the foreign drug is authorized by the FRA. Guidance will elaborate on information the manufacturer should provide to the Minister to demonstrate that this requirement is met.

Differences between drugs

Comment: Many industry stakeholders wanted clarification through guidance on the types of differences between a foreign drug and proposed Canadian drug that would not rule out deeming for a certain set of information under the Order. One company requested that the term “conditions of use” be defined to prevent ambiguity in the assessment of differences. A few individuals raised concerns that FRA decisions may not fully account for Canadian clinical practice, population-specific risks, and health system and access considerations, with suggestions to require comparison between Canadian and foreign contexts. Response: Clarity on the interpretation of conditions of use and differences that do not rule out deeming will be provided in guidance. Taking into account the Canadian clinical landscape, Health Canada will examine aspects of the submission that are specific to the Canadian context, like the Canadian label, which includes the product monograph. Further, the RMP requirements, which come into force on April 1, 2027, specifically take into account the Canadian context and will not be subject to deeming under the Order. In addition, the Order requires that the manufacturer provide information identifying differences, including related to clinical information, between the drug and foreign drug and demonstrate that the differences would not impact the safety or effectiveness of the drug.

Sets of information

Comment: Many stakeholders agreed with the breakdown of deeming by sets of information and with the greater flexibility it would provide. A few industry stakeholders, including associations, requested that the Order provide similar flexibility for supplements, with deeming of smaller portions of these submissions. Several veterinary stakeholders asked for more clarity and specificity on what clinical and non-clinical information would be deemed versus subject to review by Health Canada. Response: The general deeming option in the Order has been revised to provide the manufacturer with the opportunity to request deeming for any or all of the sets of clinical, non-clinical or C&M information in a supplement. Amendments were also made to reference the submission requirements in the FDR that are considered within the scope of C&M, clinical and non-clinical information for additional clarity on which aspects of the Minister’s examination would be deemed. Guidance will elaborate further on this aspect.

Post-market measures

Comment: Industry stakeholders requested clarity on how post-market measure requirements in the Order would be implemented and how they would interact with T&Cs. An association representing health care professionals and an industry stakeholder pointed to the importance of post-market measures being tailored to the Canadian regulatory context, with the former expressing support for the Department maintaining a full review of RMPs. One individual recommended the use of targeted T&Cs in place of the post-market condition included in the proposal at CGI, while another recommended that the Order prevent deeming on the basis of decisions related to foreign drugs with conditional authorizations abroad until the T&C authority comes into force on April 1, 2027. Response: Taking these considerations into account, the Order was revised, by

These amendments were made to add clarity on the definition of post-market measure, remove some burden for manufacturers, and in recognition that the Canadian context would always be considered in the imposition of T&Cs. The amended FDR T&Cs authority, once it comes into force on April 1, 2027, could be used by the Minister as a more targeted mechanism, for example, to obtain information on the fulfillment of confirmatory trials with an FRA.

With regards to concerns about the Order coming into force prior to the T&C authority, it is anticipated that few NOCs would be issued using deeming during that period taking into account the time it would take for a submission to be filed by a manufacturer and reviewed by the Minister. In alignment with current practice, where necessary, the Department will use letters of undertaking to, for example, further characterize the benefits of a drug during that period. Any known or potential risks would be addressed through pharmacovigilance tools currently being used by Health Canada through policy, such as risk management plans or risk mitigation plans prior to market authorization. On April 1, 2027, the requirement for RMPs to be submitted for certain drugs for human use will also come into force.

Additional safeguards and additional information

Comment: Some stakeholders recommended that safeguards be included in the Order, such as requiring foreign review reports under the Order, providing for communication with FRAs in the general deeming and 120-day options, requiring that two trusted FRAs reach a positive decision prior to deeming under the joint review and 120-day options, and inclusion of measures to prevent disproportionate influence by industry on what classes of drugs are included in the IbR List. In addition, a few patient groups and an industry association recommended that Health Canada have the ability to request additional information (e.g. information addressing the Canadian context). One individual questioned whether drugs authorized with the use of reliance should become Canadian Reference Products and another recommended that the Order only allow for a certain percentage of NDSs and ANDSs to use deeming each year to prevent dangerous downsizing of the Department. In addition, some individuals recommended that the Order preserve case-by-case discretion, that the Minister retain control over the indications included on a label, and that it take into consideration that emerging safety signals and changes in FRA policies may occur faster than IbR List updates can keep up with. Response: Health Canada considers that the existing safeguards built into the Order will ensure that deeming only takes place in circumstances that are unlikely to result in unacceptable risks or uncertainty respecting health, safety or, if applicable, the environment. For example, to mitigate potential risks and uncertainties, the Order requires manufacturers to provide information that they possess or have immediate access to about FRA refusals and withdrawals of an application for a corresponding foreign drug while their submission is under Health Canada review. In addition, the Order was amended to require that manufacturers provide the Minister with any additional information to demonstrate that the applicable requirements of the Order are met where requested by the Minister.

Foreign review reports or information may be requested from a manufacturer to enable and support the Department’s review of certain elements of a submission, such as RMPs and labels, including product monographs. This information was not considered necessary under the Order, and additionally may not always be available for older drugs. Similarly, where necessary for the purposes of assessing the safety and effectiveness of a new drug, the Minister may use the existing authorities in the FDR to request information from a manufacturer respecting the safety and effectiveness of the drug. Communication with FRAs will continue to occur, including within the deeming context. The Order does not exempt from any rules or filing requirements under the FDR, including those linked to the definition of the Canadian Reference Product. Drug submissions for which deeming is sought under the Order will be required to meet all the submission filing requirements under the FDR and, once authorized, will be treated like any other drug authorized for sale under the FDR.

Canadian and foreign withdrawals/refusals

Comment: A few industry associations pointed to the importance of not preventing submissions that are currently under review by Health Canada or that were previously withdrawn after having received a notice of non-compliance or deficiency from Health Canada from being eligible for deeming. Response: The Department acknowledges the importance to industry that the Order allow for submissions that are already under review to be eligible for deeming. Health Canada will continue to engage industry on approaches that can be taken to facilitate clearing of backlogs and to prevent them from occurring. With regards to the request that submissions that were previously withdrawn after receiving a notice of non-compliance or deficiency be eligible for deeming, given that the issuance of a notice under paragraph C.08.004(1)(b) means that Health Canada determined that a submission does not comply with the safety and effectiveness requirements set out under C.08.002, C.08.002.1, C.08.003 or C.08.005.1 of the FDR, as applicable, the filing of another submission for that drug that pertains to any of the same matters will continue to be ineligible for deeming. Health Canada would proceed to review the full submission.

Comment: In the context of withdrawals and refusals of applications with FRAs, some stakeholders pointed to ambiguity in the term “another drug” and the possibility for it to be misinterpreted to refer to the broader therapeutic class. Response: For clarity, the Order was amended to replace the use of “another drug” with the defined term of a “corresponding foreign drug.” Additionally, a manufacturer must only provide information about withdrawals or refusals of applications for a corresponding foreign drug about which the manufacturer possesses or has immediate access to information.

Deeming options

120-day and joint review

Comment: The majority of innovators do not support the requirement to submit information at two specific points during the review process under the 120-day and joint review options. Several stakeholders asked for clarity on the Canadian filing date in the 120-day option. Some individuals felt that the 120-day option may lead to inefficiencies and that it may be difficult for the Department to operationalize. Response: After consideration of feedback, as well as the identification of possible operational issues, Health Canada has revised the Order to remove the first time point for submitting differences information under the 120-day option. The requirements to demonstrate that the proposed Canadian drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug, as well as conditions of use that fall within those of the foreign drug were maintained at the first time point to mitigate the chance of a submission being filed seeking deeming under the 120-day option in the Order that is not eligible for deeming. Under the 120-day option, after the foreign drug is authorized, the manufacturer must provide the information about strength, dosage form, route of administration, medicinal ingredients and conditions of use, as well as other information, including related to differences between the proposed Canadian drug and the foreign drug. Requiring information about differences after the foreign drug is authorized by the FRA was maintained to help ensure that the Order does not introduce unacceptable risks or uncertainties to health, safety or the environment. The filing date will continue to be the date that the submission is found to be administratively complete by Health Canada. The Guidance on management of drug submissions and applications explains what Health Canada considers to be an “administratively complete” drug submission.

Comment: Several stakeholders, including industry and veterinary professional associations and veterinary groups, asked that the 120-day option be extended to comparative submissions with an extended filing period. However, others have expressed concern over the Order’s potential to negatively impact the domestic industry by tilting competition towards importers and multinationals. Two associations — one representing the domestic industry and the other representing innovators — explicitly recommended exclusion of comparative submissions from the 120-day option. Response: Taking into account concerns raised by the domestic manufacturing industry, complexities in IP regimes, and differences in timelines related to IP protections across foreign jurisdictions, Health Canada did not extend the 120-day option to comparative submissions.

Comment: A number of stakeholders also asked that SNDSs and ANDSs be included in the joint review option. Response: Health Canada extended the joint review option to apply to non-comparative SNDSs. Taking into account the limited number of comparative submissions filed under Access for joint review with Health Canada, in part due to the Department’s shorter review timelines in comparison to partner FRAs, the concerns raised by the domestic manufacturing industry, complexities in IP regimes, and differences in timelines related to IP protections across foreign jurisdictions, Health Canada did not include comparative submissions, including ANDSs, in the joint review option.

Possession or immediate access to information

Comments: Industry stakeholders and an association representing them raised concerns about the possibility of a manufacturer filing a submission without having rights to the data supporting it, including clinical, non-clinical and chemistry and manufacturing information. Response: The Order includes a requirement that the manufacturer demonstrate that it possesses or has immediate access to certain information respecting the foreign drug. This was included to verify that there is a relationship between the sponsor filing the submission and the market authorization holder of the foreign drug.

Intellectual property

Comments: Industry stakeholders raised concerns about the potential for circumvention of the Patented Medicines (Notice of Compliance) Regulations and the data protection regime under the FDR, where a submission makes a comparison to a foreign drug without expressing a link to approved Canadian products. Response: Under the ANDS and NDS pathways of the FDR, manufacturers of subsequent entry drugs (generic and biosimilar drugs) can seek an NOC based on demonstrated similarity to an approved reference drug (for example in the case of generic drugs, a Canadian reference product as defined in section C.08.001.1 of the FDR). This is done by filing a comparative submission that relies, in part, on the previously approved evidence of safety and effectiveness regarding the reference drug. The IP regimes apply to comparative submissions, including their supplements, filed under the FDR, irrespective of the Order.

Cost-benefit analysis (CBA)

Comment: Several stakeholders indicated that the estimated minimum of 19 submissions per year using the Order was overly conservative and may signal that the Order was expected to have only limited uptake. Response: The minimum estimate of 19 submissions per year was presented based on limited information at the time to establish a floor for analytical purposes. Since then, Health Canada has undertaken further analysis, and while a stepwise approach to the implementation of the Order is planned, there is significant uncertainty at this point regarding the number of requests for deeming under the Order given how the classes of drugs and FRAs on the IbR List may vary over time. As a result, the CBA has been revised to adopt a more qualitative approach, with costs and benefits presented on a per-submission basis.

Implementation and out-of-scope feedback

Comment: In addition to the feedback on the Order outlined above, Health Canada received a significant number of substantive comments on the implementation of the Order and population of the IbR List. Many industry, association and veterinary stakeholders recognized that success of the Order would depend on how it is implemented, including the classes of drugs and FRAs to be included on the IbR List. In some cases, stakeholders provided recommendations for classes of drugs that could be included on the IbR List (e.g. antimicrobials, cancer drugs), or that a particular (i.e. narrow or broad) approach be taken to the classes of drugs to be included in the IbR List. Response: These comments were considered as part of the Department’s efforts to implement and operationalize the Order and will be addressed through mechanisms such as policy and guidance published for consultation upon publication of the Order in Canada Gazette, Part II (CGII). The Department engaged stakeholders on a proposed approach to the IbR List through the IbR Consultation. It will consult on any proposed changes to the IbR List and publish updates on the Government of Canada website in conformity with the Health Canada Incorporation by Reference Policy.

Domestic industry concerns

Comment: A number of stakeholders representing the domestic pharmaceutical industry highlighted concerns that the Order would disadvantage domestic manufacturers and that more needs to be done to strengthen the domestic industry. One individual specifically pointed to the disadvantage for Quebec-based francophone manufacturers who cannot file in other jurisdictions that do not accept submissions written in French. Response: As described earlier in the consultation section, the Department is working closely with federal and provincial partners, including Innovation, Science and Economic Development Canada and Global Affairs Canada, to support both the health needs of Canadians and the resilience of the pharmaceutical sector, particularly in the current geopolitical context. Health Canada is actively exploring what further measures could be advanced to support domestic manufacturing in alignment with its regulatory mandate and broader government objectives.

Performance standards and fees

Comment: Industry stakeholders commented and strongly encouraged the need to establish shorter timelines for drugs reviewed with the use of the Order, with some also advocating for lower fees. Some suggested that shorter review timelines could be done by policy, as the Department gains experience with the Order. Response: The current fee structure under the Fees in Respect of Drugs and Medical Devices Order was implemented on April 1, 2020, with the intent to ultimately cover 75% of pre-market review costs and 67% of post-market costs. With rising submission complexity, labour costs and other factors, the fees currently collected cover less than 50% of program costs. Health Canada will keep the existing fees and related service standards in place when the Order comes into force to ensure simplicity, predictability, and consistency with the current cost recovery framework. The Department will monitor the required effort over time to handle regular submissions and those where deeming is used. Based on its findings, the Department will determine what measures to put in place to reflect the identified level of effort to process and review these submissions.

Out of scope

Comment: Health Canada also received a number of additional comments that were outside the scope of the regulatory proposal, including that:

Indigenous engagement, consultation and modern treaty obligations

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted on the Order. The assessment did not identify any modern treaty implications or obligations.

In addition, a United Nations Declaration Consistency Analysis was conducted. The assessment did not identify potential intersections between the proposal and the rights and interests of First Nations, Inuit and MĂ©tis, and no inconsistencies with the United Nations Declaration on the Rights of Indigenous Peoples (UN Declaration) are apparent.

Instrument choice

The following non-regulatory and regulatory options were considered.

Option 1: To continue with the current reliance on foreign regulatory information

The FDR allow the Minister to examine information or material obtained from an FRA in her examination of a drug submission. Reliance activities under the FDR have to date been guided primarily by internal and external policy, guidance documents and operational procedures. Stakeholders may view these types of reliance decisions as sometimes lacking transparency or predictability, since they are grounded in ministerial discretion under the FDA scheme. This could limit Health Canada’s ability to participate fully in international joint reviews and move towards increased collaboration in regulatory decision-making in the future.

Option 2: Proposing regulatory amendments to the FDR

The Governor in Council (GIC) has the authority to make regulations concerning the issuance of authorizations for drugs. An amendment to the FDR could be made to allow the Minister to authorize a new drug submission on the basis of decisions or documents produced by FRAs. A GIC regulatory amendment would create a transparent, legally binding framework for this form of reliance, offering legal certainty and accountability. It would allow Health Canada to clearly articulate the conditions and parameters under which such reliance could occur, and to provide predictability and regulatory confidence for both industry and international partners. This would also facilitate the use of a reliance approach in the Minister’s examination of information and material filed in a drug submission and reduce the duplication of effort among jurisdictions in the examination of information filed with respect to drug submissions.

This option would provide a strong legal foundation and predictability for the use of this form of reliance by the Minister. However, this comes at the cost of flexibility and responsiveness. This option may be best suited for mature reliance models that have been tested and refined, ensuring that the regulatory framework reflects proven and stable practices. This was not pursued, as it would not permit the Department to address the issues in a more timely and efficient manner. In addition, the Department has a purpose-built authority to allow deeming based on decisions made by, or information or documents produced by, an FRA in the Food and Drugs Act.

Option 3: Develop a ministerial order enabling the deeming of certain FDR requirements met on the basis of reliance for drugs (chosen option)

The deeming authority, under section 30.06 of the Food and Drugs Act, authorizes the Minister to, by order, deem on the basis of decisions made, or documents or information produced by FRAs that certain legislative or regulatory requirements related to specific, identified classes of therapeutic products are met. The authority allows for the imposition of conditions in the Order that the Minister considers necessary. This legislative rule is intended to provide a targeted and more timely approach that complements the GIC regulations, including those that pertain to new drug authorizations.

Ministerial orders are legally binding instruments, providing a clear and authoritative basis for deeming in the context of the Minister’s examination of certain submissions for new drugs without the need for GIC amendment of the FDR. An order would enhance predictability and transparency for manufacturers. These orders can also be made, amended or revoked more readily than GIC regulatory instruments, allowing Health Canada the agility to respond quickly to changes in the pharmaceutical industry and in international partnerships with foreign regulators.

Health Canada is proceeding with Option 3 after determining it to be the most appropriate instrument choice at this time. Where appropriate and required, future regulatory amendments could be considered to formalize such an approach under the FDR.

Regulatory analysis

Benefits and costs

The CBA seeks to explain the benefits and costs of the Order. The information used for the analysis was limited and collected through consultations with industry stakeholders and uses Health Canada internal data and estimates.

Since prepublication of the Order in CGI, Health Canada has undertaken further analysis and internal engagement to better understand the potential costs and benefits of the Order. This highlighted uncertainty regarding the expected number of submissions requesting deeming under the Order, as this is a business decision for manufacturers, provided their submission meets the Order’s requirements. Therefore, there is limited information at this time to support a robust estimate of the number of submissions that would seek to use the Order annually.

For the prepublication of the Order in CGI, a minimum estimate of 19 submissions per year was presented based on limited information at the time to establish a floor. Feedback received following prepublication suggested that this estimate may have been interpreted as signalling that the Order was expected to have only limited uptake.

While there is uncertainty regarding the number of submissions that might be eligible for deeming under the Order, Health Canada currently believes that while the total will be more than 19, the total will not meet the threshold for a significant impact regulatory proposal within the policy period time frame of analysis. Therefore, in accordance with the Cabinet Directive on Regulation: Policy on Cost-Benefit Analysis, a qualitative analysis has been adopted.

Rather than estimating total impacts based on an uncertain annual number of submissions, the analysis presents estimated average costs and benefits in 2026 dollars on a per-submission basis, where possible. This is to provide greater transparency regarding the potential costs and benefits of the Order while acknowledging the uncertainty surrounding the expected number of requests for deeming by industry.

Baseline scenario versus regulatory scenario

In the baseline scenario, demand from Canadians for access to more drugs is expected to continue to increase, along with the number and complexity of drug submissions received by Health Canada. Currently, there is no mechanism that allows the Minister’s examination of certain aspects of drug submissions to have been deemed complete on the basis of decisions or documents from comparable FRAs. As a result, ongoing efforts and initiatives to reduce access gaps would continue within existing frameworks and mechanisms, without additional tools to improve review efficiency and international collaboration.

In the regulatory scenario, manufacturers can choose to request that the Minister’s examination of certain portions of an eligible submission be deemed complete based on a decision or document produced by a listed FRA. The Order should reduce review timelines, support the health and safety of Canadians, and help encourage earlier introduction of drugs to the Canadian market by creating an additional review tool for the examination of drug submissions and enabling greater international collaboration.

Net impact

On a per-submission basis, industry is expected to benefit from the faster approvals and earlier introduction of new drugs to Canada, in addition to an average reduction of 1.5 information requests per submission, resulting in average cost savings of $27,675 per submission. Industry is also expected to incur an average cost of $9,600 per submission to demonstrate eligibility under the Order and to provide information on differences between the proposed Canadian drug and foreign drug, where applicable. In some cases, a manufacturer may also incur costs associated with providing descriptions of post-market measures provided for by an FRA, as well as information related to foreign withdrawals and refusals. As a result, the average net quantifiable savings to industry are estimated to be $18,075 per submission.

Canadians are expected to benefit from the Order, as it will support the health and safety of Canadians and the goal of improving timely access to certain drugs. This could contribute to improved health outcomes for Canadians should those drugs become authorized with the use of deeming.

The Order could have a negative impact on the competitiveness of domestic manufacturers, particularly those whose products are sold only in Canada. However, the Department intends to take a stepwise approach and populate the IbR List in consultation with stakeholders and is working with other Departments to support Canadian industry.

Benefits
Benefits to industry

Additional submission examination tool

Manufacturers with drugs that belong to a class of drugs on the IbR List that are approved by listed FRAs are expected to benefit from this Order, as it facilitates reduced review timelines and can provide increased flexibility, efficiency and predictability in the drug submission review process. Industry stakeholders noted that deeming should allow manufacturers to leverage decisions and documents from listed FRAs, helping to streamline access to multiple markets. Savings are expected to be realized over time, as Health Canada adds classes of drugs and FRAs to the IbR List in consultation with stakeholders.

Additionally, the Order will introduce a 120-day filing option, applicable to non-comparative NDSs and SNDSs. This option enables earlier processing and screening by Health Canada than under some other parts of the Order, as the Department will process and screen a submission prior to an authorization having been issued by a listed FRA. A manufacturer will have the option to file a submission with Health Canada within 120 days of the foreign filing, leveraging an anticipated positive FRA decision for non-comparative NDSs and SNDSs. This option is expected to encourage earlier filing of drug submissions in Canada, thereby reducing the filing gap, and facilitate faster approvals.

The Order will facilitate review efficiency over the years and can encourage the earlier introduction of new drugs to Canada.

Reduced information requests

The Order is expected to reduce the overall number of information requestsfootnote 7 received by industry from Health Canada during the review of a submission where deeming operates. Information requests can lead to multiple rounds of back-and-forth communication, which can extend review timelines and add to industry workload and costs. Under the Order, the FDR requirement for the Minister to examine certain information in a submission would be deemed complete based on a decision of, or documents produced by, a listed FRA, which, in turn, should reduce the volume of information requests issued for those portions of the submission that are subject to deeming.

Through consultation feedback, some industry stakeholders stated that information requests would decrease by an average of 1.5 per submission where deeming operates. This is a conservative estimate, as Health Canada and other industry stakeholders expect a higher reduction in information requests. Moreover, industry stakeholders indicated that responding to a single information request can require up to 20 hours of expert and regulatory work, which costs an average of $18,450 per response, or $27,675 per submission for an average of 1.5 responses. As a result, it is anticipated that the reduction in information requests would result in cost savings for industry, with savings likely to increase over time as more requests for deeming under the Order are made.

Benefits to Government

Managing resources

Globally and in Canada, there has been an increase in the number and complexity of drug submissions over the years, resulting in pressures to review timelines. Drug submission reviews are resource intensive, as Health Canada must examine the safety, efficacy and quality of new drugs to help ensure the health and safety of Canadians. As a result, the Order is expected to help alleviate some of these pressures by shifting the level of resources required to review submissions subject to deeming over time, as classes of drugs and FRAs are added to the IbR List.

Like industry, Health Canada would also see the benefits of the Order gradually increase over the years. However, these benefits will become known over time, as the Department adds classes of drugs and FRAs to the IbR List once the Order is implemented. At this time, the level of effort needed to review drug submissions where the Order applies remains unclear and will only become better understood over time as Health Canada gains experience with the Order once implemented. As a result, potential cost savings to the Department are uncertain at this stage.

Reduced information requests

Health Canada is expected to issue fewer information requests during the review process to manufacturers with drug submissions seeking deeming, as the FDR requirements for the Minister to examine certain portions of eligible submissions would be deemed complete based on a decision of, or document produced by, a listed FRA. Industry has expressed to Health Canada that information requests related to drug submissions where the Order applies will decrease by 1.5, on average. Although the Department may issue more labelling-related information requests, the overall number of information requests is still expected to be lower for submissions where deeming operates, given that the estimate is conservative. Issuing fewer information requests will improve Health Canada’s efficiency in the review process.

Benefits to Canadians

Improved access to new drugs

The Order provides the Minister with an additional tool for the efficient review of submissions without compromising the safety, efficacy and quality of new drugs available in Canada. It would also support the health and safety of Canadians by enabling faster and greater efficiency in reviewing submissions for drugs that are not currently on the Canadian market. While the types of drug classes and number of requests manufacturers submit for deeming once the Order comes into force are uncertain, the Order could benefit Canadians in a number of ways. For example, paediatric indications for drugs that already have an adult indication approved in Canada would move paediatric treatment from off label use to an approved indication. This would reduce uncertainty concerning dosage, potentially reduce adverse drug reactions in children, and improve children’s health. The Order would also lead to benefits with respect to submissions for drugs intended for both food-producing and non-food-producing animals that are currently not authorized in Canada.

Overall, the Order is expected to support the goal of improving timely access to certain drugs for Canadians, should those drugs become authorized with the use of deeming, thereby contributing to improved health outcomes for Canadians.

Costs
Costs to industry

Demonstration of eligibility and differences

Manufacturers seeking deeming will need to submit a complete drug submission in accordance with the FDR, as well as information demonstrating that they meet all requirements in the Order for deeming to occur. This will include providing the Minister with information demonstrating that the sale of the foreign drug has been authorized by an FRA set out on the IbR List in relation to the applicable class of drugs and providing the Minister with the labels that were most recently approved by the FRA in connection with the foreign drug.

Based on cost estimates provided by industry, manufacturers seeking deeming with respect to their drug submissions will incur a cost, on average, of $1,150 per filing to demonstrate that their submission is eligible for deeming under the Order with respect to basic requirements that apply in all cases.

Additionally, manufacturers will be required to provide a description of any differences that exist between the drug subject to a submission in Canada and the foreign drug, related to the set(s) of information in the submission being deemed. Manufacturers will also be required to demonstrate that any differences would not impact the safety or effectiveness of the proposed Canadian drug if authorized by Health Canada.

Through consultations, industry stakeholders stated that differences can exist between a foreign drug and a drug proposed for sale in Canada and that providing some flexibility related to these differences would allow more submissions to be eligible for deeming under the Order. Industry stakeholders also added that the cost of providing information describing these differences and demonstrating that they would not impact the safety or effectiveness of the drug can range from $5,000–$12,500, depending on the complexity and type of the submission, costing an average of $8,450 per submission.

Overall, demonstration of eligibility and differences is estimated to cost an average of $9,600 per submission.

Description of foreign post-market measures, withdra-wals and refusals

Where applicable, manufacturers will also be required to identify and describe any post-market measures provided for by an FRA for the foreign drug authorization that relate to the sets of information that would be deemed under the Order.

If manufacturers possess or have immediate access to information to the effect that an application for authorization filed with a listed FRA to sell a corresponding foreign drug was withdrawn or refused, they must provide information demonstrating that the reasons for withdrawal or refusal of that application would not impact the safety or effectiveness of the proposed Canadian drug, in addition to the text of a refusal decision.

Based on an internal analysis of a comparable requirement, the Department estimates that 15% of submissions seeking deeming would be affected by these information requirements related to FRA decisions. This includes providing information related to refusals from listed FRAs or withdrawals of certain foreign applications for authorization or describing post-market measures provided for a foreign drug. A Health Canada costing surveyfootnote 8 estimated that it costs industry approximately $2,085 per report on foreign safety measures.

Additional information related to Order requirements

Under the Order, a manufacturer seeking deeming must provide additional information requested by the Minister to demonstrate that all the applicable requirements of the Order are met. Under this instrument, manufacturers are already required to provide information alongside their submission demonstrating their eligibility for deeming. As a result, the costs to manufacturers associated with responding to such requests are expected to be minimal, given the additional information requested by the Minister is expected to be readily available.

Increased requests for foreign review reports

As part of standard practice to support the drug review process, Health Canada often receives foreign review information and reports from manufacturers as part of a submission. Although it is not a regulatory requirement under the Order, it is expected that there will be an increase in the number of requests for foreign review information and reports from Health Canada to manufacturers for submissions where deeming is sought to facilitate evaluation of non-deemed components.

Increased competition on domestic manufacturers

The Order is expected to encourage increased entry of new drugs to the Canadian market by facilitating reduced timelines and more efficient reviews of drug submissions. Manufacturers with products that belong to classes of drugs on the IbR List that are approved by a listed FRA would be encouraged to enter the Canadian market. Over the years, as the number of classes of drugs and FRAs on the IbR List expands, competition for market share could increase and may affect the competitiveness of domestic companies that have drugs solely sold in Canada. Some industry stakeholders expressed that the Order could potentially have negative impacts on Canadian companies whose operations and product development are primarily focussed on Canada. Those manufacturers could be at a disadvantage in comparison to multinational companies, given that they may not have a decision or documents from an FRA that they can leverage for deeming under the Order.

Costs to Government

Reviewing submissions seeking deeming under the Order

Where a manufacturer is requesting deeming, the Minister would verify whether all requirements under the Order are met and the submission is therefore eligible for deeming. This includes reviewing the description of any differences between the drug subject to a submission in Canada and the foreign drug that was authorized by a corresponding listed FRA. Where differences could impact safety or effectiveness, deeming would not operate for that portion of the submission.

At this time, the level of effort and review time required to verify submission eligibility for deeming, including whether the requirements under the Order are met and whether any identified differences are acceptable, remains unclear and will become better understood over time after the coming into force of the Order. It is expected that costs to Health Canada associated with these activities would vary depending on the complexity and type of the submission.

Implementation costs

Health Canada will incur internal implementation costs associated with necessary modifications to the Drug Submission Tracking System to accommodate submissions requesting deeming under the Order, as well as the development and ongoing maintenance of the IbR List and forms required to facilitate deeming requests and submissions. Additional implementation costs related to information technology (IT) may arise over time as operational and implementation needs evolve. This may include costs associated with maintaining Health Canada’s ability to accept submissions in the globally harmonized submission format, the electronic Common Technical Document (eCTD), should that format be updated and adopted by FRAs. Without such maintenance and upgrade activities, it is anticipated that sponsors would be unwilling to reformat their dossier submissions between an FRA submission and a Health Canada submission, impacting the ability to leverage the Order for submissions. As a result, IT implementation will be an ongoing effort beyond publication in CGII, and total costs therefore remain unclear at this stage.

Impact of additional drugs on establishment licensing

The Order is expected to bring new drugs onto the Canadian market. Manufacturers that do not already operate in Canada will have to apply for and obtain a Drug Establishment License (DEL), while those already present on the Canadian market may need to amend their DEL. Health Canada would conduct compliance inspections and related activities in support of the DEL process. Increased costs due to the DEL process would typically be fully recovered from industry; however, no increase in funding is associated with this Order, so any increased workload would be addressed through a risk-based reallocation of licensing resources.

Impact of additional drugs on general compliance and enforcement

Health Canada carries out activities related to compliance verification, recalls, drug shortage management and other compliance and enforcement activities as part of its normal regulatory activities. Any increase in the number of drugs authorized through the Order, which would have otherwise not entered the Canadian market, would represent additional workload for Health Canada compliance and enforcement activities. There are no additional resources allocated for compliance and enforcement activities associated with the Order, so any increase in workload would have to be absorbed through a redistribution of existing resources.

Indirect impact to HTA organizations

Canadian HTA organizations conduct drug reimbursement reviews and provide recommendations to the federal and provincial governments. These organizations may face resource challenges if the Order leads to a sudden increase in drug approvals.

In addition, HTA organizations rely on Health Canada’s drug reviews to conduct thorough and objective evaluations of the clinical, economic, patient, and clinician evidence on drugs, and use these evaluations to provide reimbursement recommendations and advice to federal, provincial, and territorial public drug plans. These organizations could encounter difficulties conducting evaluations if information usually provided in Health Canada review reports, summaries of decisions, or similar documents is not available as the result of the deeming process.

Small business lens

The Policy on Limiting Regulatory Burden on Business defines a small business as any business, including its affiliates, that has fewer than 100 employees or less than $5 million in annual gross revenues. According to Health Canada’s records, there are 609 registered small businesses: 449 working with human drugs and 160 working with veterinary drugs. It is expected that Canadian small businesses will not utilize the Order, as it is assumed that they are unlikely to have a decision or document from an FRA applicable to their drug submissions that they can seek to leverage for deeming under the Order.

One-for-one rule

The one-for-one rule does not apply, as there is no incremental change in administrative burden on business.

Regulatory cooperation and alignment

Provinces and territories

Canada’s provinces and territories use assessments and recommendations from HTAs to inform their decisions around the use and public coverage of prescription drugs for human use. Manufacturers of qualifying submissions for biological and pharmaceutical drugs are able to opt in to an aligned review pathway with HTAs to reduce duplication and time lags between Health Canada authorization and HTA recommendations.footnote 9 Consultations with both HTAs and provinces and territories sought opportunities for alignment of reviews where deeming would operate under the Order.

International reliance

This Order is not part of a formal regulatory cooperation plan. However, the use of reliance is not unique to Canada and is common practice globally. A number of jurisdictions offer authorization pathways that rely on decisions or documents made by certain identified regulatory authorities as in this Order. While the approach utilized for reliance differs between regulators, many are similar in scope and requirements. For example, Australia and Switzerland both include reliance in their legislation or regulations to varying degrees, with further details made available in guidance. Other regulators are implementing reliance entirely through policy/guidance, including the United Kingdom and Singapore. Australia, Switzerland, the United Kingdom and Singapore all provide for the use of reliance broadly across drug classes based on authorization decisions and require submission of review reports from specified FRAs. While the manner in which reliance would be enabled in Canada would differ from that of these other regulators, as it would take into account our specific legislative framework, many of the requirements under the Order are similar to those of other jurisdictions. A few notable differencesfootnote 10 recognition to meet the requirement for the Minister to examine parts of a drug submission on the basis of foreign decisions for the General Deeming and 120-Day Filing options, and the use of an IbR list.

Joint review initiatives

There are growing international interest and use of joint review initiatives, such as the Access Consortium that allows for joint reviews to be conducted by peer regulatory authorities, including Australia, Singapore, Switzerland, the United Kingdom and Canada, where the same submission is being filed at the same time to one or more of these jurisdictions. This Order will provide for the further leveraging of work done by partner FRAs as part of joint reviews in the Minister’s examination of non-comparative NDSs and SNDSs under the FDR.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment, a Climate, Nature and Economy Lens analysis was conducted and concluded that there will be no expected important environmental effects, either positive or negative, resulting from this Order.

Gender-based analysis plus

Health Canada expects that this Order will have a positive impact on all Canadians. Depending on classes of drugs added to the IbR List and the drugs authorized, there is potential for some individuals to receive a greater benefit and for some barriers faced by equity-seeking and rights-holding populations (e.g. women and gender-diverse people, Indigenous populations) to be addressed.

Implementation, compliance and enforcement, and service standards

Implementation

This Order will come into force upon its publication in CGII.

It will only apply to those new drugs that belong to a class listed on the IbR List in relation to an FRA also set out in relation to that class on the IbR List. As previously mentioned, Health Canada will make changes to the IbR List as the Department gains experience with the Order, as the needs of Canadians evolve, and as the Department continues to assess the classes of drugs and FRAs that could be included on the IbR List.

Health Canada will publish draft guidance for consultation upon publication of the Order in CGII. This guidance will aid manufacturers in understanding the requirements that a manufacturer must meet for a submission to be eligible for the Order so that deeming under the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment.

Compliance and enforcement

Compliance and enforcement of the Order will be in accordance with a risk-based approach, aligned with existing departmental policies, including Health Canada’s Compliance and enforcement policy for health products (POL-0001). Health Canada employs a wide range of compliance and enforcement actions and tools. Some actions and tools are designed to help regulated parties understand their responsibilities under the law (e.g. compliance promotion), while other actions and tools are designed to induce compliance with the law. For example, failure to comply with the requirements of the Order could result in the Department taking compliance and enforcement action in accordance with POL-0001.

Service standards

Health Canada would keep the existing fees and related service standards in place at the time the Order comes into force to ensure simplicity, predictability, and consistency with the current cost recovery framework. The Department will monitor the required effort over time to handle these submissions and determine what measures to put in place to reflect the expected lower level of effort and timelines to process and review these submissions.

Contact

Debra Haltrecht
Acting Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
150 Tunney’s Pasture Driveway, Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Address locator: 301H
Email: lrm.consultations-mlr@hc-sc.gc.ca