Canada Gazette, Part I, Volume 159, Number 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

December 20, 2025

Statutory authority
Food and Drugs Act

Sponsoring department
Department of Health

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 the information and material^{footnote 1} on its safety, efficacy and quality must be examined by the Minister of Health (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 assess 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 more 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. Further, despite having globally recognized alignment and competitive review timelines at Health Canada, stakeholders have recently 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 significant steps in recent years to meet the realities of a changing landscape, including seeking to reduce gaps in market access to drugs through a number of initiatives that have been implemented over the last decade. These initiatives have contributed to narrowing that access gap but there is still more to be done. Health Canada must keep pace with the challenges this presents by becoming a more agile and efficient regulator through risk-based approaches and continuing to utilize new tools and leverage our international relationships with comparable foreign regulators.

A regulatory approach which modifies the manner in which the Minister may examine a new drug submission by leveraging international collaboration and reliance, would allow Health Canada to refocus resources, as needed, as one way of further supporting the health and safety of Canadians, and the public interest. In addition, this approach could help narrow the gap in product availability, and could contribute to earlier availability of products, on the Canadian market. Further, such an approach would provide 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.

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 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. Products that Health Canada regulates are sold in an increasingly global marketplace; however, different regulatory requirements between jurisdictions can create burden and act as trade barriers. They can also slow economic growth and innovation by limiting the products and services that can access the Canadian marketplace. There is also an increasing need to align approaches for product authorizations and one way to do so is by relying on decisions and documents made by comparable foreign regulators.

Increasingly, there has been a drive internationally for greater collaboration and reliance amongst regulators to provide for the sharing of scientific expertise and efficiencies, streamline processes for the pharmaceutical industry and help facilitate market authorization through harmonization or convergence of regulatory requirements, standards and practices amongst regulators. This use of collaboration and reliance allows a regulator to make strategic choices regarding where they focus their resources based on where they are most needed, taking into account the health and safety of Canadians, and the public interest. It benefits regulatory authorities, the pharmaceutical industry and patients by helping to decrease the time to approval and by contributing to earlier availability of new products to market.

Within this environment, the proposed Order would seek to

• further support the health and safety of Canadians by leveraging international partnerships using a risk-based approach to generate greater efficiencies in Health Canada reviews of submissions for drugs in Canada without compromising established requirements under the Food and Drug Regulations (FDR);
• reduce the delay in filing of submissions for drugs in Canada;
• continue to strengthen and expand the use of information and decisions from foreign regulatory authorities (FRAs) with the longer-term goal of increased collaboration in regulatory decision-making; and
• enable Health Canada to refocus resources as needed, as one way to support the health and safety of Canadians.

As one component of the Government of Canada’s broader RTR commitment, the proposed Order would help encourage earlier availability of drugs to the Canadian market by facilitating more efficient reviews of drug submissions and enabling greater international collaboration, including joint reviews and reliance with regulatory partners while maintaining the safety, effectiveness and quality of these products.

Description

Health Canada uses its existing authorities under the Food and Drugs Act and FDR to consider information or other material obtained from other regulatory authorities in its examination of new drug submissions. To further support and increase the Department’s use of reliance on FRAs, the Order would, 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:

• drug submissions for which a decision has already been made by an FRA about a foreign drug (General Deeming);
• drug submissions for which a decision by an FRA to authorize a foreign drug has not yet been made, provided the submissions are filed in Canada within 120 days of being filed with an FRA (120-day Filing); and
• drug submissions subject to joint review by Health Canada with one or more FRAs (Joint Reviews).

In providing for deeming in these three circumstances, the Order would account for differences in what the deeming would be based on (i.e. decision 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.

Scope

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

• new drug submissions (NDSs), abbreviated NDS (ANDSs), supplements to NDS (SNDSs), or supplements to ANDS (SANDSs) for General Deeming;
• non-comparative NDS and SNDS for 120-day Filing; and
• NDS for Joint Reviews.

The inclusion of comparative submissions, including ANDSs and SANDSs, for the 120-day option, and ANDS, SNDS, and SANDS for the joint review option will be explored in the development of the Order before publication in Canada Gazette, Part II.

The Order would not extend to extraordinary use new drug submissions, nor their supplements. In addition, the Order would not apply in relation to emergency/alternate pathways (i.e. Special Access Program, Emergency Drug Release for veterinary drugs, or public health emergency drugs).

The filing requirements for submissions and supplements under the FDR are not affected by this Order. Once a NOC is issued, all post-market requirements would apply to the drug to which the Order applied, as they do for any new 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) would set out the classes of drugs and FRAs that would be within the scope of the Order. An ambulatory IbR List would indicate the classes of drugs that would be eligible. This approach provides for flexibility and allows updates to be made as needed, while considering the health and safety risks involved in managing the IbR list. These classes of drugs could be further refined by certain qualifiers (e.g. uses/indications, target populations, dosage forms, modes of action). FRAs would also be set out in the IbR List (listed FRA) in relation to the classes of drugs. The decision to add an FRA to the IbR List would take into account several factors, including similarity to Canadian requirements and standards, a history of collaboration with Health Canada, and a history of conducting thorough reviews consistent with Health Canada’s standards. Before adding a class of drugs or an FRA to the IbR List under this Order, the Minister would consider 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.

The Minister would only add to the IbR List where that threshold has been met. Examples of classes of drugs that could be added to the IbR List include

• drugs that include pediatric conditions of use that are not currently authorized in Canada and/or drugs where a child-friendly format is not authorized in Canada that include pediatric conditions of use;
• drugs for non-food-producing (companion) animal use that are not currently authorized in Canada; and
• drugs for food-producing animals where a product is not authorized in Canada and there is unmet medical need.

Over time, changes to the IbR List may occur as the Department continues to assess the classes of drugs and FRAs that could be included on or removed from the IbR List. As is standard practice, the Department would 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.

At publication in Canada Gazette, Part I, two parts are proposed to the IbR List. Part 1 would list classes of drugs and the corresponding FRAs for each class for General Deeming and 120-day Filing. Part 2 would list the classes of drugs and corresponding FRAs for each class for joint reviews.

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 would be unlikely to result in unacceptable risks or uncertainties to health, safety or, if applicable, the environment, and taking into account its benefits and conditions, the Order would set out requirements that would need to be met for deeming to occur. For example, one requirement would be for the drug to belong to a class of drugs on the IbR List. In addition, in the case of General Deeming and 120-day Filing, the Order would require 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 would need to submit a full drug submission in accordance with the existing requirements in the FDR, as well as information demonstrating that they meet all requirements in the Order for deeming to occur, such as having provided

• the labels approved by the FRA for use with the foreign drug; and
• evidence demonstrating that the foreign drug is currently authorized by an FRA set out on the IbR List.

Health Canada may also request foreign review information and reports through guidance.

In the cases of General Deeming and 120-day Filing, a manufacturer must also identify whether an application for another drug filed with an FRA listed on Part 1 of the IbR List was withdrawn or refused by the FRA. Another drug refers to drugs

• that are part of the same class;
• with the same strength, dosage form, route of administration and medicinal ingredient(s); and
• with conditions of use that fall within those proposed for the Canadian drug.

Where there has been a withdrawal or refusal of an application for another drug, the manufacturer would be required to provide a rationale as to why the reasons for the withdrawal or refusal of such drugs submitted for authorization to FRAs would not impact the safety or effectiveness of the proposed Canadian drug. Where a prior submission, or supplement that relates to any of the same matters, for a drug that was previously filed in Canada and was withdrawn after having received a notice of deficiency or a notice of non-compliance from Health Canada or was previously refused under the FDR, the submission or supplement would not be eligible for deeming under the Order.

Each of the options explicitly set out those specific components of the examination that could be deemed. Certain options require the manufacturer to identify those parts of the submission where they would have the Minister’s examination deemed to have been completed on the basis of it having been reviewed by a listed FRA on the applicable part of the IbR List.

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

• label, including the product monograph;
• brand name;
• assessment as to whether there is a likelihood that the new drug would be mistaken for another drug in the case of new drugs for human use;
• the withdrawal period of the new drug if intended for administration to food-producing animals (i.e. to ensure tissues and food products derived from the animal are safe for human consumption); and
• the risk management plan package, once the regulatory provisions under the FDR requiring risk management plans (RMPs) for certain drugs for human use come into force on April 1, 2027.

Notably, some of these components are not explicitly referred to in the proposed Order as they do not fall within chemistry and manufacturing (C&M)^{footnote 2}, non-clinical^{footnote 3} or clinical^{footnote 4} information that would be deemed (i.e. label, brand name and its assessment).

Once all the 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 would be deemed to have taken place on the basis of a decision, or documents produced, by an FRA.

The Department would be transparent about which drug submissions were approved with the use of deeming (e.g. by inclusion in the product monograph and summary basis of decisions).

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

Under the Order, a drug submitted for authorization in Canada would be 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 for the foreign drug.

However, the Order would 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, but are not limited to, the use of different packaging, product markings or a colourant added to comply with the FDR. The Order could also still apply if there are clinical differences between the drug submitted for authorization in Canada and the foreign drug.

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

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

Post-market measures

The Order would require the manufacturer to identify and describe any post-market measures provided for by the FRA on the authorization, or that they intend to provide for in the case of joint reviews, of the foreign drug related to those components of the submission or supplement for which the use of deeming is proposed. These may include confirmatory trials, registries and conditions. The manufacturer would need to provide information demonstrating which of those measures could be relevant in Canada in order to optimize the benefits and manage the risks and uncertainties related to the drug. For those measures that are relevant, the manufacturer would demonstrate that the post-market measures, or post-market measures equivalent to them, could be implemented in Canada.

After an NOC is issued for the drug, the Order would require that the manufacturer notify Health Canada as post-market measures are fulfilled in relation to the authorization of the foreign drug (e.g. where there were confirmatory trials required by a foreign jurisdiction), to ensure that Health Canada remains informed on them being resolved. In addition, as previously described, once an NOC is issued, all post-market requirements would apply to the drug to which the Order applied, as they do for any new drug authorized in Canada.

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 could use the T&Cs authority to impose or amend T&Cs for new drugs authorized in Canada, which are equivalent to those set by the FRA. To facilitate this, the Order would deem the considerations to be taken into account under the T&Cs authority as having been completed where the FRA has provided for post-market measures in relation to its decision to authorize the foreign drug, provided that they are technically feasible and relevant to the Canadian market.

Intellectual property considerations

The intellectual property 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 proposed 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 intellectual property regimes would apply to comparative submissions, including their supplements, filed under the FDR, irrespective of the proposed Order.

Deeming options

General Deeming

Where the manufacturer would like to leverage a decision made by an FRA, the Order would provide the manufacturer with the option to request deeming of the Minister’s examination of the safety and effectiveness of a new drug based on one or more of the following sets of information:

• (1) C&M information;
• (2) non-clinical information; or
• (3) clinical information.

This would allow for flexibility where a smaller component of a submission could be deemed for an NDS or ANDS.

Given that most supplements relate to either a significant quality or clinical difference, a more targeted split between C&M, non-clinical and clinical has not been proposed for these submission types.

120-day Filing

To enable earlier processing, screening and beginning of the review, a manufacturer would have the option of filing a submission with Health Canada within 120 days of the foreign filing for a foreign drug. This would 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, which could help bring new drugs to Canadians. While, the proposed draft Order does not include the 120-day option for comparative submissions, including ANDSs and SANDSs, their inclusion will be explored in the development of the Order before publication in the Canada Gazette, Part II.

To help facilitate the issuance of an NOC after the foreign authorization is obtained, this part of the Order would only apply to submissions where C&M, as well as non-clinical and clinical components are deemed.

Certain information would need to be provided by the manufacturer when they file their submission in Canada, such as proof of filing an application to sell the foreign drug with the FRA and a demonstration that the differences between the drug and foreign drug with respect to clinical, non-clinical and C&M information would not impact the safety and effectiveness of the drug proposed for sale in Canada.

After the FRA authorizes the drug, the manufacturer would provide additional documents required under the Order to Health Canada, such as the foreign authorization from the FRA and any label approved by the FRA for use with the foreign drug. Given that there could be changes made to the drug subject to the submission or supplement in the course of the FRA’s review, the manufacturer would 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 or supplement after the FRA authorizes the drug.

Joint reviews

Where a joint review is being conducted by Health Canada with one or more FRAs on the IbR List, the Order would deem a part of the examination required of the Minister complete on the basis of documents prepared by the FRA(s), enabling the Department to more fully leverage the reviews conducted by their 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. To be able to benefit from the Order for a submission subject to joint review, the manufacturer would be required to demonstrate that certain requirements are met, including that their drug is part of a class identified on the IbR List. The Order would allow for the deeming of the examination of the components of the submission that relate to an FRA’s review report.

The proposed draft Order includes NDS for joint reviews. The inclusion of ANDS, SNDS, and SANDS will be explored by Health Canada before publication in the Canada Gazette, Part II, in the development of the Order.

Following the development of the applicable review report(s) by the FRA(s), the manufacturer would need to demonstrate whether there are any differences between the drug subject to the submission filed with the Minister in comparison to that filed with the FRA related to the components of the submission being deemed, and that these differences would not impact the drug’s safety or effectiveness if an NOC were to be issued. The demonstration of differences at this point of the joint review would reflect any changes to the submission that would have taken place during the course of review by the FRA.

The Minister would be in communication with those FRAs that lead the review of components of the drug submission. Where the FRA intends to provide for post-market measures, the manufacturer would be required to describe the measures, and demonstrate which of those measures could be relevant in Canada in order to optimize the benefits and manage the risks and uncertainties related to the drug. For those measures that are relevant, the manufacturer would demonstrate that the post-market measures, or post-market measures equivalent to them, could be implemented in Canada.

The Order would not deem the examination of regulatory requirements necessary for the Canadian context, such as the withdrawal period for drugs intended for administration to food-producing animals, and differences related to the component of a submission being deemed specific to the drug filed with Health Canada. In addition, as there are components of a submission that are unique to a specific region (Module 1 of the electronic Common Technical Document for human drug submissions, and Part I of veterinary drug submissions), all regulators would continue to conduct independent reviews of these components, such as administrative and labelling documents.

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, where

• the class of drugs would not be on the IbR List, for example, because Health Canada continues to assess the health and safety considerations around the use of deeming with respect to that class of drugs; or
• the FRAs would not be on the IbR List for a class of drugs, for example, because the foreign drugs are not regulated and reviewed in a similar manner by the FRAs.

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

Regulatory development

Consultation

Early engagement was undertaken with Health Technology Assessment organizations (HTAs) and the pan-Canadian Pharmaceutical Alliance (pCPA). In addition, sessions were held with key national stakeholder organizations (and select members as nominated by those organizations), with which Health Canada hosts regular multilateral and bilateral meetings to discuss and consult on regulatory issues of mutual interest, exchange information, and share expertise. These engagement sessions focussed on the design of the Order and provided the Department with an opportunity to obtain efficient and informal feedback on the design and technical aspects of the proposed approach prior to its publication in Canada Gazette, Part I. It also enabled the Department to leverage industry knowledge and experience with international reliance approaches early on and to identify any potential challenges with the proposed design and consider potential mitigation strategies. Consultations with stakeholders are ongoing. This section reflects comments received from stakeholders as of November 14, 2025.

Consultation with national review and negotiation bodies

HTAs and pCPA stakeholders were interested in learning about the Order and appreciative of being engaged early on in its development. Questions were raised about how the Order would be operationalized. HTAs asked if they could be notified when submissions are filed under the 120-day filing option. Attendees were informed that the Department would examine this possibility. Concerns were raised regarding the availability of review reports from FRAs, for joint reviews in particular. General concerns were also raised about how the Order would interact with the aligned HTA review process. Health Canada will continue to engage HTAs and pCPA, as well as provinces and territories to help ensure timely and coordinated access to drugs.

Summary of comments received from industry stakeholders

Industry stakeholders, including associations representing them, had mixed reactions to Health Canada’s proposal. They agreed with the submission types that would be included in the Order, with having the ability to deem components of a submission, and with the Order allowing for some differences in the drug proposed for sale in Canada relative to the foreign drug to reflect the realities of their supply chains. They also emphasized the importance of maintaining a robust review capacity within Health Canada and ensuring transparency in the drugs approved with the use of deeming.

The generics industry suggested that the Order be piloted with a smaller subset of drugs, that complex generics be included within the scope of drugs on the IbR List and that the declaration of bioequivalence with the Canadian Reference Product (CRP) apply to drugs approved with the use of deeming.

Industry stakeholders cautioned that their use of the Order would depend on the availability of supporting guidance, the addition of broad classes to the IbR List, reduced requirements specific to the Canadian context, the ability to update information relating to what would be deemed part way through the review for the 120-day filing option and joint reviews, faster review timelines, and alignment with downstream processes for drug coverage and pricing negotiations. Some stakeholders asked whether fees would be impacted by the Order. Some industry stakeholders raised concerns that the Order would disadvantage domestic manufacturers and that efforts should be made to incentivize and strengthen the domestic industry and that the use of the Order be limited. Most concerns pertained to the manner in which the Order would be implemented.

Health Canada has noted these considerations and will take them into account in the implementation of the Order. Concerns related to Canadian-specific requirements under the FDR, which create an additional burden, will be contemplated as part of other work the Department is undertaking.

To respond to recommendations that the Department continue to declare the bioequivalence of ANDS drugs to their CRPs, note that the deeming Order would not exempt from any requirements under the FDR, which means that the requirement that an NOC issued in respect of an ANDS state the name of the CRP and constitute a declaration of equivalence for that ANDS drug will apply to ANDS drugs approved with the use of the Order.

Regarding concerns around the domestic pharmaceutical industry, it is not the intention of the Order to disadvantage Canadian manufacturers that produce primarily for the domestic market or change their filing practices. The Order would not exempt from any submission requirements under the FDR and all requirements in the Order would need to be met for a manufacturer to benefit from deeming, including a full review having been conducted by an FRA identified on the IbR List, and Health Canada in the case of joint reviews. The Order will facilitate and encourage international collaboration and the use of decisions and documents obtained from FRAs in the review of certain drug submissions. This can contribute to the health and safety of Canadians by encouraging the more efficient review of submissions, and potentially the earlier approval, for new drugs in Canada that are authorized by foreign regulators. The Government of Canada has taken steps to strengthen the domestic industry through initiatives like the Biomanufacturing and Life Sciences Strategy, which are outside of the scope of this proposal.

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 proposal. 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 Métis, 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 allows the Minister to consider 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 deeming 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 for the Minister to use to leverage 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 (proposed 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 new drug submissions 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 proposing to proceed 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 cost-benefit analysis (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.

Key assumptions:

• All benefits and costs are presented in 2025 dollars;
• A discount rate of 7% is used in the analysis;
• The analysis evaluates the benefits and costs over 10 periods (each period equivalent to 12 months), starting from the publication date in Canada Gazette, Part II;
• Implementation of the Order would start with limited classes of drugs and FRAs on the IbR List. As Health Canada and industry continue to adapt to the Order, updates to the IbR List would be made; and
• The minimum estimated number of annual submissions using the deeming approach is 19, based on the classes of drugs assumed to be included on the IbR List when the Order is first implemented.

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 efficiency and international collaboration.

In the proposed regulatory scenario, manufacturers could choose to use an approach that would allow the Minister’s examination of certain components of a submission to have been deemed complete based on a decision or documents produced by a listed FRA. The use of deeming would improve drug availability and allow Health Canada to refocus its resources, as needed, to further support the health and safety of Canadians.

Benefits

Benefits to industry

Additional submission examination options

Manufacturers with listed classes of new drugs approved by listed FRAs are expected to benefit from this proposed Order, as it provides increased flexibility, efficiency and predictability in the drug submission review process. Industry stakeholders noted that deeming would allow manufacturers to leverage decisions and documents from listed FRAs, helping to streamline access to multiple markets. Given the Order will be targeting limited classes of drugs and FRAs to start, which would be updated as Health Canada continues the assessment for the purpose of the Order, savings are expected to be realized over time as drug classes and FRAs are added to the IbR List.

Additionally, the proposed Order would introduce a 120-day filing option, applicable to certain submissions where C&M, non-clinical, and clinical information would be deemed. This option would enable earlier processing, screening and review in Canada prior to an authorization having been issued by a listed FRA. A manufacturer would 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 would encourage earlier filing of drug submissions in Canada and allow Health Canada to get a head start on the review of non-deemed components. All requirements of the proposed Order must still be met ahead of authorization.

Through this proposed Order, these options would improve efficiency gradually over the years and could encourage the earlier introduction of new products to Canada.

Reduced information requests

The proposed Order is expected to reduce the number of information requests^{footnote 5} received by industry from Health Canada during the review process of a submission using deeming. Information requests can lead to multiple rounds of back-and-forth communication, which can extend review timelines and add to industry workload. Under the proposed Order, the FDR requirement for the Minister to examine certain components of a submission would be deemed to have taken place based on a decision of, or documents produced by, a listed FRA, which, in turn should reduce the volume of information requests issued for submission components that are subject to deeming.

Through consultation feedback, industry stated that information requests would decrease by an average of 1.5 per submission using deeming. Assuming industry would submit a minimum of 19 drug submissions each year under the proposed Order, an average minimum reduction of 28.5 information requests is expected annually. This is a conservative estimate, as Health Canada expects 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. As a result, it is anticipated that the reduction in information requests would result in a total cost savings of $3.69 million PV, or $525,825 annualized over 10 periods.

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, which resulted in pressures to review timelines. Drug submission reviews are resource intensive, as Health Canada must examine the safety, efficacy and quality of the new drugs to help ensure the health and safety of Canadians. As a result, the introduction of the Order would help alleviate some of these pressures and allow Health Canada to refocus its resources where necessary to protect and promote the health and safety of Canadians.

Like industry, Health Canada would also see the benefits of the proposed Order gradually over the years, as deeming would initially be available for a few specific classes of drugs and FRAs on the IbR List and it would take the Department some time to adjust to reviewing drug submissions that rely on deeming. At this time, the level of effort needed to review drug submissions using the Order is unclear but will be explored prior to publication in the Canada Gazette, Part II. Nonetheless, the Order is expected to result in cost savings to Health Canada over the 10 periods of analysis and enable the Department to put its resources where necessary to help protect and promote the health and safety of Canadians.

Reduced information requests

Health Canada is expected to issue fewer information requests during the review process to applicants with drug submissions using deeming, as the FDR requirement for the Minister to examine certain components of eligible submissions would be deemed to have taken place 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 using the Order will decrease by 1.5, on average, resulting in a minimum reduction of 28.5 information requests each year. At this time, the level of effort involved in the back-and-forth communications related to an information request is unclear but will be explored for publication in the Canada Gazette, Part II. Issuing fewer clarification requests would improve Health Canada’s efficiency in the review process and result in cost savings over the 10-period analysis and enable the Department to put its resources where they can have the biggest impact for Canadians (e.g. the review of highly complex drug submissions).

Benefits to Canadians

Improved access to new products

There has been an increasing demand over the years from Canadians for improved availability of drugs. Industry has indicated that they expect the Order would support the goal of improving access to new drugs for Canadians more quickly. Depending on the classes of drugs and FRAs included on the IbR List, the Order could significantly improve the health of Canadians that require drugs not currently available on the Canadian market once they become authorized. Drugs that include pediatric conditions of use that are not currently authorized in Canada and/or drugs where a child-friendly format is not authorized in Canada that include pediatric conditions of use are an example of classes of drugs that could be added to the IbR List and, once available, would have a positive impact on Canadians.

The proposed Order would provide 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 available in Canada. It would also enable Health Canada to refocus its resources where necessary to protect and promote the health and safety of Canadians, which allows for greater efficiency in reviewing drugs that address unmet medical needs and are not currently on the Canadian market. This includes benefits for drugs intended for both non-producing and producing animal use that are currently not authorized in Canada.

Costs

Costs to industry

Eligibility evidence for consideration under the Order

The manufacturer would need to submit a complete drug submission in accordance with the FDR, as well as information demonstrating that they meet all requirements in the proposed Order to be considered for deeming, including providing the Minister with evidence demonstrating that the foreign drug has been authorized by an FRA set out on the IbR List and providing the Minister with the labels approved by the FRA for use with the foreign drug. Based on cost estimates provided by industry, manufacturers seeking drug authorizations through deeming would incur a cost, on average, of $1,150 per filing to demonstrate that their submission is eligible to be considered under the proposed Order.

It is expected that the number of submissions that would utilize the deeming approach would fluctuate across the 10 periods, as the IbR List is amended and both manufacturers and Health Canada adjust to the changes. Given the initial approach Health Canada is taking with the proposed Order, Health Canada expects a minimum of 19 submissions using deeming annually. This is estimated to result in a total cost of $153,465 PV, or $21,850 annualized over 10 periods.

Description of measures by listed FRAs

Manufacturers would be required to describe any post-market measures that are required by an FRA to optimize the benefits and manage risks and uncertainties associated with a foreign drug related to the sets of information and material that would be deemed under the proposed Order. The manufacturer would also be required to demonstrate which of those post-market measures could be relevant if the drug was authorized in Canada, and where they are, demonstrate whether equivalent measures could be implemented in Canada.

Manufacturers must also disclose if a drug submission filed with a listed FRA to sell a drug in the same class as the drug subject to a submission in Canada and that also has the same strength, dosage form, route of administration and medicinal ingredient, as well as conditions of use that fall within those of the drug proposed for authorization in Canada, was withdrawn or refused and, if so, provide information including a rationale demonstrating that the reasons for withdrawal or refusal of that application would not affect the safety or effectiveness of the proposed Canadian drug.

The Department estimates that 15% of submissions would be affected by these information requirements related to FRA decisions. This includes negative decisions from FRAs on the IbR List or withdrawals of certain foreign applications for authorization or providing post-market measures on an authorization for the foreign drug. Using this as a proxy, it is estimated that a minimum of three drug submissions made under the Order would have to describe post-market measures that are imposed by an FRA for a foreign drug. A Health Canada costing survey^{footnote 6} estimated that it costs industry approximately $2,045 to report on foreign safety measures. This is expected to result in a total cost of $43,090 PV, or $6,135 annualized over 10 periods.

Demonstration of differences

Under the proposed Order, manufacturers would be required to provide a description of any differences between the drug subject to a submission or supplement in Canada and the foreign drug, related to the part(s) of the submission or supplement being deemed. Manufacturers would 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 manufacturers to utilize the proposed Order. These differences could include, but are not limited to, the use of different packaging, product markings or a colourant added to comply with the FDR. Consideration is being given to what differences would be acceptable, which will be explored in the development of the Order for the Canada Gazette, Part II. Industry stakeholders also added that the cost of providing a description of these differences can range from $5,000–$12,500 depending on the complexity and type of the submission, costing an average of $8,450 per submission. As Health Canada expects a minimum of 19 submissions using deeming annually, providing a description of differences would cost industry an estimated total cost of $1.12 million PV, or $160,550 annualized over 10 periods.

Post-market fulfillment notification

Under the proposed Order, it would be required that manufacturers with drugs authorized following deeming notify Health Canada as certain post-market measures (e.g. confirmatory trials) are fulfilled in relation to the authorization of the foreign drug to ensure that Health Canada remains informed on them being resolved. This requirement is in addition to all post-market requirements set out in the FDR for approved drugs, such as the notification of Foreign Regulatory Actions requirement.

Based on a comparable notification requirement, the Department estimates an increase of 15% for notifications to Health Canada regarding post-market measures required by an FRA affecting a foreign drug. Therefore, it is estimated that manufacturers with drugs approved using deeming would generate a minimum of three notifications to Health Canada regarding the fulfillment of certain post-market measures in foreign jurisdictions.

A Health Canada costing survey^{footnote 7} found that filing an administrative notification to submit foreign information to the Department can cost an average of $523 per notification. This is expected to result in a total cost of $11,020 PV, or $1,569 annualized over 10 periods.

Increased requests for foreign review reports

Health Canada receives foreign review information and reports from manufacturers as part of a submission, which is standard practice to support the drug review process. Although it is not a regulatory requirement under the proposed Order, it is expected that there would be an increase in the number of requests for foreign review information and reports from Health Canada to manufacturers for submissions using deeming.

Increased competition on domestic manufacturers

The proposed Order would encourage increased entry of new drugs to the Canadian market by facilitating more efficient reviews of drug submissions. Manufacturers with drugs listed on the IbR List and approved by a listed FRA would be encouraged to enter the Canadian market. However, Health Canada intends to initially include limited classes of drugs and FRAs on the IbR List, which is not expected to result in increased competition to domestic manufacturers over the short term.

Over the years, Health Canada can expand the number of classes of drugs and FRAs on their IbR List. This could create greater competition for market share and may have an impact on the competitiveness of domestic companies that have drugs solely sold in Canada, thus providing a potential advantage to some over others.

It has been expressed by some industry stakeholders that the Order could potentially have negative impacts on Canadian companies whose operations and product development are primarily focussed on Canada. Those manufacturers could likely be at a disadvantage in comparison to multinational companies, given that they may not have a decision from an FRA that they can leverage for deeming under the proposed Order.

Costs to Government

Reviewing submissions using the Order

The proposed Order would cover limited classes of drugs and FRAs on the IbR List at the time of coming into force, as both Health Canada and industry would need time to gain experience with the Order and learn how to use it most effectively. Where a manufacturer is requesting deeming, the Minister would verify whether all requirements under the Order are met and is therefore eligible for deeming to occur. This would include reviewing the description of any differences between the drug subject to a submission in Canada versus what was approved by a listed FRA. If requirements of the Order are not met, deeming would not be used for that component of the submission.

The Department expects a minimum of 19 submissions using the Order annually. Health Canada would continue to assess and make updates to the IbR List. Therefore, it is expected that the number of submissions using the Order would increase over the years as updates are made to the IbR List. At this time, there is uncertainty regarding the level of effort and review time required to verify whether a submission subject to deeming for certain components meets the requirements of the Order. It is expected that costs to Health Canada to proceed to such a verification would vary depending on the complexity and type of the submission. These costs will be explored for publication in the Canada Gazette, Part II.

Reviewing post-market fulfillment notifications

Under the proposed Order, Health Canada is expected to receive additional notifications from manufacturers with drugs approved using the Order. The Department would incur costs associated with reviewing and processing these notices, including assessing the information provided by manufacturers to determine whether any action is required to address potential safety or efficacy issues.

It is estimated that manufacturers with drugs approved using the Order would generate a minimum of three notifications to Health Canada regarding the fulfillment of certain post-market measures in foreign jurisdictions. At this time, there is uncertainty regarding the level of effort and review time required to review and process this information. However, the costs to Health Canada are expected to be moderate. These costs will be explored for publication in the Canada Gazette, Part II.

Indirect impact to HTA organizations

The proposed Order would start with limited classes of drugs and FRAs on the IbR List with the intent to expand in the future, which could help encourage greater entry of drugs into the Canadian market over time. Canadian HTA organizations conduct drug reimbursement reviews and provide recommendations to the federal and provincial governments. These organizations may face resource challenges if the proposed Order leads to a sudden increase in faster 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 uses 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 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 drugs for human use and 160 working with veterinary drugs. It is expected that Canadian small businesses would not utilize the proposed Order, as it is assumed that they are unlikely to have a decision from an FRA that they can leverage for deeming.

One-for-one rule

The one-for-one rule applies since there is an incremental increase in administrative burden on business, and a new regulatory title is being introduced. The increase in administrative burden is a result of the foreign measures notification requirement. However, the proposed Order would be exempt from the administrative burden count as notifying Health Canada regarding the fulfillment of certain post-market measures is a necessary component of maintaining the safety and effectiveness of new drugs approved through the Order.

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 biologic 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 8} Consultations with both HTAs and provinces and territories will be ongoing to seek opportunities for alignment of reviews where Health Canada would use a deeming approach under the proposed 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 made by certain identified regulatory authorities as proposed 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 implement 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, the reliance principles used by Health Canada in developing this proposed Order are generally similar to that of other jurisdictions. A notable difference would include Health Canada’s use of foreign decisions for the General Deeming and 120-Day Filing options, instead focussing the departmental review on those aspects of the submission that are specific to Canada.

Joint review initiatives

There is 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 would provide for the further leveraging of work done by partner FRAs as part of joint reviews in the Minister’s examination of NDSs 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 proposal.

Gender-based analysis plus

Health Canada expects that the proposed Order will have a positive impact on all Canadians. Depending on classes of drugs added to the IbR List and the products 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 would come into force upon publication in the Canada Gazette, Part II.

It would only apply to those new drugs that belong to a class listed on the IbR in relation to an FRA also set out 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.

To support the implementation of the Order, Health Canada will publish guidance following the publication of the Order in the Canada Gazette, Part II. This guidance will aid manufacturers in understanding the requirements that a manufacturer must meet for a submission to be eligible for the Order and conditions that would apply 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 proposed 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 to process 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
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3001
Email: lrm.consultations-mlr@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Minister of Health proposes to make the annexed Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs under section 30.06^{footnote a} of the Food and Drugs Act ^{footnote b}.

Interested persons may make representations concerning the proposed Order within 70 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Debra Haltrecht, Acting Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3001, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca).

Ottawa, December 3, 2025

Marjorie Michel
Minister of Health

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.

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)

notice of compliance

means a notice of compliance issued under section C.08.004 of the Regulations. (avis de conformité)

post-market measure

means any that a foreign regulatory authority has provided for, or intends to provide for, in order to optimize the benefits associated with a foreign drug, manage the risks associated with a foreign drug or manage the uncertainties relating to those benefits or risks. (mesure après la mise en marché)

Regulations

means the Food and Drug Regulations. (Règlement)

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 section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission filed under section C.08.002 of the Regulations is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the drug that is the subject of the submission belongs to a class of drugs that is set out in Subpart 1 of Part 1 of the List;
• (b) the manufacturer indicates to the Minister in writing that it seeks the requirement in section C.08.004 of the Regulations to be deemed to be met under this section in respect of any of the following sets of information included in the submission:
  • (i) non-clinical information,
  • (ii) clinical information,
  • (iii) chemistry and manufacturing information;
• (c) the manufacturer provides the Minister with information that demonstrates
  • (i) that the sale of a foreign drug is authorized by a foreign regulatory authority set out in Subpart 1 of Part 1 of the List in relation to the class of drugs to which the drug belongs,
  • (ii) that the drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
  • (iii) that the conditions of use for the drug fall within the conditions of use for the foreign drug, and
  • (iv) with respect to the set or sets of information that the manufacturer indicates under paragraph (b),
    • (A) any differences between the drug and the foreign drug, and
    • (B) that any such differences would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug;
• (d) the manufacturer provides the Minister with
  • (i) any label that is approved by the foreign regulatory authority in connection with the foreign drug,
  • (ii) if the manufacturer is aware that an application for authorization to sell another drug was filed with a foreign regulatory authority that is set out in Subpart 1 of Part 1 of the List in relation to the class of drugs referred to in paragraph (a) and was withdrawn by the applicant or was refused by the foreign regulatory authority,
    • (A) in the case where the application was refused, the text of that decision, and
    • (B) in any case, a rationale in writing as to how the reasons for the withdrawal or refusal of the application would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug,
  • (iii) if applicable, a description of the post-market measures that the foreign regulatory authority has provided for in respect of the authorization referred to in subparagraph (c)(i) that relate to any set of information that the manufacturer indicates under paragraph (b),
  • (iv) if the foreign regulatory authority has provided for any post-market measures referred to in subparagraph (iii), information that demonstrates
    • (A) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the submission, and
    • (B) that the post-market measures referred to in clause (A), or measures equivalent to them, could be implemented in Canada in respect of the drug, and
  • (v) information that demonstrates that the manufacturer possesses or has immediate access to information that was
    • (A) submitted to the foreign regulatory authority by the holder of the authorization referred to in subparagraph (c)(i) to obtain the authorization,
    • (B) submitted to the foreign regulatory authority by that holder in respect of any post-market measures referred to in subparagraph (iii),
    • (C) provided by the foreign regulatory authority to that holder in respect of those measures, and
    • (D) submitted to the foreign regulatory authority by that holder in respect of the risks associated with the foreign drug or the uncertainties relating to those risks;
• (e) neither of the following circumstances has occurred in respect of another new drug submission previously filed by the manufacturer for the drug:
  • (i) in the case where the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations and the manufacturer did not amend the submission under subsection C.08.004(2) of the Regulations, the applicable period referred to in that subsection ended, or
  • (ii) the Minister issued a notice to the manufacturer under paragraph C.08.004(3)(b) of the Regulations; and
• (f) subject to subsection (4), the decision of the foreign regulatory authority to authorize the sale of the foreign drug referred to in subparagraph (c)(i) is not one for which it relied on a decision of another foreign regulatory authority.

Scope of deemed requirement

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

Exceptions

(3) Despite subsection (2), the requirement referred to in that subsection is not deemed to be met under this section in respect of the following information included in the new drug submission:

• (a) information that is related to any differences identified under clause (1)(c)(iv)(A);
• (b) in the case of a drug intended for administration to food-producing animals, the withdrawal period of the drug; and
• (c) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Non-application — joint review

(4) Paragraph (1)(f) does not apply if the decision of the foreign regulatory authority referred to in subparagraph (1)(c)(i)

• (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Subpart 1 of Part 1 of the List in relation to the class of drugs to which the drug belongs; and
• (b) was a decision for which the foreign regulatory authority relied on the examination of information by the other foreign regulatory authority.

Definition of another drug

(5) In subsection (1), another drug, in respect of the drug that is the subject of the new drug submission, means any other drug that meets the following criteria:

• (a) it belongs to the class of drugs referred to in paragraph (1)(a);
• (b) it has the same strength, dosage form, route of administration and medicinal ingredient as the drug; and
• (c) it has conditions of use that fall within the conditions of use of the drug.

Deeming — application filed for foreign drug

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

Requirements for deeming

(2) Subject to subsections (3) and (4), the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission filed under section C.08.002 of the Regulations is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the drug that is the subject of the submission belongs to a class of drugs that is set out in Subpart 2 of Part 1 of the List;
• (b) at the time the submission is filed,
  • (i) the manufacturer indicates to the Minister in writing that it seeks the requirement in section C.08.004 of the Regulations to be deemed to be met under this section in respect of non-clinical information and clinical information as well as chemistry and manufacturing information included in the submission,
  • (ii) the manufacturer provides the Minister with information that demonstrates
    • (A) that it filed the submission within 120 days after the day on which an application for authorization to sell a foreign drug was filed with a foreign regulatory authority set out in Subpart 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs,
    • (B) that the drug would have the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug, if the foreign regulatory authority were to approve the application,
    • (C) that the conditions of use for the drug would fall within the conditions of use for the foreign drug, if the foreign regulatory authority were to approve the application, and
    • (D) with respect to non-clinical information and clinical information as well as chemistry and manufacturing information included in the submission,
      • (I) any differences between the drug and the foreign drug, if the foreign regulatory authority were to approve the application, and
      • (II) that any such differences would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug, and
  • (iii) if the manufacturer is aware that an application for authorization to sell another drug was filed with a foreign regulatory authority that is set out in Subpart 2 of Part 1 of the List in relation to the class of drugs referred to in paragraph (a) and was withdrawn by the applicant or was refused by the foreign regulatory authority, the manufacturer provides the Minister with
    • (A) in the case where the application was refused, the text of that decision, and
    • (B) in any case, a rationale in writing as to how the reasons for the withdrawal or refusal of the application would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug;
• (c) after the application for authorization to sell the foreign drug is approved by the foreign regulatory authority,
  • (i) the manufacturer provides the Minister with information that demonstrates
    • (A) that the sale of the foreign drug is authorized by the foreign regulatory authority,
    • (B) that the drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
    • (C) that the conditions of use for the drug fall within the conditions of use for the foreign drug, and
    • (D) with respect to non-clinical information and clinical information as well as chemistry and manufacturing information included in the submission,
      • (I) any differences between the drug and the foreign drug, and
      • (II) that any such differences would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug, and
  • (ii) the manufacturer provides the Minister with
    • (A) any label that is approved by the foreign regulatory authority in connection with the foreign drug,
    • (B) if applicable, a description of the post-market measures that the foreign regulatory authority has provided for in respect of the authorization referred to in clause (i)(A) that relate to non-clinical information, clinical information or chemistry and manufacturing information included in the submission,
    • (C) if the foreign regulatory authority has provided for any post-market measures referred to in clause (B), information that demonstrates
      • (I) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the submission, and
      • (II) that the post-market measures referred to in subclause (I), or measures equivalent to them, could be implemented in Canada in respect of the drug, and
    • (D) information that demonstrates that the manufacturer possesses or has immediate access to information that was
      • (I) submitted to the foreign regulatory authority by the holder of the authorization referred to in clause (i)(A) to obtain the authorization,
      • (II) submitted to the foreign regulatory authority by that holder in respect of any post-market measures referred to in clause (B),
      • (III) provided by the foreign regulatory authority to that holder in respect of those measures, and
      • (IV) submitted to the foreign regulatory authority by that holder in respect of the risks associated with the foreign drug or the uncertainties relating to those risks;
• (d) neither of the following circumstances has occurred in respect of another new drug submission previously filed by the manufacturer for the drug:
  • (i) in the case where the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations and the manufacturer did not amend the submission under subsection C.08.004(2) of the Regulations, the applicable period referred to in that subsection ended, or
  • (ii) the Minister issued a notice to the manufacturer under paragraph C.08.004(3)(b) of the Regulations; and
• (e) subject to subsection (5), the decision of the foreign regulatory authority to authorize the sale of the foreign drug referred to in clause (c)(i)(A) is not one for which it relied on a decision of another foreign regulatory authority.

Scope of deemed requirement

(3) The requirement in section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission is deemed to be met under this section only in respect of non-clinical information and clinical information as well as chemistry and manufacturing information included in the new drug submission.

Exceptions

(4) Despite subsection (3), the requirement referred to in that subsection is not deemed to be met under this section in respect of the following information included in the new drug submission:

• (a) information that is related to any differences identified under subclause (2)(c)(i)(D)(I);
• (b) in the case of a drug intended for administration to food-producing animals, the withdrawal period of the drug; and
• (c) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Non-application — joint review

(5) Paragraph (2)(e) does not apply if the decision of the foreign regulatory authority referred to in clause (2)(c)(i)(A)

• (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Subpart 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs; and
• (b) was a decision for which the foreign regulatory authority relied on the examination of information by the other foreign regulatory authority.

Definition of another drug

(6) In subsection (2), another drug, in respect of the drug that is the subject of the new drug submission, means any other drug that meets the following criteria:

• (a) it belongs to the class of drugs referred to in paragraph (2)(a);
• (b) it has the same strength, dosage form, route of administration and medicinal ingredient as the drug; and
• (c) it has conditions of use that fall within the conditions of use of the drug.

Deeming — joint review involving Minister

4 (1) Subject to subsection (2), the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission filed under section C.08.002 of the Regulations is deemed to be met on the basis of a document or documents produced by one or more foreign regulatory authorities if the following requirements are met:

• (a) the drug that is the subject of the submission belongs to a class of drugs that is set out in Part 2 of the List;
• (b) the manufacturer indicates to the Minister in writing that it seeks the requirement in section C.08.004 of the Regulations to be deemed to be met under this section in respect of certain components of the following sets of information included in the submission that are to be examined in the context of the joint review referred to in paragraph (c):
  • (i) non-clinical information,
  • (ii) clinical information, and
  • (iii) chemistry and manufacturing information;
• (c) the Minister conducts a joint review with one or more foreign regulatory authorities that pertained to both the drug and a foreign drug;
• (d) all of the foreign regulatory authorities involved in the joint review are set out in Part 2 of the List in relation to the class of drugs to which the drug belongs;
• (e) the Minister has received a copy of a document or documents produced by one or more of those foreign regulatory authorities that relates to the joint review and that sets out
  • (i) in the case where only one foreign regulatory authority participated in the joint review, the conclusions of the examination by that foreign regulatory authority of certain components of the following sets of information included in the submission:
    • (A) non-clinical information,
    • (B) clinical information, and
    • (C) chemistry and manufacturing information, and
  • (ii) in the case where more than one foreign regulatory authority participated in the joint review, the conclusions of the examination by those foreign regulatory authorities in respect of those components of the sets of information referred to in clauses (i)(A) to (C) included in the submission;
• (f) the Minister communicated with the foreign regulatory authority or authorities that examined the components of the sets of information referred to in clauses (e)(i)(A) to (C) included in the submission as to whether post-market measures are intended to be provided for in relation to the foreign drug that relate to the components that were examined;
• (g) if a foreign regulatory has communicated to the Minister its intention to provide for any post-market measures referred to in paragraph (f), the manufacturer, after being informed by the Minister of the foreign regulatory authority’s intention, provides the Minister with
  • (i) a description of those post-market measures, and
  • (ii) information demonstrating
    • (A) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the submission, and
    • (B) that the post-market measures referred to in clause (A), or measures equivalent to them, could be implemented in Canada in respect of the drug; and
• (h) the manufacturer provides the Minister with information that demonstrates
  • (i) that the drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
  • (ii) that the conditions of use for the drug fall within the conditions of use for the foreign drug,
  • (iii) for any document referred to in paragraph (e), any differences between the drug and the foreign drug in respect of the components of the sets of information referred to in clauses (e)(i)(A) to (C) included in the submission that are addressed by the conclusions set out in the document, if applicable, and
  • (iv) that any such differences would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug.

Scope of deemed requirement

(2) The requirement in section C.08.004 of the Regulations that the Minister complete an examination of a new drug submission is deemed to be met under this section only in respect of the components of the sets of information referred to in clauses (1)(e)(i)(A) to (C) included in the new drug submission that are addressed by the conclusions set out in the document or documents referred to in paragraph (1)(e).

Exceptions

(3) Despite subsection (2), the requirement referred to in that subsection is not deemed to be met under this section in respect of the following information included in the new drug submission:

• (a) information that is related to any differences identified under subparagraph (1)(h)(iii);
• (b) in the case of a drug intended for administration to food-producing animals, the withdrawal period of the drug; and
• (c) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Abbreviated New Drug Submissions

Deeming — already authorized foreign drug

5 (1) Subject to subsections (2) and (3), the requirement in section C.08.004 of the Regulations that the Minister complete an examination of an abbreviated new drug submission filed under section C.08.002.1 of the Regulations is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the drug that is the subject of the submission belongs to a class of drugs that is set out in Subpart 3 of Part 1 of the List;
• (b) the manufacturer indicates to the Minister in writing that it seeks the requirement in section C.08.004 of the Regulations to be deemed to be met under this section in respect of any of the following sets of information included in the submission:
  • (i) non-clinical information,
  • (ii) clinical information, and
  • (iii) chemistry and manufacturing information;
• (c) the manufacturer provides the Minister with information that demonstrates
  • (i) that the sale of a foreign drug is authorized by a foreign regulatory authority set out in Subpart 3 of Part 1 of the List in relation to the class of drugs to which the drug belongs,
  • (ii) that the drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
  • (iii) that the conditions of use for the drug fall within the conditions of use for the foreign drug, and
  • (iv) with respect to the set or sets of information that the manufacturer indicates under paragraph (b),
    • (A) any differences between the drug and the foreign drug, and
    • (B) that any such differences would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug;
• (d) the manufacturer provides the Minister with
  • (i) any label that is approved by the foreign regulatory authority in connection with the foreign drug,
  • (ii) if the manufacturer is aware that an application for authorization to sell another drug was filed with a foreign regulatory authority that is set out in Subpart 3 of Part 1 of the List in relation to the class of drugs referred to in paragraph (a) and was withdrawn by the applicant or was refused by the foreign regulatory authority,
    • (A) in the case where the application was refused, the text of that decision, and
    • (B) in any case, a rationale in writing as to how the reasons for the withdrawal or refusal of the application would not — if the Minister were to issue a notice of compliance in respect of the submission — impact the safety or effectiveness of the drug,
  • (iii) if applicable, a description of the post-market measures that the foreign regulatory authority has provided for in respect of the authorization referred to in subparagraph (c)(i) that relate to any set of information that the manufacturer indicates under paragraph (b),
  • (iv) if the foreign regulatory authority has provided for any post-market measures referred to in subparagraph (iii), information that demonstrates
    • (A) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the submission, and
    • (B) that the post-market measures referred to in clause (A), or measures equivalent to them, could be implemented in Canada in respect of the drug, and
  • (v) information that demonstrates that the manufacturer possesses or has immediate access to information that was
    • (A) submitted to the foreign regulatory authority by the holder of the authorization referred to in subparagraph (c)(i) to obtain the authorization,
    • (B) submitted to the foreign regulatory authority by that holder in respect of any post-market measures referred to in subparagraph (iii),
    • (C) provided by the foreign regulatory authority to that holder in respect of those measures, and
    • (D) submitted to the foreign regulatory authority by that holder in respect of the risks associated with the foreign drug or the uncertainties relating to those risks;
• (e) neither of the following circumstances has occurred in respect of another abbreviated new drug submission previously filed by the manufacturer for the drug:
  • (i) in the case where the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations and the manufacturer did not amend the submission under subsection C.08.004(2) of the Regulations, the applicable period referred to in that subsection ended, or
  • (ii) the Minister issued a notice to the manufacturer under paragraph C.08.004(3)(b) of the Regulations; and
• (f) subject to subsection (4), the decision of the foreign regulatory authority to authorize the sale of the foreign drug referred to in subparagraph (c)(i) is not one for which it relied on a decision of another foreign regulatory authority.

Scope of deemed requirement

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

Exceptions

(3) Despite subsection (2), the requirement referred to in that subsection is not deemed to be met under this section in respect of the following information included in the abbreviated new drug submission:

• (a) information that is related to any differences identified under clause (1)(c)(iv)(A);
• (b) in the case of a drug intended for administration to food-producing animals, the withdrawal period of the drug; and
• (c) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Non-application — joint review

(4) Paragraph (1)(f) does not apply if the decision of the foreign regulatory authority referred to in subparagraph (1)(c)(i)

• (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Subpart 3 of Part 1 of the List in relation to the class of drugs to which the drug belongs; and
• (b) was a decision for which the foreign regulatory authority relied on the examination of information by the other foreign regulatory authority.

Definition of another drug

(5) In subsection (1), another drug, in respect of the drug that is the subject of the abbreviated new drug submission, means any other drug that meets the following criteria:

• (a) it belongs to the class of drugs referred to in paragraph (1)(a);
• (b) it has the same strength, dosage form, route of administration and medicinal ingredient as the drug; and
• (c) it has conditions of use that fall within the conditions of use of the drug.

Supplements

Definitions

6 The following definitions apply in this section and in sections 7 and 9.

submission

means a new drug submission that is filed under section C.08.002 of the Regulations or an abbreviated new drug submission that is filed under section C.08.002.1 of the Regulations. (présentation)

supplement

means a supplement to a submission that is filed under section C.08.003 of the Regulations. (supplément)

Deeming — already authorized foreign drug

7 (1) Subject to subsection (2), the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a supplement is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the drug that is the subject of the supplement belongs to a class of drugs that is set out in
  • (i) in the case of a supplement to a new drug submission, Subpart 1 of Part 1 of the List, and
  • (ii) in the case of a supplement to an abbreviated new drug submission, Subpart 3 of Part 1 of the List;
• (b) the manufacturer provides the Minister with information that demonstrates
  • (i) that the sale of a foreign drug is authorized by a foreign regulatory authority set out in the following Subpart of Part 1 of the List in relation to the class of drugs to which the drug belongs:
    • (A) in the case of a supplement to a new drug submission, Subpart 1, and
    • (B) in the case of a supplement to an abbreviated new drug submission, Subpart 3,
  • (ii) that the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would have the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
  • (iii) that the conditions of use for the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would fall within the conditions of use for the foreign drug, and
  • (iv) with respect to the matters to which the supplement pertains,
    • (A) any differences between the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — and the foreign drug, and
    • (B) that any such differences would not impact the safety or effectiveness of the drug,
• (c) the manufacturer provides the Minister with
  • (i) any label that is approved by the foreign regulatory authority in connection with the foreign drug,
  • (ii) if the manufacturer is aware that an application for authorization to sell another drug was filed with a foreign regulatory authority that is set out in the applicable Subpart of Part 1 of the List referred to in clause (b)(i)(A) or (B), as the case may be, in relation to the class of drugs referred to in paragraph (a) and was withdrawn by the applicant or was refused by the foreign regulatory authority,
    • (A) in the case where the application was refused, the text of that decision, and
    • (B) in any case, a rationale in writing as to how the reasons for the withdrawal or refusal of the application would not — if the Minister were to issue a notice of compliance in respect of the supplement — impact the safety or effectiveness of the drug,
  • (iii) if applicable, a description of the post-market measures that the foreign regulatory authority has provided for in respect of the authorization referred to in subparagraph (b)(i) that relate to any matter to which the supplement pertains,
  • (iv) if the foreign regulatory authority has provided for any post-market measures referred to in subparagraph (iii), information that demonstrates
    • (A) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the supplement, and
    • (B) that the post-market measures referred to in clause (A), or measures equivalent to them, could be implemented in Canada in respect of the drug, and
  • (v) information that demonstrates that the manufacturer possesses or has immediate access to information that was
    • (A) submitted to the foreign regulatory authority by the holder of the authorization referred to in subparagraph (b)(i) to obtain the authorization,
    • (B) submitted to the foreign regulatory authority by that holder in respect of any post-market measures referred to in subparagraph (iii),
    • (C) provided by the foreign regulatory authority to that holder in respect of those measures, and
    • (D) submitted to the foreign regulatory authority by that holder in respect of the risks associated with the foreign drug or the uncertainties relating to those risks;
• (d) neither of the following circumstances has occurred in respect of another supplement previously filed by the manufacturer for the drug that relates to any matter to which the supplement pertains:
  • (i) in the case where the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations and the manufacturer did not amend the supplement under subsection C.08.004(2) of the Regulations, the applicable period referred to in that subsection ended, or
  • (ii) the Minister issued a notice to the manufacturer under paragraph C.08.004(3)(b) of the Regulations; and
• (e) subject to subsection (3), the decision of the foreign regulatory authority to authorize the sale of the foreign drug referred to in subparagraph (1)(b)(i) is not one for which it relied on a decision of another foreign regulatory authority.

Scope of deemed requirement

(2) The requirement in section C.08.004 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 following information included in the supplement:

• (a) information that is related to any differences identified under clause (1)(b)(iv)(A);
• (b) if a matter referred to in any of paragraphs C.08.003(2)(b), (g) and (g.1) and subparagraph C.08.003(2)(h)(v) of the Regulations is significantly different from the information contained in the submission for the drug, information that relates to the matter;
• (c) if, due to a matter specified in subsection C.08.003(2) of the Regulations — other than the brand name of a drug for human use — that the supplement concerns, it is necessary to modify the drug’s labels, material referred to in subparagraph C.08.003(3.1)(a)(i) or (ii) of the Regulations, as the case may be;
• (d) if the supplement concerns the brand name of a drug for human use, information referred to in subparagraphs C.08.003(3.1)(b)(i) and (ii) of the Regulations; and
• (e) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Non-application — joint review

(3) Paragraph (1)(e) does not apply if the decision of the foreign regulatory authority referred to in subparagraph (1)(b)(i)

• (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in the applicable Subpart of Part 1 of the List referred to in clause (b)(i)(A) or (B), as the case may be, in relation to the class of drugs to which the drug belongs; and
• (b) was a decision for which the foreign regulatory authority relied on the examination of information by the other foreign regulatory authority.

Definition of another drug

(4) In subsection (1), another drug, in respect of the drug that is the subject of the supplement, means any other drug that meets the following criteria:

• (a) it belongs to the class of drugs referred to in paragraph (1)(a);
• (b) it has the same strength, dosage form, route of administration and medicinal ingredient as the drug; and
• (c) it has conditions of use that fall within the conditions of use of the drug.

Deeming — application filed for foreign drug

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

Requirements for deeming

(2) Subject to subsection (3), the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a supplement to a new drug submission filed under section C.08.003 of the Regulations is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the drug that is the subject of the supplement belongs to a class of drugs that is set out in Subpart 2 of Part 1 of the List;
• (b) at the time the supplement is filed,
  • (i) the manufacturer provides the Minister with information that demonstrates
    • (A) that it filed the supplement within 120 days after the day on which an application for authorization to sell a foreign drug, that relates to the matters to which the supplement pertains, was filed with a foreign regulatory authority set out in Subpart 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs,
    • (B) that the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would have the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug, if the foreign regulatory authority were to approve the application,
    • (C) that the conditions of use for the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would fall within the conditions of use for the foreign drug, if the foreign regulatory authority were to approve the application,
    • (D) with respect to the matters to which the supplement pertains,
      • (I) any differences between the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — and the foreign drug, if the foreign regulatory authority were to approve the application, and
      • (II) that any such differences would not impact the safety or effectiveness of the drug, and
  • (ii) if the manufacturer is aware that an application for authorization to sell another drug, that relates to the matters to which the supplement pertains, was filed with a foreign regulatory authority that is set out in Subpart 2 of Part 1 of the List in relation to the class of drugs referred to in paragraph (a) and was withdrawn by the applicant or was refused by the foreign regulatory authority, the manufacturer provides the Minister with
    • (A) in the case where the application was refused, the text of that decision, and
    • (B) in any case, a rationale in writing as to how the reasons for the withdrawal or refusal of the application would not — if the Minister were to issue a notice of compliance in respect of the supplement — impact the safety or effectiveness of the drug;
• (c) after the application for authorization to sell the foreign drug is approved by the foreign regulatory authority,
  • (i) the manufacturer provides the Minister with information that demonstrates
    • (A) that the sale of the foreign drug is authorized by the foreign regulatory authority,
    • (B) that the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would have the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug,
    • (C) that the conditions of use for the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — would fall within the conditions of use for the foreign drug,
    • (D) with respect to the matters to which the supplement pertains,
      • (I) any differences between the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — and the foreign drug, and
      • (II) that any such differences would not impact the safety or effectiveness of the drug, and
  • (ii) the manufacturer provides the Minister with
    • (A) any label that is approved by the foreign regulatory authority in connection with the foreign drug,
    • (B) if applicable, a description of the post-market measures that the foreign regulatory authority has provided for in respect of the authorization referred to in clause (i)(A) that relate to any matter to which the supplement pertains,
    • (C) if the foreign regulatory authority has provided for any post-market measures referred to in clause (B), information that demonstrates
      • (I) which of those post-market measures could be relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, if the Minister were to issue a notice of compliance in respect of the supplement, and
      • (II) that the post-market measures referred to in subclause (I), or measures equivalent to them, could be implemented in Canada in respect of the drug, and
    • (D) information that demonstrates that the manufacturer possesses or has immediate access to information that was
      • (I) submitted to the foreign regulatory authority by the holder of the authorization referred to in clause (i)(A) to obtain the authorization,
      • (II) submitted to the foreign regulatory authority by that holder in respect of any post-market measures referred to in clause (B),
      • (III) provided by the foreign regulatory authority to that holder in respect of those measures, and
      • (IV) submitted to the foreign regulatory authority by that holder in respect of the risks associated with the foreign drug or the uncertainties relating to those risks;
• (d) neither of the following circumstances has occurred in respect of another supplement previously filed by the manufacturer for the drug that relates to any matter to which the supplement pertains:
  • (i) in the case where the Minister issued a notice to the manufacturer under paragraph C.08.004(1)(b) of the Regulations and the manufacturer did not amend the supplement under subsection C.08.004(2) of the Regulations, the applicable period referred to in that subsection ended, or
  • (ii) the Minister issued a notice to the manufacturer under paragraph C.08.004(3)(b) of the Regulations; and
• (e) subject to subsection (4), the decision of the foreign regulatory authority to authorize the sale of the foreign drug referred to in clause (c)(i)(A) is not one for which it relied on a decision of another foreign regulatory authority.

Scope of deemed requirement

(3) The requirement in section C.08.004 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 following information included in the supplement:

• (a) information that is related to any differences identified under subclause (2)(c)(i)(D)(I);
• (b) if a matter referred to in any of paragraphs C.08.003(2)(b), (g) and (g.1) and subparagraph C.08.003(2)(h)(v) of the Regulations is significantly different from the information contained in the submission for the drug, information that relates to the matter;
• (c) if, due to a matter specified in subsection C.08.003(2) of the Regulations — other than the brand name of a drug for human use — that the supplement concerns, it is necessary to modify the drug’s labels, material referred to in subparagraph C.08.003(3.1)(a)(i) or (ii) of the Regulations, as the case may be;
• (d) if the supplement concerns the brand name of a drug for human use, information referred to in subparagraphs C.08.003(3.1)(b)(i) and (ii) of the Regulations; and
• (e) the submission certificate referred to in paragraph C.08.005.1(1)(d) of the Regulations.

Non-application — joint review

(4) Paragraph (2)(e) does not apply if the decision of the foreign regulatory authority referred to in clause (2)(c)(i)(A)

• (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Subpart 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs; and
• (b) was a decision for which the foreign regulatory authority relied on the examination of information by the other foreign regulatory authority.

Definition of another drug

(5) In subsection (2), another drug, in respect of the drug that is the subject of the supplement, means any other drug that meets the following criteria:

• (a) it belongs to the class of drugs referred to in paragraph (2)(a);
• (b) it has the same strength, dosage form, route of administration and medicinal ingredient as the drug; and
• (c) it has conditions of use that fall within the conditions of use of the drug.

Condition Related to Deeming

Condition — notification relating to post-market measures

9 The manufacturer of a drug must notify the Minister of the fulfillment of any post-market measure that has been provided for by a foreign regulatory authority in respect of a foreign drug as soon as feasible after the manufacturer becomes aware that the measure has been fulfilled if the following requirements are met:

• (a) the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a submission or supplement was deemed to be met under this Order in respect of a submission or supplement filed for a drug on the basis of a decision of, or a document produced by, a foreign regulatory authority that relates to the foreign drug;
• (b) the Minister issued a notice of compliance in respect of the submission or supplement;
• (c) the foreign regulatory authority who issued the authorization for sale of the foreign drug provided for post-market measures in respect of the authorization;
• (d) those post-market measures relate to information contained in the submission or supplement for which the requirement on the Minister in section C.08.004 of the Regulations was deemed to be met under this Order; and
• (e) the manufacturer provided information under the applicable section of this Order to the Minister that demonstrates that
  • (i) those post-market measures are relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, and
  • (ii) those post-market measures, or measures equivalent to them, could be implemented in Canada in respect of the drug.

Amendments to this Order

10 The portion of section 6 of this Order before the first definition is replaced by the following:

Definitions

6 The following definitions apply in this section and sections 7, 8.1 and 9.

11 This Order is amended by adding the following after section 8:

Terms and Conditions — Drug Identification Number

Deeming — consideration of matters

8.1 (1) Subject to subsection (2), the requirement in subsection C.01.014.21(1) of the Regulations that the Minister consider the matters set out in paragraphs C.01.014.21(1)(a) to (e) of the Regulations before imposing terms and conditions on a drug identification number assigned for a drug or amending such terms and conditions is deemed to be met on the basis of a decision of a foreign regulatory authority if the following requirements are met:

• (a) the requirement in section C.08.004 of the Regulations that the Minister complete an examination of a submission or supplement was deemed to be met under this Order, other than under section 4, in respect of a submission or supplement filed for a drug on the basis of a decision of a foreign regulatory authority that relates to a foreign drug;
• (b) the Minister issued a notice of compliance in respect of the submission or supplement;
• (c) the foreign regulatory authority who issued the authorization for sale of the foreign drug provided for post-market measures in respect of the authorization;
• (d) those post-market measures relate to information contained in the submission or supplement for which the requirement on the Minister in section C.08.004 of the Regulations was deemed to be met under this Order; and
• (e) the manufacturer provided information under the applicable section of this Order to the Minister that demonstrates that
  • (i) those post-market measures are relevant to optimizing the benefits associated with the drug, managing the risks associated with the drug or managing the uncertainties relating to those benefits or risks, and
  • (ii) those post-market measures, or measures equivalent to them, could be implemented in Canada in respect of the drug.

Scope of deemed requirement

(2) The requirement in subsection C.01.014.21(1) of the Regulations that the Minister consider the matters set out in paragraphs C.01.014.21(1)(a) to (e) of the Regulations before imposing terms and conditions on a drug identification number assigned for a drug or amending such terms and conditions is not deemed to be met under this section in respect of the matter referred to in paragraph C.01.014.21(1)(d) of the Regulations.

Coming into Force

Publication

12 (1) Subject to subsection (2), this Order comes into force on the day on which it is published in the Canada Gazette, Part II.

April 1, 2027

(2) Sections 10 and 11 come into force on April 1, 2027.

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• contain personal information
• contain protected or classified information of the Government of Canada
• express or incite discrimination on the basis of race, sex, religion, sexual orientation or against any other group protected under the Canadian Human Rights Act or the Canadian Charter of Rights and Freedoms
• contain hateful, defamatory, or obscene language
• contain threatening, violent, intimidating or harassing language
• contain language contrary to any federal, provincial or territorial laws of Canada
• constitute impersonation, advertising or spam
• encourage or incite any criminal activity
• contain external links
• contain a language other than English or French
• otherwise violate this notice

The federal institution managing the proposed regulatory change retains the right to review and remove personal information, hate speech, or other information deemed inappropriate for public posting as listed above.

Confidential Business Information should only be posted in the specific Confidential Business Information text box. In general, Confidential Business Information includes information that (i) is not publicly available, (ii) is treated in a confidential manner by the person to whose business the information relates, and (iii) has actual or potential economic value to the person or their competitors because it is not publicly available and whose disclosure would result in financial loss to the person or a material gain to their competitors. Comments that you provide in the Confidential Business Information section that satisfy this description will not be made publicly available. The federal institution managing the proposed regulatory change retains the right to post the comment publicly if it is not deemed to be Confidential Business Information.

Your comments will be posted on the Canada Gazette website for public review. However, you have the right to submit your comments anonymously. If you choose to remain anonymous, your comments will be made public and attributed to an anonymous individual. No other information about you will be made publicly available.

Comments will remain posted on the Canada Gazette website for at least 10 years.

Please note that communication by email is not secure, if the attachment you wish to send contains sensitive information, please contact the departmental email to discuss ways in which you can transmit sensitive information.

Privacy notice

The information you provide is collected under the authority of the Financial Administration Act, the Department of Public Works and Government Services Act, the Canada–United States–Mexico Agreement Implementation Act,and applicable regulators’ enabling statutes for the purpose of collecting comments related to the proposed regulatory changes. Your comments and documents are collected for the purpose of increasing transparency in the regulatory process and making Government more accessible to Canadians.

Personal information submitted is collected, used, disclosed, retained, and protected from unauthorized persons and/or agencies pursuant to the provisions of the Privacy Act and the Privacy Regulations. Individual names that are submitted will not be posted online but will be kept for contact if needed. The names of organizations that submit comments will be posted online.

Submitted information, including personal information, will be accessible to Public Services and Procurement Canada, who is responsible for the Canada Gazette webpage, and the federal institution managing the proposed regulatory change.

You have the right of access to and correction of your personal information. To seek access or correction of your personal information, contact the Access to Information and Privacy (ATIP) Office of the federal institution managing the proposed regulatory change.

You have the right to file a complaint to the Privacy Commission of Canada regarding any federal institution’s handling of your personal information.

The personal information provided is included in Personal Information Bank PSU 938 Outreach Activities. Individuals requesting access to their personal information under the Privacy Act should submit their request to the appropriate regulator with sufficient information for that federal institution to retrieve their personal information. For individuals who choose to submit comments anonymously, requests for their information may not be reasonably retrievable by the government institution.