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

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

And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and conditions, the annexed Order is unlikely to result in unacceptable health, safety or, if applicable, environmental risks or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks;

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

• Return to footnote ^aS.C. 2024, c. 17, s. 328

• Return to footnote ^bR.S., c. F-27

Ottawa, July 7, 2026

La ministre de la Santé, Marjorie Michel Minister of Health

Interpretation

Marginal note:Definitions

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

  abbreviated new drug submission

  abbreviated new drug submission means an abbreviated new drug submission filed under section C.08.002.1 of the Regulations. (présentation abrégée de drogue nouvelle)

  corresponding foreign drug

  corresponding foreign drug, in respect of the drug that is the subject of a new drug submission, an abbreviated new drug submission or a supplement to either such submission, means

  • (a) the foreign drug referred to in subparagraph 2(1)(c)(i), clause 3(2)(b)(ii)(A), subparagraph 5(1)(c)(i), subparagraph 6(1)(c)(i) or clause 7(2)(b)(ii)(A), as the case may be; and

  • (b) any other foreign drug that meets the following criteria:

    • (i) in the case of a new drug submission or an abbreviated new drug submission,

      • (A) it belongs to the class of drugs to which the drug that is the subject of the submission belongs,

      • (B) it has the same strength, dosage form, route of administration and medicinal ingredient as that drug, and

      • (C) it has conditions of use that fall within the conditions of use of that drug, and

    • (ii) in the case of a supplement to a new drug submission or to an abbreviated new drug submission,

      • (A) it belongs to the class of drugs to which the drug that is the subject of the supplement belongs,

      • (B) it has the same strength, dosage form, route of administration and medicinal ingredient as that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement, and

      • (C) it has conditions of use that fall within the conditions of use of that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement. (drogue étrangère correspondante)

  drug

  drug means a new drug but does not include a public health emergency drug. (drogue)

  List

  List means the document entitled List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents, published by the Government of Canada on its website, as amended from time to time. (Liste)

  new drug submission

  new drug submission means a new drug submission filed under section C.08.002 of the Regulations. (présentation de drogue nouvelle)

  notice of compliance

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

  post-market measure

  post-market measure means any measure that a foreign regulatory authority provides for in respect of a foreign drug for any of the following purposes:

  • (a) optimizing the benefits and managing the risks associated with the foreign drug;

  • (b) managing significant uncertainties relating to those benefits and risks;

  • (c) collecting information to enable the continuous assessment of those benefits and risks, the identification of any changes to them and the management of the uncertainties. (mesure après la mise en marché)

  Regulations

  Regulations means the Food and Drug Regulations. (Règlement)

  supplement

  supplement means a supplement filed under section C.08.003 of the Regulations. (supplément)

• Marginal note: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.

• Marginal note:Interpretation — information

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

New Drug Submissions

Marginal note:Deeming — already authorized foreign drug

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

  • (a) the drug belongs to a class of drugs that is set out in Division 1 of Part 1 of the List;

  • (b) the manufacturer indicates to the Minister that it seeks the applicable 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) the information referred to in paragraphs C.08.002(2)(g), (k) and (m) and C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those paragraphs relate to non-clinical information,

    • (ii) the information referred to in paragraphs C.08.002(2)(g) to (i), (k) and (m) and C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those paragraphs relate to clinical information,

    • (iii) the information referred to in paragraphs C.08.002(2)(a), (c) to (f), (l) and (m) of the Regulations, to the extent that those paragraphs relate to chemistry and manufacturing information;

  • (c) the manufacturer provides the Minister with information that demonstrates

    • (i) that the sale of the foreign drug is authorized by a foreign regulatory authority set out in Division 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 any set of information that the manufacturer indicates under paragraph (b),

      • (A) any difference between the drug and the foreign drug, and

      • (B) that any such difference 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) the labels that were most recently approved by the foreign regulatory authority in connection with the foreign drug,

    • (ii) a description of any post-market measure that the foreign regulatory authority has provided for in respect of the authorization referred to in subparagraph (c)(i) that relates to any set of information that the manufacturer indicates under paragraph (b), other than a measure set out in a risk management plan for the drug included in the submission,

    • (iii) 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 measure referred to in subparagraph (ii), and

      • (C) provided by the foreign regulatory authority to that holder in respect of any such measure, and

    • (iv) if the manufacturer possesses or has immediate access to information to the effect that an application for authorization to sell a corresponding foreign drug was filed with a foreign regulatory authority that is set out in Division 1 of Part 1 of the List in relation to the class of drugs to which the drug belongs 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, information that demonstrates 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;

  • (e) the following circumstances have not occurred in respect of another new drug submission, an abbreviated new drug submission or a supplement to either such 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, the manufacturer did not amend the submission or supplement under subsection C.08.004(2) of the Regulations within the applicable period referred to in that subsection, 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 is not one that relied on a decision of another foreign regulatory authority.

• Marginal note:Scope of deeming

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

• Marginal note:Exception

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

• Marginal note:Non-application — joint review

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

  • (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Division 1 of Part 1 of the List in relation to the class of drugs to which the drug that is the subject of the new drug submission belongs; and

  • (b) relied on the examination of information by the other foreign regulatory authority.

Marginal note:Deeming — application filed for foreign drug

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

• Marginal note:Requirements for deeming

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

  • (a) the drug belongs to a class of drugs that is set out in Division 2 of Part 1 of the List;

  • (b) at the time the submission is filed,

    • (i) the manufacturer indicates to the Minister that it seeks the applicable requirement in section C.08.004 of the Regulations to be deemed to be met under this section in respect of all of the following sets of information included in the submission:

      • (A) the information referred to in paragraphs C.08.002(2)(g), (k) and (m) and C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those paragraphs relate to non-clinical information,

      • (B) the information referred to in paragraphs C.08.002(2)(g) to (i), (k) and (m) and C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those paragraphs relate to clinical information,

      • (C) the information referred to in paragraphs C.08.002(2)(a), (c) to (f), (l) and (m) of the Regulations, to the extent that those paragraphs relate to chemistry and manufacturing information,

    • (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 the foreign drug was filed with a foreign regulatory authority set out in Division 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, and

      • (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

    • (iii) if the manufacturer possesses or has immediate access to information to the effect that an application for authorization to sell a corresponding foreign drug was filed with a foreign regulatory authority that is set out in Division 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs 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, information that demonstrates 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 all of the sets of information referred to in clauses (b)(i)(A) to (C),

        • (I) any difference between the drug and the foreign drug, and

        • (II) that any such difference 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) the labels that were most recently approved by the foreign regulatory authority in connection with the foreign drug,

      • (B) a description of any post-market measure that the foreign regulatory authority has provided for in respect of the authorization referred to in clause (i)(A) that relates to any set of information referred to in clauses (b)(i)(A) to (C), other than a measure set out in a risk management plan for the drug included in the submission,

      • (C) 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 measure referred to in clause (B), and

        • (III) provided by the foreign regulatory authority to that holder in respect of any such measure, and

      • (D) if the manufacturer possesses or has immediate access to information to the effect that an application for authorization to sell a corresponding foreign drug was filed with a foreign regulatory authority that is set out in Division 2 of Part 1 of the List in relation to the class of drugs to which the drug belongs and was withdrawn by the applicant or was refused by the foreign regulatory authority,

        • (I) in the case where the application was refused, the text of that decision, and

        • (II) in any case, information that demonstrates 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;

  • (d) the following circumstances have not occurred in respect of another new drug submission, an abbreviated new drug submission or a supplement to either such 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, the manufacturer did not amend the submission or supplement under subsection C.08.004(2) of the Regulations within the applicable period referred to in that subsection, 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 is not one that relied on a decision of another foreign regulatory authority.

• Marginal note:Scope of deeming

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

• Marginal note:Exception

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

• Marginal note:Non-application — joint review

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

  • (a) relates to a joint review between the foreign regulatory authority and another foreign regulatory authority that is set out in Division 2 of Part 1 of the List in relation to the class of drugs to which the drug that is the subject of the new drug submission belongs; and

  • (b) relied on the examination of information by the other foreign regulatory authority.