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

Marginal note:Deeming — application filed for foreign drug

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

• 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 supplement to a new drug submission is deemed to be met, in respect of the drug that is the subject of the supplement, on the basis of a decision to authorize the sale of a foreign drug if the following requirements are met:

  • (a) the drug belongs to a class of drugs that is set out in Division 2 of Part 3 of the List;

  • (b) at the time the supplement 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 the portion of the following sets of information included in the supplement:

      • (A) the information referred to in subparagraphs C.08.003(2)(h)(i) to (iv) and paragraphs C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those provisions relate to non-clinical information,

      • (B) the information referred to in subparagraphs C.08.003(2)(h)(i) to (iv) and paragraphs C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those provisions relate to clinical information, and

      • (C) the information referred to in paragraphs C.08.003(2)(a), (c) to (f) and (i) 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 supplement within 120 days after the day on which an application for authorization to sell the foreign drug — that relates to the matters to which the supplement pertains — was filed with a foreign regulatory authority set out in Division 2 of Part 3 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, and

      • (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, 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 — that relates to any matter to which the supplement pertains — was filed with a foreign regulatory authority that is set out in Division 2 of Part 3 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 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, and

      • (D) with respect to the portion referred to in subparagraph (b)(i),

        • (I) any difference 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 difference 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, 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 the portion referred to in subparagraph (b)(i), other than a measure set out in a risk management plan for the drug included in the supplement, if applicable,

      • (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 — that relates to any matter to which the supplement pertains — was filed with a foreign regulatory authority that is set out in Division 2 of Part 3 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 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;

  • (d) the following circumstances have not occurred in respect of a new drug submission, an abbreviated new drug submission or another supplement to either such submission 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, 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 supplement is deemed to be met under this section only in respect of the portion referred to in subparagraph (2)(b)(i).

• 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 3 of the List in relation to the class of drugs to which the drug that is the subject of the supplement belongs; and

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

Marginal note:Deeming — joint review involving Minister

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

• Marginal note:Requirements for deeming

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

  • (a) the drug belongs to a class of drugs that is set out in Division 3 of Part 3 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 the portion of the following sets of information, included in the supplement, that is to be examined by a foreign regulatory authority in the context of the joint review:

    • (i) the information referred to in subparagraphs C.08.003(2)(h)(i) to (iv) and paragraphs C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those provisions relate to non-clinical information,

    • (ii) the information referred to in subparagraphs C.08.003(2)(h)(i) to (iv) and paragraphs C.08.005.1(1)(b) and (c) of the Regulations, to the extent that those provisions relate to clinical information, and

    • (iii) the information referred to in paragraphs C.08.003(2)(a), (c) to (f) and (i) of the Regulations, to the extent that those paragraphs relate to chemistry and manufacturing information;

  • (c) the Minister conducts the joint review that pertains to the drug and a foreign drug with the foreign regulatory authority and the application to sell the foreign drug that was filed with that authority relates to the matters to which the supplement pertains;

  • (d) the foreign regulatory authority is set out in Division 3 of Part 3 of the List in relation to the class of drugs to which the drug belongs;

  • (e) the Minister has received a copy of the document produced by the foreign regulatory authority in the context of the joint review that sets out the conclusions of its examination of the portion referred to in paragraph (b); and

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

    • (i) that the drug — as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement — has 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 referred to in paragraph (c),

    • (ii) 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 — fall within the conditions of use for the foreign drug, if the foreign regulatory authority were to approve the application referred to in paragraph (c), and

    • (iii) with respect of the portion referred to in paragraph (b),

      • (A) any difference 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 referred to in paragraph (c), and

      • (B) that any such difference 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.

• 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 supplement is deemed to be met under this section only in respect of the portion referred to in paragraph (2)(b) that is addressed by the document referred to in paragraph (2)(e).

• Marginal note:Exception

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

• Marginal note:Exception

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

Condition

Marginal note:Provision of information

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

Coming into Force

Marginal note:Publication

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