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 — joint review involving Minister

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

• 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 new drug submission is deemed to be met, in respect of the drug that is the subject of the submission, on the basis of a document referred to in paragraph (e) produced in the context of a joint review if the following requirements are met:

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

    • (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, and

    • (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 Minister conducts the joint review that pertains to the drug and a foreign drug with the foreign regulatory authority;

  • (d) the foreign regulatory authority is set out in Division 3 of Part 1 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 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, and

    • (iii) with respect to the portion referred to in 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.

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

• 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).

Abbreviated New Drug Submissions

Marginal note:Deeming — already authorized foreign drug

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

  • (a) the drug belongs to a class of drugs that is set out in Part 2 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.08.002.1(2)(c) and (d) 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.08.002.1(2)(c) and (d) 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) and (l) and C.08.002.1(2)(c) and (d) 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 Part 2 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 Part 2 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 a new drug submission, another 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 an abbreviated new drug submission is deemed to be met under this section only in respect of any set of information that the manufacturer indicates under paragraph (1)(b).

• 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 Part 2 of the List in relation to the class of drugs to which the drug that is the subject of the abbreviated new drug submission belongs; and

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

Supplements

Marginal note:Deeming — already authorized foreign drug

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

  • (a) the drug belongs to a class of drugs that is set out in

    • (i) in the case of a supplement to a new drug submission, Subdivision 1 of Division 1 of Part 3 of the List, and

    • (ii) in the case of a supplement to an abbreviated new drug submission, Subdivision 2 of Division 1 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 any of the following sets of information included in the supplement:

    • (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,

    • (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 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 one of the following Subdivisions of Division 1 of Part 3 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, Subdivision 1, and

      • (B) in the case of a supplement to an abbreviated new drug submission, Subdivision 2,

    • (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 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, 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;

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

    • (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 — that relates to any matter to which the supplement pertains — was filed with a foreign regulatory authority that is set out in the applicable Subdivision of Division 1 of Part 3 of the List referred to in clause (c)(i)(A) or (B), as the case may be, 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 supplement — impact the safety or effectiveness of the drug;

  • (e) 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

  • (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 supplement is deemed to be met under this section only in respect of the portion referred to in 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 the applicable Subdivision of Division 1 of Part 3 of the List referred to in clause (1)(c)(i)(A) or (B), as the case may be, 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.