Food and Drug Regulations (C.R.C., c. 870)

C.08.001.1 For the purposes of this Division,

Canadian reference product

Canadian reference product means

• (a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug,

• (b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or

• (c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)

designated COVID-19 drug

designated COVID-19 drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19; (drogue désignée contre la COVID-19)

pharmaceutical equivalent

pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)

specifications

specifications means a detailed description of a new drug and of its ingredients and includes

• (a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,

• (b) a detailed description of the methods used for testing and examining the ingredients, and

• (c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications)

• C.08.002 (1) No person shall sell or advertise a new drug unless

  • (a) the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister;

  • (b) the Minister has issued, under section C.08.004 or C.08.004.01, a notice of compliance to the manufacturer of the new drug in respect of the submission; and

  • (c) the notice of compliance in respect of the submission has not been suspended under section C.08.006.

  • (d) [Repealed, SOR/2014-158, s. 10]

• (2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

  • (a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;

  • (b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;

  • (c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;

  • (d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;

  • (e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;

  • (f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;

  • (g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

  • (h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;

  • (i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;

  • (j) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug;

  • (j.1) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages;

  • (k) a statement of all the representations to be made for the promotion of the new drug respecting

    • (i) the recommended route of administration of the new drug,

    • (ii) the proposed dosage of the new drug,

    • (iii) the claims to be made for the new drug, and

    • (iv) the contra-indications and side effects of the new drug;

  • (l) a description of the dosage form in which it is proposed that the new drug be sold;

  • (m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production;

  • (n) in the case of a new drug intended for administration to food-producing animals, the withdrawal period of the new drug; and

  • (o) in the case of a new drug for human use other than a designated COVID-19 drug, an assessment as to whether there is a likelihood that the new drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of the other drug.

• (2.1) A manufacturer may file, for a designated COVID-19 drug, a new drug submission that does not meet the requirements set out in paragraphs (2)(g) and (h) if the submission contains

  • (a) a statement that the submission contains evidence to establish that the requirement set out in paragraph (b) is met; and

  • (b) sufficient evidence to support the conclusion that the benefits associated with the designated COVID-19 drug outweigh the risks for the purpose and under the conditions of use recommended, with consideration given to the uncertainties relating to those benefits and risks as well as the public health need related to COVID-19.

• (2.2) A manufacturer may file, for a designated COVID-19 drug for human use, a new drug submission that does not meet the requirements set out in paragraph (2)(j.1) if the submission contains a draft of every label to be used in connection with the designated COVID-19 drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the designated COVID-19 drug.

• (2.3) If, at the time a new drug submission is filed for a designated COVID-19 drug, the manufacturer is unable to provide the Minister with information or material referred to in any of paragraphs (2)(e) to (k), (m) and (n) or in paragraph (2.1)(b) or subsection (2.2) or that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when the manufacturer will provide the Minister with the missing information or material.

• (2.4) Subsections (2.1) to (2.3) apply if

  • (a) the new drug submission contains a statement that the submission is for a designated COVID-19 drug; and

  • (b) the purpose and conditions of use specified in the new drug submission in respect of the designated COVID-19 drug relate only to COVID-19 and the submission contains a statement to that effect.

• (2.5) Subsections (2.1) to (2.3) do not apply if the manufacturer is seeking a notice of compliance for a designated COVID-19 drug on the basis of a direct or indirect comparison between the designated COVID-19 drug and another designated COVID-19 drug.

• (3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

  • (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

  • (b) samples of the ingredients of the new drug;

  • (c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

  • (d) any additional information or material respecting the safety and effectiveness of the new drug.

• C.08.002.01 (1) A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if

  • (a) the new drug is intended for

    • (i) emergency use in situations where persons have been exposed to a chemical, biological, radiological or nuclear substance and action is required to treat, mitigate or prevent a life-threatening or other serious disease, disorder or abnormal physical state, or its symptoms, that results, or is likely to result, from that exposure, or

    • (ii) preventative use in persons who are at risk of exposure to a chemical, biological, radiological or nuclear substance that is potentially lethal or permanently disabling; and

  • (b) the requirements set out in paragraphs C.08.002(2)(g) and (h) cannot be met because

    • (i) exposing human volunteers to the substance referred to in paragraph (a) would be potentially lethal or permanently disabling, and

    • (ii) the circumstances in which exposure to the substance occurs are sporadic and infrequent.

• (2) Subject to subsections (3) and (5), an extraordinary use new drug submission shall contain

  • (a) an attestation, signed and dated by the senior executive officer in Canada of the manufacturer filing the submission and by the manufacturer’s senior medical or scientific officer, certifying that the conditions referred to in paragraphs (1)(a) and (b) are met, together with sufficient supporting information to enable the Minister to determine that those conditions are met; and

  • (b) sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

    • (i) the information and material described in paragraphs C.08.002(2)(a) to (f), (i) to (m) and (o),

    • (ii) information respecting the pathophysiological mechanism for the toxicity of the chemical, biological, radiological or nuclear substance and describing the new drug’s ability to treat, mitigate or prevent that mechanism,

    • (iii) detailed reports of in vitro studies respecting the toxicity and activity of the new drug in relation to the recommended purpose,

    • (iv) detailed reports of studies, in an animal species that is expected to react with a response that is predictive for humans, establishing the safety of the new drug, and providing substantial evidence of its effect, when used for the purpose and under the conditions of use recommended,

    • (v) information confirming that the end point of animal studies is clearly related to the desired benefit in humans,

    • (vi) information demonstrating that there is a sufficient understanding of the pharmacokinetics and pharmacodynamics of the new drug in animals and in humans to enable inferences to be drawn in respect of humans so as to allow for the selection of an effective dose in humans,

    • (vii) information respecting the safety of the new drug in humans, including detailed reports of clinical trials, if any, establishing the safety of the new drug,

    • (viii) information, if any, respecting the effectiveness of the new drug in humans for the purpose or under the conditions of use recommended,

    • (ix) a plan for monitoring and establishing the safety and effectiveness of the new drug under the conditions of use recommended that includes procedures for gathering and analyzing data, and

    • (x) any available assessment reports regarding the new drug prepared by regulatory authorities in countries other than Canada.

• (3) Reports referred to in subparagraph (2)(b)(iii) or information referred to in subparagraph (2)(b)(vi) may be omitted if the extraordinary use new drug submission includes a detailed scientific explanation as to why the reports are or the information is not available.

• (4) Any information or material that is necessary to enable the Minister to assess the safety and effectiveness of the new drug shall, at the request of the Minister, be added to the extraordinary use new drug submission, including

  • (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed to be sold;

  • (b) samples of the ingredients of the new drug;

  • (c) samples of the new drug in the dosage form in which it is proposed to be sold; and

  • (d) any information omitted by virtue of subsection (3).

• (5) If an extraordinary use new drug submission is in respect of a new purpose for a new drug for which a notice of compliance has been issued under section C.08.004, the information and material referred to in subparagraph (2)(b)(i) may be omitted unless any of it is different from that which was originally submitted.

C.08.002.02 Despite sections C.08.002 and C.08.003, no manufacturer or importer shall sell a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 except to

• (a) the Government of Canada or the government of a province for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative; or

• (b) a municipal government, or an institution of such a government, on receipt of a written order signed by a senior official of the government or institution or by his or her duly authorized representative.

• C.08.002.1 (1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product,

  • (a) the new drug is the pharmaceutical equivalent of the Canadian reference product;

  • (b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;

  • (c) the route of administration of the new drug is the same as that of the Canadian reference product; and

  • (d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.

• (2) An abbreviated new drug submission or an abbreviated extraordinary use new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

  • (a) the information and material described in

    • (i) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), in the case of an abbreviated new drug submission, and

    • (ii) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission;

  • (b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;

  • (c) evidence from the comparative studies conducted in connection with the submission that the new drug is

    • (i) the pharmaceutical equivalent of the Canadian reference product, and

    • (ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;

  • (d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

  • (e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.

• (3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission or an abbreviated extraordinary use new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

  • (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

  • (b) samples of the ingredients of the new drug;

  • (c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

  • (d) any additional information or material respecting the safety and effectiveness of the new drug.

• (4) For the purposes of this section, in the case of an abbreviated new drug submission, a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 is not a Canadian reference product.