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

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• (d) [Repealed, SOR/2014-158, s. 10]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