Food and Drug Regulations

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.