Food and Drug Regulations

C.05.005 An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer and shall contain the following information and documents:

• (a) a copy of the protocol for the clinical trial;

• (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;

• (c) a clinical trial attestation, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, containing

  • (i) the title of the protocol and the clinical trial number,

  • (ii) the brand name, the chemical name or the code for the drug,

  • (iii) the therapeutic and pharmacological classifications of the drug,

  • (iv) the medicinal ingredients of the drug,

  • (v) the non-medicinal ingredients of the drug,

  • (vi) the dosage form of the drug,

  • (vii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor,

  • (viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the drug,

  • (ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application,

  • (x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and

  • (xi) a statement

    • (A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and

    • (B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading;

• (d) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;

• (e) an investigator’s brochure that contains the following information, namely,

  • (i) the physical, chemical and pharmaceutical properties of the drug,

  • (ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested,

  • (iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested,

  • (iv) any toxicological effects in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the drug,

  • (v) any results of carcinogenicity studies in any animal species tested in respect of the drug,

  • (vi) any results of clinical pharmacokinetic studies of the drug,

  • (vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans, and

  • (viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

• (f) if the drug contains a human-sourced excipient, including any used in the placebo,

  • (i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or

  • (ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient;

• (g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and

• (h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.