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

• C.03.302. (1) Sections C.03.303 to C.03.319 apply to the sale and importation of study drugs.

• (2) Sections C.03.001 to C.03.209 and Divisions 5 and 8 do not apply to study drugs.

• (3) Sections C.03.303 to C.03.319 do not apply to a study drug manufactured from a bulk process intermediate that is of biological origin.

C.03.303. No person shall sell or import a study drug unless all of the following requirements are met:

• (a) the study drug is for use only in a study;

• (b) the study drug has been previously tested in human subjects and its safety in humans has been demonstrated;

• (c) if the study drug is to be imported, the manufacturer of the drug has a representative in Canada who is responsible for its sale;

• (d) the sponsor is authorized under section C.03.309 to sell or import the study drug; and

• (e) the sponsor complies with sections C.03.310 to C.03.316.

• C.03.304. (1) The purpose of a study is to obtain data on any of the following:

  • (a) the pharmacokinetics or metabolism of the study drug;

  • (b) normal human biochemistry or physiology; or

  • (c) changes caused to human biochemistry or physiology by aging, disease or medical interventions.

• (2) A study is not primarily intended to do any of the following:

  • (a) discover, identify or verify the pharmacodynamic effects of the study drug;

  • (b) identify adverse reactions;

  • (c) fulfil an immediate therapeutic or diagnostic purpose; or

  • (d) ascertain the safety or efficacy of the study drug.

• C.03.305. (1) A study shall meet all of the following requirements:

  • (a) before the study drug is used in the study, there is sufficient data from testing it in animals and humans to demonstrate its safety in humans;

  • (b) the amount of active ingredients or combination of active ingredients in the study drug has been shown not to cause any clinically detectable pharmacodynamic effect in humans;

  • (c) the total radiation dose incurred annually by a study subject, including from multiple administrations of the study drug, from significant contaminants or from impurities and from the use of other procedures for the purposes of the study, will be not more than 50 mSv;

  • (d) any concomitant drug used in the study has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a concomitant drug that is a new drug, has been issued a notice of compliance under section C.08.004;

  • (e) study subjects shall be at least 18 years old and have legal capacity at the time of the study;

  • (f) female study subjects shall

    • (i) be confirmed at the outset of the study, on the basis of a pregnancy test, as not being pregnant or state in writing that they are not pregnant, and

    • (ii) be advised that if they are lactating, they are to suspend lactation for 24 hours after the administration of the study drug; and

  • (g) the study shall not involve more than 30 study subjects.

• (2) Despite paragraph (1)(g), a study may involve more than 30 study subjects if the sponsor provides the Minister with a scientific rationale for the increase and the Minister approves it.