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

Positron-emitting Radiopharmaceuticals

Interpretation

C.03.301 The following definitions apply in this section and in sections C.03.302 to C.03.319.

adverse reaction

adverse reaction means an undesirable and unintended response in a study subject or other person to a study drug that is caused by the administration of any dose of the study drug. (réaction indésirable)

good clinical practices

good clinical practices means generally accepted clinical practices that are designed to protect the rights, safety and well-being of study subjects and other persons. (bonnes pratiques cliniques)

import

import means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. (importer)

other person

other person means an individual who comes into physical contact with a study subject. (autre personne)

protocol

protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a study. (protocole)

qualified investigator

qualified investigator means the physician and member in good standing of a professional medical association in Canada to whom a sponsor gives the responsibility for the proper conduct of the study at a given study site, who is entitled to practise their profession under the laws of the province where the study site is located. (chercheur qualifié)

research ethics board

research ethics board means a body described in section C.03.306. (comité d’éthique de la recherche)

serious adverse reaction

serious adverse reaction means an adverse reaction that results in any of the following consequences for the study subject or other person:

• (a) their in-patient hospitalization or its prolongation;

• (b) a congenital malformation;

• (c) persistent or significant disability or incapacity;

• (d) a life-threatening condition; or

• (e) death. (réaction indésirable grave)

serious unexpected adverse reaction

serious unexpected adverse reaction means a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the study drug. (réaction indésirable grave et imprévue)

sponsor

sponsor means a person who is responsible for the conduct of a study. (promoteur)

study

study means a basic clinical research study that involves human subjects and that is described in sections C.03.304 and C.03.305. (étude)

study drug

study drug means a positron-emitting radiopharmaceutical that is used in a study. (drogue destinée à l’étude)

study site

study site means the location where all or part of a study is conducted. (lieu d’étude)

Application

• 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.

Prohibition

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.

Purpose of Study

• 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.

Requirements

• 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.

Research Ethics Board

C.03.306 A research ethics board has all of the following characteristics:

• (a) its principal mandate is to approve the initiation of and to periodically review biomedical research that involves human subjects in order to protect their rights, safety and well-being;

• (b) it has at least five members, a majority of whom are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, is composed of both men and women and includes at least the following:

  • (i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline,

  • (ii) one member knowledgeable in ethics,

  • (iii) one member knowledgeable in Canadian laws relevant to the research to be approved,

  • (iv) one member whose primary experience and expertise are in a non-scientific discipline, and

  • (v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or with the study site; and

• (c) it has no affiliations with the sponsor that could compromise its ability to fulfil its principal mandate, or that could be perceived to do so.