Natural Health Products Regulations

63 The following definitions apply in this Part.

adverse event

adverse event means any adverse occurrence in the health of a clinical trial subject who is administered a natural health product, that may or may not be caused by the administration of the natural health product, and includes an adverse reaction, a serious adverse reaction and a serious unexpected adverse reaction. (incident thérapeutique)

clinical trial

clinical trial means an investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, or to ascertain its safety or efficacy. (essai clinique)

good clinical practices

good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section 74. (bonnes pratiques cliniques)

import

import means to import a natural health product into Canada for the purpose of sale in a clinical trial. (importer)

investigator’s brochure

investigator’s brochure means a document containing the preclinical and clinical information in respect of the natural health product that is described in paragraph 66(e). (brochure du chercheur)

protocol

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

qualified investigator

qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where the clinical trial site is located and who is

• (a) in the case of a clinical trial respecting a natural health product to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and

• (b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié)

research ethics board

research ethics board means a body that is not affiliated with the sponsor, and

• (a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and

• (b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration Act, that is composed of both men and women and that includes at least

  • (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 or, if the clinical trial is in respect of a natural health product to be used for dental purposes only, is from a medical or dental discipline,

  • (ii) one member knowledgeable in complementary or alternative health care,

  • (iii) one member knowledgeable in ethics,

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

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

  • (vi) 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 the site where the clinical trial is to be conducted. (comité d’éthique de la recherche)

sponsor

sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur)