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

Regulations are current to 2017-07-03 and last amended on 2017-06-20. Previous Versions

Application for Authorization

  •  (1) The sponsor shall submit to the Minister an application for authorization to sell or import a study drug that contains the information set out in subsection (2) as well as sufficient information to demonstrate that all of the following criteria are met:

    • (a) the use of the study drug will not endanger the health of any study subject or other person;

    • (b) the study is not contrary to the best interests of the study subjects; and

    • (c) the objectives of the study can reasonably be achieved.

  • (2) The application shall contain all of the following information:

    • (a) the title of the study and the protocol code or identification;

    • (b) the purposes and a concise description of the study;

    • (c) the number of study subjects;

    • (d) the brand name, if any, of the study drug;

    • (e) the chemical or generic name of the active ingredients in the study drug;

    • (f) a qualitative list of the non-active ingredients of the study drug;

    • (g) the maximum mass of the study drug to be administered to each study subject;

    • (h) the radioactive dose range of the study drug, expressed in MBq or mCi;

    • (i) the effective dose or effective dose equivalent of the study drug, expressed in mSv/MBq or rem/mCi;

    • (j) the sponsor’s name and civic address, its postal address if different, and its telephone number, fax number and email address;

    • (k) the manufacturer’s name and civic address, its postal address if different, and its telephone number, fax number and email address;

    • (l) in the case of an application for importation, the name and civic address, the postal address if different, and the telephone number, fax number and email address of the manufacturer’s representative in Canada who is responsible for the sale of the study drug;

    • (m) the name and civic address of each study site;

    • (n) for each study site, the name, civic address, telephone number, fax number and email address of the qualified investigator;

    • (o) the proposed starting date for the study at each study site, if known;

    • (p) for each study site, the name, civic address, telephone number, fax number and email address of the research ethics board;

    • (q) a statement, dated and signed by the research ethics board for each study site, that certifies that it has reviewed and approved the study, the protocol and the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form;

    • (r) a list of any previous applications for an authorization to sell or import a drug for a study related to the current study; and

    • (s) a statement, dated and signed by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, that certifies both of the following:

      • (i) the study will be conducted in accordance with these Regulations, and

      • (ii) all of the information contained or referred to in the application is complete and accurate and is not false or misleading.

  • SOR/2012-129, s. 5.

Additional Information

 If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice.

  • SOR/2012-129, s. 5.

Authorization

 After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study sites in respect of which the sale or importation are authorized.

  • SOR/2012-129, s. 5.

Notice

 The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day.

  • SOR/2012-129, s. 5.

Good Clinical Practices

 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that

  • (a) the study is scientifically sound and clearly described in its protocol;

  • (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations;

  • (c) systems and procedures are implemented that assure the quality of every aspect of the study;

  • (d) at each study site, there is only one qualified investigator;

  • (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator;

  • (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks;

  • (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

  • (h) the requirements respecting information and records set out in section C.03.315 are met; and

  • (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026.

  • SOR/2012-129, s. 5.

Labelling

 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug

  • (a) bears an inner label that sets out both of the following:

    • (i) the unique batch number for the study drug, and

    • (ii) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”; and

  • (b) is accompanied by a package insert that sets out all of the following information:

    • (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator,

    • (ii) the chemical or generic name of the active ingredients in the study drug,

    • (iii) the name and civic address of the manufacturer,

    • (iv) the name and civic address of the sponsor,

    • (v) the code or other identification of the protocol,

    • (vi) the warnings and precautions in respect of the use of the study drug, and

    • (vii) a list of the possible adverse reactions that are associated with the use of the study drug.

  • SOR/2012-129, s. 5.

Submission of Information

  •  (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following:

    • (a) the use of the study drug may endanger the health of a study subject or other person;

    • (b) the study may be contrary to the best interests of the study subjects;

    • (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or

    • (d) information submitted in respect of the study drug or study is false or misleading.

  • (2) The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice.

  • SOR/2012-129, s. 5.
 
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