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

Regulations are current to 2017-09-27 and last amended on 2017-06-20. Previous Versions

Labelling

 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:

  • (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;

  • (b) the name, number or identifying mark of the drug;

  • (c) the expiration date of the drug;

  • (d) the recommended storage conditions for the drug;

  • (e) the lot number of the drug;

  • (f) the name and address of the sponsor;

  • (g) the protocol code or identification; and

  • (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).

  • SOR/2001-203, s. 4;
  • SOR/2012-16, s. 8(F).

Records

  •  (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

  • (2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

  • (3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including

    • (a) a copy of all versions of the investigator’s brochure for the drug;

    • (b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;

    • (c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event;

    • (d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons;

    • (e) records respecting the shipment, receipt, disposition, return and destruction of the drug;

    • (f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that

      • (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and

      • (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;

    • (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and

    • (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

  • (4) The sponsor shall maintain all records referred to in this Division for a period of 25 years.

  • SOR/2001-203, s. 4.

Submission of Information and Samples

  •  (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that

    • (a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;

    • (b) the clinical trial is contrary to the best interests of a clinical trial subject;

    • (c) the objectives of the clinical trial will not be achieved;

    • (d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or

    • (e) information submitted in respect of the drug or the clinical trial is false or misleading.

  • (2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.

  • SOR/2001-203, s. 4;
  • SOR/2012-16, s. 9(F).

Serious Unexpected Adverse Drug Reaction Reporting

  •  (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:

    • (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and

    • (b) if it is fatal or life threatening, within seven days after becoming aware of the information.

  • (2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

  • (3) Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial.

  • SOR/2001-203, s. 4;
  • SOR/2017-18, s. 16.

Discontinuance of a Clinical Trial

  •  (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall

    • (a) inform the Minister no later than 15 days after the date of the discontinuance;

    • (b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor;

    • (c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and

    • (d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.

  • (2) If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h).

  • SOR/2001-203, s. 4.

Suspension and Cancellation

  •  (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

    • (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug;

    • (b) any information submitted in respect of the drug or clinical trial is false or misleading;

    • (c) the sponsor has failed to comply with good clinical practices; or

    • (d) the sponsor has failed to provide

      • (i) information or samples of the drug as required under section C.05.009 or C.05.013, or

      • (ii) information or a report under section C.05.014.

  • (2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless

    • (a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension;

    • (b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that

      • (i) the situation giving rise to the intended suspension did not exist, or

      • (ii) the situation giving rise to the intended suspension has been corrected; and

    • (c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b).

  • (3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

  • (4) If the Minister has suspended an authorization under subsection (1), the Minister shall

    • (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or

    • (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

  • SOR/2001-203, s. 4;
  • SOR/2012-16, s. 10.
 
Date modified: