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

Serious Unexpected Adverse Drug Reaction Reporting

• C.05.014 (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.

Discontinuance of a Clinical Trial

• C.05.015 (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).

Suspension and Cancellation

• C.05.016 (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).

• C.05.017 (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.

• (2) 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.

• (3) 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 60 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 did not exist or that it has been corrected; or

  • (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 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).

DIVISION 6