Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (SOR/2022-18)

Marginal note:Issuance

21 The Minister must issue a COVID-19 drug authorization if the following requirements are met:

• (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 20;

• (b) the applicant has submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); and

• (c) the Minister determines that

  • (i) the use of the drug that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects or other persons,

  • (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and

  • (iii) the objectives of the clinical trial are achievable.

Marginal note:Additional information prior to clinical trial

22 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug unless the holder has

• (a) for each clinical trial site, obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20(2)(a) and the informed consent form that contains the statement referred to in paragraph 20(2)(b); and

• (b) submitted to the Minister the information and material referred to in subparagraphs 20(2)(c)(ix) and (x) and paragraphs 20(2)(d) and (n), if it was not submitted at the time of submitting the application.

Marginal note:Terms and conditions

23 The Minister may, at any time, impose terms and conditions on a COVID-19 drug authorization or amend those terms and conditions.

Marginal note:Prohibition

• 24 (1) Subject to subsection (2), if the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) is significantly different from the substance of the information or material contained in the application for a COVID-19 drug authorization,

  • (a) the conduct of the clinical trial referred to in the authorization that is issued as a result of that application is no longer authorized for the purposes of section 3.1 of the Act; and

  • (b) the holder of the authorization must not import or sell the COVID-19 drug for which the authorization was issued.

• Marginal note:Amendment

  (2) Subsection (1) does not apply if

  • (a) the holder of the COVID-19 drug authorization has submitted to the Minister an application to amend the authorization;

  • (b) for each clinical trial site, the holder has obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20(2)(a) and the informed consent form that contains the statement referred to in paragraph 20(2)(b);

  • (c) the holder has submitted to the Minister the information and material referred to in subparagraphs 20(2)(c)(ix) and (x) and paragraphs 20(2)(d) and (n), if it was not submitted at the time of submitting the application;

  • (d) the Minister determines that the requirements set out in subparagraphs 21(c)(i) to (iii) are met;

  • (e) the holder has submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); and

  • (f) the Minister amends the authorization.

• Marginal note:Immediate change

  (3) Despite subsections (1) and (2), if an immediate change is required to be made to the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) because the clinical trial or the use of the COVID-19 drug that is tested in the clinical trial endangers the health of a clinical trial subject or other person, the holder of the authorization may immediately make the change.

• Marginal note:Immediate change — application to amend

  (4) The holder of the authorization must, within 15 days after making the change referred to in subsection (3), submit the application referred to in subsection (2) to amend the authorization.

Marginal note:Prohibition — import

25 A holder of a COVID-19 drug authorization must not import a COVID-19 drug for which the authorization has been issued if the sale of the drug would constitute a violation of the Act.

Marginal note:Prohibition — import and sale

26 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued unless the holder has a representative in Canada who is responsible for the sale of the drug.

Marginal note:Marketed drugs

27 Paragraphs 20(2)(e) to (l), section 33 and paragraphs 35(2)(a) to (c) do not apply to a COVID-19 drug for which a COVID-19 drug authorization has been issued if

• (a) the use of the drug is consistent with the standard of medical practice;

• (b) the drug has been issued a notice of compliance under subsection C.08.004(1) of the Food and Drug Regulations or has been assigned a drug identification number under subsection C.01.014.2(1) of those Regulations; and

• (c) the clinical trial for which the authorization has been issued is in respect of a purpose or condition of use other than that for which the notice of compliance was issued or drug identification number was assigned.

Marginal note:Good clinical practices

28 A holder of a COVID-19 drug authorization must ensure that the clinical trial for which the authorization has been issued is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, must ensure that

• (a) the clinical trial is scientifically sound and clearly described in the protocol;

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

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

• (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins;

• (e) at each clinical trial site, there is no more than one qualified investigator;

• (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of a health care professional who is authorized to provide medical care and make medical decisions;

• (g) each person who is involved in the conduct of the clinical trial is qualified by education, training and experience to perform their respective tasks;

• (h) informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before they participate in the clinical trial, but only after that person has been informed of

  • (i) the risks and anticipated benefits to their health arising from participation in the clinical trial, and

  • (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; and

• (i) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 and 4 of Part C of the Food and Drug Regulations, with the exception of sections C.02.019, C.02.025 and C.02.026 of those Regulations.

Marginal note:Suspension

• 29 (1) The Minister may suspend, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if

  • (a) the Minister determines that any of the requirements set out in subparagraphs 21(c)(i) to (iii) is no longer met;

  • (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); or

  • (c) the holder of the authorization has contravened these Regulations or any provisions of the Act relating to the drug.

• Marginal note:Reinstatement

  (2) The Minister must reinstate a COVID-19 drug authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Marginal note:Additional information and material

• 30 (1) The Minister may request that an applicant for a COVID-19 drug authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

• Marginal note:Time, form and manner

  (2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Marginal note:Discontinuance

31 If a holder of a COVID-19 drug authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

• (a) notify the Minister, in writing, of the discontinuance and the reasons for it;

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

• (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale 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.

Marginal note:Discretionary revocation

• 32 (1) The Minister may revoke, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 29(2).

• Marginal note:Mandatory revocation

  (2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 31(a).

Marginal note:Labelling

• 33 (1) A person must not import or sell a COVID-19 drug for which a COVID-19 drug authorization has been issued or conduct a clinical trial in respect of such a drug unless the drug has a label that sets out the following information:

  • (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 contact information of the holder of the authorization; and

  • (g) the protocol code or identification.

• Marginal note:Presentation of information

  (2) The information required by subsection (1) to be set out on the label must be in English and in French.

Marginal note:Serious unexpected adverse drug reaction

34 A holder of a COVID-19 drug authorization must inform the Minister of any serious unexpected adverse drug reaction that has occurred inside or outside Canada, in respect of the COVID-19 drug that is tested in the clinical trial, as follows:

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

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

Marginal note:Records

• 35 (1) A holder of a COVID-19 drug authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information.

• Marginal note:Content

  (2) The holder of the authorization must maintain complete and accurate records, which include the following, in respect of a COVID-19 drug for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations:

  • (a) the information and material referred to in paragraphs 20(2)(e) to (k);

  • (b) records respecting each change made to the information and material referred to in paragraph (a), 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 the indication for use and the dosage form of the drug at the time of the adverse event;

  • (d) in respect of a drug that meets the requirements of paragraphs 27(a) to (c), records respecting any serious unexpected adverse drug reaction that has occurred inside or outside Canada;

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

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

  • (g) for each clinical trial site, an undertaking, signed and dated by the qualified investigator prior to the commencement of their responsibilities in respect of the clinical trial stating 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, in whole or in part, by the holder, 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 subjects or other persons;

  • (h) 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 a research ethics board for that site; and

  • (i) for each clinical trial site, an attestation, signed and dated by a research ethics board, 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.

• Marginal note:Retention period

  (3) The holder — or former holder, in the case of an authorization that has been revoked in whole — of the authorization must retain all records referred to in subsection (2) for a period of 15 years.