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

Marginal note:Incident reporting

14 A holder of a COVID-19 medical device authorization must, within 10 days after becoming aware of an incident inside or outside Canada involving a COVID-19 medical device for which the authorization has been issued, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.

Marginal note:Records

• 15 (1) A holder of a COVID-19 medical device 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 information and material referred to in subsection 4(2), in respect of a COVID-19 medical device for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with these Regulations.

• Marginal note:Retention period

  (3) The holder of the authorization must retain all records for the period during which the authorization has not been revoked in whole.

Marginal note:Distribution records

• 16 (1) A holder of a COVID-19 medical device authorization must maintain a distribution record in respect of each device that is imported or sold under the authorization or tested in a clinical trial under the authorization.

• Marginal note:Withdrawal

  (2) The distribution record must contain sufficient information to permit complete and rapid withdrawal of the COVID-19 medical device for which the authorization has been issued.

• 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  (3) The holder — or former holder, in the case of an authorization that has been revoked in whole — of the authorization must retain the distribution record for the longer of

  • (a) the projected useful life of the device, and

  • (b) two years after the date on which the holder took possession, care or control of the device in Canada.

• Marginal note:Timely retrieval

  (4) Distribution records must be maintained in a manner that will allow their timely retrieval.

Marginal note:Complaint handling

17 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, maintain records of the following:

• (a) any reported problems relating to the performance characteristics or safety of the device that are received by the holder after the device was first sold in Canada; and

• (b) all actions taken by the holder in response to those problems.

Marginal note:Documented procedures

18 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, establish and implement documented procedures that will enable the holder to carry out

• (a) an effective and timely investigation of the problems referred to in paragraph 17(a); and

• (b) an effective and timely recall of the device.

Marginal note:Information — recall

• 19 (1) A holder of a COVID-19 medical device authorization must, on or before recalling a COVID-19 medical device for which the authorization has been issued, provide the Minister with the following:

  • (a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

  • (b) the name and contact information of the manufacturer and, if applicable, the importer, as well as the name and contact information of the establishment where the device was manufactured, if different from that of the manufacturer;

  • (c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which it was discovered;

  • (d) an evaluation of the risk associated with the defectiveness or possible defectiveness;

  • (e) the number of affected units of the device that were manufactured or sold in Canada or imported into Canada;

  • (f) the period during which the affected units of the device were sold in Canada;

  • (g) the name of each person to whom the affected device was sold and the number of units sold to each person;

  • (h) a copy of any communication issued with respect to the recall;

  • (i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion;

  • (j) the proposed action to prevent a recurrence of the problem; and

  • (k) the name, title and telephone number of the representative of the holder of the authorization to contact for any information concerning the recall.

• Marginal note:Information — after completion of recall

  (2) The holder of the authorization must, as soon as feasible after the completion of the recall, prepare and submit to the Minister a report on

  • (a) the results of the recall; and

  • (b) the action taken to prevent a recurrence of the problem.

• Marginal note:Submission on holder’s behalf

  (3) Despite subsections (1) and (2), the holder of the authorization may permit the importer of the COVID-19 medical device to prepare and submit, on the holder’s behalf, the information and material required under those subsections if the importer has the same information and material.

• Marginal note:Notice to Minister

  (4) The holder of the authorization must notify the Minister, in writing, if the holder has permitted the importer to prepare and submit the information and material with respect to the recall on the holder’s behalf.

PART 2COVID-19 Drugs

Marginal note:Application

• 20 (1) An application for a COVID-19 drug authorization must be signed and dated by the applicant’s senior medical or scientific officer in Canada and their senior executive officer and must be submitted to the Minister in the form and manner specified by the Minister.

• Marginal note:Content

  (2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

  • (a) the protocol of the proposed clinical trial;

  • (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;

  • (c) a clinical trial attestation containing

    • (i) the title of the protocol and the clinical trial number,

    • (ii) the brand name, chemical name or code for the drug,

    • (iii) the therapeutic and pharmacological classifications of the drug,

    • (iv) the medicinal ingredients of the drug,

    • (v) the non-medicinal ingredients of the drug,

    • (vi) the dosage form of the drug,

    • (vii) the name and contact information of the applicant,

    • (viii) if the drug is to be imported, the name and contact information of the applicant’s representative in Canada who is responsible for the sale of the drug,

    • (ix) for each clinical trial site, the name and contact information of the qualified investigator, if known at the time of submitting the application,

    • (x) for each clinical trial site, the name and contact information of the research ethics board that approved the protocol referred to in paragraph (a) and the informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and

    • (xi) a statement that

      • (A) the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and

      • (B) all information and material contained in, or referenced by, the application is complete and accurate and is not false or misleading;

  • (d) the name and contact information of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;

  • (e) the physical, chemical and pharmaceutical properties of the drug;

  • (f) the pharmacological aspects of the drug, including its metabolites in all animal species tested;

  • (g) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested;

  • (h) any toxicological effects of the drug in any animal species tested under a single dose study, a repeated dose study or a special study;

  • (i) any results of carcinogenicity studies in any animal species tested in respect of the drug;

  • (j) any results of clinical pharmacokinetic studies of the drug;

  • (k) any of the following information that was obtained from previous clinical trials in humans in respect of the drug;

    • (i) safety,

    • (ii) pharmacodynamics,

    • (iii) efficacy, and

    • (iv) dose responses;

  • (l) if the drug contains a human-sourced excipient, including any used in the placebo,

    • (i) in the case where the excipient has been assigned a drug identification number under subsection C.01.014.2(1) of the Food and Drug Regulations or, in the case of a new drug, has been issued a notice of compliance under subsection C.08.004(1) of those Regulations, a statement to that effect, or

    • (ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the excipient;

  • (m) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) of the Food and Drug Regulations or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01 of those Regulations, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and

  • (n) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.

• Marginal note:Marketed drug

  (3) If the application for the authorization is in respect of a COVID-19 drug that meets the requirements of paragraphs 27(a) to (c), the application must also contain

  • (a) a copy of the label of the drug; and

  • (b) information demonstrating that the proposed use of the drug is consistent with the standard of medical practice.

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.