SOR/2022-1820222
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20223
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FOOD AND DRUGS ACTPATENT ACTClinical Trials for Medical Devices and Drugs Relating to COVID-19 RegulationsP.C.2022-10020222
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Her Excellency the Governor General in Council, on the recommendation of the Minister of Health with respect to the provisions of the annexed Regulations other than sections 53 and 54, and on the recommendation of the Minister of Health and the Minister of Industry with respect to those sections 53 and 54, makes the annexed Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations pursuant tosection 30a of the Food and Drugs Actb; andS.C. 2021, c. 7, s. 9R.S., c. F-27subsection 134(1)c of the Patent Actd.S.C. 2018, c. 27, s. 199R.S., c. P-4Interpretation
DefinitionsThe following definitions apply in these Regulations.Act means the Food and Drugs Act. (Loi)COVID-19 means the coronavirus disease 2019. (COVID-19)COVID-19 drug means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. (drogue utilisée en lien avec la COVID-19)COVID-19 drug authorization means an authorization to do any of the following activities:import or sell a COVID-19 drug that is to be tested in a clinical trial;conduct a clinical trial in respect of such a drug. (autorisation relative à une drogue utilisée en lien avec la COVID-19)COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical utilisé en lien avec la COVID-19)COVID-19 medical device authorization means an authorization to do any of the following activities:import or sell a COVID-19 medical device that is to be tested in a clinical trial;conduct a clinical trial in respect of such a device. (autorisation relative à un instrument médical utilisé en lien avec la COVID-19)incident means any incident that involves a COVID-19 medical device tested in a clinical trial and thatis related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; orhas led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. (incident)qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and whoconducts a clinical trial; orin the case of a clinical trial conducted by a team, is the responsible leader of that team. (chercheur compétent)research ethics board means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. (comité d’éthique de la recherche)
Words and expressionsUnless the context requires otherwise, words and expressions used in these Regulations have the same meaning as in the Medical Devices Regulations and the Food and Drug Regulations, as applicable.Definition of clinical trialHowever, clinical trial has the same meaning as in section 2 of the Act, except as otherwise provided.
Application
ApplicationThese Regulations apply to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug.Non-application — COVID-19 medical deviceThe Medical Devices Regulations, other than sections 6 and 7 and Schedule 1, do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if a COVID-19 medical device authorization has been issued for that device and the authorization has not been revoked in whole.Non-application — COVID-19 drugThe following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if a COVID-19 drug authorization has been issued for that drug and the authorization has not been revoked in whole:the Food and Drug Regulations, other than sections A.01.022 to A.01.024, A.01.026, A.01.041, A.01.042, A.01.050, A.01.067, A.01.068, C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.051, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136 and C.01.435 and Divisions 2 and 4 of Part C; andthe Blood Regulations.
COVID-19 Medical Devices
ApplicationAn application for a COVID-19 medical device authorization must be submitted to the Minister in the form and manner specified by the Minister.ContentThe application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:the name and contact information of the applicant and, if applicable, the importer;the name and class of the device;a description of the device and of the materials used in its manufacture and packaging;a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;the identifier of the device, 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;the name and contact information of the manufacturer as they appear on the device label;the address where the device is manufactured, if the address is different from the one provided in the contact information under paragraph (f);the diagnosis, treatment, mitigation or prevention for which the device is required;a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and of any recalls of the device in those countries;the known information in relation to the quality, safety and effectiveness of the device;the directions for use, unless directions are not required for the device to be used safely and effectively;an attestation by the applicant that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls;a copy of the label of the device;the name of the qualified investigator and their qualifications, including their training and experience;the name and contact information of the institution at which the clinical trial is proposed to be conducted;the protocol of the proposed clinical trial, including the number of clinical trial subjects, the number of units of the device proposed to be used for the clinical trial, the hypothesis for and objective of the clinical trial, the period of time during which the clinical trial will be conducted and a copy of the informed consent form;a written undertaking from the qualified investigator toconduct the clinical trial in accordance with the protocol provided by the applicant,inform each clinical trial subject of any risks and benefits associated with the use of the device and obtain the subject’s informed consent for its use, andnot permit the device to be used by any other person except under the direction of the qualified investigator; andin the case of a Class III or IV device, for each clinical trial site, the name and contact information of the research ethics board that approved the protocol and informed consent form referred to in paragraph (p), if known at the time of submitting the application.Class II devicesDespite subsection (2), if the application for the authorization is in respect of a COVID-19 medical device that is a Class II device, the information and material set out in paragraphs (2)(c), (h) to (j), (n) and (q) may be omitted from the application.
IssuanceThe Minister must issue a COVID-19 medical device authorization if the following requirements are met:the applicant has submitted to the Minister an application that meets the requirements set out in section 4;the applicant has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); andthe Minister determines thatthe use of the device that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects, users or other persons,the clinical trial is not contrary to the best interests of clinical trial subjects, andthe objectives of the clinical trial are achievable.
Research ethics board approvalA holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device unless the holder has obtained, for each clinical trial site, the approval of a research ethics board in respect of the protocol and informed consent form referred to in paragraph 4(2)(p).
Terms and conditionsThe Minister may, at any time, impose terms and conditions on a COVID-19 medical device authorization or amend those terms and conditions.
ProhibitionSubject to subsection (2), if the substance of any of the information or material referred to in paragraphs 4(2)(a) to (d), (f), (h), (j), (k) and (p) and, if applicable, submitted under subsection 10(1) is significantly different from the substance of the information or material contained in the application for a COVID-19 medical device authorization,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; andthe holder of the authorization must not import or sell the COVID-19 medical device for which the authorization was issued.AmendmentSubsection (1) does not apply ifthe holder of the COVID-19 medical device authorization has submitted to the Minister an application to amend the authorization;the Minister determines that the requirements set out in subparagraphs 5(c)(i) to (iii) are met;the holder has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); andthe Minister amends the authorization.
SuspensionThe Minister may suspend, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, ifthe Minister determines that any of the requirements set out in subparagraphs 5(c)(i) to (iii) is no longer met;the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); orthe holder of the authorization has contravened these Regulations or any provisions of the Act relating to the device.ReinstatementThe Minister must reinstate a COVID-19 medical device 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.
Additional information and materialThe Minister may request that an applicant for a COVID-19 medical device 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.Time, form and mannerThe applicant or holder must submit the information or material in the time, form and manner specified by the Minister.
DiscontinuanceIf a holder of a COVID-19 medical device authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,notify the Minister, in writing, of the discontinuance and the reasons for it;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, users or other persons; andin respect of each clinical trial site at which the trial is discontinued, stop the importation or sale of the device as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the device that have been sold.
Discretionary revocationThe Minister may revoke, in whole or in part, a COVID-19 medical device 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 9(2).Mandatory revocationThe Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 11(a).
LabellingA person must not import or sell a medical device for which a COVID-19 medical device authorization has been issued or conduct a clinical trial in respect of such a device unless the device has a label that sets out the following information:the name of the device;the name and contact information of the manufacturer;the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family;in the case of a Class III or IV device, the control number;if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;a statement indicating that the device is sterile, if the device is to be sold in a sterile condition;the expiry date of the device, if applicable;the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;the directions for use, unless directions are not required for the device to be used safely and effectively;any special storage conditions applicable to the device;a statement indicating that the device is an investigational device;a statement indicating that the device is to be used by qualified investigators only; andin the case of an in vitro diagnostic device, a statement indicating that the performance specifications of the device have not been established.Presentation of informationThe information required by subsection (1) to be set out on the label must be in English and in French.
Incident reportingA 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.
RecordsA 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.ContentThe 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.Retention periodThe holder of the authorization must retain all records for the period during which the authorization has not been revoked in whole.
Distribution recordsA 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.WithdrawalThe 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.Retention periodThe 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 ofthe projected useful life of the device, andtwo years after the date on which the holder took possession, care or control of the device in Canada.Timely retrievalDistribution records must be maintained in a manner that will allow their timely retrieval.
Complaint handlingA 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: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; andall actions taken by the holder in response to those problems.
Documented proceduresA 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 outan effective and timely investigation of the problems referred to in paragraph 17(a); andan effective and timely recall of the device.
Information — recallA 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: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;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;the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which it was discovered;an evaluation of the risk associated with the defectiveness or possible defectiveness;the number of affected units of the device that were manufactured or sold in Canada or imported into Canada;the period during which the affected units of the device were sold in Canada;the name of each person to whom the affected device was sold and the number of units sold to each person;a copy of any communication issued with respect to the recall;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;the proposed action to prevent a recurrence of the problem; andthe name, title and telephone number of the representative of the holder of the authorization to contact for any information concerning the recall.Information — after completion of recallThe holder of the authorization must, as soon as feasible after the completion of the recall, prepare and submit to the Minister a report onthe results of the recall; andthe action taken to prevent a recurrence of the problem.Submission on holder’s behalfDespite 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.Notice to MinisterThe 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.
COVID-19 Drugs
ApplicationAn 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.ContentThe application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:the protocol of the proposed clinical trial;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;a clinical trial attestation containingthe title of the protocol and the clinical trial number,the brand name, chemical name or code for the drug,the therapeutic and pharmacological classifications of the drug,the medicinal ingredients of the drug,the non-medicinal ingredients of the drug,the dosage form of the drug,the name and contact information of the applicant,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,for each clinical trial site, the name and contact information of the qualified investigator, if known at the time of submitting the application,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, anda statement thatthe clinical trial will be conducted in accordance with good clinical practices and these Regulations, andall information and material contained in, or referenced by, the application is complete and accurate and is not false or misleading;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;the physical, chemical and pharmaceutical properties of the drug;the pharmacological aspects of the drug, including its metabolites in all animal species tested;the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested;any toxicological effects of the drug in any animal species tested under a single dose study, a repeated dose study or a special study;any results of carcinogenicity studies in any animal species tested in respect of the drug;any results of clinical pharmacokinetic studies of the drug;any of the following information that was obtained from previous clinical trials in humans in respect of the drug;safety,pharmacodynamics,efficacy, anddose responses;if the drug contains a human-sourced excipient, including any used in the placebo,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, orin any other case, sufficient information to support the identity, purity, potency, stability and safety of the excipient;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; andthe proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.Marketed drugIf 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 containa copy of the label of the drug; andinformation demonstrating that the proposed use of the drug is consistent with the standard of medical practice.
IssuanceThe Minister must issue a COVID-19 drug authorization if the following requirements are met:the applicant has submitted to the Minister an application that meets the requirements set out in section 20;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); andthe Minister determines thatthe 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,the clinical trial is not contrary to the best interests of clinical trial subjects, andthe objectives of the clinical trial are achievable.
Additional information prior to clinical trialA 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 hasfor 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); andsubmitted 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.
Terms and conditionsThe Minister may, at any time, impose terms and conditions on a COVID-19 drug authorization or amend those terms and conditions.
ProhibitionSubject 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,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; andthe holder of the authorization must not import or sell the COVID-19 drug for which the authorization was issued.AmendmentSubsection (1) does not apply ifthe holder of the COVID-19 drug authorization has submitted to the Minister an application to amend the authorization;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);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;the Minister determines that the requirements set out in subparagraphs 21(c)(i) to (iii) are met;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); andthe Minister amends the authorization.Immediate changeDespite 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.Immediate change — application to amendThe 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.
Prohibition — importA 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.
Prohibition — import and saleA 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.
Marketed drugsParagraphs 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 ifthe use of the drug is consistent with the standard of medical practice;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; andthe 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.
Good clinical practicesA 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 thatthe clinical trial is scientifically sound and clearly described in the protocol;the clinical trial is conducted, and the drug is used, in accordance with the protocol and these Regulations;systems and procedures that assure the quality of every aspect of the clinical trial are implemented;for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins;at each clinical trial site, there is no more than one qualified investigator;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;each person who is involved in the conduct of the clinical trial is qualified by education, training and experience to perform their respective tasks;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 ofthe risks and anticipated benefits to their health arising from participation in the clinical trial, andall other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; andthe 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.
SuspensionThe Minister may suspend, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, ifthe Minister determines that any of the requirements set out in subparagraphs 21(c)(i) to (iii) is no longer met;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); orthe holder of the authorization has contravened these Regulations or any provisions of the Act relating to the drug.ReinstatementThe 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.
Additional information and materialThe 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.Time, form and mannerThe applicant or holder must submit the information or material in the time, form and manner specified by the Minister.
DiscontinuanceIf 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,notify the Minister, in writing, of the discontinuance and the reasons for it;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; andin 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.
Discretionary revocationThe 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).Mandatory revocationThe 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).
LabellingA 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 statement indicating that the drug is an investigational drug to be used only by a qualified investigator;the name, number or identifying mark of the drug;the expiration date of the drug;the recommended storage conditions for the drug;the lot number of the drug;the name and contact information of the holder of the authorization; andthe protocol code or identification.Presentation of informationThe information required by subsection (1) to be set out on the label must be in English and in French.
Serious unexpected adverse drug reactionA 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:within 15 days after becoming aware of the reaction, if it is neither fatal nor life‑threatening; andwithin seven days after becoming aware of the reaction, if it is fatal or life‑threatening.
RecordsA 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.ContentThe 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:the information and material referred to in paragraphs 20(2)(e) to (k);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;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;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;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;records respecting the shipment, receipt, disposition, return and destruction of the drug;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 thatthe qualified investigator will conduct the clinical trial in accordance with good clinical practices, andthe 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;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; andfor 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.Retention periodThe 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.
General
Remote written informed consentIf a qualified investigator is not able to obtain, in person, the written informed consent of a person to participate in a clinical trial in respect of a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or a COVID-19 drug for which a COVID-19 drug authorization has been issued, the qualified investigator may obtain the written informed consent remotely.Non-written informed consentIn the case where the person is not able to provide their written informed consent, the qualified investigator may obtain their non-written informed consent if the following conditions are met:the qualified investigator reads the contents of the informed consent form to the person;the person provides their informed consent before a witness; andan attestation by the witness that the person has provided their informed consent is provided to the qualified investigator as soon as feasible.
Other Clinical Trials
Exemption — certain drugsA person that is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.Clarification — suspension and cancellationFor greater certainty, the exemption does not applyif the authorization to sell or import the drug is suspended in its entirety; orin respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the drug is suspended or cancelled in respect of that site.Definition of clinical trialIn this section, clinical trial has the same meaning as in section C.05.001 of the Food and Drug Regulations.
Exemption — positron-emitting radiopharmaceuticalsA person that is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study — and any other person that conducts the study — is, in respect of the study, exempt from section 3.1 of the Act.Clarification — suspension and cancellationFor greater certainty, the exemption does not applyif the authorization to sell or import the radiopharmaceutical is suspended in its entirety; orin respect of the conduct of the study at a study site, if the authorization to sell or import the radiopharmaceutical is suspended or cancelled in respect of that site.
Exemption — natural health productsA person that is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.Clarification — suspension and cancellationFor greater certainty, the exemption does not applyif the authorization to sell or import the natural health product is suspended in its entirety; orin respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the natural health product is suspended or cancelled in respect of that site.DefinitionsThe following definitions apply in this section.clinical trial has the same meaning as in section 63 of the Natural Health Products Regulations. (essai clinique)natural health product has the same meaning as in subsection 1(1) of the Natural Health Products Regulations. (produit de santé naturel)
Exemption — medical devicesA person that is authorized under Part 3 of the Medical Devices Regulations to sell a medical device for investigational testing — and any person that conducts the testing of the device — is, in respect of the testing, exempt from section 3.1 of the Act.ExceptionThe exemption does not apply in respect of any person to whom the medical device can no longer be sold as a result of a measure taken by the Minister under subsection 85(2) of the Medical Devices Regulations.
Suspension — deemed holderAn authorization to conduct a clinical trial in respect of a drug is suspended ifthe holder is deemed to hold the authorization under any of sections 180 to 182 of the Budget Implementation Act, 2019, No. 1; andthe holder’s authorization to sell or import the drug for the purposes of the clinical trial is suspended undersection C.03.317, C.05.016 or C.05.017 of the Food and Drug Regulations, orsection 80 or 81 of the Natural Health Products Regulations.ReinstatementAn authorization that is suspended under subsection (1) is reinstated if the authorization referred to in paragraph (1)(b) is reinstated.Revocation — deemed holderAn authorization to conduct a clinical trial in respect of a drug or medical device is revoked ifthe holder is deemed to hold the authorization under any of sections 180 to 183 of the Budget Implementation Act, 2019, No. 1; andthe holder’s authorization to sell or import the drug or device for the purposes of the clinical trial is cancelledin the case of a drug, undersection C.03.319 or paragraph C.05.016(4)(b) or C.05.017(3)(b) of the Food and Drug Regulations, orparagraph 82(b) of the Natural Health Products Regulations, andin the case of a device, under paragraph 85(2)(b) of the Medical Devices Regulations.Partial suspensions or revocationsIf the authorization referred to in paragraph (1)(b) or (3)(b) is only partially suspended or cancelled, the authorization to conduct the clinical trial is suspended or revoked to the same extent.
Transitional Provisions
Definition of Interim Order No. 2In sections 43 to 52, Interim Order No. 2 means the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 3, 2021, and published in Part I of the Canada Gazette on May 22, 2021.
ApplicationsAn application for a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 2 before the day on which this section comes into force and in respect of which no decision has been made before that day is deemed to be an application for a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under these Regulations.
AuthorizationsA COVID-19 medical device authorization or a COVID-19 drug authorization that was issued or reinstated by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization issued or reinstated under these Regulations.
Approval — research ethics boardAny approval of a research ethics board that was obtained by a holder of a COVID-19 medical device authorization or a holder of a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force is deemed to be an approval of the research ethics board obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under these Regulations.
Terms and conditionsAny terms and conditions that were imposed on a COVID-19 medical device authorization or a COVID-19 drug authorization by the Minister under Interim Order No. 2 before the day on which this section comes into force are deemed to be terms and conditions imposed on the COVID-19 medical device authorization or the COVID-19 drug authorization under these Regulations.
Amendment applicationsAn application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 2 before the day on which this section comes into force and in respect of which no decision has been made before that day is deemed to be an application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under these Regulations.
Amended authorizationA COVID-19 medical device authorization or a COVID-19 drug authorization that was amended by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization amended to the same extent under these Regulations.
SuspensionA COVID-19 medical device authorization or a COVID-19 drug authorization that was suspended in whole or in part by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization suspended in whole or in part to the same extent under these Regulations.
Request — additional information and materialA request for additional information or material, including samples, that was made by the Minister under Interim Order No. 2 before the day on which this section comes into force is deemed to be a request for additional information or material under these Regulations.
DiscontinuanceA notice of discontinuance provided to the Minister, or information in respect of discontinuance provided in writing to a qualified investigator, by the holder of a COVID-19 medical device authorization or a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force is deemed to be a notice of discontinuance or information provided under these Regulations.
Revocation in partA COVID-19 medical device authorization or a COVID-19 drug authorization that was revoked in part by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization revoked in part to the same extent under these Regulations.
Consequential Amendments, Related Amendments and Coming into ForceConsequential AmendmentsCertificate of Supplementary Protection Regulations
[Amendments]
Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages)
[Amendments]
Related AmendmentsFood and Drug Regulations
[Amendments]
Natural Health Products Regulations
[Amendments]
Coming into Force
RegistrationSubject to subsection (2), these Regulations come into force on the day on which they are registered.Cessation of effect of interim orderSections 1 to 53 come into force on the day following the day on which the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 3, 2021, and published in the Part I of the Canada Gazette on May 22, 2021, ceases to have effect.[Note: Sections 1 to 53 in force February 27, 2022.]
SOR/2022-182022-02-27