Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 20
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. 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;