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Depending on the type of clinical trial, sponsors may be required to file a Clinical Trial Application (CTA) for human drug clinical trials. Instances where a CTA must be filed are summarized in the chart below.
This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.
Food and Drug Regulations-Amendment (Schedule No.1024) Clinical Trial Framework
The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials
Consultation on guidance document: Drugs for Clinical Trials Involving Human Subjects.
Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.
As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of the protocol. Health Canada authorizes this protocol and the Research Ethics Board approves it. During the pandemic, there may be more deviations from the established protocol.
This Ministerial Order (MO) will give Health Canada an additional 15 days to review all clinical trial applications and amendments submitted under Division 5 of the Food and Drug Regulations.
The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.