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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.

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.

Food and Drug Regulations-Amendment (Schedule No.1024) Clinical Trial Framework

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.

The pre-CTA consultation meeting provides an opportunity for the sponsor to present relevant data, discuss concerns and resolve issues regarding drug development. It also gives Health Canada an opportunity to provide guidance on the acceptability of the proposed trial(s).

All Clinical Trial Applications (CTAs) and Clinical Trial Application Amendments (CTA-As) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada.

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Provides answers to frequently asked questions about Health Canada filing requirements for clinical trials

Clinical trials can be an important treatment option. However, like all drugs, the drugs used in clinical trials have possible benefits and risks. There is often less information about the safety and efficacy of a drug being studied in a clinical trial than for an authorized drug.

Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.