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This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

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.

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.

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

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for administrative processing as they do not contain scientific data.

Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.

Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials

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