Clinical trials for drugs
Clinical trials are tests done to look at the safety and effectiveness of a drug in humans.
About clinical trials
Clinical trials and drug safety
About clinical trials, how they work and how we oversee them
Canada’s search portal for clinical trials
Information on Health Canada-approved clinical trials involving pharmaceutical, biologic and radiopharmaceutical drugs
Inspections of clinical trials for human drugs
How and why we monitor clinical trials through inspections and other measures, such as tracking adverse reactions
Modernizing clinical trial regulations
Our plan to improve access to novel therapies, about the 2021 consultation on modernizing the clinical trials regulations
Clinical information on drugs
Information on trials of new drugs to assess safety and efficacy, making information available after regulatory reviews
Notices and announcements about drugs
List of current and past announcements, including consultations and guidance documents on drugs
Guidance on conducting clinical trials
Guidance for clinical trial sponsors: Clinical trial applications
How to complete and file a clinical trial application or amendment
Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036)
The regulatory requirements for manufacturing, handling and storing clinical trial drugs
Guidance on the registration of clinical trials and public disclosure of results
Where and how to register a clinical trial, report results and find information on the Canadian clinical trial search portal
Drugs for clinical trials involving human subjects (GUI-0100)
How to comply with Part C, Division 5 of the regulations while following international good clinical practice standards
Clinical trial applications (CTAs) for pharmaceuticals quality (chemistry and manufacturing) guidance
How to prepare the quality portion of a clinical trial application
Guidance on expanded access for clinical trials
The regulatory requirements and how to access expanded access clinical trials
Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043)
How we rate clinical trial inspection observations and inspection outcomes based on risk
Draft guidance on decentralized clinical trials
Know the regulatory considerations for conducting decentralized clinical trials in Canada
Guidance on clinical trials for drug products
Guidelines on how to interpret policies, legislation and regulations