Draft guidance on expanded access clinical trials: Notice
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Background
Clinical trials, including expanded access clinical trials, are investigations that can sometimes help to provide access to novel therapies before they have been authorized for sale by Health Canada. This could include therapies for serious or life-threatening conditions where authorized drugs may be limited for certain patients (for example, related to oncology, rare diseases and some mental health disorders).
Health Canada has developed a draft guidance document on expanded access clinical trials. This document highlights and provides more information on an existing mechanism that may interest sponsors of clinical trials, health care providers and potential patients.
The regulatory requirements for "drugs for clinical trials involving human subjects" are outlined in Part C, Division 5 of the Food and Drug Regulations. As the regulations already support the use of expanded access clinical trials, the draft guidance will take effect at the same time as the consultation process.
About expanded access clinical trials
An expanded access clinical trial is a type of clinical trial. It provides access to investigational drugs that have the potential to treat people:
- living with a medical condition who do not qualify for other clinical trials or
- are not able to participate in one
Expanded access clinical trials can be designed to reach a larger, potentially more diverse population of participants, in more accessible, real-world settings. Thus, they may provide greater access to investigational drugs for some patients who may benefit from treatment.
How you can get involved
We're looking for your feedback on the draft guidance.
After the consultation period ends on October 31, 2024, we will review all written submissions. Your comments will be made public in a "what was heard" report and will be considered when we finalize the guidance. This final version will be developed as part of Health Canada's broader clinical trial modernization initiative.
Learn more:
- Consultation on draft guidance on expanded access clinical trials
- Draft guidance on expanded access clinical trials
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St.
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca
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