Draft guidance on expanded access clinical trials: Closed consultation
From: Health Canada
Current status: Closed
This consultation ran from August 2 to October 31, 2024.
Health Canada has published a draft guidance document on expanded access clinical trials. This document describes the current regulatory requirements for this type of clinical trial.
Who was the focus of this consultation
The Government of Canada engaged with interested parties, including:
- health care providers
- industry stakeholders
- sponsors of clinical trials
- patient advocacy organizations
What we heard
To access the summary report of the consultation, please see What we heard: Draft guidance on expanded access clinical trials.
Key points for discussion
An expanded access clinical trial is a type of clinical trial that provides access to investigational drugs that have the potential to treat people living with medical conditions who:
- do not qualify for other clinical trials or
- are not able to participate in one
Expanded access clinical trials can be designed for a larger, potentially more diverse population of participants, in more accessible settings.
Health Canada has published a draft guidance document to describe the regulatory requirements for expanded access clinical trials, as they are currently set out in the Food and Drug Regulations (Part C, Division 5).
Learn more:
- Notice abut the draft guidance on expanded access clinical trials
- Draft guidance on expanded access clinical trials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, Holland Cross - Tower B
Address Locator: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca