Share your ideas: Consultation on draft guidance on expanded access clinical trials

From: Health Canada

Current status: Open

Opened on August 2, 2024, and will close to new input on 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Health Canada has published a draft guidance document on expanded access clinical trials.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.

Join in: how to participate

Send us an email
Send an email to bpsip-bpspiconsultation@hc-sc.gc.ca with your ideas or comments to make yourself heard.

Participate by mail
Send a letter with your ideas and input to the address in contact information below.

Who is the focus of this consultation

The Government of Canada will engage with interested parties, including:

• patient advocacy organizations
• health care providers
• industry stakeholders
• sponsors of clinical trials

Key points about the draft guidance

Expanded access clinical trials are 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Health Canada has published a draft guidance document to describe the regulatory requirements for expanded access clinical trials, as they are currently set out in the Food and Drug Regulations, Division 5. We will develop a final document based on the comments we receive.

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• Notice abut the draft guidance on expanded access clinical trials
• Draft guidance on expanded access clinical trials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