Draft guidance on expanded access clinical trials: Closed consultation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Health Canada has published a draft guidance document on expanded access clinical trials.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

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Health Canada has published a draft guidance document to describe the regulatory requirements for expanded access clinical trials, as they are currently set out in the Food and Drug Regulations (Part C,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).

We will review the comments and feedback received from participants on the draft guidance and publish a "what we heard" report in early 2025. After this, we will develop final guidance to support expanded access in Canada.

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• Notice abut the draft guidance on expanded access clinical trials
• Draft guidance on expanded access clinical trials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