2024-08-02 16:20:00
From: Health Canada
Current status: Open
Consultations begin on August 2, 2024, and will end on October 31, 2024.
Health Canada has developed draft guidance to expand access to clinical trials. This document describes the current regulatory requirements for such clinical trials.
Get Involved: How to Get Involved
Send us an email
Send an email to bpsip-bpspiconsultation@hc-sc.gc.ca with your thoughts or opinions and make your voice heard.
write to us
Write your thoughts and comments to the address listed in the contact details below.
The target of this consultation
Health Canada will engage with interested parties, including:
Patient Advocacy Organizations Healthcare Providers Healthcare Industry Stakeholders Clinical Trial Sponsors
Key points of the draft guidance
An expanded access clinical trial is a type of clinical trial that provides the opportunity to study drugs that may treat people with:
Not eligible or unable to participate in other clinical trials
Expanded clinical trials could be designed for larger and potentially more diverse groups of participants in more accessible settings.
Health Canada has developed draft guidance describing the regulatory requirements for expanded clinical trials, currently defined in Part C, Part 5 (Drugs for use in clinical trials in human subjects) food and drug regulations Enforced by Health Canada. We will develop a final document based on the comments received.
learn more:
Contact us
Office of Policy, Science and International Programs
The Goods Administration
Health Products and Food Branch
health canada
1600, Scott Street
Dutch Cross, Section B
Address index: 3106B
Ottawa ON K1A 0K9
Email: bpsip-bpspiconsultation@hc-sc.gc.ca
1723181266
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