Health Canada has launched a consultation on its draft guidance document to explain the regulatory requirements for expanded access clinical trials, as they are currently set out in the Food and Drug Regulations, Division 5. 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
Please find all information on this consultation at: https://www.canada.ca/en/health-canada/programs/consultation-draft-guidance-expanded-access-clinical-trials.html. The consultation period ends on October 31 and Health Canada will make comments public in a “what was heard” report. A final version of the guidance document is anticipated to be developed as part of Health Canada’s broader clinical trial modernization initiative. Please also note Health Canada will be hosting two webinar information sessions on this draft guidance:
N2’s Rapid Response Team is meeting to finalize its response and is open to feedback from all N2 members. Please send any feedback you’d like to provide to the N2 Rapid Response Team to n2@n2canada.ca by September 22
