Pangaea Express: Health Canada Extends Consultation Period for Clinical Trial Regulations

Health Canada has extended the consultation period on the proposed Clinical Trials Regulations, the Regulations Amending Certain Regulations Relating to Clinical Trials and three associated draft guidance documents. The comment period has been extended to 120 days and is open from December 20, 2025 to April 19, 2026.

The proposed Regulations affect the conduct of trials and the sale of drugs used in trials allowing for a more flexible, risk-based approach to oversight with terms and conditions. They would facilitate decentralized trials with consent provided orally or via electronic signatures and expanding the types of professionals who can act as investigators.

If you have not already done so, you can still comment on these proposed Regulations and Guidance to help diminish delays, especially for more innovative drug trials, and ensure Canada remains competitive as a destination for clinical trial sites.

For more information, please contact Suzanne Solman at ssolman@pangaea-consultants.com or Marla Weingarten at mweingarten@pangaea-consultants.com.