Pangaea Express: Health Canada implements an interim policy for clinical trials

Health Canada has implemented an interim policy for clinical trials in Canada that will be in place until the new Clinical Trials Regulations come into force, expected spring 2028. This interim policy will advance 3 specific elements of the Clinical Trials Modernization initiative:

1. Research Ethics Boards:

• Updating how to notify Health Canada about ethics approvals in multi-site trials, in line with coordinated ethics review models
• Contact information for research ethics board only needs to be included once as long as:
  • The same board has previously been identified for approving other sites in trial
  • Board’s contact information has already been provided to Health Canada and is up to date
• Sponsor is responsible for obtaining and retaining all research ethics board approvals for participating sites in accordance with applicable local requirements

This interim policy identifies several initiatives and organizations that have facilitated more streamlined ethics review systems in Canada.

2. Qualification requirements of a “qualified investigator”

• A “qualified investigator” may be a physician or dentist authorized under FDR or
• An individual with education, training and experience required to conduct the clinical trial (if not a physician or dentist, medical decisions outside the licensed scope of practice of the investigator must be made by a qualified physician/dentist responsible for oversight of the trial site)

3. Documented informed consent:

• Moving from "written" to "documented" informed consent allows for new approaches for obtaining consent, such as:
  • Remote or electronic platforms that enable real-time, interactive consent discussions conducted using audio and video technologies
  • Electronic signatures and documentation of consent where it is provided orally, either in person or remotely

Modernizing Clinical Trials Regulations and draft guidance documents were published in the Canada Gazette, Part I and consultations ended April 19, 2026. See What we heard: Consulting on modernizing clinical trials for summarized themes. The final version of the regulations is expected to be published spring 2027 with a one-year coming-into-force period.

Health Canada is not waiting for the Regulation’s publication and implementation but has taken feedback from previous consultations (the draft guidance on decentralized clinical trials and the proposed Clinical Trial Regulations and accompanying guidance) to immediately advance 3 important elements to help improve the conduct of clinical trials in Canada.

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