Health Canada has issued an interim policy notice effective Septembre 14, 2026, outlining temporary measures to modernize clinical trial oversight in Canada. Intended to bridge the gap until the proposed Clinical Trials Regulations come into force (anticipated for spring 2028), this policy aligns Canadian requirements with international standards such as ICH E6 while targeting three key operational areas:
- Streamlined Ethics Reviews for Multi-Site Trials: Under coordinated ethics review models, sponsors notifying Health Canada of new trial sites only need to provide a Research Ethics Board’s (REB) full contact details once. If the REB previously approved other sites in the same trial, subsequent notifications require only the board’s name and approval date. However, sponsors remain fully responsible for retaining complete REB approval records for inspector verification.
- Competency-Based “Qualified Investigator” (QI) Roles: Expanding beyond the traditional requirement that a QI must be a physician or dentist; the interim policy allows other suitably trained and educated individuals to serve as QIs. For non-physician/dentist QIs, any medical decisions outside their licensed scope of practice must be made by a licensed physician or dentist on the trial team who oversees participant care.
- Flexible “Documented” Informed Consent: Departing from strict “written” consent requirements, the policy accepts non-traditional consent methods—such as interactive remote video discussions, electronic platforms, and electronic signatures—provided the consent process is properly documented, complies with ICH E6 principles, and meets relevant legal standards.
Despite these added flexibilities, trial sponsors must maintain full compliance with Good Clinical Practices (GCP), Tri-Council Policy Statement guidelines, and applicable legal/institutional standards. Sponsors remain responsible for securing valid REB approvals, verifying investigator competencies, providing signed REB attestations, and maintaining thorough documentation for Health Canada clinical trial inspections.
