As we previously reported, Health Canada consulted on the framework for clinical trials, including on the new Clinical Trials Regulations and draft and updated guidance documents. Health Canada has now published a What we heard overview of the results of the consultation. There was general support for efforts to modernize the clinical trial regulations from stakeholders who provided feedback. Health Canada expects to publish the final version of the regulations in the Canada Gazette, Part II, in spring 2027, followed by a one-year coming-into-force period.
Additionally, Health Canada has published a notice of an interim policy for the modernization of the clinical trial framework. Based on the consultations, Health Canada identified opportunities to advance three elements through policy:
- updating how to notify Health Canada about ethics approvals in multi-site trials;
- expanding the scope of a "qualified investigator" to non-physician/dentist competent investigators (those who have the education, training and experience required to conduct the clinical trial), so long as medical care is assured by a physician or a dentist; and
- acceptability of non-traditional "documented" informed consent approaches, including remote and electronic methods.
The interim policy will be replaced by final policies when the new Clinical Trials Regulations come into force, which is anticipated to be in spring 2028.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.