Canada’s Intellectual Property Firm

Health Canada invites submissions containing high quality real world evidence

On April 16, 2019, Health Canada released a notice inviting drug submissions containing high quality real world evidence along with a document providing principles for the collection and evaluation of real world evidence.

Submissions containing real world evidence are encouraged in the following circumstances: to “expand evidence-based indications for populations often excluded from clinical trials”; “for drugs/diseases where clinical trials are unfeasible”; or “where clinical trials are unethical”. Sponsors must clearly identify that a submission contains real world evidence. When real world evidence is used as pivotal evidence, a sponsor must also (i) provide a rationale for its use; (ii) provide a detailed explanation of its collection/analysis; (iii) demonstrate how biases in data collection were mitigated; and (iv) contact Health Canada to determine whether a pre-submission meeting would be beneficial.

A further joint document regarding the use of real world evidence is in development by Health Canada, CADTH and INESSS with an anticipated release date of later this year.