On 16 April 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:

  • to "expand evidence-based indications for populations often excluded from clinical trials";
  • "for drugs/diseases where clinical trials are unfeasible"; and
  • "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:

  • provide a rationale for its use;
  • provide a detailed explanation of its collection and analysis;
  • demonstrate how biases in data collection were mitigated; and
  • 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 expected to be published later in 2019 by Health Canada, the Canadian Agency for Drugs and Technologies in Health and the Institut national d'excellence en santé et en services sociaux.

For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.