Canada’s Drug Agency: Guidance Document On Use Of AI Methods & Summary Of Precision Medicine Initiatives

In July 2026, Canada’s Drug Agency (CDA) published Use of Artificial Intelligence Methods to Generate Real-World Evidence Submitted to Canada’s Drug Agency for HTA. This guidance document describes principles for use of AI methods to extract variables from unstructured data to generate real-world evidence for health technology assessment submissions. The CDA emphasizes that AI should only be used when clearly justified and should not yet replace well-established approaches when those can produce reliable results.

The guidance document lists governance considerations and appraisal principles:

• governance considerations include transparency in the rationale and justification for use of AI methods and the need for human oversight and validation.
• appraisal principles include an emphasis on transparency and explainability, including in reporting on AI methods for extraction and curation of real-world data, the validation approach and results, and in reporting risk.

The CDA also published a summary of initiatives to support evidence-based decision making about precision medicines and launched new webpages dedicated to its precision medicine work.

CDA’s initiatives include:

• Testing Procedure Assessments, including for biomarker testing required for precision-based therapies submitted for reimbursement review;
• a pan-Canadian assessment framework for biomarkers used in cancer care; and
• collaboration through the Pan-Canadian Cancer Genomics Community of Practice.

 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.