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.
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.