Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making

The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.

Transparency, Man writing on transparent screen
New RWE Guidance Underscores the Importance Of Transparency • Source: Shutterstock

Health Canada and the Canadian health technology appraisal bodies, CADTH and INESSS, have collaborated to produce new guidance on reporting real -world evidence (RWE) that can be used for both regulatory and HTA decision making. The pharmaceutical industry hopes the guidance will lead to quicker access to medicines.

The guidance “lays the foundation for the use of RWE in regulatory approval and Health Technology Assessment in Canada, starting with the

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