Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making

Canada’s Drug and Health Technology Agency (CADTH) collaborated with Health Canada and other stakeholders to develop the Guidance for Reporting RWE to Support Decision-making. This guidance promotes the use of high-quality real world data (RWD) and real world evidence (RWE) in drug development and regulatory decision-making. It also emphasizes the importance of transparent and comprehensive reporting of RWE studies to assess reliability and reproducibility.

While traditional clinical trials are still the main source of evidence for regulatory decision-making, Health Canada recognizes there is value in using RWD/RWE.

We are open to receiving submissions that rely on high-quality RWD/RWE in certain situations, such as:

To support the use of RWD/RWE in regulatory decision-making, we have produced several documents, including:

The CADTH guidance aligns with the principles outlined in these documents. You may also find reporting templates such as the ISPE-ISPOR HARmonized Protocol Template to Reproducibility (HARPER) and STaRT-RWE helpful in developing high-quality RWE studies.

Regulatory decision-making requires unique considerations beyond the scope of the CADTH guidance. For this reason, we encourage sponsors to engage with us with tangible plans about why and how they will rely on RWD/RWE for a drug submission. We recommend that sponsors consult the following:

The usefulness of RWD/RWE in regulatory decision-making will be determined case by case. We will base our decision on the methodologies used to generate the evidence, as well as the reliability and relevance of the RWD/RWE.

In their submissions, sponsors should:

Health Canada continues to collaborate with domestic and international partners on the use of RWD/RWE in regulatory decision-making and to develop and harmonize RWD/RWE reporting standards.

For any RWD/RWE-related questions or for more information, sponsors may contact us by email at

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