RWE 201 – Beyond Clinical Trials: Health Canada’s Commitment to Real World Evidence


Health Canada is dedicated to enhancing drug accessibility, affordability, and correct usage within the country. To achieve this, it’s maximizing (optimizing) the use of real world evidence (RWE) for its regulatory decisions. RWE is generated from real world data (RWD) and offers an alternative source for assessing drug safety, efficacy, and effectiveness. This is especially crucial when conventional clinical trials are not suitable [1].

While clinical trials are often deemed the gold standard for drug evaluation, they might not always be feasible or representative of the broader population. The rising availability of RWD globally can provide deeper insights, particularly for specific patient groups, potentially leading to faster and broader drug access.

Incorporating RWE into the drug regulation process is a priority for Health Canada, and they’re continually refining their expertise in this realm. To solidify the role of RWE, they are collaborating with key stakeholders like industry representatives and health technology assessment entities. A recent joint document with Canada’s Drug and Health technology Agency (published May 2023) provides guidance on the effective use of RWE (Guidance for Reporting Real-World Evidence). Insights from this collaborative venture will be explored more in this series [2] [3].

Quality assurance of RWE is paramount. Factors to determine its quality encompass data reliability, study design, statistical analysis, and results interpretation. Protocol development is a cornerstone of high-quality RWE. Health Canada has pinpointed fifteen essential aspects to address during this phase, from research design to study results communication. Especially with retrospective data, maintaining RWE quality demands rigorous research questions, validated data elements, and transparency [4].

For drug submissions utilizing RWE, Health Canada sets forth stringent review requirements. Sponsors must transparently present their use of RWE, give reasons for its choice over traditional methods, detail RWE collection and analysis processes, and tackle potential biases. Pre-submission consultations with Health Canada are also advisable.

In conclusion, Health Canada’s proactive stance on RWE underpins its commitment to drug accessibility and affordability. By harnessing RWE, they aim to cater to groups often overlooked in clinical trials, address certain patient or disease challenges, and amplify drug accessibility rates. Emphasizing collaboration, protocol development, and data quality, Health Canada is setting a robust, transparent standard for RWE utilization throughout the drug’s life cycle.



[1] Health Canada – Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making (April 2019)


[2] Canada’s Drug and Health technology Agency (CDHTA) – Real-World Evidence for Decision-Making (August 2023)


[3] Canada’s Drug and Health technology Agency (CDHTA) – Guidance for Reporting Real-World Evidence (May 2023)


[4] Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle (March 2019)


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