RWE 101 – Regulatory Compliance

Regulatory compliance in the context of real-world evidence (RWE) refers to ensuring that the generation and use of RWE for regulatory purposes are in accordance with applicable laws, regulations, and guidelines. RWE is increasingly being used to support regulatory decision-making in healthcare, particularly in the evaluation of the safety and effectiveness of medical products.

To ensure regulatory compliance when using RWE, organizations must follow the regulatory requirements and guidelines set forth by regulatory agencies such as the FDA in the United States, the EMA in the European Union, and other national regulatory bodies. These requirements and guidelines include criteria for the selection and use of RWE sources, study design, data quality, data privacy, and transparency.

For example, the FDA has published guidance on the use of RWE in regulatory decision-making, which outlines the criteria for using RWE to support the approval of new indications for existing drugs and to satisfy post-marketing study requirements. The guidance stresses the importance of ensuring that RWE studies are designed to address the regulatory question at hand, have appropriate data quality, and include appropriate statistical analyses.

In addition, regulatory compliance in the context of RWE also requires organizations to adhere to ethical standards for the protection of human subjects and patient privacy. Organizations must ensure that RWE studies are conducted in accordance with ethical principles, and that the data collected and analyzed are anonymized, pseudoanonymised, or de-identified to protect patient privacy.

Overall, regulatory compliance in the context of RWE requires organizations to carefully follow regulatory requirements and guidelines to ensure that the RWE generated and used for regulatory purposes is of high quality, meets ethical standards, and meets the regulatory agency’s criteria for acceptability.

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