Standardizing Real-World Data and Evidence: Insights from the ICH Reflection Paper

The reflection paper on “ICH Reflection Paper on Pursuing Opportunities for Harmonisation in Using Real-World Data (RWD) to Generate Real-World Evidence (RWE), with a Focus on Effectiveness of Medicines” was co-developed by the European Medicines Agency, the U.S. FDA, and Health Canada, and adopted by the ICH Assembly in June 2024. The paper aims to standardize the terminology and formats for RWD and RWE in regulatory submissions and promote the registration of study protocols and reports. This effort, following a public consultation in 2023, marks a significant commitment to harmonizing RWE guidelines, supporting its integration into regulatory decision-making. Future steps will include additional public consultations.¹

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References

1. ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines. (2024). In European Medicines Agency (Report EMA/CHMP/ICH/295401/2023; pp. 3–12). https://www.ema.europa.eu/en/documents/other/ich-reflection-paper-pursuing-opportunities-harmonisation-using-real-world-data-generate-real-world-evidence_en.pdf

Disclaimers

• The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
• Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
• No official support by any organization(s) has been provided or should be inferred

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