EMA Pushes for Global Harmonization in Real-World Evidence Use for Medicine Evaluation

This paper discusses the evolving role of Real-World Data (RWD) and Real-World Evidence (RWE) in evaluating medicines. The European Medicines Agency (EMA) adopted this document on July 3, 2024, for the European Union. It highlights the need for international collaboration to address gaps in terminology, data quality, and study designs.

Real-world data can also generate evidence suitable for regulatory decision-making, such as in point-of-care trials and non-interventional studies. The paper proposes a stepwise approach to harmonize terminology, assess data quality, and establish common principles for integrating real-world evidence into regulatory submissions. The objective is to engage the International Committee of the Red Cross (ICH) on convergent terminology for RWD and RWE, format for protocols and reports, and promote protocol and report registration.

Source: https://www.ich.org/page/reflection-papers##~https://www.ema.europa.eu/en/documents/other/ich-reflection-paper-pursuing-opportunities-harmonisation-using-real-world-data-generate-real-world-evidence_en.pdf##~https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-council-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich##~https://admin.ich.org/sites/default/files/2024-06/ICH_Reflection%20Paper_RWE_2024_0521_EndorsedbyICHAssembly_2024_0604.pdf

Region: All Markets, European Union