EMA/ICH – Publication of an 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

The reflection paper adopted in June 2024 aims "to harmonise real-world evidence terminology. It also looks to enable the convergence of general principles for planning and reporting studies using real-world data to support regulatory decision-making." The reflection paper identifies the following areas for harmonisation: Convergence on terminology for real-world data and real-world evidence Format for protocols and reports of study results submitted to regulatory agencies throughout the lif...