EMA - 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

9th July 2024

EMA are pleased to share with you the reflection paper on “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”.

This reflection paper was co-developed by the European Medicines Agency, the United States of America's (USA) Food and Drug Administration (FDA), and Health Canada and adopted in June 2024 by the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly.

The objectives of the reflection paper are to engage ICH on the convergence of terminology for Real-World Data (RWD) and Real-World Evidence (RWE), on the format for protocols and reports of study results submitted to regulatory agencies throughout the lifecycle of medicinal products, and on promoting registration of protocols and reports.

It was updated following a public consultation initiated in 2023 by ICH to gather public comments from relevant (non-ICH) stakeholders.

This milestone represents an important public commitment from ICH (and thus EMA) for an initial step of an incremental approach towards harmonisation of regulatory RWE guidance, to further enable the integration of RWE into regulatory submissions and timely regulatory decision-making. When the proposed guideline work progresses, this will include plans for further public consultation and engagement.

For further details on this topic, please consult the following links: EMA ICH webpage - ICH webpage

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