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 lifecycle of medicines
- Promoting registration of protocols and reports
More information on the EMA and ICH Websites.
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vroby (21 octobre 2024). 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. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/12jhd
