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ICH reflection paper on integrating real-world evidence into regulatory decision-making

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a reflection paper for public consultation to harmonise real-world evidence terminology and enable the convergence of general principles for planning and reporting studies using real-world data to support regulatory decision-making. 

The paper is co-authored by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Health Canada. The reflection paper builds on the 2022 statement from ICMRA, which offers a strategic approach for future ICH guidelines on the assessment of real-world data and real-world evidence.

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.

The public consultation is open until 30 September 2023.