EMA publishes ICH Reflection Paper on RWD / RWE

The European Medicines Agency (EMA) has published the final version of the ICH Reflection Paper on the harmonization of the possible use of Real-World Data (RWD) and Real-World Evidence (RWE) in the regulatory environment.

The draft ICH Reflection Paper on RWE was published for public consultation last year. The paper was revised further to comments received during the public consultation held from June to September 2023. In addition, a summary report of comments received on the Reflection Paper during public consultation has been published on the ICH Reflection Papers website.

The reflection paper aims to harmonize RWE  terminology. It also looks to enable the convergence of general principles for planning and reporting studies using RWD to support regulatory decision-making.

The document identifies the following areas for harmonization:

• 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

In addition, the paper includes a useful Annex summarizing existing regulatory guidances and other resources related to RWD / RWE.

More information is available in the ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate RWE, with a focus on effectiveness of medicines published on the EMA website.