The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines”, co-authored by EMA, US-FDA (Food and Drug Administration) and Health Canada (Canada).

This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas:

• Convergence on terminology for RWD and RWE.
• Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines.
• Registration of study protocols and reports.
• The assessment of RWD and RWE for regulatory purposes.

The benefit of such harmonization is applicable to all types of medicinal products at any stage of their lifecycle, i.e., from development/pre-approval to post-marketing monitoring. ICH guidance can increase the efficiency of resources across a large number of stakeholders, by aligning expectations of medicines regulators, medicines developers/pharmaceutical industry, patient advocacy groups, contract research organisations, academia, and other stakeholders using RWD to generate evidence on medicinal products.

So, the proposal can support timely decisions on the development of innovative treatments, help to address unmet medical needs, and support the safe and effective use of medicines.

EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment.

Comments should be provided using the template through the link https://bit.ly/43QLvCq to be sent to ich@ema.europa.eu by 30 September 2023.

Your opinion is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD/RWE in medicines regulation.