EMA launches public consultation on patient experience data

Oct 16, 2025

The European Medicines Agency (EMA) has opened a public consultation on the “Reflection paper on patient experience data”. Patients experience data provide valuable insight on their preferences on treatments or outcomes to medicines regulators and other decision-makers in healthcare systems.

The reflection paper aims to encourage medicines’ developers to gather and include data reflecting patients’ real-life perspectives and preferences throughout the lifecycle of medicines and to describe general principles on how to generate, collect and analyse this data.

Feedback from medicine developers, patient groups, researchers and other decision-makers on this consultation will help shape the EU approach to patient experience data with the aim to improve evidence generation and optimise the development of future medicines towards outcomes most relevant to patients.

To learn more about this document visit the EMA webpage. You can send your feedback until 31 January 2026.