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EMA – A path to better include patients’ perspectives in the regulation of medicines

EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.

Patients’ perspectives on medicines and their benefits and risks are of great value to EMA. Patient experience data provide medicines regulators and other decision-makers in healthcare systems with valuable insights into what matters most to patients, beyond other well-established scientific outcomes. An example of the value of these data are cancer medicines where patients may, in some cases, prioritise quality of life over traditional clinical endpoints like overall survival. As such, patients’ lived experiences, reflected in quantitative or qualitative patient experience data, can play a complementary role to other types of data currently collected, notably through clinical trials, and further inform regulator’s decision-making on medicines.

The reflection paper is intended for medicine developers, patient groups, researchers and other decision-makers. It encourages medicines’ developers to gather and include data reflecting patients’ real-life perspectives and preferences throughout the lifecycle of medicines (i.e. during pre-authorisation, benefit-risk evaluation and post-authorisation), and describes general principles on how to generate, collect and analyse this data. To support developers in this process, the Agency offers early interaction platforms, such as scientific advice and qualification of novel methodologies, to discuss specific development plans and proposals for regulatory submissions.

This draft reflection paper is open for public consultation until 31 January 2026. Comments should be provided using the template for submission of comments and sent to PED_RP@ema.europa.eu.

More information on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (22 novembre 2025). EMA – A path to better include patients’ perspectives in the regulation of medicines. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/156rq


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