Patient experience data (PED) reflection paper

The reflection paper on the patient experience data (PED) encourages medicine developers and other stakeholders to include this type of data in medicine development and marketing authorisation applications for human medicines. These are data that directly reflect the patient experience, without doctors or other parties interpreting them.

This reflection paper encourages stakeholders and developers to engage at an early stage with regulators to discuss inclusion of patient experience data (PED) in medicine development programmes and marketing authorisation applications (MAAs).  

Keywords: patient experience data, patient engagement, patient reported outcomes, patient preference studies, patient-generated digital data, clinical trials, real-world data

Current version

Reflection paper on patient experience data

Draft: consultation open Consultation dates: 29/09/2025 to 31/01/2026 Reference Number: EMA/CHMP/PRAC/148869/2025 Summary:

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Submission of comments on Reflection paper on patient experience data (EMA/CHMP/PRAC/268899/2025)