EMA reflection paper on Patient Experience Data (PED)

1:1
First published on 29 September, this EMA reflection paper encourages early dialogue with regulators on how patient experience data can strengthen evidence packages in medicines development and marketing authorisation.

This EMA reflection paper promotes the inclusion of patient experience data (PED) in medicine development programmes and marketing authorisation applications, defining PED as data that directly reflect the patient experience without interpretation by clinicians or others. It encourages early engagement with regulators to discuss planned approaches and highlights relevant PED types and sources, including patient‑reported outcomes, patient preference studies, patient‑generated digital data, clinical trial data and real‑world data, with the aim of improving how patient experience is captured and used in regulatory decision‑making.

Acces this publication (pdf)
scientific paper

Source

European Medicines Agency (EMA)

Link to cite

Acces to Link >

You might also be interested in

European Parliament

European Parliament draft report urges a binding EU rare disease action framework

A legislative own initiative file in the Parliament’s new public health committee sets out what an EU “rare disease action framework” could look like — and why it could change how Europe measures progress for patients.
Woman helping out a person with a disease

Women’s Day highlights widening gender inequalities in rare diseases

Drawing on Europe-wide patient and carer surveys, ERDERA highlights how gender can shape diagnostic delays, care burden and the evidence base for rare-disease research.
European Parliament Photograph

New European Parliament study maps options for an EU rare disease action plan

European Parliament research service assessment, published in February 2026, identifies 31 measures that could form an EU rare disease action plan, highlighting European Reference Networks and cross-border collaboration including ERDERA as drivers of EU added value.
Publicaciones (1)

EU rare disease action plan- European Added Value Assessment

This study investigates possible measures that could be taken at EU level to address these challenges. It finds significant European added value in harmonising coordination and access across the 27 Member States, mainly in terms of improved diagnostic tools and availability of medical treatment, better health outcomes, particularly lower infant mortality, and improved well-being of family members and caregivers.

ERDERA's

search form