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
scientific paper

Source

European Medicines Agency (EMA)

You might also be interested in

Scientist reading a journal article 2026

Longitudinal progression, metrics, age-dependence, and modifiers of ataxia severity in SCA27B: a multicentre study of 219 patients

The multicentre observational study analysed 661 assessments from 219 people with SCA27B to examine disease progression, clinical outcome metrics and demographic or genetic modifiers.
Conference "Advancement of Treatments for Rare Diseases" in Cyprus, June 2026

Cyprus conference connects European research priorities with the path to rare disease treatments

At the “Advancement of Treatments for Rare Diseases” conference in Nicosia, European and national policymakers joined clinicians, researchers, regulators, industry representatives and patient advocates to examine how stronger coordination can translate scientific progress into better prevention, diagnosis, treatment and access to care for people living with rare diseases.
ERDERA clinical trial call

ERDERA Clinical Trial Call – Call Text

Call text draft setting out rules, eligibility and staged application process for the ERDERA Clinical Trial Call 2026.
Open_Academy_2025-48-1536x1152

Open Academy x ERDERA Schools

June 7 - June 10
The Open Academy x ERDERA accompanies patient advocates by offering rare-disease specific comprehensive training programmes that empower advocates with the knowledge, skills and confidence they need to engage with different stakeholders as equal partners.

ERDERA's

search form