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.
