EMA's multidisciplinary guidelines on patient experience data offer advice on how to include this type of data in medicine development programmes and marketing authorisation applications for human medicines.
Patient experience data reflect patients’ experience or preferences on treatments or outcomes directly, without any interpretation by a clinician or anyone else.
These 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.
For a complete list of scientific guidelines open for consultation, see Public consultations.
For more information on multidisciplinary guidelines, see:
The reflection paper below is open for consultation between 29 September 2025 and 31 January 2026: