EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation

10th October 2025

EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation

Summary: The European Medicines Agency (EMA) has published a draft reflection paper on incorporating patient experience data into the regulation of medicines. This initiative aims to enrich regulatory decision-making by considering patients' real-life experiences and preferences.

Key Points:

• Definition of Patient Experience Data: The paper defines patient experience data as information directly reflecting patients' experiences or preferences regarding treatments or outcomes, without interpretation by clinicians or others.

• Importance in Regulatory Decisions: Such data offer valuable insights into what matters most to patients, complementing traditional clinical outcomes. For instance, in cancer treatments, patients may prioritize quality of life over overall survival rates.

• Encouraging Data Collection: EMA encourages medicine developers to gather and include patient experience data throughout the medicine lifecycle, from pre-authorisation to post-authorisation.

• Support for Developers: To assist developers, EMA offers early interaction platforms, such as scientific advice and qualification of novel methodologies, to discuss specific development plans and proposals for regulatory submissions.

• Sources of Patient Experience Data: Data can be obtained through Patient Reported Outcomes (PROs), Patient Preference Studies (PPSs), and other forms of information from patient engagement activities.

• Public Consultation: The draft reflection paper is open for public consultation until 31 January 2026. Stakeholders are invited to provide feedback using the provided template and submit comments to PED_RP@ema.europa.eu.

Link: EMA's Reflection Paper on Patient Experience Data

 

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