The European Medicines Agency believes that patients’ involvement in the evaluation of medicines, in particular in the assessment of benefit and risk lies at the heart of the regulatory process. The EMA also believes that incorporating the knowledge, views and preferences of patients throughout the lifecycle of medicines, from early stages of development to authorisation and monitoring of safety and efficacy, adds value to the scientific assessment.

Please read the recent report of the EMA on finding ways to further involve patients in the benefit-risk assessment of medicines.