The European Union (EU) pharmacovigilance system ensures the promotion and protection of public health through a proactive, transparent, risk proportionate and patient-centred approach.

The Pharmacovigilance Risk Assessment Committee is at the core of the operations of the EU pharmacovigilance system and is responsible for assessing and monitoring the safety of medicines in the EU.

Enhancing involvement of patients, increasing the EU capacity to use real-world data, developing new scientific methods, achieving better pharmacovigilance for medication errors and the simplification of processes are future drivers of the system.