PRAC (Pharmacovigilance Risk Assessment Committee)

The Pharmacovigilance Risk Assessment Committee (PRAC) is a European expert body that evaluates the safety of medicines, particularly concerning potential side effects or risks. Its role is to monitor reports of adverse reactions, assess whether a medicine remains safe for use, and recommend actions like updates to safety information or, if necessary, restrictions or withdrawals. PRAC's work helps ensure that medicines available to patients are both effective and have acceptable risk levels, making drug safety a priority through continuous review and risk management.