PRACs

PRAC, the Pharmacovigilance Risk Assessment Committee, is a committee of the European Medicines Agency (EMA) responsible for assessing and monitoring the safety of medicines intended for human use within the European Union. Established in 2012 as part of the EU’s pharmacovigilance modernization, PRAC focuses on evaluating safety signals, reviewing risk management plans, and advising on measures to minimize risks while preserving access to beneficial medicines. It also reviews periodic safety update reports and other safety data to inform regulatory decisions and public communications.

Composition and governance: PRAC is composed of representatives from the national competent authorities of EU/EEA member states, with a chair and vice-chair elected from among its members. The committee may include observers or liaison representatives from healthcare professional organizations and patient or consumer groups. It operates with support from the EMA's scientific secretariat and data systems such as EudraVigilance to access safety data and perform signal detection and assessment.

Functions and procedures: The committee evaluates suspected adverse reactions, assesses safety signals, and conducts benefit-risk evaluations for medicines on the EU market. It issues opinions and recommendations that guide EU-level regulatory actions, including labeling changes, additional warnings, usage restrictions, or, in extreme cases, withdrawal of a product. PRAC collaborates with other EMA committees and national authorities as needed, particularly in complex risk assessments or cross-cutting safety issues, contributing to ongoing pharmacovigilance throughout the lifecycle of medicinal products.

Impact: PRAC opinions and recommendations shape safety labeling, risk minimization measures, and the regulatory actions taken by the European Commission and member states, thereby supporting safer use of medicines across the EU.