The Pharmacovigilance Risk Assessment Committee (PRAC) is one of the 7 scientific committees of the European Medicines Agency (EMA) which is responsible for monitoring and evaluating the safety of human medicines distributed in Europe. The committee was established in 2012 to align with the pharmacovigilance legislation and to help strengthen the medicines’ safety monitoring.

Role of PRAC

The major responsibility of the PRAC is to analyze all the details of risk management of human medicines. This includes:

  • Detecting and assessing the risks associated with the medicines; minimizing and communicating their adverse effects while considering their therapeutic effects
  • Developing post-authorization safety studies
  • Pharmacovigilance audit

The committee also provides recommendations on the matter of pharmacovigilance and risk management to the following:

  1. Committee for Medicinal Products for Human Use (CHMP) – The committee is for medicines and their referral procedures which are centrally authorized.
  2. Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) – The committee is for use of medicines in the member states.
  3. The EMA secretariat, European Commission and Management Board.

Complying with the safety norms of PRAC is a pre-requisite for entering Europe’s human medicines market. To know more about the regulations of the European market and how to make a successful market entry, reach out to us at