Basic Information on the PRAC

Basic information about PRAC

The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicinal products. The Committee meets once a month. EMA publishes the agendas, minutes and highlights of its plenary meetings.

The PRAC was formally established under the pharmacovigilance legislation that came into force in 2012 to help strengthen monitoring of the safety of human medicines across Europe. The notice on the founding meeting of the PRAC, which was held by the EMA from July 19 to 20, 2012 in Brussels, is available on EMA's website, or here.

The role of PRAC

PRAC is responsible for assessing all aspects of risk management of the use of human medicinal products, including:

  • detection, assessment, minimisation and communication about the risk of adverse reactions, while taking the therapeutic effect of the medicinal product into account
  • design and evaluation of post-authorisation safety studies
  • pharmacovigilance audit


The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:

All information on the roles and activities of the PRAC, as well as agendas, minutes and the most important safety information from the PRAC sessions, are available on EMA's website, or here.