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
Recommendations
The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:
- Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicinal products and referral procedures
- Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) on the use of a medicine in member states
- the EMA secretariat, Management Board and the European Commission, as applicable
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.
