The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines.
The PRAC's recommendations are considered by the Committee for Medicinal Products for Human Use (CHMP) when it adopts opinions for centrally authorised medicines and referral procedures and by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) when it provides a recommendation on the use of a medicine in Member States.
- See the full overview of the PRAC's role
The members and alternates of the PRAC are nominated by European Union Member States, in consultation with the Agency's Management Board. They are chosen on the strength of their qualifications and expertise with regard to pharmacovigilance matters and risk assessments of medicines for human use.
To represent healthcare professionals and patient organisations, the European Commission appoints two members and two alternates following consultation with the European Parliament. The European Commission also appoints six independent scientific experts.
All serve on the Committee for a period of three years which is renewable once.
The PRAC is composed of:
- a chair and a vice chair, elected by serving PRAC members;
- one member and an alternate nominated by each of the 28 Member States;
- one member and an alternate nominated by Iceland and by Norway;
- six independent scientific experts nominated by the European Commission;
- one member and an alternate nominated by the European Commission after consultation of the European Parliament to represent healthcare professionals;
- one member and one alternate nominated by the European Commission after consultation of the European Parliament to represent patients organisations.