The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing all aspects of the risk management of medicines for human use. This includes the detection, assessment, minimisation and communication relating to the risk of adverse reactions, while taking the therapeutic effect of the medicine into account. It also has responsibility for the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.
The PRAC generally provides these recommendations to the Committee for Medicinal Products for Human Use (CHMP), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Decision-making is either consensual or by majority vote.
For more information see page of PRAC.