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 main responsibility of the PRAC is to prepare recommendations on any questions relating to pharmacovigilance activities related to a medicine for human use and on risk-management systems, including the monitoring of the effectiveness of those risk-management systems.
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), the European Medicines Agency secretariat, Management Board and European Commission, as applicable.
The 'PRAC rules of procedure' provide full details of the PRAC's responsibilities, its composition and the roles of its members.
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European Medicines Agency
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