Pharmacovigilance Risk Assessment Committee (PRAC)
Role of the PRAC
The PRAC is responsible for assessing all aspects of risk management of human medicines, including:
- the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account;
- design and evaluation of post-authorisation safety studies;
- pharmacovigilance audit.
- Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicines 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 European Commission, as applicable.
For full details, see: