The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines.
The PRAC was formally established in line with the pharmacovigilance legislation which came into effect in 2012 to help strengthen the safety monitoring of medicines across Europe.
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.
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 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:
How useful is this page?
Average rating:Based on 14 ratings
Add your rating:
- See all ratings
1 ratings0 ratings0 ratings6 ratings7 ratings
European Medicines Agency
30 Churchill Place
London E14 5EU