PRAC is responsible for assessing all aspects of risk management of human medicines, including:
PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to 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.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) meets once a month. EMA publishes the agendas, minutes and highlights of its plenary meetings.
Friday after Committee plenary
Before start of Committee plenary
After Committee plenary where minutes are adopted
PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use
PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections
Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted
EMA concludes review of semaglutide medicines and starts review of two chickenpox vaccines