Updated on 20 July 2012
The setting up of the committee is one of the main deliverables of the new pharmacovigilance legislation
Singapore: The European Medicines Agency is holding the first meeting of its newly formed Pharmacovigilance Risk Assessment Committee (PRAC).
The new committee will play a major role in overseeing the safety of medicines in the European Union. Its establishment is one of the main deliverables of the new pharmacovigilance legislation that came into operation on July 1, 2012. The legislation aims to save lives by strengthening the Europe-wide system for monitoring the safety of medicines.
In addition to its role in the protection of public health, the PRAC will operate under unprecedented levels of transparency. There will be much more proactive publication of information on safety issues, the PRAC will have the possibility of holding public hearings, and agendas and minutes of its meetings will be published.
"Medicines such as antibiotics, vaccines, treatments for heart disease, diabetes or cancers have had an enormous impact on individuals' health", said Guido Rasi, the Executive Director of the European Medicines Agency. "But we all know that no medicine is without risk, and our role as regulators is to ensure that over the lifecycle of a medicine its benefits for patients are greater than the potential harm through side effects. The establishment of the PRAC will make the existing system even more robust, as we will now have a dedicated committee responsible for assessing and monitoring safety issues for human medicines."