The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament. This is a major step towards the legislation coming into force, currently expected for mid-2012. The new Directive and Regulation propose a number of changes that will strengthen the way the safety of medicines for human use is monitored in the European Union (EU).
The impact on the work of the Agency is expected to be considerable. The proposed changes include enhanced monitoring of the benefits and risks of medicines post-authorisation, replacement of the Pharmacovigilance Working Party with a Committee, and an increased level of transparency of safety information.
The Directive and Regulation are still awaiting adoption by the Council of the European Union.