Press Release: Strengthening medicines safety monitoring

A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalisation and strengthening. The current EU legal framework is complex and duplicative and there is a need to clarify roles and responsibilities. Differing implementation by Member States has led to complex and diverse reporting requirements for the industry and decision-making at EU-level is overly complicated. Commission Vice-President Günter Verheugen announced on 26 February 2007 a strengthening of the EU pharmacovigilance system. The proposals focus on clarifying the roles and responsibilities for pharmacovigilance, simplifying reporting rules and ensuring that robust safety studies are carried out to support rapid EU decision-making. These reforms will provide better public health protection and the safe use of new and innovative medicines.