EU's medicines safety monitoring needs strengthening, says Commission

A public consultation has shown that the current European Union system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening. The European Commission says that differing implementation by member states has led to complex and diverse reporting requirements for the industry and decision-making at the EU-level is overly complicated.

As a result, Commission Vice President Gunter Verheugen has announced 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, he said.

Commissioner Verheugen, responsible for enterprise and industry, said: "we will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with on the basis of more robust data. Rationalization of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens. This is an example of reducing administrative burdens for enterprises, without compromising safety."