New pharmacovigilance legislation comes into operation in EU

The European Medicines Agency yesterday welcomed the start of new European Union legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

"The progress made in health care would not have been possible without medicines and the research and development community behind them. But we need smart regulation for the system to be able to continue to deliver safe and effective medicines," said the Agency's executive director Guido Rasi, adding: "The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders."

The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the EU member states in December 2010. Highlights of the new legislation include: