The legislation - was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010 – is designed to improve how drug safety is assessed in the real world.
European Medicines Agency (EMA) executive director Guido Rasi said: “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.”
Key features include a Pharmacovigilance Risk Assessment Committee (PRAC) to advise the CHMP, clarification of roles of all ‘actors’ in monitoring drug safety and efficacy in Europe as well as measure to engage patients and physicians in the reporting of adverse events.
The new rules are also designed to improve the collection of key information on medicines, through risk-proportionate, mandatory post-authorisation safety and efficacy studies.
The first meeting of the PRAC will be on 19 and 20 July 2012.
More to follow…