Brussels, 07/05/2014 (Agence Europe) - On Friday 2 May, the European Medicines Agency (EMA) presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU's new pharmacovigilance legislation. The EMA, the national competent authorities in the member states and the European Commission have collaborated closely in fulfilling their responsibilities for implementing the new legislation, said EMA. “Pharmacovigilance” refers to the practices used to monitor the safety of medicinal products and develop remedies to reduce risks to health.
The report, which covers the period 2 July 2012 to 1 July 2013, reveals overall positive results with regard to the impact of the new legislation on public health: better collection of key information on medicines, improved analysis and understanding of data and information, improved timeliness of procedures and greater transparency. Among the achievements during the first-year reporting period are: 1) an increase of more than 9,000 in patient reports of suspected adverse drug reactions; 2) product information changes as a consequence of assessment of signals of new or changing safety issues with certain medicines; 3) initiation of a number of major public health reviews, for example, on combined hormonal contraceptives, venous thrombo-embolism and Codeine-containing products used for pain relief in children; 4) publication of a catalogue with training material for the implementation of the new legislation. (IL)