2012 annual report on EudraVigilance published
The European Medicines Agency (EMA) has published the first annual report on EudraVigilance for the European Parliament, the Council and the Commission, which covers the period from 1 January to 31 December 2012.
It is the third time the Agency has issued an annual report on the EudraVigilance database. However, it is the first time that this report has been published under a provision of the new pharmacovigilance legislation, for submission to the European Parliament, the Council and the European Commission.
The EudraVigilance database is a web-based information system designed to collect, manage and analyse reports of suspected side effects to medicinal products.
The report published today provides information on the activities undertaken in 2012 in terms of development of new functionalities, data collection and quality, data analysis, transparency, communication and training.
The data held in EudraVigilance are key to ensuring the continuous safety monitoring of medicines by the EMA and the Member States, as well as facilitating the decision making of the Pharmacovigilance Risk Assessment Committee (PRAC) and other committees of the EMA.
By 31 December 2012, the EudraVigilance database held a total of 3,867,243 adverse reaction reports, referring to 2,224,670 individual cases.
During 2012, the EudraVigilance database received and processed approximately 70,000 expedited adverse reaction reports per month for authorised medicines. These were subsequently made available for signal detection and data analysis by the EMA and medicines regulatory agencies in the Member States.