The European Medicines Agency’s Management Board has endorsed the work programme and budget 2012. The work programme forecasts a stable number of applications for marketing authorisation for human and veterinary medicines in 2012. The work programme is accompanied by a budget of €222.5 million, an increase of 6.5% over 2011.

Last 15 December 2011, the European Medicines Agency’s Management Board has endorsed the Agency work programme and budget 2012. The work programme forecasts a stable number of applications for marketing authorisation for human and veterinary medicines in 2012. The Agency expects some 112 applications in total (2011: 111), with 52 applications for new medicines for human use, in addition to 13 new orphan medicines and 39 generic applications (2011: 47, 13 and 45 respectively). Some 9 applications for new veterinary medicines are expected, with 3 generic applications (2011: 8 and 3 respectively). The Board noted the 10% increase in expected requests for scientific advice for human medicines.

In addition, the Management Board endorsed an implementation plan for the new pharmacovigilance legislation starting in July 2012. Activities contributing to public health are given the highest priority, followed by activities increasing transparency and improving communication, followed by simplification measures. The legislation was proposed recently by the Commission. The Management Board also endorsed the ‘Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities’. The paper sets out practical steps to be taken during the evaluation of marketing authorisation applications submitted to the Agency or national competent authorities and when providing advice on clinical trials conducted outside of the EU/EEA in the medicine development phase.

With regard to the 2012 Agency Budget, it is approved by the Management Board a budget of €222.5 million, an increase of 6.5% over 2011, that includes fee revenue of €171 million (2010: €161 million) and a European Union (EU) contribution of €51 million (2010: €28). The special orphan medicines fund given by the EU has been increased from €4.9 million to €6 million. The workforce foreseen for 2012 remains at the level for 2011, with the staff ceiling fixed at 737.