EMA Plans 2012 Workload

The European Medicines Agency (EMA) has unveiled its work program for 2012, which forecasts a slight increase in marketing authorization applications for new medicines compared with 2011. In addition, EMA said that it will, where needed, strengthen the quality, regulatory, and scientific consistency of its assessment process.

According to a press statement, the EMA is expecting around 52 marketing authorizations for new medicines, as well as 13 orphan medicines and 39 generic-drug applications (compared with 47, 13, and 45, respectively, in 2011). The EMA also believes that there will be a 10% increase in requests for scientific advice, including joint advice with the EMA and health technology-assessment bodies.

EMA also provided updates on other focuses and ongoing projects. One important focus for EMA in 2012 will be the implementation of the new pharmacovigilance legislation, which was adopted by the Council and the European Parliament last year and comes into effect in July 2012. Among other things, the legislation is expected to strengthen the current pharmacovigilance system and enable patients to report adverse drug reactions directly to the competent authorities. EMA’s implementation plan for the legislation will involve the establishment of the Pharmacovigilance Risk Assessment Committee, which will have its first meeting in July 2012.

Next year, EMA will also be working on improving its policy for handling conflicts of interest for scientific-committee members and experts and staff. EMA introduced a revised policy on handling conflicts of interest last year, but has since then discussed proposals for further revisions on handling conflicts of interests for members of the management board. The revisions are expected to be adopted in March 2012.

The 2012 work program will be accompanied by a EUR 222.5-million ($291 million) budget, which represents a 6.5% increase over 2011. The budget comes from fee revenue (EUR 171 million [$224 million] in 2011 compared with EUR 161 million [$211 million] in 2010) and the EU, which will contribute EUR 51 million ($70 million) in 2011 compared with EUR 28 million ($37 million) in 2010. In addition, the special orphan medicines fund awarded by the EU will increase to EUR 6 million ($7.85 million) in 2011, up from EUR 4.9 million ($6.4 million) in 2010.