EMEA CONCERNED OVER RISE IN APPLICATIONS, 2007 BUDGET

The European Medicines Agency's (EMEA) management board has issued a release addressing a rise in applications for medicines in 2006 and concerns over budget situation for next year. The agency also announced new transparency measures.

The EMEA is seeing an increase in applications in this year. The initial application forecast for the year has been revised from 61 to 91 applications, an increase of 49 percent. At the management board's Sept. 28 meeting, the EMEA executive director indicated that this unforeseen increase was due in part to applications for new innovative medicines and for new uses of approved medicines, and in part to some additional generic, biosimilar and multiple applications. Above all, it was stressed that the applications were unexpected, and the executive director urged companies to enter into dialogue with the agency earlier to discuss their filing strategy.

The management board also expressed concerns for the budget for 2007, in particular because the requested European Community contribution to the agency's budget has been significantly reduced in the current round of 2007 EU budget discussions. The agency had originally requested ⁈6.32 million euros, but current indications are that the agency could receive only a small increase over the 2006 amount of 34 million euros.

Additionally, using new authority granted under the revised EU pharmaceutical legislation, the management board announced it has agreed to publish information on the withdrawal by a company of its marketing authorization application after the agency's opinion but before the commission's decision on marketing authorization. The agency will also publish information on withdrawals by applicants, and on refusals by the agency, of applications concerning new indications for approved medicines, in an effort to increase transparency.