EMEA RECEIVED RECORD NUMBER OF DRUG APPLICATIONS IN 2006

The European Medicines Agency (EMEA) has announced that it reviewed more new drugs in 2006 than in any previous year.

Last year the agency received record numbers of initial marketing authorization applications, post-authorization variation applications and requests for scientific advice, the agency said. While the volume of applications increased, the EMEA was able to achieve a substantial reduction in assessment times for initial evaluation, orphan designation and scientific advice, helping to speed up the availability of new and innovative drugs.

The EMEA received 781 applications for marketing authorization in 2006. The agency adopted 51 positive opinions for initial marketing authorization — the highest number ever. In addition, 104 orphan designation applications were received.

"I am very pleased by our performance in 2006, which was one of the busiest years ever, and the first full year in which we operated under the terms of the revised pharmaceutical legislation," EMEA Executive Director Thomas Lönngren said. "The fact that we managed record numbers of applications while speeding up assessment times demonstrates that we have successfully adapted to the new legal framework."