EMEA positive opinions surge repeated in 2007

The European Medicines Agency (EMEA) gave a positive opinion to the European Commission for the award of a marketing authorization for 50 drugs in 2007 versus 51 in the previous year. The figures confirm an upward trend in the EU compared with earlier years, as well as raising questions about the performance of the US Food and Drug Administration, which only cleared 19 products in 2007, a 24-year low.

In 2004, the EMEA gave positive opinions in 34 cases with seven applications being withdrawn prior to a ruling by the agency. The following year saw an increase in the number of applications considered by a drop in the approval ratio: 24 positive, one negative and 15 withdrawn. However, the surge in successful marketing authorization applications in 2006, with 51 recommended, four negative opinions and eight withdrawn, appears to have been maintained in 2007.