81 European marketing authorization recommendations in 2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorization in 2013, compared with 57 in 2012. This compares with 87 in 2011, 51 in 2010 and 117 in 2009.

In line with the previous years, the number of drugs containing a new active substance is quite high, with 38 medicines containing active ingredients that had never been used in drugs before compared with 35 in 2012, 25 in 2011 and 15 in 2010. The number of generics is stable compared with 2012 but generally decreasing over the last few years.

One in every two applicants received scientific advice from the CHMP during the development phase of their medicine. Seeking and following scientific advice has been proven to significantly increase the probability of a positive outcome, with a 90% success rate at the time of marketing-authorisation application for companies that request and follow scientific advice compared with a 30% success rate for companies that do not request scientific advice.