EMA/CHMP marketing authorization recommendations rises one third on last year

The European Medicines Agency says that 44 medicines have been recommended for marketing authorization by its Committee for Medicinal Products for Human Use (CHMP), compared with 33 by the same time last year.

While the number of generics is stable, the number of medicines containing new active substances is higher than last year, with 20 medicines containing active substances that had never been used in medicines before.

The EMA said almost one in every two applicants received scientific advice from the agency’s CHMP during the development phase of their medicines. Seeking and following scientific advice has been proven to significantly increase the probability of a positive outcome. A study has shown that the approval rate is 90% when sponsors comply with scientific advice compared with 30% when they do not.