Number of new medicine evaluation applications received by EMA up 30%

At its October 4, 2018, meeting in London, the Management Board of the European Medicines Agency heard an update on the Agency’s activities in the first half of 2018.

In human medicine, the EMA recommended the first two CAR-T cell medicines for approval in the European Union (EU). These innovate medicines present a new approach in the treatment of cancer and were also the first medicines supported through the EMA’s PRIority MEdicines (PRIME) scheme to receive positive opinions from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The number of new initial evaluation applications for human medicines received in the first half of 2018 was 30% higher than that received during the same period in 2017 (47 in the first half 2018 versus 36 in the first half of 2017).