The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 30 new active substances (NAS) for marketing authorization in 2019, down from 42 the previous year. The agency also recommended just six new orphan medicines for authorization, the fewest in recent years and a drop from the 17 new orphan medicines recommended in 2018. In comparison, the US FDA (FDA) Center for Drug Evaluation and Research (CDER) approved 48 novel drugs in 2019, down from 59 in 2018, 21 of which were orphan products. While most of the products EMA recommended in 2019 have also been approved by FDA, four have not been approved in the US. Learn More