EMA recommended approval of 84 medicines in 2018

The European Medicines Agency has published an overview of its key recommendations of 2018 on the authorization and safety monitoring of medicines for human use.

New medicines are essential for public health as they can improve the treatment of diseases. In 2018, EMA recommended 84 medicines for marketing authorization. Of these, 42 had a new active substance which has never been authorized in the European Union before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies.

For its part, the US Center for Drug Evaluation and Research (CDER) approved 59 novel drugs in 2018, more than any prior year, but this does not include generics or biosimilars. Thus the figure well exceeds the EMA’s 42 total of novel drugs.