42 new active substances have been authorized in the EU in 2018
EMA has published an overview of its key recommendations of 2018 on the authorization and safety monitoring of medicines for human use.
In 2018, EMA recommended 84 medicines for marketing authorization. Of these, 42 had a new active substance which has never been authorized in the EU before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advance therapies.
An overview of some of the most notable recommendations included in the document.