EMA's 2017 drug approval tally underperforms that of FDA

The European Medicines Agency has today published an overview of its key recommendations of 2017 regarding the authorization of new medicines and the safety monitoring of medicines, which shows that its tally of novel drug approvals was well below that achieved by its US peer.

Advances in medicines authorizations are essential for public health as they have the potential to improve the treatment of diseases, the EMA stated. In 2017, the EMA recommended 92 medicines for marketing authorization, a figure which includes clearance of generic medicines.

Of these, 35 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, the Agency noted.