EMA Issues Summary of 2016 Highlights

The European Medicines Agency (EMA) has published a four-page document to summarize its main achievements relating to marketing authorizations of new medicines and the safety monitoring of authorized medicines during the past year.

The following items are referred to in the report:

• The agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing authorization, including 27 new active substances. A total of 17 out of the 81 had an orphan designation.

• Seven medicines received a recommendation for marketing authorization following an accelerated assessment. This mechanism is reserved for medicines that have the potential to address unmet medical needs, and allows for faster assessment of eligible medicines by EMA’s scientific committees (within up to 150 days rather than up to 210 days).

• Eight medicines received a recommendation for a conditional marketing authorization, one of the possibilities in the EU to give patients early access to new medicines. This tool allows for the early approval of a medicine on the basis of less complete clinical data than normally required if the medicine addresses an urgent unmet medical need. These medicines are subject to specific post-authorization obligations for medicines developers that aim to obtain complete data on the medicine, according to EMA.

• 59 extensions of indication were recommended in 2016. The extension of the use of a medicine that is already approved in a new therapeutic indication can also offer fresh opportunities for patients, EMA stated.

To view the full document, click here.