EMA Annual Report Lists 27 New Active Substances, Highlights PRIME Pathway

The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances.

The report highlights the launch of the PRIME expedited review pathway, the agency’s initiative to publicize clinical trial data, and advancements in the use of big data, patient registries and real world evidence.

In 2015, the EMA recommended 93 medicines for approval, with 39 new active substances.

The EMA received 84 PRIME applications for expedited review and approved 15 — 10 of which were advanced therapies. Eight medicines received recommendations for conditional marketing authorizations.