EMA urging firms with Ebola candidates to seek orphan status

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola to apply for orphan designation.

Medicines with recognized orphan status have access to a range of incentives to stimulate development and facilitate placing on the market. This includes free scientific advice from EMA, fee waivers and 10 years of market exclusivity once the medicine is authorized. Applications for orphan designation of Ebola medicines will be treated as a priority and the EMA has committed to fast-tracking their evaluation.

Orphan designation provides a regulatory framework to facilitate dialogue between EMA and the developers of a medicine, from the early stages of development. Early and regular interaction with EMA can significantly speed up the development of medicines.