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pharmiweb.com today | 21 October 2014

Speeding up development of Ebola treatments and vaccines

The European Medicines Agency (EMA) encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Medicines with recognised 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 ofmarket exclusivity once the medicine is authorised....

Applications for orphan designation of Ebola medicines will be treated as a priority and 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.

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