EU encourages development of "orphan drug" for Ebola
Xinhua, October 21, 2014 Adjust font size:
The European Medicines Agency (EMA), the European Union (EU)'s pharmaceutical regulator, on Monday encouraged developers of Ebola treatments or vaccines to apply for orphan designation.
Such applications would be treated as a priority and the agency said it was committed to fast-tracking their evaluation.
Developers of Ebola medicines are encouraged to submit applications for orphan designation to both EMA and the Food and Drug Administration in the United States in parallel to help speed up the development process for these medicines globally, according to EMA.
Orphan designation can be granted for medicines under development that are intended for the prevention or treatment of life-threatening conditions affecting no more than 5 in 10,000 people in the EU, as is the case for Ebola, said EMA.