Designation of orphan drug number 1000 by the European Medicines Agency (EMA), a system that allows companies that develop medicines for patients with rare diseases to benefit from a series of incentives. They - recalls the EMA - include development assistance, reduced fees for regulatory procedures and commercial protection once the product reaches the market. Organ drug designations are granted by the European Commission on the recommendation of EMA's Committee for Orphan Medicinal Products. This measure was introduced in 1999 to stimulate the development of research into diseases that would otherwise have been forgotten by industry, despite the fact that around 30 million Europeans live with a rare disease, which affects 5 out of 10,000 people. The equivalent of about 250,000 patients for each pathology.
June 12, 2012 – PharmaKronos