EMA: Committee for Orphan Medicinal Products - strengthened interactions with patients and international partners

Source: European Medicines Agency (EMA) Area: News The European Medicines Agency's Committee for Orphan Medicinal Products will this year begin focusing on integrating the views of patients, expanding international cooperation and collaborating with health-technology-assessment (HTA) bodies for a better understanding of orphan designation. The Orphan-Medicinal-Product Regulation was introduced in the European Union (EU) to incentivise the development of medicines for rare diseases. Orphan designation can be granted at any stage of the development process to medicines that are intended for diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 people in the EU or for which development costs would not be covered by the marketing return without incentives.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news