The European Union Committee of Experts on Rare Diseases: three productive years at the service of the rare disease community

Table 4 Key facts and state of play in December 2013: The clinical added value of Orphan Medicinal Products¹

•	1234 positive opinions for orphan product designation from 1798 applications submitted since 2000 at EU level and a total of 1219 European Commission designations
•	85 orphan designated products have received marketing authorisation by end of 2013 at EU level
•	EUCERD Recommendation on Improving Informed Decisions Based on the Clinical Added Value of Orphan Medicinal Products Information Flow adopted in September 2012
•	Recommendation proposes four key time points for information sharing to improve the pricing and reimbursement decision process

¹Data from the report of the European Medicines Agency's Committee on Orphan Medicinal Products December 2013 [http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2014/01/WC500159429.pdf].

ISSN: 1750-1172