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

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

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
  1. 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].