Comparing access to orphan medicinal products in Europe

Table 2 Orphan Designations and Marketing Authorisations

	2001–2005	2006–2010	2011	2012	2013	2014	2015	2016 (Jan-May)	Total
Number of OMPs designations	173	355	86	118	124	182	185	137	1360
Number of OMPs authorised	22	45	7	12	10	17	20	10	143
% OMPs Designations ^a	12.7%	12.7%	8.1%	10.2%	8.1%	9.3%	10.8%	7.3%	10.5%
Average months elapsed from designation to authorisation ^b	72.7	54.0	47.1	29.4	19.9	15.6	n/a	n/a	54.7

Source: Authors’ elaboration from data available at EMA website
^aThis percentage denotes the proportion of OMPs authorised compared to the number of designations granted by the EC during the same period of time.
^bThe computation of months from designation to authorisation is specific to the product, the last orphan designation which was authorised was designated in 2014 (but authorised in later years)

ISSN: 1750-1172