0213-9111 0213-9111 S0213-91112020000200008 10.1016/j.gaceta.2019.02.008 España España España España España España España 00 04 2020 00 04 2020 34 2 141 149

1 European Communities 2000 2 US Food and Drug Administration 2013 78 113 113 35117-35 3 2014 3 399-422 4 NICE Citizens Council 2004 5 European Medicines Agency (EMA) 6 2017 5 1 7 2015 10 1-24 8 European Commission 2016 9 2016 10 European Commission 11 European Medicines Agency (EMA) 12 13 14 Orphanet 2018 15 2017 548 158 16 2018 17 2017 18 2009 19 2018 21 553-60 20 2018 7 57-64 21 2014 15 335-40 22 2018 21 525-31 23 2011 6 62 24 2014 9 22 25 2015 89 125-35 26 2017 18 715-30 27 2007 23 36-42 28 2008 14 16-7 29 2005 331 1016-9 30 2007 23 397-404 31 2017 12 50 32 2013 8 1-15 33 2012 36 455-63 34 2016 14 1-8 35 2011 36 NICE 2017 37 National Institute for Health and Care Excellence (NICE) 2008 2nd 38 2010 24 154-70 39 2013 16 703-71 40 2016 34 967-9 41 2016 313 857