List of the latest marketing authorisations and orphan medicinal products designations

Detailed information on European orphan medicinal products designation applications is available on the EMAwebsite. A full list of designated and authorised orphan medicinal products in Europe available at: ec.europa.eu.

Learn more about the Orphan designation process in Europe

Latest orphan medicines designations

2018

Jan - Feb - Mar - Apr - May

2017

Jan - Feb - Mar - Apr - May - Jun - July- Sep - Oct - Nov - Dec

Overview of Orphan Medicinal Product Designation Procedure since 2000

Year	Applications submitted	Positive COMP opinions	Applications withdrawn	Negative COMP opinions	Designations granted by the Commission	Orphan medicinal products authorised	Orphan designations included in authorised therapeutic indication
2018	96	69	39	2	73	8	8
2017	260	144	96	2	138	14	15
2016	330	220	82	2	209	14	14
2015	258	177	94	1	190	14	21
2014	329	196	61	2	187	15	16
2013	201	136	60	1	136	7	8
2012	197	139	52	1	148	10	12
2011	166	111	45	2	107	5	5
2010	174	123	51	2	128	4	4
2009	164	113	23	0	106	9	9
2008	119	86	31	1	73	6	7
2007	125	97	19	1	98	13	13
2006	104	81	20	2	80	9	11
2005	118	88	30	0	88	4	4
2004	108	75	22	4	73	6	6
2003	87	54	41	1	55	5	5
2002	80	43	30	2	49	4	4
2001	83	62	27	1	64	3	3
2000	72	26	6	0	14	0	0
Total	3071	2040	828	27	2025	150	162