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Table 1 Main characteristics and distribution of the marketing authorizations of medicinal products for human use and active ingredients (NCEs), 1995-2009

From: Does the development of new medicinal products in the European Union address global and regional health concerns?

  Period 1995-1999 Period 2000-2004 Period 2005-2009
Characteristics Num. of authorizations (%) Num. of NCEs (%) Num. of authorizations (%) Num. of NCEs (%) Num. of authorizations (%) Num. of NCEs (%)
Total 86 (100) 70 (100) 143 (100) 116 (100) 291 (100) 152 (100)
Type of intervention       
   Prevention 15 (17.4) 12 (17.1) 13 (9.1) 7 (6.0) 56 (19.2) 19 (12.5)
   Diagnosis 4 (4.6) 3 (4.3) 4 (2.8) 4 (3.4) 5 (1.7) 5 (3.3)
   Treatment 65 (75.6) 53 (75.7) 122 (85.3) 101 (87.1) 214 (73.5) 120 (78.9)
   Palliative care/rehabilitation 2 (2.3) 2 (2.9) 4 (2.8) 4 (3.4) 16 (5.5) 8 (5.3)
Disease seriousness       
   Serious disease 59 (68.6) 50 (71.4) 104 (72.7) 86 (74.1) 191 (65.6) 109 (71.7)
   Nonserious disease 11 (12.8) 9 (12.9) 21 (14.7) 17 (14.6) 44 (15.1) 20 (13.2)
   Risk factor for serious disease 16 (18.6) 11 (15.7) 18 (12.6) 13 (11.2) 56 (19.2) 23 (15.1)
New mechanism of action 18 (20.9) 17 (24.3) 44 (30.8) 42 (36.2) 32 (11.0) 27 (17.8)
Fixed-dose combinations 6 (7.0) 4 (5.7) 13 (9.1) 8 (6.9) 37 (12.7) 18 (11.8)
Biotechnological/biological product 27 (31.4) 24 (34.3) 52 (36.4) 41 (35.3) 77 (26.5) 42 (27.6)
Orphan medicinal product* - - 18 (12.6) 18 (15.5) 39 (13.4) 39 (25.7)
Generic and/or "biosimilar"* - - - - 69 (23.7) -
  1. Data do not sum to 100% because of rounding errors *The European Commission granted marketing authorizations for: orphan medicinal products in 2001, "biosimilar" products in 2006, and generic products in 2007. NCEs = New chemical entities.