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