From: Linking market authorizations of medicines with disease burden in South Africa
Year | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | Total |
---|---|---|---|---|---|---|---|
NCEs registered | 76 | 54 | 43 | 18 | 19 | 57 | 267 |
Generics registered | 600 | 549 | 477 | 403 | 423 | 327 | 2779 |
Vaccines registered | 3 | 1 | 2 | 3 | 1 | 3 | 13 |
Total number of medicines registered | 679 | 604 | 522 | 424 | 443 | 387 | 3059 |
Median time to approval in months (total) | 48 | 47 | 62 | 64 | 69 | 72 | 60* |
Generics median time to approval (months) | 48 | 47 | 62 | 64 | 69 | 74 | 61* |
NCEs median time to approval (months) | 48 | 51 | 49 | 66 | 69 | 47 | 55* |
Vaccines median time to approval (months) | 35 | - | 41 | 64 | - | 35 |
WHO/DDD classification Total number of medicines registered (NCEs registered)a | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | NCEs registered |
---|---|---|---|---|---|---|---|
A (alimentary tract and metabolism) (n = 195) | 53 (14) | 34 (3) | 58 (4) | 18 (6) | 14 (3) | 18 (8) | 38 |
B (blood and blood forming organs) (n = 51) | 16 (4) | 13 (10) | 7 (1) | 3 (0) | 7 (0) | 5 (0) | 15 |
C (cardiovascular system) (n = 577) | 105 (18) | 144 (2) | 87 (0) | 82 (0) | 92 (2) | 67 (10) | 32 |
D (dermatologicals) (n = 32) | 6 (1) | 7 (0) | 6 (0) | 11 (0) | 2 (0) | – | 1 |
G (genitourinary system and sex hormones) (n = 104) | 22 (3) | 10 (6) | 19 (1) | 21 (4) | 14 (3) | 18 (1) | 18 |
H (systemic hormonal preparations, excl. sex hormones and insulins) (n = 42) | 6 (1) | 2 (1) | 6 (3) | 8 (0) | 14 (1) | 6 (6) | 12 |
J (anti-infectives for systemic use) (n = 634) | 149 (3) | 114 (9) | 110 (5) | 91 (6) | 110 (1) | 60 (0) | 24 |
L (antineoplastic and immunomodulating agents) (n = 353) | 89 (21) | 49 (10) | 50 (17) | 40 (1) | 65 (7) | 60 (11) | 67 |
M (musculoskeletal system) (n = 117) | 8 (1) | 22 (2) | 20 (1) | 24 (0) | 18 (0) | 25 (0) | 4 |
N (nervous system) (n = 727) | 154 (6) | 177 (10) | 127 (8) | 97 (0) | 84 (1) | 88 (12) | 37 |
P (antiparasitic products, insecticides and repellents) (n = 5) | – | 2 (0) | 2 (0) | – | – | 1 (1) | 1 |
R (respiratory system) (n = 183) | 65 (2) | 29 (0) | 23 (0) | 19 (0) | 16 (0) | 31 (8) | 10 |
S (sensory organs) (n = 30) | 5 (2) | 1 (0) | 3 (0) | 6 (0) | 7 (1) | 8 (0) | 3 |
V (various) (n = 9) | 1 (0) | – | 4 (3) | 4 (3) | – | 6 | |
Medicines registered by company type | |||||||
Local generic manufacturer | 216 | 224 | 145 | 176 | 175 | 138 | 1074 |
International generic manufacturer | 334 | 308 | 283 | 185 | 222 | 184 | 1516 |
Multinational R&D pharma company | 129 | 72 | 94 | 63 | 46 | 65 | 469 |