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Table 1 General characteristics—registered medicines

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
  1. aAverage of medians