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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