Table 1 The identified activities within the three end-to-end registration processes employed by SAHPRA between 2011 and 2022 and the median timelines of the activities

Cycle

Median time in calendar days for registration activities for the MCC process (2011–2017)

1

682

201

–

-

74 (0 finalised)

347

2

186

62

–

72 (168 finalised)

76

3

56

76

–

74 (116 finalised)

76

4

31

47

–

32 (35 finalised)

56

5

16

16

–

20 (6 finalised)

-

Median finalisation timeline

1470

Median registration timeline

2092

Cycle

Median time in calendar days for registration activities for the BCP (2019–2022)

1

278

63

29

35

30 (0 finalised)

84

2

22

35

15

30

15 (30 finalised)

33

3

10

30

10

20

15 (58 finalised)

22

4

7

7

5

10

10 (25 finalised)

20

5

2

11

5

15

5 (13 finalised)

–

Median finalisation timeline

501

Median registration timeline

591

Cycle

Median time in calendar days for registration activities for the RBA phase 1 pilot study (2021–2022)

1

431

5

8

–

2 (3 finalised & 2 withdrawn)

25

2

2

2

6

–

1 (44 finalised)

18

3

1

1

7

–

1 (6 finalised & 2 withdrawn)

10

4

1

1

7

–

1 (4 finalised)

–

Median finalisation timeline

68

Median registration timeline

511

Cycle

Median time in calendar days for registration activities for the RBA phase 2 pilot study (2022)

1

 ~ 2 years

5

8

–

1 (6 finalised)

28

2

2

2

7

–

1 (102 finalised & 1 withdrawn)

15

3

1

1

7

–

1 (44 finalised & 2 withdrawn)

12

4

1

1

5

–

1 (7 finalised)

–

Median finalisation timeline

73

Median registration timeline

–