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Half yearly performance report - January to June 2015

16 December 2015

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8. Access to unapproved therapeutic goods

8.1 Special access scheme

The Special Access Scheme (SAS) provides for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:

  • Category A: persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment. In this case prescribers are required to notify the TGA of the use.
  • Category B: all other patients. In this case prescribers are required to apply to the TGA for the use.
Table 38: SAS medicines notifications and applications
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Category A notifications
Total Category A notifications 17 648 18 698 19 162
Category B applications
Approved 9 675 10 338 10 869
Cancelled 181 172 328
Rejected 22 47 14
Pending at end of reporting period 32 74 43
Total Category B applications 9 910 10 631 11 254
Table 39: SAS devices notifications and applications
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Category A notifications
Total Category A notifications 1139 1968 1488
Category B applications
Approved 1159 1121 950
Cancelled 11 75 100
Rejected 16 17 10
Pending at end of reporting period 65 5 17
Total Category B applications 1251 1218 1077
Table 40: SAS biologicals notifications and applications
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Category A notifications
Total Category A notifications 24 38 77
Category B applications
Approved 1135 1225 1217
Cancelled 0 0 0
Rejected 4 1 0
Pending at end of reporting period 23 0 22
Total Category B applications 1162 1226 1239

8.2 Clinical trials

Clinical trial notifications provide access to unapproved therapeutic goods where patients are participating in a clinical trial. Notifications are based on trial sites; however an application can be made to extend the trial to other locations. Unapproved therapeutic goods can include biologicals, devices or medicines or a combination of any of the three types of goods.

Table 41: New trial notifications that include unapproved therapeutic goods received by State or Territory (single and multi-site trials)
NSW Vic Qld SA WA Tas ACT NT Total
2014 Jan-Jun Medicine 123 92 26 25 11 1 0 0 278
Device 30 18 4 0 4 0 0 0 56
Biological 1 1 1 0 0 0 0 0 3
Medicine and device 72 19 8 7 4 0 0 0 110
Device and biological 0 0 1 0 0 0 0 0 1
Medicine and biological 0 1 0 0 0 0 0 0 1
Jul-Dec Medicine 97 95 47 20 14 3 2 0 278
Device 35 18 4 3 10 0 0 0 70
Biological 1 2 2 0 2 0 0 0 7
Medicine and device 113 32 3 11 3 0 0 0 162
Device and biological 0 0 1 0 0 0 0 0 1
Medicine and biological 0 0 0 0 0 0 0 0 0
2015 Jan-Jun Medicine 49 91 29 26 25 6 2 0 228
Device 19 25 3 10 11 1 1 0 70
Biological 0 0 1 0 0 0 0 0 1
Medicine and device 42 62 33 21 20 3 4 0 185
Device and biological 0 0 0 0 0 0 0 0 0
Medicine and biological 0 0 0 0 0 0 0 0 0
Table 42: New trial notifications that include unapproved therapeutic goods by phase (total number of trial sites notified)
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Clinical trial type

Phase 1

68

83

77

Phase 2

130

124

143

Phase 3

153

198

170

Phase 4

32

34

37

Bioavailability/equivalence

2

3

2

None specified

64

76

70

Total 449 518 499
Table 43: All notifications (includes new trials and new sites for existing trials) that include unapproved therapeutic goods, received by State or Territory (single and multi-site trial sites notified)
NSW Vic Qld SA WA Tas ACT NT Total
2014 Jan-Jun Medicine 601 400 86 52 22 5 1 0 1167
Device 93 41 4 0 4 0 0 0 142
Biological 6 1 0 0 0 0 0 0 7
Medicine and device 376 81 49 31 5 3 0 0 545
Device and biological 0 0 1 0 0 0 0 0 1
Medicine and biological 0 0 0 0 0 0 0 0 0
Jul-Dec Medicine 297 285 209 102 76 14 14 5 1002
Device 36 41 11 15 13 0 1 0 117
Biological 1 3 4 0 2 2 0 0 12
Medicine and device 191 252 140 102 62 11 9 1 768
Device and biological 1 0 0 0 0 0 0 0 1
Medicine and biological 0 0 0 0 0 0 0 0 0
2015 Jan-Jun Medicine 234 296 173 91 101 20 9 1 925
Device 32 46 9 14 16 1 1 0 119
Biological 0 0 2 0 0 0 0 0 2
Medicine and device 252 300 208 121 100 21 7 1 1010
Device and biological 0 0 0 0 0 0 0 0 0
Medicine and biological 0 0 0 0 0 0 0 0 0
Table 44: All notifications: This includes new trials and new sites for existing trials that include unapproved therapeutic goods received by phase (total number of trial sites notified).
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Clinical trial type

Phase 1

94

131

131

Phase 2

421

436

583

Phase 3

978

1088

1184

Phase 4

210

116

154

Bioavailability/equivalence

5

4

2

None specified

154

125

136

Total 1862 1900 2190

8.3 Authorised prescribers

Table 45: Authorised prescriber approvals for medicines and medical devices
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Number of approvals for medicines 213 324 356
Number of approvals for medical devices 88 129 144

Licencing and manufacturing

8.4 Manufacturing licences

Table 46: Manufacturing licence applications and status of existing licences
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New licences granted 12 8 11
Withdrawn application 23 21 35
Revoked licences - voluntary 13 6 22
Revoked licences - TGA 0 0 0
Ceased 0 0 0
Suspended - Voluntary 1 0 0
Suspended - TGA 0 0 0

As at 30 June 2015, there were 404 Australian companies holding manufacturing licences covering 448 sites.

Table 47: Manufacturing licence application outcomes
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Inspections conducted 78 102 96
Satisfactory compliance 89% 97% 89%
Marginal compliance 10% 3% 11%
Unacceptable 1% 0% 0%
Processing time
Initial inspections conducted within 3 months of application 87% 88% 100%
Re-inspections conducted within 6 months of due date 64% 67% 64%

Applicants often submit applications for Good Manufacturing Practice (GMP) licences before completing all of their systems and processes. It is therefore common for initial applications to be conducted later than the target of 3 months.

8.5 Manufacturing certifications

Table 48: Manufacturing certification application by status
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New applications received 69 38 56
Re-inspection applications 87 83 69
Applications completed
Certified 77 67 48
Rejected 0 39 98
Total completed 77 106 146

As at 30 June 2015, there were 419 overseas manufacturers covering 446 manufacturing sites.

Table 49: Manufacturing certification outcomes
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Inspections conducted 53 47 86
Satisfactory compliance 83% 86% 94%
Marginal compliance 17% 11% 4%
Unacceptable 0% 3% 2%
Processing time
Initial certifications inspections conducted within 6 months of application 68% 90% 84%
Certification re-inspections conducted within 6 months of due date 51% 81% 80%

Applicants often submit applications for GMP certification before completing all of their systems and processes. It is therefore common for initial applications to be conducted later than the target of 6 months.

8.6 Good Manufacturing Practice (GMP) clearances

GMP clearance is required for all medicines (unless exempt) supplied in Australia. This includes products supplied to sponsors by overseas manufacturers.

Table 50: GMP clearance application status
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received 1875 1998 2050
Renewal applications 420 684 1141
Applications completed
Approved 3539 1897 2550
Rejected 73 224 91
Total completed 3612 2123 2641

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