You are here

Half-yearly performance reports - July to December 2014

31 March 2015

Book pagination

1. Market authorisation

1.1 Prescription medicines

Table 1 Definitions and specified periods (statutory timeframes)
Application category Definition Specified period Working days
Category 1 application An application to register a prescription medicine via the normal process of evaluation. Examples of Category 1 applications are new substances, extensions of indication, and new routes of administration. Notification of acceptance or rejection of an application
40
Completion of evaluation 255
Category 2 application An application to register a prescription medicine with the same formulation, dosage and indications as in two acceptable countries and for which two independent evaluation reports are available. Notification of acceptance or rejection of an application 20
Completion of evaluation 175
Category 3 application An application to register or to vary the registration of a prescription medicine where the application does not require the support of clinical, pre-clinical or bio-equivalence data, e.g. change in site of manufacture. Period in which to make a decision or raise an objection
45
From acceptance to delegate's decision 45

In the case of prescription medicines, an 'application' relates to a single change to a single product. A 'submission' includes a number of applications submitted at the one time, in accordance with the Therapeutic Goods Regulations 1990 (the Regulations). The TGA tracks each submission and each product application within each submission.

Category 2 submissions are rarely received. They will only be documented in this report if a submission has been processed.

1.1.1 Workflow of applications

Table 2 Workflow of Category 1 pre-submissions and submissions and Category 3 submissions
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Overall
Pre-submissions/submissions received1 894 1029 936 929
Submissions finalised2 900 1022 960 919
On hand at end of reporting period 656 663 639 666
Category 1
Pre-submissions received1 279 235 238 228
Submissions finalised2 191 230 206 174
On hand at end of reporting period 534 539 571 588
Category 3
Submissions received 675 794 698 701
Submissions finalised2 709 792 754 745
On hand at end of reporting period 122 124 68 78

In the case of prescription medicines, an applicant must first lodge a 'pre-submission', which provides details of a proposed application, at least 2¼ months prior to lodgement of the full 'submission', allowing the TGA to identify milestone dates and plan resource requirements.

1. Includes submissions still in the pre-submission stage.

2. Includes submissions withdrawn or rejected at acceptance for evaluation stage.

Table 3 Category 1 pre-submissions received by fee category and the number of submitted applications for those pre-submissions
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Fee category Pre-subs Apps Pre-subs Apps Pre-subs Apps Pre-subs Apps
New Chemical Entity 28 96 24 50 17 38 32 55
Extension of indications 22 70 16 43 20 30 22 >33
Major variation 20 86 18 80 25 27 25 >37
New generic product 78 613 75 670 71 331 87 >371
Additional trade name 19 90 13 50 28 40 20 >99
Minor variation 5 23 14 6 3 6 6 >9
Changes to PI with evaluation 47 160 42 135 47 57 36 >42
All Others 0 0 33 0 27 0 0 >0
Total 219 1138 235 1034 238 529 228 >646

PI=Product Information; Pre-subs=pre-submissions; Apps=applications.

Table 4 Number of submissions other than Category 1, 2 and 3
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Safety related request 392 437 358 360
Self-assessable request 735 685 582 608
Minor editorial change to PI 94 299 264 272
Correction of error 66 87 98 94
Request for Orphan Drug Designation 8 10 11 44
Not yet determined 0 0 0 0
Total 1284 1518 1313 1345

PI=Product Information

Table 5 Outcomes of submissions
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Approved by delegate
Category 1 168 208 178 166
Category 3 695 785 744 737
Sub-total 856 993 922 903
Rejected by delegate
Category 1 4 5 9 1
Category 3 1 0 0 0
Sub-total 5 5 9 1
Withdrawn by Sponsor
Category 1 19 17 19 7
Category 3 13 7 10 8
Sub-total 32 24 29 15
Rejected in application entry
Category 1 0 0 0 0
Category 3 0 0 0 0
Sub-total 0 0 0 0
Total finalised submissions
Category 1 191 230 206 174
Category 3 709 792 754 745
Total number of submissions 900 1022 960 919

1.1.2 Prescription medicines processing times

Figure 1 Processing times for Category 1 applications finalised: July to 31 December 2014

Figure 1 Processing times for Category 1 applications finalised: July to 31 December 2014

PI=Product Information; NCEs=New Chemical Entities.

Table 6 Mean processing times for Category 1 and Category 3 submissions (working days)
2013 y2014-d
Target Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Category 1 submissions
Acceptance to evaluation completed 135 197* 198* 199* 135
Evaluation completed to delegate's decision 120 45 46 46 36
Net overall TGA evaluation time 255 177 178 178 171
Category 3 submissions
Receipt and payment to acceptance 5 8 7 8 7
Acceptance to evaluation completed 30 16 20 19 18
Evaluation completed to delegate's decision 10 2 2 2 2
Net overall TGA evaluation time 45 29 28 0 26

* The previous periods also included the pre-submission processing times.

1.2 Over-the-counter medicines

The over-the-counter (OTC) application categorisation framework1 outlined below defines the different OTC medicine application levels and the key application criteria.

Table 7 Categorisation of OTC medicines applications
Application category Definition
N1 An application submitted as a 'Clone'.
N2 An application which complies with an over-the-counter medicine monograph.
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4.
N4

An application for a 'generic' medicine where the medicine:

is included in Appendix X (but which is not a level N1 application) and/or

includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher level of assessment and/or

requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data.

N5 An application for a new product that is an extension to a 'generic category' product or an application for a product containing a new chemical entity as an active ingredient.
C1 Quality and non-quality changes.
C2 Quality changes or non-quality changes - no safety and efficacy data required.
C3 Umbrella branding - higher level of assessment or non-quality changes - safety and efficacy data may be required.
C4 Non-quality changes - data are required.

1.2.1 Performance during July to December 2014

Table 8 Summary of received, in progress and completed applications
Application category Number received Number completed1 Number in progress
N1 88 116 11
N2 8 8 0
N3 21 21 12
N4 45 58 37
N5 8 17 7
Sub-total 170 220 67
C1 255 261 21
C2 125 134 27
C3 2 3 2
C4 11 0 11
Sub-total 393 398 61
Total 563 618 128
  1. See Table 9 for details of the outcomes of these applications. In this context 'completed' means the delegate has made a decision or the application is no longer being processed because it was returned to the applicant as 'not valid' or 'not effective' or 'withdrawn'.
Table 9 Completed OTC applications by application category
Outcome
Application category Returned Withdrawn Rejected Approved Total
N1 1 9 0 106 116
N2 0 0 0 8 8
N3 2 0 0 19 21
N4 7 5 0 46 58
N5 5 0 0 12 17
Percentage of N applications 7% 6% 0% 87% 100%
C1 0 4 0 257 261
C2 1 4 0 129 134
C3 0 0 0 3 3
C4 0 0 0 0 0
Percentage of C applications 0% 2% 0% 98% 100%
Total number of applications 16 22 0 580 618
Table 10 Processing times against target time by application category
Elapsed working days1
Application category Number Range Mean Median Target time2 %within target
N1 106 1-52 30 31 45 94
N2 8 26-44 29 26 75 100
N3 19 6-101 51 43 150 100
N4 46 19-169 125 133 170 100
N5 12 89-137 123 137 210 100
C1 257 0-52 8 6 20 96
C2 129 0-107 16 10 64 99
C3 3 24-176 84 51 120 673
C4 0 N/A N/A N/A 170 N/A
Total 580

This table reports on performance undertakings made during the design of the new OTC premarket business processes. These are subject to ongoing review. As at 31 December 2014, the average processing times were well below the target.

N/A=Not applicable.

  1. Between acceptance of application to a formal notification of decision
  2. The target is 80% completed within the agreed timeframe.
  3. C3 applications were low in number and one of the three applications exceeded the target time due to atypical complexities.

1.2.2 Trend data – July 2013 to December 2014

The TGA has been undertaking a business process reform that has resulted in changes to the application categories, target times and a number of other elements. As a result more detail is available, but at this time not all data are available for the full 36 months.

Figure 2 Number of new applications received

Figure 2 - graph of the number of new applications received from July 2013 to December 2014

Figure 3 Number of change applications received

Figure 3 - graph of the number of change applications received from July 2013 to December 2014

Table 11 new-e applications, notifications-e and variations applications received
2013 2014
Jul-Dec Jan-Jun Jul-Dec
New applications received
N1 55 138 88
N2 2 0 8
N3 29 18 21
N4 34 13 45
N5 9 5 8
Total 129 174 170
Notifications and variations
C1 231 183 255
C2 230 129 125
C3 5 8 2
C4 2 0 11
Total 468 320 393
1.2.2.1 Applications in progress
Table 12 Applications in progress (screening and evaluation)
2013 2014
31 Dec 30 Jun1 31 Dec
New applications in progress
N1 21 39 11
N2 2 0 0
N3 37 11 12
N4 51 49 37
N5 16 16 7
Total 127 91 67
Notifications and variations
C1 19 26 21
C2 75 36 27
C3 5 5 2
C4 5 0 11
Total 104 43 61
  1. The number of in progress applications at the end of June 2014 stated in Table 8 of the Jan-Jun 2014 report did not include applications in screening. The in progress applications for June 2014 in this table have been corrected to include applications in both screening and evaluation.
1.2.2.2 Applications completed
Table 13 new-g, variation and notification applications
2012 2013 2014
Application category/decision Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New applications: N1-N5
Total completed 184 187 97 212 220
Approved 137 172 86 189 191
Rejected 0 1 1 1 0
Withdrawn by sponsor 23 7 2 8 14
Returned to sponsor 24 7 8 14 15
Clone: N1
Total completed 48 136 116
Approved 45 131 106
Rejected 0 0 0
Withdrawn by sponsor 3 5 9
Returned/failed screening 0 0 1
Other new: N2-N5
Total completed 56 71 104
Approved 45 58 85
Rejected 0 0 0
Withdrawn by sponsor 3 3 5
Returned/failed screening 8 10 14
Variations: C2-C4
Total completed N/A N/A 176 179 137
Approved 182 129 176 178 132
Rejected 4 2 0 0 0
Withdrawn by sponsor N/A N/A N/A 1 4
Returned/failed screening 0 0 0 0 1
Notifications: C1
Approved/acknowledged N/A N/A 232 184 257
Rejected N/A N/A 0 0 0
Withdrawn by sponsor N/A N/A 16 7 4

N/A=not applicable.

Table 14 Average working days to decision (from acceptance of application)
2013 2014
Jul-Dec Jan-Jun Jul-Dec
New applications % % %
N1 98 98 94
N2 100 100 100
N3 100 100 100
N4 N/A 100 100
N5 100 N/A 100
Variations
C1 92 84 96
C2 100 98 99
C3 100 100 67
C4 N/A 100 N/A

N/A=not applicable.

Table 15 Average working days to decision (from acceptance of application)
2013 2014
Jul-Dec Jan-Jun Jul-Dec
New applications received
N1 = 45 working days 22 21 30
N2 = 75 working day N/A 49 29
N3 = 150 working days 48 97 51
N4 = 170 working days N/A 105 125
N5 = 210 working days 30 N/A 123
Variations
C1 = 20 working days 13 16 8
C2 = 64 working days 22 40 16
C3 = 120 working days 35 33 84
C4 = 170 working days N/A 69 N/A

The processing times achieved so far are well within TGA target times agreed during the design of the new OTC premarket business processes.

1.3 Export only medicines

1.3.1 New applications, variations and processing times

Table 16 New applications for export only medicines
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 175 70 83 60 65
Not accepted 0 0 0 0 0
Withdrawn 7 5 2 5 7
Approved 155 73 82 55 61
Rejected 0 0 0 0 0
Total completed 162 78 84 60 68
Total in progress at the end of the reporting period 26 18 17 17 14
Table 17 Variations and groupings for export only medicines
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 38 69 22 53 47
Not accepted 0 0 0 0 0
Withdrawn 6 1 0 1 2
Approved 40 74 22 52 39
Rejected 0 0 0 0 0
Total completed 46 75 22 53 41
Total in progress at the end of the reporting period 7 1 1 1 7
Table 18 Processing times for new-k applications and variations for export only medicines
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New applications
Average TGA processing time (working days) 27 27 24.8 23.8 20
Percentage processed within target timeframe (31 days) 74% 92% 80% 98% 100%
Average sponsor response time (working days) 2 11.3 5 8.6 6.8
Variations
Average TGA processing time (working days) 31 24 24.7 21.6 12
Percentage processed within target timeframe (31 days) 88% 91% 90% 98% 100%
Avrage sponsor response time (working days) 0 7.5 0 0 0

All 18 applications incomplete at the end of June 2014 were still within the agreed 4 weeks period of their receipt and were satisfactorily progressing in terms of their assessment.

Table 19 Processing times for applications in progress for export only medicines
2012 2013 2014
Time taken to date Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
0-4 weeks 74% 63% 50% 100% 71%
4-8 weeks 3% 11% 45% 0% 14%
8-12 weeks 0% 21% 0% 0% 5%
12-16 weeks 3% 0% 0% 0% 0%
>16 weeks 20% 5% 5% 0% 10%
Total number of applications received 213 139 105 113 112
Total incomplete at end of reporting period 33 19 18 18 21
Number awaiting response from sponsor 16 6 1 0 6

1.3.2 Export certifications for medicines

Table 20.1 Applications for export certifications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 805 1044 954 1078 1146
Certificates issued 884 926 995 1093 1155
Applications rejected 0 0 0 0 0
Table 20.2 Processing times - Applications for export certifications
2012 2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun
From receipt of application to completion of processing (average number of working days) 1 1 1 1 1
From processing completed to issue of certificate (average number of working days) 11 12 12 11 11
Average TGA processing time (target 15 working days) 12 13 13 12 12
Percentage processed in less than 16 working days (target 100%) 99% 98% 96% 98% 99%

1.4 Complementary medicines

1.4.1 Registered complementary medicines

Table 21 Applications for registered complementary medicines
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications for new registered complementary medicines
Applications received 2 0 1 1
Approved 1 1 0 3
Rejected 0 1 0 1
Withdrawn by sponsor 4 0 0 0
Lapsed 0 0 0 0
Total new-l applications on hand at 31 December 2014 = 31
Applications for variations to registered complementary medicines
Applications received 9 11 8 20
Approved 7 12 5 15
Rejected 1 0 0 1
Withdrawn by sponsor 0 0 0 0
Lapsed 0 0 0 0
Total variations applications on hand at 31 December 2014 = 9
  1. Three of these active applications are different dosage forms of the same product line.

1.4.2 Listing of new ingredients and listing of new medicines for supply in Australia

Table 21 Applications for registered complementary medicines
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 10 3 1 2
Approved 3 5 2 4
Rejected 1 1 4 0
Withdrawn by sponsor 0 1 0 0
Lapsed 0 0 0 0
Total new applications on hand at 31 December 2014 = 4

Figure 4 Applications received for new listed medicine products

Figure 4 - Line graph showing the number of applications received for new listed medicine products from January 2008 to December 2014

These statistics include all listed complementary medicines and sunscreens.

Table 23 Number of listed medicines processed

Table 23 Number of listed medicines processed
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Medicines for supply in Australia
New medicine entries 872 954 970 1022
Changes (major and minor) 784 853 604 596
Cancellations 958 207 1490 370
Total 2614 2014 3064 1988

1.5 Registration of biologicals

Table 24 Biologicals application workflow
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Applications received
Technical Master File (TMF) new 0 0 0
TMF annual updates 5 1 5
TMF variations 13 8 5
TMF notifications 10 4 5
Plasma Master File annual updates 13 12 6
Biological Class 2 - new applications 0 1 1
Biological Class 3 - new applications 0 0 0
Biological Class 2 - variations 0 0 2
Biological Class 3 - variations 3 4 1
Total 44 30 25
Applications completed
Technical Master File (TMF) new 0 0 0
TMF annual updates 1 0 2
TMF variations 16 1 6
TMF notifications 9 1 5
Plasma Master File annual updates 7 6 9
Biological Class 2 - new applications 0 0 9
Biological Class 3 - new applications 0 0 4
Biological Class 2 - variations 0 0 1
Biological Class 3 - variations 1 3 0
Total 34 11 36
On hand at end of reporting period
Technical Master File (TMF) new 2 2 2
TMF annual updates 5 4 4
TMF variations 1 7 0
TMF notifications 1 3 2
Plasma Master File annual updates 6 6 7
Biological Class 2 - new applications 19 20 11
Biological Class 3 - new applications 2 2 2
Biological Class 2 - variations 0 0 1
Biological Class 3 - variations 2 1 1
Total 38 45 30

For information about Biological Classes, see Australian Regulatory Guidelines for Biologicals.

1.6 Inclusion of medical devices

1.6.1 Medical devices application workflow

Table 25 Class 1 medical device application workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 1439 886 1405 1302
Applications finalised 1439 1489 1398 1303

For explanation of Classes of Medical Devices, see Australian Regulatory Guidelines for Medical Devices.

Table 26 Class 1 measuring and sterile medical device application workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total Class 1 measuring and sterile medical devices
Applications received 151 221 132 164
Applications completed 117 242 142 165
Applications on hand 117 81 49 10
Class 1 measuring medical devices
Applications received 21 33 24 33
Applications completed 19 34 27 30
Applications on hand 17 13 7 3
Class 1 sterile medical devices
Applications received 130 188 108 131
Applications completed 98 208 115 135
Applications on hand 110 68 42 7
Table 27 Class IIa and IIb medical device application workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
total-o Class 1 measuring and sterile medical devices
Applications received 151 221 132 164
Applications completed 117 242 142 165
Applications on hand 117 81 49 10
Class 1 measuring medical devices
Applications received 21 33 24 33
Applications completed 19 34 27 30
Applications on hand 17 13 7 3
Table 28 Class III and AIMD medical device application workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total Class III, Class III Joint Reclassification and AIMDs
Applications received 12561 543 394 394
Applications completed 5531 555 640 457
Applications on hand 10141 1628 1690 493
Class III medical devices
Applications received 1021 271 219 243
Applications completed 379 194 262 184
Applications on hand 783 437 355 218
Class III Joint Reclassification medical devices
Applications received 10151 215 150 114
Applications completed 3691 329 329 231
Applications on hand 6701 1109 891 252
AIMD medical devices
Applications received 64 57 25 37
Applications completed 44 32 49 42
Applications on hand 77 82 50 23
  1. The increase in applications received and applications on hand for the April to June quarter 2013 was due to the up classification of joint implants.
    AIMD = Active Implantable Medical Device.

Figure 5 Outcomes of applications completed between July and December 2014

Figure 5 - Graph displaying the outcomes of applications completed between July and December 2014

1.6.2 Medical devices processing times

Figure 6 Processing times for applications finalised (all medical devices): July to December 2014

Figure 6 - Graph displaying processing times for applications finalised (all medical devices): July to December 2014

Table 29 Application audits of non-IVD medical devices completed: July to December 2014
Percentage within target Average TGA days
Level 1 Compulsory Audit Assessment (30 working day target) 77% 19
Level 2 Compulsory Audit Assessment (60 working day target) 18% 97
Non-Compulsory Audit Assessment (30 working day target) 54% 52

TGA received a high number of applications for ARTG inclusion for shoulder, knee and hip joint replacement devices during 2013. This had impact on resources allocation for audit assessments of other applications. Over the past 18 months, the number of outstanding application audits has gradually reduced for level 1 compulsory audit assessments and non-compulsory audit assessments.

1.7 Inclusion of in vitro diagnostic medical devices

1.7.1 IVD medical devices workflow

Table 30 IVD application workflow (all classes)
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 267 275 363 199
Applications completed 254 294 319 265
Applications on hand 88 48 126 23

Figure 7 IVD applications received by class

Figure 7 - Graph displaying number of IVD applications received by class

Table 31 Class 1 IVD application workflow and outcomes
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Class 1 IVDs
Applications received 59 64 86 53
On hand 2 1 8 3
Completed 59 65 79 72
Approved 56 65 78 66
Rejected 0 0 0 0
Withdrawn 3 0 1 6
Class 2 IVDs
Applications received 146 110 145 77
On hand 21 10 28 5
Completed 148 120 127 104
Approved 133 113 123 94
Rejected 1 0 1 1
Withdrawn 14 7 3 9
Class 3 IVDs
Applications received 57 77 108 55
On hand 27 16 34 15
Completed 47 85 90 74
Approved 39 80 77 61
Rejected 0 0 1 2
Withdrawn 7 5 12 11
Class 4 IVDs
Applications received 5 24 24 14
On hand 0 0 1 0
Completed 5 24 23 15
Approved 4 24 22 15
Rejected 0 0 0 0
Withdrawn 1 0 1 0
Totals
Approved 228 282 300 236
>Rejected 1 0 2 3
>Withdrawn 24 12 17 26

The figures for withdrawn applications only include those applications that were withdrawn after payment, not applications that were withdrawn prior to payment for the application.

Figure 8 Outcomes of IVD applications selected for application audit: July to December 2014

Figure 8 - Graph displaying outcomes of IVD applications selected for application audit: July to December 2014

1.8 Medical device conformity assessment applications

Table 32 Medical device (including IVD) conformity assessment applications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 104 118 136 98 112
Applications completed 91 116 121 162 115
Applications on hand 178 180 195 131 125
Table 33 IVD conformity assessment application workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Applications received 19 25 14 16
Applications completed 10 16 24 25
Applications on hand 67 79 68 22

1.9 Export certifications for medical devices

Table 34 Applications for export certifications workflow
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Export Certification Assessments
Applications completed 161 228 152 222 239
Export certificates issued 151 206 161 198 255
Applications rejected/withdrawn 0 0 2 0 8
Average processing times (working days)
Export certificates (target = 5 days) 5 4 3 3 3
Percentage processed within target time (Target >90%) 66% 89% 98% 98% 95%

1.10 Blood permits for export processed

Figure 10 Number of permits processed

Figure 10 - Graph displaying number of permits processed for 6 month time-spans from July 2012 to December 2014

1.11 Access to unapproved therapeutic goods

The TGA is in the process of transitioning to an electronic lodgement system for clinical trial notifications (CTN). In 2014, clinical trials that include medical devices have been processed using the same database as that for medicines and biologicals. The figures provided for 2014 combines reporting for biologicals, medicines and devices into a single table for notifications received by State or Territory (tables 36 and 39). Previously clinical trials involving medical devices and biologicals were reported in a separate subsection, this subsection now refers back to tables 36 and 39.

It should also be noted that for tables 37 and 40, the values for notifications categorised as “none specified” has increased as well as the final total values for 2014. This is because these values include data for devices.

1.11.1 Clinical trial notifications: medicines

Table 35 New trial notifications that include a medicine or biological received by State or Territory (single & multi-site trials)
2012 2013
Jul-Dec Jan-Jun Jul-Dec
New South Wales 207 143 164
Victoria 122 110 106
Queensland 29 30 33
South Australia 38 25 41
Western Australia 20 18 10
Tasmania 0 0 1
Australian Capital Territory 0 0 0
Northern Territory 0 0 0
Total 416 326 355
2014
Jan-Jun (total = 449) Jul-Dec (total = 518)
M D B M&D D&B M&B M D B M&D D&B M&B
New South Wales 123 30 1 72 0 0 97 35 1 113 0 0
Victoria 92 18 1 19 0 1 95 18 2 32 0 0
Queensland 26 4 1 8 1 0 47 4 2 3 1 0
South Australia 25 0 0 7 0 0 20 3 0 11 0 0
Western Australia 11 4 0 4 0 0 14 10 2 3 0 0
Tasmania 1 0 0 0 0 0 3 0 0 0 0 0
Australian Capital Territory 0 0 0 0 0 0 2 0 0 0 0 0
Northern Territory 0 0 0 0 0 0 0 0 0 0 0 0
Total 278 56 3 110 1 1 278 70 7 162 1 0

M=medicine, D=device, B=biological

2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Table 37 New trial notifications that include a therapeutic good (biological, device or medicine) received by phase (single & multi-site trial)
Phase 1 85 65 132 68 83
Phase 2 128 86 102 130 124
Phase 3 155 131 70 153 198
Phase 4 34 28 32 32 34
Bioavailability/equivalence 5 4 5 2 3
None specified 9 12 14 64* 76*
Total 416 326 355 449* 518*

*this number now combines those CTNs which involve device(s)

Figure 11 Total notifications and new trial notifications that include a medicine or biological

Figure 11 - Graph displaying the total notifications and new trial notifications that include a medicine or biological

Table 38 Notifications that include a medicine or biological received by State or Territory (total number of trial sites notified)
2012 2013
Jul-Dec Jan-Jun Jul-Dec
New South Wales 435 404 492
Victoria 460 415 507
Queensland 312 311 268
South Australia 165 168 193
Western Australia 151 125 123
Tasmania 28 29 31
Australian Capital Territory 29 25 33
Northern Territory 4 0 1
Total 1584 1477 1648
Table 39 All Notifications that include a therapeutic good (biological, device or medicine) received by State or Territory (single & multi-site trials)
2014
Jan-Jun (total = 1862) Jul-Dec (total = 1900)
M D B M&D D&B M&B M D B M&D D&B M&B
New South Wales 601 93 6 376 0 0 297 36 1 191 1 0
Victoria 400 41 1 81 0 0 285 41 3 252 0 0
Queensland 86 4 0 49 1 0 209 11 4 140 0 0
South Australia 52 0 0 31 0 0 102 15 0 102 0 0
Western Australia 22 4 0 5 0 0 76 13 2 62 0 0
Tasmania 5 0 0 3 0 0 14 0 2 11 0 0
Australian Capital Territory 1 0 0 0 0 0 14 1 0 9 0 0
Northern Territory 0 0 0 0 0 0 5 0 0 1 0 0
Total 1167 142 7 545 1 0 1002 117 12 768 1 0

M=medicine, D=device, B=biological

Table 40 Notifications that include a therapeutic good (biological, device or medicine) received by phase (total number of trial sites notified)
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Phase 1 143 115 123 94 131
Phase 2 465 355 374 421 436
Phase 3 842 890 1020 978 1088
Phase 4 120 96 95 210 116
Bioavailability/equivalence 5 4 5 5 4
None specified 9 17 31 154* 125*
Total 1584 1477 1648 1862* 1900*

*this number now combines those CTNs which involve device(s)

1.11.2 Special access scheme

The Special Access Scheme refers to arrangements which provide 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 patients are defined as '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'.
  • Category B patients are all other patients that do not fit the Category A definition.
Table 41 Category A notifications and Category B applications for medicines
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total notifications (Category A) 19,795 15,790 19,259 17,648 18,698
Applications received (Category B) 8792 9036 12,938 10,027 10,631
Approved 8626 8681 12,557 9675 10,338
Cancelled 31 45 226 181 172
Rejected 30 53 13 22 47
Pending at end of reporting period 105 257 142 32 74
Table 42 Category A notifications and Category B applications for devices
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total notifications (Category A) 1130 649 1561 1139 1968
Applications received (Category B) 1543 1143 1415 1257 1218
Approved 1542 1142 1408 1159 1121
Cancelled 0 1 5 11 75
Rejected 1 0 0 16 17
Pending at end of reporting period 0 0 2 65 5
Table 43 Category A notifications and Category B applications for biologicals
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total notifications (Category A) 3 9 5 24 38
Applications received (Category B) 788 964 962 1171 1229
Approved 788 964 961 1135 1225
Rejected 0 0 0 4 1
Pending at end of reporting period 0 0 1 23 0

1.11.4 Authorised prescribers

Table 44 Authorised prescriber approvals for medicines and medical devices
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Number of approvals - medicines 402 251 221 213 324
Number of approvals - medical devices 116 141 101 88 129

1.11.5 Import permits

Table 45 Import permits issued for medicines under Regulation 5G and 5H of the Customs (Prohibited Imports) Regulations 1956
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Number of approvals 344 402 273 219 224

1.12 Orphan drug designations

Table 46 Number of orphan drug designations
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Number of designations 23 6 11 11 11

Book pagination