Half-yearly performance reports - July to December 2014

31 March 2015

The TGA prepares statistical performance reports that are presented biannually to the Therapeutic Goods Industry Consultative Committee (TICC) for information.

For the information of all our stakeholders, we will now also be publishing the reports on the TGA website.

We value your feedback as to how useful the information is to you and any suggestions you may have as to how we can improve the presentation or content of the information in the reports.

Please email your feedback to tgabusinessplanning@tga.gov.au.

What the TGA regulates

31 March 2015

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

The TGA is responsible for ensuring that therapeutic goods available for supply in or exported from Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

The TGA regulates the supply, manufacturing and advertising of these products:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from supermarkets
  • complementary medicines, these include vitamins, herbal and traditional
  • medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
  • vaccines, blood products, and other biologics.

How the TGA regulates

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The TGA regulates therapeutic goods through:

  • premarket assessment and market authorisation
  • postmarket monitoring and enforcement of standards; and
  • ensuring manufacturing facilities, whether in Australia or overseas, comply with internationally recognised standards.

Therapeutic goods are divided broadly into three classes: biologicals, medicines and medical devices. Unless exempt, biologicals and medical devices must be 'included' and medicines must be entered as either 'registered' or 'listed' medicines on the ARTG before they may be supplied in or exported from Australia.

If a problem is discovered with a medicine, device or manufacturer, the TGA is able to take a variety of regulatory actions. Possible actions vary and may include continued monitoring through to withdrawing the product from the market or in some circumstances referral to the Commonwealth Director of Public Prosecutions for possible prosecution in relation to criminal offences.

Regulating medicines

The regulation of medicines includes the following features:

  • classifying the medicine based on different levels of risk to the person taking them
  • implementing appropriate regulatory controls for the manufacturing processes of medicines
  • Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy
  • Ingredients in medicines with a lower risk (medicines purchased over the counter, such as complementary medicines) are required to meet standards for quality and safety
  • Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label
  • Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme that allows safety problems to be identified and actions taken to minimise any further potential for harm to patients.

Regulating medical devices

The regulation of medical devices includes:

  • classifying the medical device based on different levels of risk to the user
  • assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance
  • implementing appropriate regulatory controls for the manufacturing processes of medical devices
  • including the medical device in the Australian Register of Therapeutic Goods
  • once available for supply, medical devices are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event incident reporting programme that allows for early identification of potential safety issues.

Other therapeutic goods regulated by the TGA

The TGA also applies a risk management approach to the regulation of:

  • in vitro diagnostic medical devices (IVDs)
  • blood
  • blood components
  • plasma derivatives
  • tissue and cellular products
  • tissue and cell based derivatives
  • sterilants and disinfectants.

The half-yearly performance report

31 March 2015

The TGA provides information twice-yearly on our regulatory performance to our stakeholders through detailed statistical reports. This half-yearly performance report covers the period July to December 2014.

Our performance against our broad strategic intent is measured through twice-yearly reporting against eight agreed key performance indicators in TGA key performance indicators reports.

Key observations: January to June 2014

31 March 2015

Market authorisation

Prescription medicines

  • The number of submissions to register new prescription medicines, or to make significant variations to an existing prescription medicine (Category 1), has remained relatively consistent with previous periods over 2013 and 2014.
  • Category 3 submissions (variations to existing medicines that do not need to be supported by clinical, non-clinical or bioequivalence data) have remained relatively consistent with previous periods over 2013 and 2014.
  • All other submissions have remained relatively constant overall.
  • Mean processing times for Category 1 and 3 applications were well below the statutory timeframes of 255 days and 45 days respectively.

Over-the-counter (OTC) medicines

  • There was an increase in the total number of applications received compared with January-June 2014, although the number falls within the variability of previous periods. The number of N4 applications has tripled compared with January-June 2014.
  • There continues to be a high volume of applications to make quality and non-quality related changes (C1 and C2), compared to new applications.
  • Mean processing times for all types of applications were well below the agreed target timeframes. The percentage of applications completed within target timeframes was consistently higher than the 80% target.

Complementary medicines

  • There was one new registered complementary medicine application received between July and December 2014, which is equivalent to the previous reporting period.
  • The number of newly listed complementary medicines entered on the Australian Register of Therapeutic Goods between July and December 2014 is similar to the number of new entries reported in the previous reporting period of January to June 2014.
  • The total number of new listed medicines in 2014 showed a 28% increase from 2013.

Medical devices

  • In 2012, joint implants were reclassified from Class IIb to Class III. After an initial large increase in May and June 2013 (coinciding with the end of the waiver of application fees), the number of Class III joint reclassification applications received has noticeably reduced during the last three reporting periods.
  • The high number of joint reclassification applications has impacted on resource allocation for audit assessments of other applications. Therefore, timeframes for level 2 compulsory audit assessments and non-compulsory audit assessments are currently not meeting the target timeframes. However 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.

Special access scheme for medicines

  • The number of Category A notifications for use in patients who are terminally ill or seriously ill or have life-threatening conditions have steadily increased for all types of therapeutic goods; medicines, devices and biologicals. For medicines, the total number of Category A notifications in 2014 showed a 3.7% increase from 2013 (2013:35,049 notifications; 2014: 36,346 notifications). For devices, the total number of Category A notifications in 2014 showed a 40% increase from 2013 (2013: 2,210 notifications; 2014: 3,107 notifications in 2014). Of significant note, the total number of Category A notifications for biologicals showed a 342% increase in 2014 (2013: 14 notifications; 2014: 62 notifications).
  • The number of Category B applications for use in patients other than those with terminally ill or seriously ill/life threatening conditions decreased slightly for medicines and devices, but increased significantly for biologicals. The total number of Category B applications specifically for biologicals in 2014 showed a 25% increase from 2013 (2013: 1,926 applications; 2014: 2,400 applications).

Postmarket activities

Licencing and manufacturing

  • As at 31 December 2014, there were 414 Australian companies holding manufacturing licences covering 457 sites.
  • Between July and December 2014, 97% (99 out of 102) of licence application inspections of Australian manufacturers were found to have satisfactory compliance and the remaining 3% (3 out of 102) were found to have basic compliance.
  • As at 31 December 2014, 2681 overseas manufacturers of therapeutic goods were approved to supply the Australian market. Of these, 410 overseas manufacturers covering 422 sites were approved following a TGA inspection. The remainder were approved based on inspections conducted by equivalent international regulatory authorities.
  • Between July and December 2014, 86% (41 out of 47) of certification inspections for assessment were found to have satisfactory compliance, a further 11% (5 out of 47) were found to have marginal compliance and 3% (1 out of 47) were found to be unacceptable.

Therapeutic goods recalls

  • Between 1 July and 31 December 2014, there were a total of 366 recall actions coordinated by the TGA, comprising 22 medicines, 291 medical devices (including in vitro diagnostic medical devices; IVDs), and 53 process-related blood product recall actions.
  • The average numbers of recall actions for a six month period over the last three years were: 26 (medicines), 284 (medical devices including IVDs), 1 (biological) and 46 (blood products).

Medicine and vaccine adverse event reports

Reporting of medicine and vaccine adverse events peaked in 2013 with over 20,000 adverse event case reports received and remains above 17,000 reports being received annually. Hospital adverse event reports increased in the second half of 2014 by 28% compared to the previous year. The reason for the fluctuation is usually due to normal variation that can occur in a spontaneous reporting system. In this case it is also likely that changes in reporting requirements for sponsors regarding reporting of adverse events associated with patient support programs would have reduced the number of reports from sponsors. These reports are now considered solicited and are not required to be reported (this is also the case in the European Union).

Regulatory compliance

  • Between July and December 2014, we dealt with 576 alleged offences. The types of investigations included illegal import, supply, manufacture, claim and export. None of these offences required resolutions through the court system and therefore there were no convictions, however, one enforceable undertaking was entered into during this period as an alternative to court action. Please see Enforceable undertaking: Nutrition Warehouse Pty Limited.

Key statistics: July to December 2014

31 March 2015
Total products on the Australian Register of Therapeutic Goods (ARTG)
Category Number
Biologicals 15
Prescription medicines 14,990
OTC medicines 3419
Listed medicines 12,301
Registered Complementary Medicines 141
Export only medicines 2708
IVDs (including export only IVDs) 1712
Medical Devices (including other therapeutic goods and export only medical devices) 46,821
Total 82,107
Medicines registrations processed by TGA
Type of medicine registration Number
Prescription Medicines
New medicine entries 815
Changes (major and minor) 9070
Cancellations 87
Over-the-counter Medicines
New medicine entries 198
Changes (major and minor) 132
Cancellations 30
Complementary Medicines
New medicine entries 3
Changes (major and minor) 15
Cancellations 37
Medicine listings processed by TGA: January to June 2014
Type of listing processed Number
Medicines for supply in Australia
New medicine entries 1022
Variations 596
Cancellations 370
Medicines for export only
New medicine entries 63
Changes (major and minor) 39
Cancellations 17
Medical devices inclusions processed by TGA: January to June 2014
Medical device inclusions processed Number
Included medical devices
New entries 2863
Cancellations 688
Included medical devices for export
New entries 366
Cancellations 12
Included IVD medical devices
New entries 220
Cancellations 11
Included IVD medical devices for export
New entries 0
Cancellations 0
Other therapeutic goods
New entries 12
Cancellations 33
Other therapeutic goods for export
New entries 0
Cancellations 0
Recall information
Recall level Medicines Devices Biologicals
Recalls to consumer level 1 4 0
Recalls to retail level 10 17 0
Recalls to hospital level 8 270 0
Recalls to wholesale level 3 0 0
Total 22 291 0
Medicines adverse reaction reporting
Incoming medicines adverse reaction reports Number
Hospitals 1205
Companies 4202
General Practitioners 340
Specialists 122
Pharmacists 594
Members of the Public (Consumer) 231
Nurses, dentists, complementary 113
State/Territory Health Department 1048
General list (cause unclear) includes rejected and withdrawn 797
Total 8652
Medical device incident reports
Type of report received Number
User reports 458
Sponsor reports 2593
Total 3051

1. Market authorisation

31 March 2015

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

2. Postmarket activities

31 March 2015

2.1 Licencing and manufacturing

2.1.1 Manufacturing licences

Table 47 Manufacturing licence applications
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
New licences granted 23 13 19 22 4
Withdrawn application 9 2 7 39 21
Revoked licences - Voluntary 0 0 19 23 6
Revoked licences - TGA 0 0 1 0 0
Ceased 16 29 0 0 0
Suspended 1 4 3 1 0
Suspended - Voluntary N/A N/A 3 1 0
Suspended - TGA N/A N/A 0 0 0

As at 31 December 2014, there were 414 Australian companies holding manufacturing licences covering 457 sites.

N/A=Not applicable. The separate recording of voluntary and TGA suspension of licences commenced in 2012–13.

Figure 12 Licence application outcomes for July to December 2014

Figure 12 - Pie graph displaying licence application outcomes for July to December 2014. 97% had Satisfactory compliance, 3% had Marginal compliance and 0% were Unacceptable

Table 48 Licence application outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Inspections conducted 244 272 247 201 102
Satisfactory compliance 76% 81% 85% 89% 97%
Marginal compliance 23% 16% 12% 10% 3%
Unacceptable 1% 3% 3% 1% 0%
Initial inspections conducted within 3 months of application 81% 79% 60% 87% 56%
Re-inspections conducted within 6 months of due date 86% 68% 70% 64% 31%

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.

2.1.2 Manufacturing certifications

Table 49 Certification application status
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
New applications received 189 141 117 153 38
Re-inspection applications 235 172 229 172 83
Certified 119 130 156 133 67
Rejected 0 0 111 82 39

As at 31 December 2014, there were 410 overseas manufacturers covering 422 manufacturing sites.

Figure 13 Certification outcomes for July to December 2014

Figure 13 - Pie graph displaing certification outcomes for July to December 2014: 86%% had satisfactory compliance, 11%% marginal compliance and 3%% were unacceptable.

Table 50 Certification outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Inspections conducted 157 143 109 113 47
Satisfactory compliance 84% 87% 86% 93% 86%
Marginal compliance 14% 13% 13% 7% 11%
Unacceptable 2% 0% 1% 0% 3%
Initial certifications inspections conducted within 6 months of application 90% 80% 74% 68%* 80%
Certification re-inspections conducted within 6 months of due date 75% 82% 68% 51% 44%

*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.

2.1.3 GMP clearances

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

Table 51 Clearance application status
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Applications received 2418 3900 3941 4222 1675
Renewal applications 1067 1172 1033 1218 730
Approved 3362 4103 3644 3539 1897
Rejected 18 232 92 73 224
Table 52 Clearance application outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Evidence from a country with an MRA1 with Australia 1478 1444 1575 1500 621
Compliance Verification evidence2 520 283 316 299 130
TGA Certification 677 698 405 256 150
  1. MRA=Mutual Recognition Agreement between Australia and other countries, whereby the parties recognise and accept the certification issued by the relevant regulatory agency in each country in relation to manufacturers located within that country.
  2. Assessment of a recent GMP inspection report of the relevant overseas manufacturing site prepared by a competent overseas regulatory agency acceptable to the TGA, together with supporting manufacturing documentation supplied by the sponsor or manufacturer.

2.2 Laboratory testing

Table 53 Number of samples and products tested by TGA
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Prescription medicines Total 404 558 419 540 377
% fail 1% 2% 2% 1% 1%
OTC medicines Total 31 31 62 15 20
% fail 10% 13% 3% 0% 40%
Complementary medicines Total 54 71 42 200 77
% fail 24% 24% 24% 27% 30%
Medical devices Total 284 100 75 69 75
% fail 21% 23% 17% 30% 19%
Contract1 Total 12 3 2 47 23
% fail 25% 0% 0% 0% 22%
Unregistered2 Total 109 91 105 186 166
% fail 62% 67% 64% 82% 54%
Total samples per half year3 1000 938 816 1289 1013
Total samples per half year (excluding AHQ samples) 895 855 705 1057 738
Percentage fail per half year 17% 13% 14% 22% 19.6%
Total number of products tested per half year4 488 394 385 507 403
  1. Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices.
  2. Unregistered refers to products that meet the definition of therapeutic goods but are not on the ARTG or otherwise specifically exempted from this requirement in the legislation.  This often includes adulterated complementary medicines or counterfeit products.
  3. Includes accreditation, harmonisation and quality control (AHQ) samples.
  4. The TGA may test a number of samples of each product per reporting period.
Table 54 Laboratory testing: reason for failed samples, July to December 2014
Medical devices OTC medicines Prescription medicines Unregistered products Comp medicines Total
Contamination 5 0 1 3 1 10
Formulation 4 8 0 75 6 93
Label and packaging deficiencies 3 0 0 0 10 13
Performance 0 0 0 4 0 4
Physical or mechanical properties 2 0 4 8 6 20
Total 14 8 5 90 23 140
Table 55 Target timeframes for testing (working days)
Priority of testing Biochemical/chemical testing Microbiological testing Medical device testing
Urgent 20 (95% of target times to be met) 40 (95% of target times to be met) 20 (95% of target times to be met)
Priority 40 (80% of target times to be met) 50 (80% of target times to be met) 40 (80% of target times to be met)
Routine 50 50 50

Samples requiring biological testing are excluded from the target turnaround timeframes.

Table 56 Compliance with testing timeframes: July to December 2014
Priority Total Percentage
Medical devices Routine 122 78%
Priority 18 94%
Urgent 5 100%
OTC medicines Routine 26 65%
Priority 0 0%
Urgent 0 0%
Prescription medicines Routine 110 80%
Priority 21 100%
Urgent 0 0%
Complementary medicines Routine 91 69%
Priority 14 100%
Urgent 2 50%
Unregistered products Routine 67 69%
Priority 98 96%
Urgent 5 100%

Low numbers of samples in categories may affect compliance percentages.

Table 57 Batch release and export certification
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Batch release1 176 248 136 225 152
Export certification 26 75 23 36 5
  1. Vaccines, biotechnology and blood products: evaluation of batch release documentation.

2.3 Recalls

2.3.1 Medicine recalls

Table 58 Numbers of medicine recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to consumer level 4 4 4 2 1
Recalls to hospital level 8 8 14 8 8
Recalls to retail level 9 5 5 7 10
Recalls to wholesale level 2 2 2 3 3
Total 23 19 25 20 22
Table 59 Medicine recalls: reason for recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Adverse reactions 1 0 1 1 0
Foreign matter 0 1 1 0 3
Illegal supply 1 2 2 0 0
Impurity and degradation 0 1 0 3 3
Labelling and packaging 8 3 7 5 8
Micro-organisms 1 5 0 0 0
pH 0 0 0 0 0
Potency 0 1 1 1 1
Sterility 0 0 0 1 1
Other1 12 6 13 9 6
Total 23 19 25 20 22
  1. 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product.

2.3.2  Medical device and biological recalls

Table 60 Medical devices (including IVDs): numbers of recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to consumer level 8 11 11 11 4
Recalls to hospital level 246 265 280 262 270
Recalls to retail level 32 21 11 12 17
Recalls to wholesale level 2 3 3 2 0
Total medical device recalls 288 300 305 287 291
Table 61 Medical devices (including IVDs): reason for recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Adverse incidents 2 1 1 0 1
Diagnostic inaccuracy 46 46 37 29 38
Electrical defect 22 20 10 17 25
Illegal supply 5 0 0 0 0
Labelling and packaging 53 49 56 61 43
Mechanical and physical defects 97 119 125 100 96
Software defects 47 55 65 69 59
Sterility 2 0 1 2 5
Other1 14 10 10 9 24
Total 288 300 305 287 291
  1. 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences.
Table 62 Numbers of biologicals recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to hospital level 0 7 0 2 0

2.4 Adverse medicine reaction reports

2.4.1 Incoming adverse medicine and vaccine reaction notifications

Figure 14 Total number of incoming adverse medicine reaction notifications received

Figure 14 - Graph displaying the total number of incoming adverse medicine reaction notifications received from July 2012 to December 2014

Table 63 Source of incoming notifications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Hospitals 852 837 941 978 1205
Companies 4144 4499 5085 4183 4202
General Practitioners 349 372 357 397 340
Specialists 87 106 117 93 122
Pharmacists 552 562 717 630 594
Members of the Public (Consumer) 312 300 273 298 231
Nurses, dentists, complementary 90 99 76 117 113
State/Territory Health departments 757 1835 1276 1636 1048
General list (cause unclear) includes rejected and withdrawn 1121 1348 1256 952 797
Total 8264 9958 10098 9284 8652
Vaccine reports1 903 2125 1432 2008 1276
Average number of reports received weekly 317 383 388 357 332
  1. The data for vaccine reports comprise a subset of the total figure.

2.4.2 Communications and publications

Table 64 Communications and publications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Requests for database output or other information 3388 4440 5570 6628 N/A1
1800 number calls received 286 312 204 1132 313
Public Contact Team (PCT)- Adverse reactions/events calls received N/A N/A 175 176 172
Medicines Safety Update (MSU) bulletin numbers 4, 5 ,6 7, 8, 9 10, 11, 12 13, 14, 15 16, 17, 18
  1. This figure is not reportable due to a change in email systems in this reporting period.
  2. This figure represents the calls about adverse events received to 1800 044 114 from Health professionals, consumers, manufacturers and sponsors. This service was taken over by AAPT from Telstra in late 2013 and due to the change-over the data for January to March 2014 was not recorded.
2.4.2.1 Medicines Safety Updates (MSU): July to December 2014

Medicines Safety Updates5 are medicines safety bulletins issued six times yearly by the TGA. Three editions were published during the current reporting period.

Early warning system: July to December 2014

The TGA's Early Warning System provides current and historical information on safety concerns for medicines and medical devices (also known as therapeutic products) that the TGA has identified through its therapeutic product vigilance program. Early warnings were issued on the following medicines between July to December 2014:

No Early warnings were issued for the period July to December 2014.

Medicine alerts: July to December 2014

Alerts provided by the TGA contain important information and recommendations about therapeutic products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. The following medicine alerts were published between July and December 2014:

  • Galantamine
  • Meningitec meningococcal serogroup C conjugate vaccine suspension for injection, single dose syringe
  • Children's Panadol 1-5 years Colourfree Suspension
  • Non-steroidal anti-inflammatory drugs and diclofenac reviews
  • Serotonin-blocking medicines used to treat nausea and vomiting
  • Propofol: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches

2.5 Medical device incident reports

Table 65 Number of medical device incident reports received by financial year
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total received 1861 2161 2346 3013 3051
User reports 537 480 492 898 458
Sponsor reports 1324 1681 1854 2115 2593
Table 66 Australian incident notification workflow
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Reports entered 1271 1255 1630 1498 1662
Reports completed 1148 1865 1443 1578 2641
Reports still in progress 970 687 627 498 169
Table 67 Australian incident notification: processing times
2012 2013 2014
Target Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Mean time to investigate and resolve 90 days 34 N/A 30 59 19
Percentage of reports not resolved in target time 0% 25% N/A 16% 18% 14%

N/A = not applicable. Data unavailable due to system recording failure.

Table 68 Device incident notification report outcomes
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Reviewed and used for trend analysis purposes 459 516 736 862 1801
Reviewed, no further action required 284 754 585 583 689
Product Recall 23 29 37 42 23
Recall for Product Correction 6 10 37 18 5
Hazard Alert 1 55 41 36 40
Product Notification 1 0 1 0 1
Safety Alert 5 4 11 46 11
Product Enhancement/Improvement Notice 1 2 1 1 1
Instructions for Use Amended 9 10 28 26 15
Referral for Post-Market Review 1 2 1 2 53
Referral to TGA Office of Manufacturing Quality 1 3 0 9 1
Refer to another TGA Office 13 26 28 35 28
Company warned 0 0 1 3 0
Product Suspended from ARTG 0 1 0 0 0
Product Cancelled from ARTG 3 26 5 1 1
Manufacturing Process Improvements 22 30 18 42 11
Quality System Process Improvements 3 1 6 5 8
Maintenance Carried out by the Hospital 0 1 1 1 0
Change to Design 12 26 8 6 11
Not Device Related 26 8 11 9 6
Other 20 43 44 97 119

2.6 Listed medicine reviews

Table 69 New and completed reviews
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New reviews/investigations initiated
Targeted reviews 102 46 58 47 21
Random 2 4 19 22 13
Investigations1 22 42 7 49 38
Total 126 92 84 118 72
Reviews/investigations finalised
Targeted reviews 116 48 77 68 113
Random 27 14 6 21 20
Investigations1 38 22 23 32 46
Total 181 84 106 121 179
Reviews in progress as at last day of each 6 monthly period 190 200 271 178 86

All investigations are assessed and triaged based on a risk management approach. All investigations are actioned on this basis to provide the greatest overall benefit for the Australian public. Investigations may be finalised through a number of mechanisms, such as initiating a targeted review or referral to another area of the TGA.

  1. Investigations can include products not listed on the ARTG.
Table 70 Listing compliance review outcomes
Jul-Dec 2014
Number Percentage
No compliance breaches identified against selected listing requirements 23 17%
Medicines with verified compliance breaches against selected listing requirements 80 60%
Compliance status not determined
(Includes medicines cancelled after Section 31 notice issued, medicines not yet manufactured, financial cancellations etc.)
30 23%
Total 133 100%
Table 71 Listing compliance review issues
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Information provided in ARTG entry 6 4 3
Product: formulation/manufacturing/quality 4 8 6
Labelling and Advertising 40 49 34
Evidence 10 14 25
Other (e.g. Sponsor has failed to comply with a condition that the medicine is subject to; Sponsor has failed to comply with an additional condition of listing, etc.) 9 6 40

Individual listings may have multiple issues and actions.

Table 72 Actions taken for listed medicines
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Proposal to Cancel letter sent by the TGA 41 39 75
Medicines cancelled by TGA 7 6 45
Medicines cancelled by Sponsor after Proposal to Cancel letter issued 13 25 11
Medicines cancelled by Sponsor before compliance status could be determined e.g. after a section 31 notice was issued to Sponsor 6 18 18
Compliance reviews initiated but not able to be completed (e.g. medicine not yet manufactured or product cancelled for non - payment of fees) 9 10 13
Investigations resulting in initiation of target review 4 9 34

Individual listings may have multiple issues and actions.

2.7 Medical device postmarket reviews

Table 73 Devices verification: restricted word and targeted review workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Restricted word reviews
Reviews completed 25 27 17 7
Reviews commenced 17 20 17 4
Reviews on hand 16 14 13 0
Targeted reviews
Reviews completed 101 63 114 94
Reviews commenced 41 83 136 33
Reviews on hand 151 320 413 67

2.8 Regulatory compliance

Table 74 Numbers of alleged offences
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Import 379 325 380
Supply 195 217 177
Manufacture 10 9 5
Claims 5 5 12
Export 2 2 2
Total 591 558 576
Table 75 Categorisation of final action taken
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Investigation in progress 222 257 168
Warned 223 371 291
No offence detected 90 100 82
Goods released under Personal Import Scheme 31 33 29
Referred to another agency or department outside of TGA 17 8 5
Referred to another Office within the TGA 7 8 1
Import treated as abandoned goods by Customs 1 0 0
Recall of goods 0 2 0
Matters referred to the Commonwealth Director of Public Prosecutions 0 3 0
Total 591 782 576
Table 76 Numbers of dosage forms investigated
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Capsule 279 236 172
Tablet 214 263 260
Topical 149 97 99
Medical device 124 97 82
Injection 65 87 78
Oral liquid 36 23 24
Drops 19 7 1
Spray 13 5 14
Powder 12 20 24
Oral jelly/paste 11 17 19
Inhalator 3 2 0
Lozenge 3 2 0
Transdermal 2 2 1
Oral food 1 2 1
Reagent Test Kit 1 0 0
Other 0 6 0
Total 932 866 775
Table 77 Types of products investigated
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Complementary medicines 390 421 260
Prescription medicines 349 318 383
Medical devices 121 100 81
Homoeopathic medicines 41 1 2
OTC medicines 17 9 32
Biological products 0 0 5
Other 17 18 14
Total 935 867 777
Table 78 Numbers of special interest investigations for each type
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Unapproved product 770 678 677
Counterfeit 137 172 92
Parallel import/export 4 2 0
Manufacture without licence 2 1 0
Advertising offence 0 0 1
Traditional Chinese medicines 0 0 1
Other 5 6 2
Total 918 859 773
Table 79 Numbers of investigations by complainant type and state/territory
Origin ACT NSW NT QLD SA VIC WA Others Total
Complaints resolution 3 1 0 2 1 1 1 1 10
Customs 0 128 7 69 3 99 32 1 339
External agency 2 10 0 8 1 3 0 1 25
General public 0 15 0 4 4 4 2 100 129
Patient/practitioner 0 0 0 0 0 1 0 2 3
Sponsor/client 0 3 0 0 0 1 1 6 11
TGA internal 54 0 0 0 0 1 0 0 55
Total 59 157 7 83 9 110 36 111 572

3. Australian Register of Therapeutic Goods (ARTG)

31 March 2015

3.1 New, variations and cancelled records

Table 80 Number of medicine registrations processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Prescription medicines
New medicine entries 958 814 1013 847 815
Changes (major and minor) 7554 7439 9979 9183 9070
Cancellations 86 332 77 305 87
OTC medicines
New medicine entries 140 159 89 177 198
Changes (major and minor) 182 129 176 178 132
Cancellations 13 146 9 107 30
Complementary medicines
New medicine entries 1 1 1 0 3
Changes (major and minor) 8 7 12 5 15
Cancellations 1 6 0 17 37
Table 81 Number of listings processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Medicines for supply in Australia
New medicine entries 875 872 954 970 1022
Changes (major and minor)* 783 784 853 604 596
Cancellations 382 958 207 1490 370
Medicines for export only
New medicine entries 155 81 76 54 63
Changes (major and minor) 40 74 22 52 39
Cancellations 143 98 19 98 17

*These figures have been revised from the previous report as there were calculation errors

Table 82 Number of medical device inclusions processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Included medical devices
New entries 2584 2863 3284 2961 2863
Cancellations 482 1752 639 2649 688
Included medical devices for export
New entries 115 95 170 198 366
Cancellations 20 32 42 37 12
Included IVD medical devices
New entries 233 228 267 283 220
Cancellations 8 6 8 8 11
Included IVD medical devices for export
New entries 4 4 5 1 0
Cancellations 1 2 0 0 0
other therapeutic goods
New entries 9 12 18 10 12
Cancellations 11 38 18 84 33
other therapeutic goods for export
New entries 0 0 0 0 0
Cancellations 0 0 0 0 0
Table 83 Number of biological inclusions processed
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New entries 1 1 0 13
Cancellations 0 0 0 0
Table 84 Cancellation of registered and listed devices
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Registered devices 0 0 0 0 0
Listed devices for supply in Australia 2 6 1 3 1
Listed devices for export only 0 0 0 0 0

3.2 ARTG product entries

Figure 15 Total number of product entries on the ARTG at end of reporting period
Figure 15 - Graph displaying the total number of product entries on the ARTG at end of each 6-monthly reporting period from 31 December 2012 to 31 December 2014.

Table 85 Number of medicine entries on the ARTG
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Medicine registrations
Prescription medicines 12,316 12,792 13,720 14,259 14,990
OTC medicines 3193 3096 3177 3249 3419
Complementary medicines 91 198 193 175 141
Total registered medicines 15,600 16,086 17,090 17,683 18,550
Medicine listings
Listed medicines 11,697 11,604 12,164 11,647 12,301
Export only medicines 2667 2650 2706 2662 2708
Total medicines 29,964 30,340 31,960 31,992 33,559
Table 86 Number of medical device entries on the ARTG
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Medical device inclusions
Included devices 39,478 40,574 42,917 43,219 45,400
Included IVDs 724 946 1205 1480 1689
Included devices for export only 722 778 906 1067 1421
Included IVDs for export only 12 14 19 23 23
other therapeutic goods
other therapeutic goods - listings and registrations 630 605 597 523 504
other therapeutic goods for export only 10 10 10 10 10
Total medical devices 41,576 42927 45654 46,322 49,047
Table 87 Number of biological entries on the ARTG
2013 2014
30 Jun 31 Dec 30 Jun 31 Dec
Biologicals 1 2 2 15
Table 88 ARTG totals
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Total registrations on the ARTG 71,540 73,289 77,617 78,316 82,621
Total number of sponsors 3443 3565 3639 3673 3833

4. Abbreviations

31 March 2015
Abbreviation Meaning
ACPM Advisory Committee on Prescription Medicines
AIMD Active Implantable Medical Device
ARTG Australian Register of Therapeutic Goods
GMP Good Manufacturing Practice
IVD In vitro diagnostic medical devices
MRA Mutual Recognition Agreement
MSU Medicines Safety Update
OLSS Office of Laboratories and Scientific Services
OTC Over-the-counter
PI Product Information
PIP Poly Implant Prothese
PMF Plasma Master File
TMF Technical Master File
WHO World Health Organisation

5. Management of data from manual sources

31 March 2015

Some of the data used in this report is initially drawn from manual record keeping systems and is reported prior to comprehensive verification. The verification process occasionally identifies errors in the original data. Where such errors are immaterial, the accurate comparative data will be reported in the next half-yearly report without being highlighted. Material or significant changes in comparative data will be reported in the next report and will include an explanatory note explaining the reason for the change.