Half-yearly performance reports
July to December 2013
May 2014
Therapeutic Goods Administration
About the Therapeutic Goods Administration
(TGA)

The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical
devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk
management approach designed to ensure therapeutic goods supplied in Australia
meet acceptable standards of quality, safety and efficacy (performance), when
necessary.

The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with
the use of medicines and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems
with medicines or medical devices. TGA investigates reports received by it to
determine any necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on
the TGA website <http://www.tga.gov.au>.
Copyright
© Commonwealth of Australia 2013.
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal
use or, if you are part of an organisation, for internal use within your organisation, but only if you or your
organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all
disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or
allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any
part of this work in any way (electronic or otherwise) without first being given specific written permission from the
Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA
Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to
<tga.copyright@tga.gov.au>.
Half-yearly performance reports, July to December 2013
Page 2 of 73
Therapeutic Goods Administration
Overview
What the TGA regulates
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:



pre-market assessment and market authorisation;
post-market 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.
Half-yearly performance reports, July to December 2013
Page 3 of 73
Therapeutic Goods Administration
A summary of the processes used in regulation is depicted below:
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 nonprescription 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
Half-yearly performance reports, July to December 2013
Page 4 of 73
Therapeutic Goods Administration

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
Key observations about the July to December 2013 report
Market Authorisation
Prescription medicines





The number of Category 1 submissions (application to register a prescription medicine
via the normal process) has remained relatively constant over the last year. However
the number of applications per submission has decreased, likely due to a reduction in
applications for different strengths being applied for or different dosage forms.
No Category 2 submissions (application to register a prescription medicine with the
same formulation, dosage and indications as in two acceptable countries or for which
two independent evaluation reports are available) were received during the last year.
Category 3 submissions (application to register or vary a registration that does not
require clinical, pre-clinical or bioequivalence data) have been increasing over the last
twelve months.
Submissions other than for Category 1,2 and 3 have almost doubled in the last twelve
months.
Average processing times for Category 1 and 3 were well below the statutory
timeframes of 255 days and 45 days respectively.
Non-prescription medicines – over the counter (OTC)



Applications decreased over the twelve month period Oct-Dec 2012- Oct-Dec 2013 but
increased in the period June-Dec 2013 compared to the first half of 2013.
The fluctuation in applications received over the last twelve months is likely due to a
combination of:
– the OTC team clearing a backlog of applications; and
– an OTC Business Process Review in 2013.
Average processing times for all types of applications continue to decrease and the
number of new applications completed within the target timeframe has increased
significantly. This is directly attributable to the progressive implementation of a new
application classification framework being developed as part of the OTC Business
Process Review
Half-yearly performance reports, July to December 2013
Page 5 of 73
Therapeutic Goods Administration
Non-prescription medicines – complementary medicines



There were no new applications received for registered complementary medicines
during Jul-Dec 2013. This is consistent with past reporting periods.
The number of new listed complementary medicines and sunscreens shows variability
over time and has increased sharply during Jul-Dec 2013.
During Jul-Dec 2013 an upgrade of the electronic Business System for new listed
medicine products came into production. The upgrade is more user friendly,
providing more help and guidance for users and this upgrade may be linked to the
increase in applications received.
Medical Devices


In 2013, joint implants were up classified to Class III. This is shown in the large
increase in applications received, completed and on hand during Apr-June 2013
relative to the applications for Jul-Dec 2013.
The number of application audits for medical devices reduced between Jul-Dec 2013
due to a more targeted approach to post-market activities with work more closely
focussed on regulatory non-compliance that could result in significant public health
risks.
Special Access Scheme for Medicines


Category A notifications for use in terminally ill or seriously ill/life threatening
conditions increased in Jul-Dec 2013 compared to the first half of 2013 but shows
variability over time.
Category B applications for use in patients other than those with terminally ill or
seriously ill/life threatening conditions shows a trend to increasing applications.
Post Market Activities
Licencing and Manufacturing




As at 31 December 2013 there were 417 Australian companies holding manufacturing
licences covering 457 sites.
During Jul – Dec 2013 90% of licence application inspections of Australian
manufacturers were found to have satisfactory compliance and a further 8% were
found to have marginal compliance.
As at 31 December 2013 there were 433 overseas manufacturers covering 433 sites.
During Jul-Dec 2013 79% of certification inspections for assessment and approval of
overseas manufacturers were found to have satisfactory compliance and a further
21% were found to have marginal compliance.
Medicine Recalls


During Jul-Dec 2013 there were 25 medicine recalls.
The average number of medicine recalls for a six month period over the last three
years is 22.
Medical Device recalls


During Jul-Dec 2013 there were 305 medical device recalls.
The average number of medical device recalls for a six month period over the last
three years is 256.
Half-yearly performance reports, July to December 2013
Page 6 of 73
Therapeutic Goods Administration
Biologicals recalls

There were no biologicals recalls during Jul-Dec 2013.
Adverse medicine reaction reports


Reporting of adverse medicine reactions has increased since 2012.
This may reflect recent action taken by TGA to encourage reporting not only from
sponsors but also from Pharmacists, GPs and State/Territory health authorities and
therefore indicate greater awareness of the importance of reporting adverse reactions.
Regulatory Compliance
During Jul –Dec 2013 the TGA dealt with 591 alleged offences.
Key statistics July to December 2013 report
Total products on the Australian Register of Therapeutic Goods (ARTG)
Category
Biologicals
Prescription medicines
OTC medicines
Listed medicines
Registered Complementary Medicines
Export only medicines
IVDs
Medical Devices
Total
Number
2
13,720
3,177
12,164
193
2,706
1,205
45,655
78,822
Recall information
Recall Level
Recalls to consumer level
Recalls to retail level
Recalls to hospital level
Recalls to wholesale level
Total recalls
Medicines
4
5
14
2
25
Devices
11
11
280
3
305
Individual human blood recalls to hospital level for Jul 2012-Jun 2013 total 1980.
Adverse medicine reaction reporting
Incoming Medicine ADR reports
Hospitals
Companies
General Practitioners
Specialists
Pharmacists
Members of the Public (Consumer)
Nurses, dentists, complementary
State/Territory Health Department
General list (cause unclear) includes rejected and withdrawn
Total
Half-yearly performance reports, July to December 2013
941
5,085
357
117
717
273
76
1,276
1,256
10,098
Page 7 of 73
Therapeutic Goods Administration
Medical Device incident reports
Number of reports received
User reports
Sponsor reports
Total received
898
2,115
3,013
Medicines applications received by TGA
Number of medicine registrations processed
Prescription Medicines
New medicine entries
Changes (major and minor)
Cancellations
OTC Medicines
New medicine entries
Changes (major and minor)
Cancellations
Complementary Medicines
New medicine entries
Changes (major and minor)
Cancellations
Number of listings processed
Medicines for supply in Australia
New medicine entries
Changes (major and minor)
Cancellations
Medicines for export only
New medicine entries
Changes (major and minor)
Cancellations
1,013
9,979
77
89
176
9
1
12
0
954
183
207
76
22
19
Devices applications received by TGA
Number of medical device inclusions processed
Included medical devices
New entries
Cancellations
Included medical devices for export
New entries
Cancellations
Included IVD medical devices
New entries
Cancellations
Included IVD medical devices for export
New entries
Cancellations
Other therapeutic goods
New entries
Cancellations
Other therapeutic goods for export
New entries
Cancellations
Half-yearly performance reports, July to December 2013
3,284
639
170
42
267
8
5
0
18
18
0
0
Page 8 of 73
Therapeutic Goods Administration
Detailed Statistical Information
Contents
Market authorisation
11
Prescription medicines ___________________________________________________ 11
Category 1 application _________________________________________________________________
Category 2 application _________________________________________________________________
Category 3 application _________________________________________________________________
Category 0 application _________________________________________________________________
Application/submission _______________________________________________________________
Workflow of Category 1, 2 and 3 applications/submissions ________________________
Processing times _______________________________________________________________________
11
11
11
11
11
12
17
Non-prescription medicines – over the counter medicines _________ 19
Workflow of applications ______________________________________________________________ 19
Processing times _______________________________________________________________________ 21
Applications in progress _______________________________________________________________ 22
Non-prescription medicines – export only medicines________________ 23
New applications, variations and processing times__________________________________ 23
Export certifications for medicines ___________________________________________________ 26
Non-prescription medicines – complementary medicines __________ 27
Registered complementary medicines for supply in Australia ______________________ 27
Listing of new ingredients and medicines for supply in Australia __________________ 27
Registration of Human Cells and Tissues ______________________________ 29
Workflow of applications ______________________________________________________________ 29
Inclusion of medical devices _____________________________________________ 29
Class 1 medical devices ________________________________________________________________
Class 1 measuring and sterile medical devices _______________________________________
Class IIa medical devices ______________________________________________________________
Class IIb medical devices ______________________________________________________________
Class III and AIMD medical devices ___________________________________________________
Medical device (non-IVD) applications selected for application audit _____________
Medical device (non-IVD) application outcomes_____________________________________
29
30
30
31
31
32
33
Medical device conformity assessment applications _________________ 33
Conformity assessment application workflow _______________________________________ 33
Inclusion of in vitro diagnostic medical devices in the ARTG _______ 34
All classes of IVD application workflow ______________________________________________
In vitro diagnostic medical device applications selected for application audit –
Quarter 1, 2013/14 ____________________________________________________________________
In vitro diagnostic medical device applications selected for application audit –
Quarter 2, 2013/14 ____________________________________________________________________
In vitro diagnostic medical device applications selected for application audit –
Quarter 1, 2013/14 ____________________________________________________________________
In vitro diagnostic medical device applications selected for application audit –
Quarter 2, 2013/14 ____________________________________________________________________
In vitro diagnostic applications received by class ___________________________________
Class 1 in vitro diagnostic medical devices ___________________________________________
Class 2 in vitro diagnostic medical devices ___________________________________________
Class 3 in vitro diagnostic medical devices ___________________________________________
Class 4 in vitro diagnostic medical devices ___________________________________________
In vitro diagnostic medical device application outcomes ___________________________
In vitro diagnostic medical device conformity assessment applications ___________
34
34
35
35
36
36
37
37
38
38
39
39
Export certifications for medical devices ______________________________ 40
Blood permits processed _________________________________________________ 40
Half-yearly performance reports, July to December 2013
Page 9 of 73
Therapeutic Goods Administration
Access to Unapproved Therapeutic Goods _____________________________ 41
Clinical Trial Notification Scheme - medicines _______________________________________
Clinical trials – medical devices _______________________________________________________
Clinical trials – biologicals _____________________________________________________________
Special Access Scheme - medicines ___________________________________________________
Special Access Scheme – medical devices ____________________________________________
Special Access Scheme – biologicals __________________________________________________
Authorised Prescribers ________________________________________________________________
Import permits _________________________________________________________________________
41
43
43
44
45
45
46
46
Orphan drug designations ________________________________________________ 46
Post-market activities
47
Licencing and manufacturing ____________________________________________ 47
Manufacturing Licences _______________________________________________________________ 47
Certifications ___________________________________________________________________________ 48
Clearances ______________________________________________________________________________ 49
Laboratories and scientific services ____________________________________ 50
Laboratory testing _____________________________________________________________________ 50
Recalls _______________________________________________________________________ 53
Medicine recalls ________________________________________________________________________ 53
Medical device recalls _________________________________________________________________ 54
Adverse medicine reaction reports _____________________________________ 55
Incoming adverse medicine reaction notifications __________________________________ 55
Communications and Publications ____________________________________________________ 56
Other Publications: ____________________________________________________________________ 56
Listed Medicine Reviews__________________________________________________ 57
New and completed reviews __________________________________________________________ 57
Listing Compliance Review Outcomes ________________________________________________ 58
Medical device post market reviews ____________________________________ 59
Regulatory compliance – random reviews ___________________________________________ 59
Regulatory compliance – restricted word reviews __________________________________ 59
Regulatory compliance – targeted reviews___________________________________________ 59
Medical device incident reports _________________________________________ 60
Medical device incident reports received ____________________________________________
Australian incident notification workflow ___________________________________________
Australian incident notification response times _____________________________________
Incident notification outcomes________________________________________________________
60
60
60
61
Regulatory compliance ___________________________________________________ 62
Alleged offences by type _______________________________________________________________
Final action taken ______________________________________________________________________
Dosage forms of products investigated _______________________________________________
Product category of products investigated ___________________________________________
Special interest investigations ________________________________________________________
Investigations by complainant type __________________________________________________
Investigations complainant type and state/territory ________________________________
62
62
63
63
64
64
65
Australian Register of Therapeutic Goods _____________________________ 65
New, variations and cancelled records _______________________________________________ 65
Registration of products _______________________________________________________________ 67
Yearly summary of activities __________________________________________________________ 69
Abbreviations used in the report ________________________________________ 71
Management of data from manual sources ____________________________ 72
Half-yearly performance reports, July to December 2013
Page 10 of 73
Therapeutic Goods Administration
Market authorisation
Prescription medicines
Definitions and specified periods (statutory time limits)
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.
Specified periods


For processing of applications – 40 working days
From acceptance of application to Delegate’s decision – 255 working days
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.
Specified periods


For processing of applications – 20 working days
From acceptance of application to Delegate’s decision – 175 working days
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.
Specified period

Period in which to raise an objection – 45 working days
Category 0 application
All prescription medicine applications received at TGA prior to the commencement of
evaluation time restrictions provided in legislation, and new non-categorised applications.
Application/submission
In the case of prescription medicines, an “application” relates to a single change to a single
product. A “submission” typically includes a number of applications all submitted at the
one time. The Office of Medicines Authorisation tracks each submission and each product
application within each submission.
Half-yearly performance reports, July to December 2013
Page 11 of 73
Therapeutic Goods Administration
Workflow of Category 1, 2 and 3 applications/submissions
Figure 1 - Category 1 workflow (no Category 2 submissions received)
600
Number of submissions
500
400
300
200
100
Pre-submissions received
Oct-Dec 2013
Jul-Sep 2013
Apr-Jun 2013
Jan-Mar 2013
Oct-Dec 2012
0
Submissions finalised
On hand at end of reporting period
Figure 2 - Category 3 workflow
450
Number of submissions
400
350
300
250
200
150
Submissions received
Submissions finalised
Half-yearly performance reports, July to December 2013
Oct-Dec 2013
Jul-Sep 2013
Apr-Jun 2013
Jan-Mar 2013
Oct-Dec 2012
100
On hand at end of reporting period
Page 12 of 73
Therapeutic Goods Administration
Table 1 - Workflow of Category 1 & 2 Pre-submissions and Category 3 submissions
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Pre-Submissions/Submissions
received*
428
486
408
474
555
Submissions finalised**
411
400
500
477
545
On hand at end of reporting period
662
748
656
653
663
Pre-Submissions received*
104
111
108
107
128
Submissions finalised**
88
77
114
127
103
On hand at end of reporting period
506
540
534
514
539
Pre-Submissions received*
0
0
0
0
0
Submissions finalised**
0
0
0
0
0
On hand at end of reporting period
0
0
0
0
0
Submissions received
324
375
300
367
427
Submissions finalised**
323
323
386
350
442
On hand at end of reporting period
156
208
122
139
124
Overall
Category 1
Category 2
Category 3
*Includes submissions in the Pre-Submission stage
**Includes submissions withdrawn or rejected at acceptance for evaluation stage
Half-yearly performance reports, July to December 2013
Page 13 of 73
Therapeutic Goods Administration
Table 2 - Category 1 Pre-submissions received by fee category and the number of submitted
applications for those Pre-submissions (no Category 2 Pre-submissions received)
2012
Oct-Dec
2013
Jan-Mar
Fee category
Pre
Subs
Apps
Pre
Subs
Apps
Pre
Subs
Apps
Pre
Subs
Apps
Pre
Subs
Apps
New Chemical
Entity
13
64
16
61
12
35
11
24
13
n/a*
Extension of
indications
3
9
9
24
13
46
7
21
9
n/a*
Major variation
12
98
7
29
13
57
10
52
8
n/a*
New generic
product
47
645
49
357
29
256
43
361
32
n/a*
Additional trade
name
12
97
5
24
14
66
7
42
6
n/a*
Minor variation
3
9
3
11
2
12
4
3
10
n/a*
Changes to PI
involving
evaluation
14
44
22
81
25
79
25
104
17
n/a*
All Others
0
0
0
0
0
0
0
0
33
n/a*
Total
104
966
111
587
108
551
107
608
128
n/a*
Apr-Jun
Jul-Sep
Oct-Dec
Notes (reference to Table 2):
A Submission is one or more applications from the same sponsor, with the same active ingredient,
submitted at the same time.
An Application corresponds to a single ARTG entry.
A streamlined submission process involving pre-submissions was introduced with effect from 1
November 2010. There is a delay of at least 2 ½ months from the time a sponsor lodges a PreSubmission until they submit a submission that can include many applications.
* A sponsor has a minimum of at least 2 ½ months to submit their submission and application
from the receipt of the Pre-submission. At the time of reporting no applications have been
received for these Pre-submissions.
The numbers of category 1 submissions received were constant during the reporting period
however the number of applications per submission decreased. This is likely due to a reduction in
the applications for different strengths being applied for and different dosage forms (I.E. 10mg
Blister pack, 10mg Bottle, 20mg Blister pack, 20mg Bottle).
Half-yearly performance reports, July to December 2013
Page 14 of 73
Therapeutic Goods Administration
Table 3 - Submissions other than Category 1, 2 and 3 by reporting period
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Safety related request
151
212
180
197
240
Self-assessable request
266
346
389
352
333
Minor editorial change to PI
13
18
76
132
167
Correction of error
8
26
29
50
37
Request for Orphan Drug
Designation
8
3
5
5
5
Not yet determined
0
0
0
0
0
Total
446
605
679
736
782
Submission type
Table 4 - Delegate’s decision made on submissions – Approved or rejected
(see interpretation notes after Table 5)
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Category 1
68
66
102
116
92
Category 2
0
0
0
0
0
Category 3
317
318
377
348
437
Total
385
384
479
464
529
Category 1
4
0
4
1
4
Category 2
0
0
0
0
0
Category 3
2
0
1
0
0
Total
6
0
5
1
4
Approved
Rejected
Half-yearly performance reports, July to December 2013
Page 15 of 73
Therapeutic Goods Administration
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Category 1
72
66
106
117
96
Category 2
0
0
0
0
0
Category 3
319
318
378
348
437
Total
391
384
484
465
533
Sub-total approved and rejected
Table 5 - Delegate’s decision made on submissions – Withdrawn or Rejected before evaluation
stage
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Category 1
10
11
8
10
7
Category 2
0
0
0
0
0
Category 3
4
5
8
2
5
Total
14
16
16
12
12
Category 1
6
0
0
0
0
Category 2
0
0
0
0
0
Category 3
0
0
0
0
0
Total
6
0
0
0
0
Withdrawn by sponsor
Rejected in application entry
Sub-total Withdrawn by Sponsor and Rejected in application entry
Category 1
16
11
8
10
7
Category 2
0
0
0
0
0
Category 3
4
5
8
2
5
Total
20
16
16
12
12
Half-yearly performance reports, July to December 2013
Page 16 of 73
Therapeutic Goods Administration
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Category 1
88
77
114
127
103
Category 2
0
0
0
0
0
Category 3
323
323
386
350
442
Total
411
400
500
477
545
Total finalised submissions
Notes (reference to Tables 4 and 5):
‘Approved or Rejected’ are decisions made by the delegate after the evaluation process has been
completed.
‘Withdrawn’ are submissions withdrawn by the sponsor before the evaluation process has been
completed.
A submission may contain both Approved and Rejected applications but is reported as ‘Approved’
if at least one of its applications is ‘Approved’.
Processing times
Figure 3 - Processing times for Category 1 applications finalised between 1 July and 31 December
2013 (no Category 2 applications)
600
500
Working Days
400
300
200
100
0
Average
Median
Range
Average
TGA Time
Median
Range
Sponsor Time
Application Type
Changes to PI
Major Variations
Half-yearly performance reports, July to December 2013
NCEs
New Generics
New Indications
Page 17 of 73
Therapeutic Goods Administration
Table 6 - Average Processing times for Category 1 and Category 3 submissions (working days)
Target
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Receipt and payment to
acceptance
40
25
37
47
47
48
Acceptance to evaluation
completed
135
162
136
131
134
128
Evaluation completed to
Delegate’s decision
120
73
37
44
47
47
Net overall TGA evaluation time
255
235
173
175
181
175
Receipt and payment to
acceptance
5
6
8
8
7
7
Acceptance to evaluation
completed
30
15
16
16
20
21
Evaluation completed to
Delegate’s decision
10
3
1
2
2
2
Net overall TGA evaluation time
45
27
25
26
29
30
Category 1 submissions
Category 3 submissions
Notes (reference to Table 6):
Figures shown are TGA-time in working days, not calendar days.
Figures provided are based on the quarter in which the action was completed. From 1 July 2007
the ‘Net Overall TGA Evaluation Time’ relates only to those submissions decided in the quarter.
Time taken to complete ADEC/ACPM activities, if any, are included in ‘Evaluation completed to
Delegate’s decision’.
For Category 1 and 2 submissions the number of evaluation days is calculated from the date that
the submission has been accepted for evaluation by the Therapeutic Goods Administration in
accordance with Section 16C(2) and 16D(2) of the Therapeutic Goods Regulations 1990. In
accordance with Section 16F(3) of the Therapeutic Goods Regulations 1990, the number of
evaluation days for Category 3 submissions is calculated from the date of lodgement or payment
of evaluation fee.
Half-yearly performance reports, July to December 2013
Page 18 of 73
Therapeutic Goods Administration
Non-prescription medicines – over the counter medicines
Workflow of applications
Figure 4 - Workflow of applications – totals
1200
Number of applications
1000
800
600
400
200
Received
Approved
Jul-Dec 2013
Jan-Jun 2013
Jul-Dec 2012
Jan-Jun 2012
Jul-Dec 2011
0
Rejected/Returned/Withdrawn
Notes (reference to Figure 4):
The number received of new applications and variations has increased in July to December 2013
compared to January to June 2013. Notifications are in line with historical variability.
Thirty two applications were rejected, withdrawn by, or returned to, sponsors during this period.
Half-yearly performance reports, July to December 2013
Page 19 of 73
Therapeutic Goods Administration
Table 7 - Non-prescription medicines – over the counter medicines workflow of applications
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Applications received
190
145
98
118
151
Total applications on hand
463
440
369
303
267
Approved
140
136
137
172
86
Rejected
1
3
0
1
1
Returned to sponsor
0
0
24
7
8
Withdrawn by sponsor
27
30
23
7
2
In progress at the end of the reporting
period
295
271
185
116
170
Variation applications received
215
146
161
112
221
Total applications on hand
445
397
298
204
288
Approved
181
233
182
129
176
Rejected
0
0
4
2
0
Returned to sponsor
0
0
0
0
0
Withdrawn by sponsor
13
27
20
5
7
In progress at the end of the reporting
period
251
137
92
68
106
Notifications received
454
680
670
419
340
Total notifications
517
746
763
470
400
Approved/acknowledged
445
646
703
394
345
Withdrawn by sponsor
6
7
9
16
14
In progress at the end of the reporting
period
66
93
51
60
41
New applications
Variations processed through TGA only
Notifications
Notes (reference to Table 7) :
The variation in applications approved during this reporting period compared with previous
reporting periods is due to the following factors:
 A drop in applications received due to the OTC Business Process Review; and
 The OTC team clearing a backlog of applications during the previous reporting period,
creating an higher than usual volume.
See also note after Figure 6
Half-yearly performance reports, July to December 2013
Page 20 of 73
Therapeutic Goods Administration
Processing times
120
100
80
60
40
20
Jul-Dec 2013
Jan-Jun 2013
Jan-Jun 2012
Jul-Dec 2012
0
Jul-Dec 2011
Average TGA processing time (working days)
Figure 5 - Average TGA processing times (working days)
New Applications & Variations Referred to ACNM
Variations Processed Through TGA
Notifications
Notes (reference to Figure 5) :
Average processing times for new applications and variations continue to decrease. The number
of new applications completed within the target time has increased significantly.
Table 8 - Non-prescription medicines – OTC medicines processing times ( working days)
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New applications and variations referred to Advisory Committee on Non-prescription Medicines
(ACNM)
Receipt and payment to Delegate’s
decision – target 71 working days
55
83
102
96
48
Company response time
135
354
204
109
120
Percentage completed within target
73
55
51
56
80
Receipt and payment to Delegate’s
decision – target 32-45 working days
69
85
66
55
48
Company response time
43
88
92
42
20
Percentage completed within target
50
38
43
69
66
Receipt and payment to completion –
target 20 working days
23
9
9
10
9
Percentage completed within target
92
99
91
93
93
Variations not referred to ACNM
Notifications
Half-yearly performance reports, July to December 2013
Page 21 of 73
Therapeutic Goods Administration
Applications in progress
Table 9 - Non-prescription medicines – over the counter medicines applications in progress as at
31 December 2013
Number in
progress
Number awaiting
response from sponsor
Type of application
Applications
170
81
Variations
106
36
Notifications
41
13
Total in progress at the end of the reporting period
317
130
Jul-Dec 2013
Jan-Jun 2013
Jan-Jun 2012
Jul-Dec 2012
650
600
550
500
450
400
350
300
250
200
Jul-Dec 2011
Total number
Figure 6 - Total number of applications in progress at the end of the reporting period
Total Number in Progress
Notes (reference to Figure 6):
The increase in the total number of applications in progress reflects the increase in number of
applications received within this period since the commencement of the new OTC reform process
in April 2013. The number of applications received before this period Jun-Dec 2012 and Jan to Jun
2013 were well down. The higher applications in progress in 2011 reflects the large backlog of
old applications that have since been cleared before the new process started.
Half-yearly performance reports, July to December 2013
Page 22 of 73
Therapeutic Goods Administration
Table 10 - Non-prescription medicines – over the counter medicines stage of processing
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Less than 10 weeks
192
182
113
126
143
10 – 12 weeks
41
9
15
15
29
12 – 16 weeks
34
27
10
9
17
More than 16 weeks
345
283
190
94
128
Total in progress at the end of the
reporting period
612
501
328
244
317
Time in progress
Non-prescription medicines – export only medicines
New applications, variations and processing times
Table 11 - New applications for export only medicines (see notes after Table 13)
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Applications received
50
175
70
83
Not accepted
0
0
0
0
Withdrawn
5
7
5
2
Approved
52
155
73
82
Rejected
0
0
0
0
Total completed
57
162
78
84
Total in progress at the end of the reporting
period
13
26
18
17
New applications
Half-yearly performance reports, July to December 2013
Page 23 of 73
Therapeutic Goods Administration
Table 12 - Variations and groupings for export only medicines
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Applications received
45
38
69
22
Not accepted
0
0
0
0
Withdrawn
3
6
1
0
Approved
33
40
74
22
Rejected
0
0
0
0
Total completed
36
46
75
22
Total in progress at the end of the reporting
period
15
7
1
1
Variation and grouping applications
Figure 7 - Average TGA processing times (working days)
Average working days
35
30
25
20
15
New Applications
Half-yearly performance reports, July to December 2013
Jul-Dec 13
Jan-Jun 13
Jul-Dec 12
Jan-Jun 12
Jul-Dec 11
10
Variations
Page 24 of 73
Therapeutic Goods Administration
Table 13 - Processing time for new applications and variations for export only medicines
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Average TGA processing time (working days)
19
27
27
24.8
Percentage processed within 31 days
98%
74%
92%
80%
Average sponsor response time (working days)
5
2
11.3
5
Average TGA processing time (working days)
17
31
24
24.7
Percentage processed within 31 days
100%
88%
91%
90%
Average sponsor response time (working days)
0
0
7.5
0
New applications
Variations
Notes (reference to Tables 11+12 + 13)
While the number of new export medicine applications (Table 11) was 83 which is normal for any
six month period, the number of variation applications (Table 12) received was significantly less
than the average number of applications received in the last three half yearly periods (Only 22
applications were received as opposed to an average of 50 applications received in each last three
six month periods). This simply means not many changes were required by sponsors to their
existing export listed medicines. 80% of the new export medicine applications and 90% of the
variation applications were processed within the target time frame of 31 days.
Average sponsor response time (Table 13) improved significantly this six month period as
compared to the previous six months period, from 11 days to 5 days for new applications, and
from 7 days to the same day for variation applications.
Table 14 - Processing time for applications in progress for export only medicines
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Total outstanding at end of reporting period
28
33
19
18
Time taken to date
0-4 weeks
61%
63%
61%
50%
4-8 weeks
26%
11%
26%
45%
8-12 weeks
18%
21%
18%
0
12-16 weeks
3%
0%
3%
0
>16 weeks
20%
5%
20%
6%
Number awaiting response from sponsor
6
16
6
1
Half-yearly performance reports, July to December 2013
Page 25 of 73
Therapeutic Goods Administration
Export certifications for medicines
Figure 8 - Average TGA processing times for export certificates (working days)
Average working days
12
10
8
6
4
2
Completion of BMU processing
Jul-Dec 2013
Jan-Jun 2013
Jul-Dec 2012
Jan-Jun 2012
Jul-Dec 2011
0
OMA - certificate issued
Table 15 - Applications for export certifications
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Applications received
1169
805
1044
954
Certificates issued
1084
884
926
995
Applications rejected
1
0
0
0
From receipt of application to completion of
BMU processing (average number of working
days)
1
1
1
1
From BMU processing completed to issue of
certificate (average number of working days)
11.5
10.8
11.7
12
Average TGA processing time (target 15
working days)
12.5
12
13
13
Percentage processed in less than 16 working
days (target 100%)
98.5%
98.6%
98.2%
96.3%
Processing times
Notes (reference to Table 15):
The number of applications for export certificates processed was within the range recorded over the
previous three half-year periods. 96% of the certificates were issued within the target time of 15 days.
Half-yearly performance reports, July to December 2013
Page 26 of 73
Therapeutic Goods Administration
Non-prescription medicines – complementary medicines
Registered complementary medicines for supply in Australia
Table 16 - Applications for new registered complementary medicines
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
2
1
1
0
0
Approved
1
0
1
1
0
Rejected
0
0
0
0
1
Withdrawn by sponsor
2
2
2
0
0
Lapsed
0
0
0
0
0
Total in progress at the end of the
reporting period
8
8
7
6
5
Table 17 - Applications for variations to registered complementary medicines
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
2
7
2
5
6
Approved
4
6
1
6
6
Rejected
0
1
0
0
0
Withdrawn by sponsor
0
0
0
0
0
Lapsed
1
0
0
0
0
Total in progress at the end of
the reporting period
1
1
2
1
1
Listing of new ingredients and medicines for supply in Australia
Table 18 - Applications for new listable substances (ingredients)
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
1
5
5
1
1
Approved
3
1
2
0
3
Rejected
1
1
0
1
0
Withdrawn by sponsor
0
0
0
1
0
Lapsed
1
0
0
0
0
Total in progress at the end of
the reporting period
6
7
7
3
4
Half-yearly performance reports, July to December 2013
Page 27 of 73
Therapeutic Goods Administration
Figure 9 - Applications received for new listed medicine products
Number of applications received
600
550
500
450
400
350
Oct-Dec 2013
Jul-Sep 2013
Apr-Jun 2013
Jan-Mar 2013
Oct-Dec 2012
Jul-Sep 2012
Apr-Jun 2012
Jan-Mar 2012
Oct-Dec 2011
Jul-Sep 2011
Apr-Jun 2011
Jan-Mar 2011
Oct-Dec 2010
Jul-Sep 2010
Apr-Jun 2010
Jan-Mar 2010
Oct-Dec 2009
Jul-Sep 2009
Apr-Jun 2009
Jan-Mar 2009
Oct-Dec 2008
Jul-Sep 2008
Apr-Jun 2008
Jan-Mar 2008
300
New Products
Notes (reference to Figure 9): These statistics include all listed complementary medicines and
sunscreens
Table 19 - Applications received (completed) through the electronic Business System for new
listed medicine products
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
New products
414
358
318
410
428
Exemption updates
0
0
0
0
0
Groupings
132
99
71
85
88
Variations
3
7
6
6
4
Update of record*
198
229
238
279
258
*’Update of record’ indicates the number of applications processed via electronic Business System by sponsors
updating existing product information on the ARTG. These updates do not attract fees.
Half-yearly performance reports, July to December 2013
Page 28 of 73
Therapeutic Goods Administration
Registration of Human Cells and Tissues
Workflow of applications
Table 20 - Human Cells and Tissue application workflow for 1 July to 31 December 2013
Received
Completed
On hand at end of
the reporting period
Technical Master File (TMF) new
0
0
2
TMF annual updates
5
1
5
TMF variations
13
16
1
TMF notifications
10
9
1
Plasma Master File (PMF)
13
7
6
Biological Class 2 – new applications
0
0
19
Biological Class 3 – new applications
0
0
2
Biological Class 3 – variations
3
1
2
Total
44
34
38
Note (reference to Table 20): There were no Biological Class 2 variations received, completed or on
hand between 1 July 2013 and 31 December 2013.
Inclusion of medical devices
Note: Figures reported in this document are accurate as at the 6 January 2014. Any variation from
previously reported statistics are a result of data quality improvements from the time of publication.
Class 1 medical devices
Table 21 - Class 1 medical device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
612
603
836
824
672
Applications finalised
612
603
836
818
671
Class 1 medical devices
Half-yearly performance reports, July to December 2013
Page 29 of 73
Therapeutic Goods Administration
Class 1 measuring and sterile medical devices
Table 22 - Class 1 measuring and sterile medical device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Total Class 1 measuring and sterile medical devices
Applications received
70
67
84
101
120
Applications completed
87
48
69
103
139
Applications on hand
32
51
66
50
31
Class 1 measuring medical devices
Applications received
20
10
11
12
21
Applications completed
19
9
10
10
24
Applications on hand
7
8
9
8
5
Applications received
50
57
73
89
99
Applications completed
72
39
59
93
115
Applications on hand
20
48
62
42
26
Class 1 sterile medical devices
Class IIa medical devices
Table 23 - Class IIa medical device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
315
338
387
383
350
Applications completed
355
323
302
371
464
Applications on hand
170
185
270
235
121
Class IIa medical devices
Half-yearly performance reports, July to December 2013
Page 30 of 73
Therapeutic Goods Administration
Class IIb medical devices
Table 24 - Class IIb medical device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
170
136
162
179
157
Applications completed
204
149
127
168
197
Applications on hand
101
88
123
103
63
Class IIb medical devices
Class III and AIMD medical devices
Table 25 - Class III and AIMD medical device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Total Class III, Class III Joint Reclassification and AIMDs
Applications received
92
225
1031*
184
359
Applications completed
255
206
347*
216
339
Applications on hand
146
165
849*
804
824
Applications received
81
88
89
123
148
Applications completed
220
92
48
57
137
Applications on hand
129
125
166
213
224
Class III medical devices
Class III Joint Reclassification medical devices
Applications received
18
82
933*
57
158
Applications completed
6
82
287*
146
183
Applications on hand
12
12
658*
567
542
Applications received
11
55
9
4
53
Applications completed
35
32
12
13
19
Applications on hand
17
40
37
24
58
AIMD medical devices
* Notes (reference to Table 25):
The increase in applications received and applications on hand for the April to June quarter are due to the
up classification of joint implants.
Half-yearly performance reports, July to December 2013
Page 31 of 73
Therapeutic Goods Administration
Medical device (non-IVD) applications selected for application audit
Table 26 - Application audits completed between 1 July to 31 December 2013
Percentage
within target
Average TGA
days
Level 1 Compulsory Audit Assessment (30 working day target)
33%
70
Level 2 Compulsory Audit Assessment (60 working day target)
31%
89
Non-Compulsory Audit Assessment (30 working day target)
38%
51
Medical device applications selected for application audit
Notes (reference to Table 26):
The number of application audits for medical devices reduced between Jul-Dec 2013 due to a
more targeted approach to post-market activities with work more closely focussed on regulatory
non-compliance that could result in significant public health risks.
Figure 10 - Processing times for applications finalised between 1 July to 31 December 2013
90
Average working days
80
70
60
50
40
30
20
10
Sponsor time
Half-yearly performance reports, July to December 2013
Level 2 Compulsory Audit
Assessment
Level 1 Compulsory Audit
Assessment
Non-Compulsory Audit
Assessment
0
TGA time
Page 32 of 73
Therapeutic Goods Administration
Medical device (non-IVD) application outcomes
Figure 11 - Outcomes of applications completed between 1 July to 31 December 2013
Class I
Class 1M
Class IS
Class IIa
Class IIb
Class III
AIMD
Class IIb Reclas
0
200
400
600
800
1000
1200
1400
1600
Number of submissions
Withdrawn
Rejected
Approved
Medical device conformity assessment applications
Conformity assessment application workflow
Table 27 - Conformity Assessment application workflow
2011
2012
2013
Jul-Dec*
Jan-Jun
Jul-Dec
Jan-Jun
Jul-Dec
Applications received
87
100
104
118
136
Applications completed**
115
67
91
116
121
Applications on hand
132
165
178
180
202
Conformity Assessments
Note (reference to Table 27):
*IVD applications added from Jul-Dec 2012 period.
** Applications completed includes applications withdrawn post payment of application fee.
Half-yearly performance reports, July to December 2013
Page 33 of 73
Therapeutic Goods Administration
Inclusion of in vitro diagnostic medical devices in the ARTG
All classes of IVD application workflow
Table 28- In-vitro device application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
137
130
137
139
136
Applications completed
123
137
117
164
130
Applications on hand
41
34
54
21
27
IVD applications
In vitro diagnostic medical device applications selected for application audit – Quarter 1,
2013/14
Figure 12 - Sponsor/TGA processing times for IVD application audits between 1 July to 30
September 2013
60
Average working days
50
40
30
20
10
Sponsor time
Half-yearly performance reports, July to December 2013
TGA time
Class 3 Comp audit
Class 2 Non-comp audit
Class 2 Comp audit
Class 1 Comp audit
0
Page 34 of 73
Therapeutic Goods Administration
In vitro diagnostic medical device applications selected for application audit – Quarter 2,
2013/14
Figure 13 - Sponsor/TGA processing times for IVD application audits between 1 October to 31
December 2013
35
Average working days
30
25
20
15
10
5
Sponsor time
Class 3 Comp audit
Class 2 Non-comp
audit
Class 1 Comp audit
Class 2 Comp audit
0
TGA time
In vitro diagnostic medical device applications selected for application audit – Quarter 1,
2013/14
Figure 14 - IVD applications selected for application audit between 1 July to 30 September 2013,
outcomes
Number of applications
25
20
15
10
5
Completed
Approved
Half-yearly performance reports, July to December 2013
Class 3 Comp audit
Class 2 Non-comp audit
Class 2 Comp audit
Class 1 Comp audit
0
Rejected/withdrawn
Page 35 of 73
Therapeutic Goods Administration
In vitro diagnostic medical device applications selected for application audit – Quarter 2,
2013/14
Figure 15 - IVD applications selected for application audit between 1 October to 31 December
2013, outcomes
20
Number of applications
18
16
14
12
10
8
6
4
2
Completed
Approved
Class 3 Comp audit
Class 2 Non-comp audit
Class 2 Comp audit
Class 1 Comp audit
0
Rejected/withdrawn
In vitro diagnostic applications received by class
Figure 16 - IVD applications received by class
80
Number received
70
60
50
40
30
20
10
Class 1 IVD
Class 2 IVD
Half-yearly performance reports, July to December 2013
Class 3 IVD
Oct-Dec 13
Jul-Sep 13
Apr-Jun 13
Jan-Mar 13
Oct-Dec 12
0
Class 4 IVD
Page 36 of 73
Therapeutic Goods Administration
Class 1 in vitro diagnostic medical devices
Table 29 - Class 1 IVD application workflow and outcomes
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
30
32
27
38
26
On hand
2
4
2
2
1
Completed
32
30
29
38
27
Approved
30
29
27
38
27
Rejected
0
0
0
0
0
Withdrawn
2
1
2
0
0
Class 1 IVD applications
Notes (reference to Table 29): The figures for withdrawn applications only include those applications
that were withdrawn after payment, not applications that were withdrawn prior to payment of the
application.
Class 2 in vitro diagnostic medical devices
Table 30 - Class 2 IVD application workflow and outcomes
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
75
74
72
52
58
On hand
23
14
21
9
10
Completed
62
83
65
63
57
Approved
62
71
62
58
55
Rejected
0
1
0
0
0
Withdrawn
0
11
3
5
2
Class 2 IVD applications
Notes (reference to Table 30): The figures for withdrawn applications only include those applications
that were withdrawn after payment, not applications that were withdrawn prior to payment of the
application.
Half-yearly performance reports, July to December 2013
Page 37 of 73
Therapeutic Goods Administration
Class 3 in vitro diagnostic medical devices
Table 31 - Class 3 IVD applications workflow and outcomes
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
30
21
36
25
52
On hand
17
14
27
10
16
Completed
27
24
23
39
46
Approved
20
18
21
35
45
Rejected
0
0
0
0
0
Withdrawn
7
5
2
4
1
Class 3 IVD applications
Notes (reference to Table 31): The figures for withdrawn applications only include those applications
that were withdrawn after payment, not applications that were withdrawn prior to payment of the
application.
Class 4 in vitro diagnostic medical devices
Table 32 -Class 4 IVD applications workflow and outcomes
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Applications received
2
3
2
24
0
On hand
0
0
0
0
0
Completed
2
3
2
24
0
Approved
2
2
2
24
0
Rejected
0
0
0
0
0
Withdrawn
0
1
0
0
0
Class 4 IVD applications
Notes (reference to Table 32): The figures for withdrawn applications only include those applications
that were withdrawn after payment, not applications that were withdrawn prior to payment of the
application.
Half-yearly performance reports, July to December 2013
Page 38 of 73
Therapeutic Goods Administration
In vitro diagnostic medical device application outcomes
Table 33 - IVD outcome of applications
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Approved
114
118
110
155
127
Rejected
0
1
0
0
0
Withdrawn
9
17
7
9
3
All classes of IVD
Notes (reference to Table 33): The figures for withdrawn applications only include those applications
that were withdrawn after payment, not applications that were withdrawn prior to payment of the
application.
In vitro diagnostic medical device conformity assessment applications
Table 34 - IVD conformity assessment application workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
In vitro diagnostic conformity assessment applications
Applications received
8
11
8
16
9
Applications completed
3
4
6
14
2
Applications on hand
26
33
34
36
43
Notes (reference to Table 34): Of the six applications completed in Apr-Jun 2013 one conformity
assessment application lapsed.
Half-yearly performance reports, July to December 2013
Page 39 of 73
Therapeutic Goods Administration
Export certifications for medical devices
Table 35 - Applications for export certifications
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
July-Dec
Applications received
217
161
228
152
Export certificates issued
187
151
206
161
Applications rejected/withdrawn
3
0
0
2
Export certificates (target = 5 days)
3
5
4
3
Percentage processed within target time (Target
>90%)
91.0%
66.0%
89%
97.5%
Applications
Processing times (average working days)
Notes (reference to Table 35):
The number of device certificate applications received was 152 in this six month period, which is
lower than the number of applications received in the previous three six-month periods. Average
processing time for the certificates was three days and 97.5% applications were processed within
the target time frame.
Blood permits processed
Figure 17 - Number of permits processed
Number of permits processed
60
50
40
30
20
10
Individual permits
Jul - Dec 13
Jan-Jun 13
Jul-Dec 12
Jan-Jun 12
0
Blood fractions
Half-yearly performance reports, July to December 2013
Annual permits
Page 40 of 73
Therapeutic Goods Administration
Access to Unapproved Therapeutic Goods
Clinical Trial Notification Scheme - medicines
Table 36 - New trial notifications that include a medicine or biological received by State or
Territory (single & multi-site trials)
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New South Wales
175
151
207
143
164
Victoria
110
111
122
110
106
Queensland
18
31
29
30
33
South Australia
29
31
38
25
41
Western Australia
12
15
20
18
10
Tasmania
4
2
0
0
1
Australian Capital Territory
2
1
0
0
0
Northern Territory
0
1
0
0
0
Summary
350
343
416
326
355
State
Notes (reference to Table 36):
Clinical trials data were previously under-reported for the period of Jul-Dec 2009 to Jul-Dec 2012. The
corrected figures for 2010/11 and 2011/12 have been provided below. For further information see the
TGA website http://www.tga.gov.au/newsroom/media-2013-clinical-trial-statistics-130801.htm:1
August 2013.
Table 37 - New trial notifications that include a medicine or biological received by phase
(single & multi-site trials)
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Phase 1
81
55
85
65
132
Phase 2
86
84
128
86
102
Phase 3
130
143
155
131
70
Phase 4
38
43
34
28
32
Bioavailability/equivalence
2
3
5
4
5
None specified
13
15
9
12
14
Summary
350
343
416
326
355
Phase
Half-yearly performance reports, July to December 2013
Page 41 of 73
Therapeutic Goods Administration
Figure 18 - Total notifications and new trial notifications that include a medicine or biological
1600
Total number
1400
1200
1000
800
600
400
200
Total Notifications
Jul-Dec 2013
Jan-Jun 2013
Jul-Dec 2012
Jan-Jun 2012
Jul-Dec 2011
0
Total New Trials
Table 38 - Notifications that include a medicine or biological received by State or Territory
(total number of trial sites notified)
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New South Wales
404
376
435
404
492
Victoria
411
456
460
415
507
Queensland
241
259
312
311
268
South Australia
186
133
165
168
193
Western Australia
121
130
151
125
123
Tasmania
19
22
28
29
31
Australian Capital Territory
19
17
29
25
33
Northern Territory
6
2
4
0
1
Summary
1 407
1 395
1 584
1 477
1648
State
Half-yearly performance reports, July to December 2013
Page 42 of 73
Therapeutic Goods Administration
Table 39- Notifications that include a medicine or biological received by phase
(total number of trial sites notified)
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Phase 1
143
92
143
115
123
Phase 2
363
308
465
355
374
Phase 3
771
825
842
890
1020
Phase 4
103
144
120
96
95
Bioavailability/equivalence
2
3
5
4
5
None specified
25
23
9
17
31
Summary
1 407
1 395
1 584
1 477
1648
Phase
Clinical trials – medical devices
Table 40 - New trial notifications received that include a medical device
Number of notifications received
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
107
130
165
168
199
Jul-Dec
6
Clinical trials – biologicals
Table 41 - New trial notifications received that include a biological
Number of notifications received
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
3
4
9
4
Half-yearly performance reports, July to December 2013
Page 43 of 73
Therapeutic Goods Administration
Special Access Scheme - medicines
Figure 19 - Category A notifications and Category B applications for medicines by reporting period
20000
Total received
18000
16000
14000
12000
Category A Notifications
Jul-Dec 2013
Jan-Jun 2013
Jul-Dec 2012
Jan-Jun 2012
8000
Jul-Dec 2011
10000
Category B Applications
Table 42 - Category A notifications and Category B applications by reporting period
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
16 570
12 948
19 795
15 790
19259
Applications received
8 537
8 676
8 792
9 036
12938
Approved
8 326
8 437
8 626
8 681
12557
Cancelled
30
14
31
45
226
Rejected
21
23
30
53
13
Pending at end of reporting period
94
202
105
257
142
Category A notifications
Total notifications
Category B applications
Note (reference to Figure 19 and Table 42):
Category A – For use in terminally ill or seriously ill / life threatening conditions.
Category B – For use in all other patients.
Half-yearly performance reports, July to December 2013
Page 44 of 73
Therapeutic Goods Administration
Special Access Scheme – medical devices
Table 43 - Category A notifications and Category B applications for devices by reporting period
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
265
290
1 130
649
1561
Applications received
2 267
2 807
1 543
1 143
1415
Approved
2 261
2 805
1 542
1 142
1408
Cancelled
0
0
0
1
5
Rejected
6
2
1
0
0
Pending at end of reporting period
0
0
0
0
2
Category A notifications
Total notifications
Category B applications
Note (reference to Table 43):
Category A – For use in terminally ill or seriously ill / life threatening conditions.
Category B – For use in all other patients.
Special Access Scheme – biologicals
Table 44 - Category A notifications and Category B applications for biologicals by reporting period
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
0
3
3
9
5
Applications received
0
13
788
964
962
Approved
0
13
788
964
961
Rejected
0
0
0
0
0
Pending at end of reporting period
0
0
0
0
1
Category A notifications
Total notifications
Category B applications
Note (reference to Table 44):
Category A – For use in terminally ill or seriously ill / life threatening conditions.
Category B – For use in all other patients.
Half-yearly performance reports, July to December 2013
Page 45 of 73
Therapeutic Goods Administration
Authorised Prescribers
Table 45 - Authorised Prescriber approvals for medicines and medical devices
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
252
207
402
251
221
22
23
116
141
101
Medicines
Number of approvals
Medical devices
Number of approvals
Import permits
Table 46 - Import permits issued for medicines by reporting period
Number of approvals
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
344
360
344
466
672
Orphan drug designations
Table 47 - Number of orphan drug designations by reporting period
Number of designations
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
14
17
23
6
11
Half-yearly performance reports, July to December 2013
Page 46 of 73
Therapeutic Goods Administration
Post-market activities
Licencing and manufacturing
Manufacturing Licences
Table 48 - Manufacturing licence applications by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
New licences granted
18
23
13
19
10
Withdrawn application
4
9
2
7
16
Revoked licences
Voluntarily
By TGA
0
0
0
19
1
10
0
Ceased
24
16
29
0
0
Suspended
Voluntarily
By TGA
1
NR
NR
1
NR
NR
4
NR
NR
3
3
0
1
1
0
Note (reference to Table 48): As at 31 December 2013 there were 417 Australian companies holding
manufacturing licences covering 457 sites. NR = Recording of voluntary or TGA suspension of licences
commenced in 2012-13
Figure 20 - Licence application outcomes for July to December 2013
8%
2%
90%
Satisfactory compliance
Marginal compliance
Unacceptable
Notes (reference to Figure 20): 38 inspections were incomplete at 31 December 2013.
Half-yearly performance reports, July to December 2013
Page 47 of 73
Therapeutic Goods Administration
Table 49 - Licence application outcomes by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
Inspections conducted
333
244
272
247
123
Satisfactory compliance
74%
76%
81%
85%
90%
Marginal compliance
24%
23%
16%
12%
8%
Unacceptable
2%
1%
3%
3%
2%
Initial inspections conducted within
3 months of application (see Note)
98%
81%
79%
60%
67%
Re-inspections conducted within 6
months of due date
99%
86%
68%
70%
67%
Notes (reference to Table 49): Applicants often submit applications for GMP licences before completing
all of their systems and processes. It is therefore common for initial applications to be conducted later
than the 3 months.
Certifications
Table 50 - Certification application status by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
New applications received
104
189
141
117
84
Re-inspection applications
233
235
172
229
85
Certified
128
119
130
156
56
Rejected
0
0
0
111
82
Notes (reference to Table 50): As at 31 December 2013 there were 433 overseas manufacturers
covering 433 sites.
Figure 21 - Certification outcomes for July to December 2013
0%
21%
79%
Satisfactory compliance
Marginal compliance
Unacceptable
Notes (reference to Figure 21): 32 certification inspections were incomplete at 31 December 2013.
Half-yearly performance reports, July to December 2013
Page 48 of 73
Therapeutic Goods Administration
Table 51 - Certification outcomes by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
Inspections conducted
134
157
143
109
60
Satisfactory compliance
81%
84%
87%
86%
79%
Marginal compliance
16%
14%
13%
13%
21%
Unacceptable
3%
2%
0%
1%
0%
Initial certifications inspections
conducted within 6 months of
application (see Note)
73%
90%
80%
74%
67%
Certification re-inspections
conducted within 6 months of due
date
65%
75%
82%
68%
64%
Notes (reference to Table 51): Applicants often submit applications for GMP licences before
completing all of their systems and processes. It is therefore common for initial applications to be
conducted later than the 6 months.
Clearances
Table 52 - Clearance application status by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
Applications received
2 511
2 418
3 900
3 941
1407
Renewal applications
829
1 067
1 172
1 033
770
Approved
3 163
3 362
4 103
3 644
2058
Rejected
8
18
232
92
46
Table 53 - Clearance application outcomes by year
2009/10
Jul-Jun
2010/11
Jul-Jun
2011/12
Jul-Jun
2012/13
Jul-Jun
2013
Jul-Dec
MRA Evidence
1 618
1 478
1 444
1 575
811
Compliance Verification evidence
455
520
283
316
130
TGA Certification evidence
638
677
698
405
110
Half-yearly performance reports, July to December 2013
Page 49 of 73
Therapeutic Goods Administration
Laboratories and scientific services
Laboratory testing
Table 54 - Number of samples and products tested
Prescription medicines
Over the counter medicines
Complementary medicines
Medical devices
Contract
Unregistered
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Total
461
663
404
558
419
% fail
3.5
0.3
0.7
1.6
1.9
Total
70
32
31
31
62
% fail
4.3
3.1
9.7
12.9
3.2
Total
95
69
54
71
42
% fail
51.6
18.8
24.1
23.9
23.8
Total
79
243
284
100
75
% fail
16.5
16.9
21.1
23
17.3
Total
34
18
12
3
2
% fail
14.7
33.3
25.0
0
0
Total
63
62
109
91
105
% fail
74.6
33.9
61.5
67
63.8
896
1252
1000
938
816
802
1087
895
855
705
17%
8%
17%
13%
14%
460
464
488
394
385
Total samples per half year1
Total samples per half year (excluding
AHQ samples)
Percentage fail per half year
Total number of products tested per half
year2
Notes (reference to Table 54):
1Includes accreditation, harmonisation and quality control samples.
2OLSS may test a number of samples of each product per reporting period.
Note: It has been noted that the previous 2 reports, for July - December 2012 and January- June
2013, contained some incorrect values in the totals for Table 54. These entries have been
corrected in this report.
Half-yearly performance reports, July to December 2013
Page 50 of 73
Therapeutic Goods Administration
Table 55 - OLSS testing: reason for fail for rejected samples between 1 July and 31 December 2013
Medical
devices
Contamination
OTC
medicines
Prescription
medicines
1
Formulation
4
Performance
7
Physical or mechanical
properties
1
7
64
1
1
73
7
12
1
8
1
3
1
13
2
8
Total
3
1
Unregistered product
Total
Comp
medicines
2
1
Label and packaging
deficiencies
Unregistered
products
1
67
10
100
Table 56 - Target timeframes for testing (working days*)
Priority of
testing
Biochemical / chemical
testing
Microbiological testing
Medical device testing
Urgent
20
40
20
Priority
40
50
40
Routine
50
50
50
Notes (reference to Table 56): *Samples requiring biological testing are excluded from the
above target turnaround times.
Half-yearly performance reports, July to December 2013
Page 51 of 73
Therapeutic Goods Administration
Table 57 - Compliance with testing timeframes this reporting period1
Medical devices
Over the counter medicines
Prescription medicines
Complementary medicines
Unregistered products
Priority
Total
Percentage
Routine
104
77%
Priority
1
100%
Urgent
0
n/a
Routine
59
73%
Priority
5
100%
Urgent
2
100%
Routine
124
77%
Priority
5
100%
Urgent
5
100%
Routine
35
97%
Priority
7
86%
Urgent
1
100%
Routine
3
67%
Priority
88
78%
Urgent
15
100%
Notes (reference to Table 57):
1Timeframes
for completion of testing are set out in Table 56.
NR – none received
Low numbers of samples in categories may affect compliance percentages.
Table 58 - Batch release and export certification
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Batch release1
167
251
176
248
136
Export certification
22
84
26
75
23
Notes (reference to Table 58):
1Vaccines, biotechnology and blood products – evaluation of batch release documentation.
Half-yearly performance reports, July to December 2013
Page 52 of 73
Therapeutic Goods Administration
Recalls
Medicine recalls
Table 59 - Medicine Recalls - By reporting period
2010
Jul-Dec
2011
Jan-Jun
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Recalls to
consumer level
1
1
2
1
4
4
4
Recalls to hospital
level
7
11
11
14
8
8
14
Recalls to retail
level
6
8
10
6
9
5
5
Recalls to
wholesale level
4
2
5
2
2
2
2
Total
18
22
28
23
23
19
25
Table 60 - Medicine Recalls - Reason for Recalls
2010
Jul-Dec
2011
Jan-Jun
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Adverse reactions
2
1
0
0
1
1
1
Foreign matter
0
0
0
0
0
1
1
Illegal supply
1
3
0
0
1
2
2
Impurity and
degradation
4
1
4
5
0
1
0
Labelling and
packaging
5
6
9
6
8
3
7
Micro-organisms
1
0
2
1
1
5
0
pH
0
0
0
0
0
0
0
Potency
0
0
0
0
0
1
1
Sterility
1
0
1
1
0
0
0
Other
4
11
12
10
12
6
13
Total
18
22
28
23
23
19
25
Half-yearly performance reports, July to December 2013
Page 53 of 73
Therapeutic Goods Administration
Medical device recalls
Table 61 - Medical device (including IVDs) - recalls by reporting period
2010
Jul-Dec
2011
Jan-Jun
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Recalls to consumer
level
5
5
9
11
8
11
11
Recalls to hospital level
159
212
219
226
246
265
280
Recalls to retail level
12
13
9
15
32
21
11
Recalls to wholesale
level
2
1
1
1
2
3
3
Total medical device
recalls
178
231
238
253
288
300
305
Jul-Dec
2013
Jan-Jun
Jul-Dec
Table 62 - Medical device (including IVDs) - Reason for recalls
2010
Jul-Dec
2011
Jan-Jun
Adverse incidents
2
0
0
1
2
1
1
Diagnostic inaccuracy
28
24
24
26
46
46
37
Electrical defect
15
21
22
25
22
20
10
Illegal supply
0
0
1
1
5
0
0
Labelling and
packaging
26
38
41
40
53
49
56
Mechanical and
physical defects
58
82
80
80
97
119
125
Software defects
42
29
56
68
47
55
65
Sterility
1
0
3
2
2
0
1
Other
6
37
11
10
14
10
10
Total
178
231
238
253
288
300
305
Jul-Dec
2012
Jan-Jun
Table 63 - Biologicals Recalls - By reporting period
Recalls to hospital level
2010
Jul-Dec
2011
Jan-Jun
0
0
Jul-Dec
Half-yearly performance reports, July to December 2013
3
2012
Jan-Jun
2
Jul-Dec
0
2013
Jan-Jun
7
Jul-Dec
0
Page 54 of 73
Therapeutic Goods Administration
Adverse medicine reaction reports
Incoming adverse medicine reaction notifications
Figure 22 - Total number of incoming adverse medicine reaction notifications received
Number of reports
10500
10000
9500
9000
8500
Jul-Dec 13
Jan-Jun 13
Jul-Dec 2012
Jan-Jun 2012
Jul-Dec 2011
8000
Total number of reports received for reporting period
Table 64 - Source of incoming notifications
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Hospitals
788
734
852
837
941
Companies
4196
4217
4144
4499
5085
General Practitioners
450
405
349
372
357
Specialists
99
87
87
106
117
Pharmacists
515
491
552
562
717
Members of the Public (Consumer)
244
222
312
300
273
Nurses, dentists, complementary
59
83
90
99
76
State/Territory Health department
1082
1131
757
1835
1276
General list (cause unclear) includes
rejected and withdrawn
776
992
1121
1348
1256
Total
8209
8362
8264
9958
10098
Vaccine reports*
1298
1422
903
2125
1432
Average number of reports received
weekly
315
321
317
383
388
Notes (reference to Table 64):
*The vaccine figures are not additional to the total figures listed above but are included within these
figures.
Half-yearly performance reports, July to December 2013
Page 55 of 73
Therapeutic Goods Administration
Communications and Publications
Table 65 - Communications and publications
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Requests for database output or other
information
3267
3764
3388
4440
5570
1800 number calls received
321
332
286
312
204
***
Medicine Safety Update (MSU) Numbers
(see reference below)
4, 5, 6
7, 8, 9
**
10,11,12
*
13,14,15
16,17,18
Other Publications:
*. International Journal of Risk & Safety in Medicine 24 (2012) 215-219. Severe muscle symptoms with lipid-lowering
agents may be confused with neurogenic claudication associated with spinal canal stenosis . Ruth L. Savage, Kristina
Star, Richard Hill.
**. WHO Signal June 2012. Fesoterodine – GI haemorrhage. Dr Richard Hill, Australia.
***. This does not include calls directed to OPR from the Public Contact Team
Early Warning System (July-Dec 2013)
Caffeine and oxedrine containing products (15 October 2013)
Hydroxyethyl starch (Voluven and Volulyte) and increased risk of mortality (9 July 2013)
Medicine Alerts (July-Dec 2013):
NordiPen used with 5 mg, 10mg and 15 mg Norditropin SimpleXx cartridges (23 July 2013)
Febridol paracetamol 500mg – 100 tablet bottles (24 July 2013)
Rotavirus vaccination and the risk of intussusception (28 August 2013)
Apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto): Information for health professionals (24
September 2013)
Apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto): Information for consumers (24 September 2013)
Pain-killers containing dextropropoxyphene – De-Gesic and Doloxene, 10 October 2013 (10 October 2013)
Oral ketoconazole (Nizoral) 200mg tablets (10 October 2013)
Mefloquine hydrochloride (Lariam) (11 October 2013)
Imigran (sumatriptan) catridge injections (11 November 2013)
Children’s Panadol Baby Drops syringe (22 November 2013)
Pain-killers containing dextropropoxyphene – De-Gesic and Doloxene (27 November 2013)
Slimming Factor (also known as Easy Trim, Que She and Chinese Herbal Diet Pills (2 December 2013)
Children’s Panadol 1-5 years suspension (13 December 2013
Half-yearly performance reports, July to December 2013
Page 56 of 73
Therapeutic Goods Administration
Listed Medicine Reviews
New and completed reviews
Table 66 - New and completed reviews
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Targeted reviews
73
102
46
58
Random
14
2
4
19
Investigation*
51
22
42
7
Total initiated
138
126
92
84
Targeted reviews
144
116
48
77
Random
31
27
14
6
Investigation*
58
38
22
23
Total
233
181
84
106
Reviews in progress as at last day of each 6
monthly period
270
190
200
271
New reviews / investigations initiated
Reviews / investigations finalised
Notes (reference to Table 66):
*Investigations can include products not listed on the ARTG
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.
Half-yearly performance reports, July to December 2013
Page 57 of 73
Therapeutic Goods Administration
Listing Compliance Review Outcomes
Notes (reference to Tables 67, 68and 69): As of September 2012, the Listing Compliance Section
implemented a new framework for conducting compliance reviews for Listed complementary medicines
(refer to http://www.tga.gov.au/industry/cm-basics-regulation-compliance-reviews.htm for more
details). As a consequence, a new system was implemented to capture the data that related to listing
compliance reviews. Because of the differences in data collection and listing compliance framework, the
data prior to September have not been reported as they are not comparable.
Table 67 - Listing Compliance Review Outcomes
Jul-Dec 2013
Number
Percentage
No compliance breaches identified against selected listing
requirements
41
50%
Medicines with verified compliance breaches against selected listing
requirements
31
37%
Compliance status not determined
(Includes medicines cancelled after Section 31 notice issued,
medicines not yet manufactured, financial cancellations etc)
11
13%
Total
83
100%
Table 68 - Listing Compliance Review issues
Jul-Dec 2013
Number
ARTG
6
Product: formulation / manufacturing / quality
4
Labelling and Advertising
40
Evidence
10
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
Table 69 - Actions taken
2013
Jul-Dec
Number
Proposal to Cancel letter sent by the TGA
41
Medicines cancelled by TGA
7
Medicines cancelled by Sponsor after Proposal to Cancel letter issued
13
Medicines cancelled by Sponsor before compliance status could be determined e.g.
after a section 31 notice was issued to Sponsor
6
Compliance reviews initiated but not able to be completed
(e.g. medicine not yet manufactured or product cancellation for non - payment of
fees)
9
Investigations resulting in initiation of target review
4
Notes (reference to Tables 68 and 69): Medicines may have multiple issues and actions
Half-yearly performance reports, July to December 2013
Page 58 of 73
Therapeutic Goods Administration
Medical device post market reviews
Regulatory compliance – random reviews
Table 70 - Devices verification - random review workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Reviews completed
21
63
66
2
2
Reviews commenced
29
0
0
0
0
Reviews on hand
156
93
27
25
23
Notes (reference to Table 70): No random reviews were commenced in Jan-Mar and Apr-Jun 2012/13.
This was due to the reallocation of TGA resources to the up classification of joint implants. This is
supported with reference to Table 24 Application Workflow.
Regulatory compliance – restricted word reviews
Table 71 - Devices verification - restricted word review workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Reviews completed
0
13
12
16
11
Reviews commenced
17
8
9
5
15
Reviews on hand
24
19
16
5
9
Regulatory compliance – targeted reviews
Table 72 - Devices verification - targeted review workflow
2012
Oct-Dec
2013
Jan-Mar
Apr-Jun
Jul-Sep
Oct-Dec
Reviews completed
26
37
64
29
34
Reviews commenced
0
18
23
27
56
Reviews on hand
211
192
151
149
171
Half-yearly performance reports, July to December 2013
Page 59 of 73
Therapeutic Goods Administration
Medical device incident reports
Medical device incident reports received
Table 73 - Number of medical device incident reports received by financial year
2007/08
2008/09
2009/10
2010/11
2011/12
2012/13
Total received
1244
1711
1861
2161
2346
3013
User reports
400
418
537
480
492
898
Sponsor reports
844
1293
1324
1681
1854
2115
Australian incident notification workflow
Table 74 - Australian incident notification workflow
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Reports entered
1218
1404
1271
1255
1630
Reports completed
1234
1112
1148
1865
1443
Reports still in progress
295
731
970
687
627
Australian incident notification response times
Table 75 - Australian incident notification - Average working days to resolve incidents and
percentage not resolved in target time
Target
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Average time to investigate
and resolve
90
days
56
51
34
**
30
Percentage of reports not
resolved in target time
0%
22%
17%
25%
**
16%
Notes (reference to Table 75): ** Data unavailable due to system recording failure.
Half-yearly performance reports, July to December 2013
Page 60 of 73
Therapeutic Goods Administration
Incident notification outcomes
Table 76 - Device incident notification report outcomes
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Reviewed and used for trend analysis purposes
957
812
459
516
736
Reviewed, no further action required
198
195
284
754
585
Product Recall1
18
14
23
29
37
Recall for Product Correction1
0
1
6
10
37
Hazard Alert1
0
3
1
55
41
Product Notification
0
0
1
0
1
Safety Alert1
2
5
5
4
11
Product Enhancement/Improvement Notice
3
6
1
2
1
Instructions for Use Amended
3
13
9
10
28
Referral for Post-Market Review
0
0
1
2
1
Referral to TGA Office of Manufacturing
Quality
2
0
1
3
0
Refer to another TGA Office
7
21
13
26
28
Company warned
0
0
0
0
1
Product Suspended from ARTG
0
0
0
1
0
Product Cancelled from ARTG
1
4
3
26
5
Manufacturing Process Improvements
6
21
22
30
18
Quality System Process Improvements
3
2
3
1
6
Maintenance Carried out by the Hospital
0
0
0
1
1
Change to Design
3
13
12
26
8
Not Device Related
3
21
26
8
11
Other
53
17
20
43
44
Notes (reference to Table 76):
Outcomes are not mutually exclusive. A report may have more than one outcome, such as instructions for
use amended plus TGA publication or product recall plus cancellation. Therefore it is possible that the
total number of outcomes will be more than completed reports.
These outcomes are as a result of an adverse event report investigation or a report for a medical device
that has been the subject of a recall or safety alert action.
The outcome of all 458 PIP reports closed during this time period was the same – TGA publication of
information. Therefore, the outcome was one publication covering all of these reports.
Half-yearly performance reports, July to December 2013
Page 61 of 73
Therapeutic Goods Administration
Regulatory compliance
Alleged offences by type
Table 77 - Count of alleged offences by type
Count
Import
379
Supply
195
Manufacture
10
Claims
5
Export
2
Total
591
Final action taken
Table 78 - Count of final action taken
Count
Investigation in progress
222
Warned
223
No offence detected
90
Goods released under personal Import Scheme
31
Referred to another agency or department outside of TGA
17
Referred to another Office within the TGA
7
Import treated as abandoned goods by Customs
1
Total
591
Half-yearly performance reports, July to December 2013
Page 62 of 73
Therapeutic Goods Administration
Dosage forms of products investigated
Table 79 - Count of dosage forms investigated
Count
Capsule
279
Tablet
214
Topical
149
Medical device
124
Injection
65
Oral liquid
36
Drops
19
Spray
13
Powder
12
Oral jelly / paste
11
Inhalator
3
Lozenge
3
Transdermal
2
Oral food
1
Reagent Test Kit
1
Total
932
Product category of products investigated
Table 80 - Count of product category of products investigated
Count
Complementary medicines
390
Prescription medicines
349
Medical devices
121
Homoeopathic medicines
41
OTC medicines
17
Other
17
Total
935
Half-yearly performance reports, July to December 2013
Page 63 of 73
Therapeutic Goods Administration
Special interest investigations
Table 81 - Count of special interest investigations for each type
Count
Unapproved product
770
Counterfeit
137
Parallel import / export
4
Manufacture without licence
2
Other
5
Total
918
Investigations by complainant type
Table 82 - Count of investigations by complainant type
Count
Customs
353
General public
159
TGA internal
42
External agency
19
Sponsor / client
10
Patient / practitioner
4
Total
587
Half-yearly performance reports, July to December 2013
Page 64 of 73
Therapeutic Goods Administration
Investigations complainant type and state/territory
Table 83 - Count of investigations by complainant type and state/territory
ACT
NSW
NT
QLD
SA
VIC
WA
Others
Customs
0
54
15
75
6
174
22
7
External agency
0
11
0
2
1
0
4
1
General public
0
14
0
7
5
13
3
117
Patient / practitioner
0
2
0
0
0
1
0
1
Sponsor / client
1
5
0
0
0
1
0
3
TGA internal
42
0
0
0
0
0
0
0
Total
43
86
15
84
12
189
29
129
Complainant type
Australian Register of Therapeutic Goods
New, variations and cancelled records
Table 84 - Number of medicine registrations processed
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New medicine entries
1098
941
958
814
1013
Changes (major and minor)
6558
7938
7554
7439
9979
Cancellations
394
302
86
332
77
New medicine entries
134
115
140
159
89
Changes (major and minor)
181
233
182
129
176
Cancellations
56
190
13
146
9
New medicine entries
0
3
1
1
1
Changes (major and minor)
8
12
8
7
12
Cancellations
1
5
1
6
0
Prescription medicines
Over the counter medicines
Complementary medicines
Half-yearly performance reports, July to December 2013
Page 65 of 73
Therapeutic Goods Administration
Table 85 - Number of listings processed
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New medicine entries
886
836
875
872
954
Changes (major and minor)
243
304
245
183
183
Cancellations
362
1361
382
958
207
New medicine entries
47
52
155
81
76
Changes (major and minor)
29
33
40
74
22
Cancellations
139
165
143
98
19
Medicines for supply in Australia
Medicines for export only
Table 86 - Number of medical device inclusions processed
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
New entries
2744
2459
2584
2863
3284
Cancellations
743
2238
482
1752
639
New entries
69
62
115
95
170
Cancellations
10
9
20
32
42
New entries
100
174
233
228
267
Cancellations
1
5
8
6
8
Included medical devices
Included medical devices for export
Included IVD medical devices
Included IVD medical devices for export
New entries
0
3
4
4
5
Cancellation
0
0
1
2
0
New entries
15
2
9
12
18
Cancellations
38
2
11
38
18
New entries
0
0
0
0
0
Cancellations
0
0
0
0
0
Other therapeutic goods
Other therapeutic goods for export
Half-yearly performance reports, July to December 2013
Page 66 of 73
Therapeutic Goods Administration
Table 87- Number of biological inclusions processed
2013
Jan-Jun
Jul-Dec
New entries
1
1
Cancellations
0
0
Biological inclusions
Table 88 - Cancellation of registered and listed devices
2011
Jul-Dec
2012
Jan-Jun
Jul-Dec
2013
Jan-Jun
Jul-Dec
Registered devices
0
0
0
0
0
Listed devices for supply in Australia
0
0
2
6
1
Listed devices for export only
0
0
0
0
0
Registration of products
Figure 23 - Total number of registrations on the Australian Register of Therapeutic Goods at end of
reporting period
80000
Number of registrations
70000
60000
50000
40000
30000
20000
10000
Total medicines
Total biological entries
Half-yearly performance reports, July to December 2013
31 Dec 2013
30 Jun 2013
31 Dec 2012
30 Jun 2012
31 Dec 2011
0
Total medical devices
Total registrations
Page 67 of 73
Therapeutic Goods Administration
Table 89 - Number of medicine products on the Australian Register of Therapeutic Goods
2011
31 Dec
2012
30 Jun
31 Dec
2013
30 Jun
31 Dec
Prescription medicines
10801
11439
12316
12792
13720
Over the counter medicines
3149
3071
3193
3096
3177
Complementary medicines
83
86
91
198
193
Total registered medicines
1433
14596
15600
16086
17090
Listed medicines
11743
11200
11697
11604
12164
Export only medicines
2755
2651
2667
2650
2706
Total medicines
28531
28447
29964
30340
31960
Medicine registrations
Medicine listings
Table 90 - Number of medical device entries on the Australian Register of Therapeutic Goods
2011
31 Dec
2012
30 Jun
31 Dec
2013
30 Jun
31 Dec
Included devices
37115
37335
39478
40574
42917
Included IVDs
330
499
724
946
1205
Included devices for export only
574
627
722
778
906
Included IVDs for export only
6
9
12
14
19
Other therapeutic goods – listings and
registrations
695
632
630
605
597
Other therapeutic goods for export only
13
10
10
10
10
Total medical devices
38733
39112
41576
42948
45655
Medical device inclusions
Other therapeutic goods
Table 91 - Number of biological entries on the Australian Register of Therapeutic Goods
2013
30 Jun
31 Dec
1
2
Biological entries
Biologicals
Half-yearly performance reports, July to December 2013
Page 68 of 73
Therapeutic Goods Administration
Table 92 - Australian Register of Therapeutic Goods totals
2011
31 Dec
2012
30 Jun
31 Dec
2013
30 Jun
31 Dec
Total registrations on the ARTG
67264
67559
71540
73289
77617
Total number of sponsors
3318
3335
3443
3565
3639
Yearly summary of activities
Number of new products, variations and cancellations
Figure 24 - Yearly summary of activities for medicine products
25000
20000
15000
10000
5000
0
2009
2010
2011
New registrations
Cancellations
2012
2013
Variations/groupings
Yearly summary
Figure 25 - Yearly summary of activities for medical device products
Number of new products, variations and cancellations
10000
9000
8000
7000
6000
5000
4000
3000
2000
1000
0
2009
2010
New registrations
2011
Cancellations
Half-yearly performance reports, July to December 2013
2012
2013
Yearly summary
Page 69 of 73
Therapeutic Goods Administration
Table 93 - Medicine products – new products, variations and groupings and cancellations by year
2009
2010
2011
2012
2013
Prescription medicines
815
1313
1911
1899
1827
Over the counter medicines
156
233
230
255
248
Registered complementary medicines
1
5
0
4
2
Listed medicines
1562
1801
1608
1710
1826
Export only medicines
156
152
107
208
157
Yearly total
2690
3504
3856
4076
4060
Prescription medicines
13789
9946
14381
15492
17418
Over the counter medicines
320
405
326
415
305
Registered complementary medicines
5
24
17
20
19
Listed medicines
331
333
453
549
366
Export only medicines
70
72
48
73
96
Yearly total
14515
10780
15225
16549
18204
Prescription medicines
329
310
811
382
413
Over the counter medicines
227
129
214
203
163
Registered complementary medicines
3
3
1
7
7
Listed medicines
1955
1673
1341
1739
1352
Export only medicines
442
214
259
311
118
Yearly total
2956
2329
2626
2642
2053
Medicines activities year summary
20161
16613
21707
23267
24317
New registrations
Variations and groupings
Cancellations
Half-yearly performance reports, July to December 2013
Page 70 of 73
Therapeutic Goods Administration
Table 94 - Medical device products – new products and cancellations by year
2009
2010
2011
2012
2013
Included devices
4972
5603
5319
5043
6147
Included devices for export only
78
90
171
177
265
Included IVDs
0
107
225
407
495
Included IVDs for export only
0
4
2
7
9
Other therapeutic goods
80
83
32
10
26
Other therapeutic goods for export only
0
3
0
0
0
Yearly total
5130
5890
5749
5644
6942
Registered devices
14
4
7
4
6
Listed devices
198
67
96
80
44
Listed devices for export only
0
0
1
3
0
Included devices
1888
2725
2711
2679
2689
Included devices for export only
11
17
36
29
74
Included IVDs
0
0
2
13
14
Included IVDs for export only
0
0
0
1
2
Other therapeutic goods
35
19
17
8
18
Other therapeutic goods for export only
3
0
0
0
0
Yearly total
2149
2832
2870
2817
2846
Medical devices yearly summary
7279
8722
8619
8461
9788
New products
Cancellations
Table 95 - Biological products – new products and cancellations by year
2013
New products
2
Cancellations
0
Biological products yearly summary
2
Table 96 - ARTG activity yearly summary
ARTG activity
2009
2010
2011
2012
2013
27440
25335
30326
31728
34107
Abbreviations used in the report
ACNM
Advisory Committee on Non-prescription Medicines
ACPM
Advisory Committee on Prescription Medicines
Half-yearly performance reports, July to December 2013
Page 71 of 73
Therapeutic Goods Administration
ADEC
Australian Drug Evaluation Committee
AIMD
Active Implantable Medical Device
ARCBS
Australian Red Cross Blood Service
ARTG
Australian Register of Therapeutic Goods
BMU
Business Management Unit
BPR
Business Process Reform
IVD
In-Vitro Diagnostic 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
TRALI
Transfusion-Related Acute Lung Injury
WHO
World Health Organisation
Management of data from manual sources
Some of the data used in this report is drawn initially 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 explain the reason for the change.
Half-yearly performance reports, July to December 2013
Page 72 of 73
Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference/Publication R14/720365