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Half-yearly performance reports
Therapeutic Goods Administration
July to December 2013
May 2014
Document title Page 2 of 76V1.0 Month 2012
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 decision-making, 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 3 of 76
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 4 of 76
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 non-
prescription medicines) are evaluated for quality, safety and efficacy Ingredients in medicines with a lower risk (medicines purchased over the counter,
such as complementary medicines) are required to meet standards for quality and safety
Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label
Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme that allows safety problems to be identified and actions taken to minimise any further potential for harm to patients.
Regulating medical devices
The regulation of medical devices includes:
classifying the medical device based on different levels of risk to the user assessing compliance with a set of internationally agreed essential principles for their
quality, safety and performance implementing appropriate regulatory controls for the manufacturing processes of
medical devices including the medical device in the Australian Register of Therapeutic Goods
Half-yearly performance reports, July to December 2013 Page 5 of 76
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 6 of 76
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 7 of 76
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 NumberBiologicals 2Prescription medicines 13,720OTC medicines 3,177Listed medicines 12,164Registered Complementary Medicines 193Export only medicines 2,706IVDs 1,205Medical Devices 45,655Total 78,822
Recall information
Recall Level Medicines DevicesRecalls to consumer level 4 11Recalls to retail level 5 11Recalls to hospital level 14 280Recalls to wholesale level 2 3Total recalls 25 305
Individual human blood recalls to hospital level for Jul 2012-Jun 2013 total 1980.
Adverse medicine reaction reporting
Incoming Medicine ADR reportsHospitals 941Companies 5,085General Practitioners 357Specialists 117Pharmacists 717Members of the Public (Consumer) 273Nurses, dentists, complementary 76State/Territory Health Department 1,276General list (cause unclear) includes rejected and withdrawn 1,256Total 10,098
Half-yearly performance reports, July to December 2013 Page 8 of 76
Therapeutic Goods Administration
Medical Device incident reports
Number of reports receivedUser reports 898Sponsor reports 2,115Total received 3,013
Medicines applications received by TGA
Number of medicine registrations processedPrescription Medicines
New medicine entries 1,013Changes (major and minor) 9,979Cancellations 77
OTC MedicinesNew medicine entries 89Changes (major and minor) 176Cancellations 9
Complementary MedicinesNew medicine entries 1Changes (major and minor) 12Cancellations 0
Number of listings processedMedicines for supply in Australia
New medicine entries 954Changes (major and minor) 183Cancellations 207
Medicines for export onlyNew medicine entries 76Changes (major and minor) 22Cancellations 19
Devices applications received by TGA
Number of medical device inclusions processedIncluded medical devices
New entries 3,284Cancellations 639
Included medical devices for exportNew entries 170Cancellations 42
Included IVD medical devicesNew entries 267Cancellations 8
Included IVD medical devices for exportNew entries 5Cancellations 0
Other therapeutic goodsNew entries 18Cancellations 18
Other therapeutic goods for exportNew entries 0Cancellations 0
Half-yearly performance reports, July to December 2013 Page 9 of 76
Therapeutic Goods Administration
Detailed Statistical Information
ContentsMarket authorisation 11
Prescription medicines_____________________________________________________11Category 1 application____________________________________________________________________11Category 2 application____________________________________________________________________11Category 3 application____________________________________________________________________11Category 0 application____________________________________________________________________11Application/submission__________________________________________________________________11Workflow of Category 1, 2 and 3 applications/submissions__________________________12Processing times__________________________________________________________________________17
Non-prescription medicines – over the counter medicines___________19Workflow of applications_________________________________________________________________19Processing times__________________________________________________________________________21Applications in progress__________________________________________________________________22
Non-prescription medicines – export only medicines_________________23New applications, variations and processing times____________________________________23Export certifications for medicines______________________________________________________25
Non-prescription medicines – complementary medicines____________26Registered complementary medicines for supply in Australia________________________26Listing of new ingredients and medicines for supply in Australia____________________27
Registration of Human Cells and Tissues_________________________________29Workflow of applications_________________________________________________________________29
Inclusion of medical devices_______________________________________________29Class 1 medical devices___________________________________________________________________29Class 1 measuring and sterile medical devices_________________________________________30Class IIa medical devices_________________________________________________________________30Class IIb medical devices_________________________________________________________________31Class III and AIMD medical devices______________________________________________________31Medical device (non-IVD) applications selected for application audit________________32Medical device (non-IVD) application outcomes_______________________________________33
Medical device conformity assessment applications___________________33Conformity assessment application workflow_________________________________________33
Inclusion of in vitro diagnostic medical devices in the ARTG_________34All classes of IVD application workflow_________________________________________________34In vitro diagnostic medical device applications selected for application audit – Quarter 1, 2013/14_______________________________________________________________________34In vitro diagnostic medical device applications selected for application audit – Quarter 2, 2013/14_______________________________________________________________________35In vitro diagnostic medical device applications selected for application audit – Quarter 1, 2013/14_______________________________________________________________________35In vitro diagnostic medical device applications selected for application audit – Quarter 2, 2013/14_______________________________________________________________________36In vitro diagnostic applications received by class______________________________________36Class 1 in vitro diagnostic medical devices_____________________________________________37Class 2 in vitro diagnostic medical devices_____________________________________________37Class 3 in vitro diagnostic medical devices_____________________________________________38Class 4 in vitro diagnostic medical devices_____________________________________________38In vitro diagnostic medical device application outcomes______________________________39In vitro diagnostic medical device conformity assessment applications_____________39
Export certifications for medical devices________________________________40Blood permits processed___________________________________________________40
Half-yearly performance reports, July to December 2013 Page 10 of 76
Therapeutic Goods Administration
Access to Unapproved Therapeutic Goods_______________________________41Clinical Trial Notification Scheme - medicines_________________________________________41Clinical trials – medical devices__________________________________________________________43Clinical trials – biologicals________________________________________________________________43Special Access Scheme - medicines______________________________________________________44Special Access Scheme – medical devices_______________________________________________45Special Access Scheme – biologicals_____________________________________________________45Authorised Prescribers___________________________________________________________________46Import permits____________________________________________________________________________46
Orphan drug designations__________________________________________________46Post-market activities 47
Licencing and manufacturing______________________________________________47Manufacturing Licences__________________________________________________________________47Certifications______________________________________________________________________________48Clearances_________________________________________________________________________________49
Laboratories and scientific services______________________________________50Laboratory testing________________________________________________________________________50
Recalls_________________________________________________________________________53Medicine recalls___________________________________________________________________________53Medical device recalls____________________________________________________________________54
Adverse medicine reaction reports_______________________________________55Incoming adverse medicine reaction notifications_____________________________________55Communications and Publications______________________________________________________56Other Publications:_______________________________________________________________________56
Listed Medicine Reviews____________________________________________________57New and completed reviews_____________________________________________________________57Listing Compliance Review Outcomes__________________________________________________58
Medical device post market reviews______________________________________59Regulatory compliance – random reviews______________________________________________59Regulatory compliance – restricted word reviews_____________________________________59Regulatory compliance – targeted reviews_____________________________________________59
Medical device incident reports___________________________________________60Medical device incident reports received_______________________________________________60Australian incident notification workflow______________________________________________60Australian incident notification response times________________________________________60Incident notification outcomes__________________________________________________________61
Regulatory compliance______________________________________________________62Alleged offences by type__________________________________________________________________62Final action taken_________________________________________________________________________62Dosage forms of products investigated_________________________________________________63Product category of products investigated_____________________________________________63Special interest investigations___________________________________________________________64Investigations by complainant type_____________________________________________________64Investigations complainant type and state/territory__________________________________65
Australian Register of Therapeutic Goods_______________________________65New, variations and cancelled records__________________________________________________65Registration of products__________________________________________________________________67Yearly summary of activities_____________________________________________________________69
Abbreviations used in the report__________________________________________71Management of data from manual sources______________________________72
Half-yearly performance reports, July to December 2013 Page 11 of 76
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/submissionIn 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 12 of 76
Therapeutic Goods Administration
Workflow of Category 1, 2 and 3 applications/submissions
Figure 1 - Category 1 workflow (no Category 2 submissions received)
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Figure 2 - Category 3 workflow
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Half-yearly performance reports, July to December 2013 Page 13 of 76
Therapeutic Goods Administration
Table 1 - Workflow of Category 1 & 2 Pre-submissions and Category 3 submissions
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Overall
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
Category 1
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
Category 2
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
Category 3
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
*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 14 of 76
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)
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
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*
Half-yearly performance reports, July to December 2013 Page 15 of 76
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 Pre-Submission 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).
Therapeutic Goods Administration
Table 3 - Submissions other than Category 1, 2 and 3 by reporting period
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Submission type
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
Table 4 - Delegate’s decision made on submissions – Approved or rejected (see interpretation notes after Table 5)
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Approved
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
Rejected
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
Half-yearly performance reports, July to December 2013 Page 16 of 76
Therapeutic Goods Administration
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Sub-total approved and rejected
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
Table 5 - Delegate’s decision made on submissions – Withdrawn or Rejected before evaluation stage
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Withdrawn by sponsor
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
Rejected in application entry
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
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 17 of 76
Therapeutic Goods Administration
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Total finalised submissions
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
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)
Average Median Range Average Median RangeTGA Time Sponsor Time
0
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Changes to PI Major Variations NCEs New Generics New Indications
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Half-yearly performance reports, July to December 2013 Page 18 of 76
Therapeutic Goods Administration
Table 6 - Average Processing times for Category 1 and Category 3 submissions (working days)
Target2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Category 1 submissions
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
Category 3 submissions
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
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 19 of 76
Therapeutic Goods Administration
Non-prescription medicines – over the counter medicines
Workflow of applications
Figure 4 - Workflow of applications – totals
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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 20 of 76
Therapeutic Goods Administration
Table 7 - Non-prescription medicines – over the counter medicines workflow of applications
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
New applications
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
Variations processed through TGA only
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
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
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 21 of 76
Therapeutic Goods Administration
Processing times
Figure 5 - Average TGA processing times (working days)
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New Applications & Variations Referred to ACNM Variations Processed Through TGA
Notifications
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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)
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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
Variations not referred to ACNM
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
Notifications
Receipt and payment to completion – target 20 working days
23 9 9 10 9
Percentage completed within target 92 99 91 93 93
Half-yearly performance reports, July to December 2013 Page 22 of 76
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
Figure 6 - Total number of applications in progress at the end of the reporting period
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Total Number in Progress
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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 23 of 76
Therapeutic Goods Administration
Table 10 - Non-prescription medicines – over the counter medicines stage of processing
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Time in progress
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
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)
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
New applications
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
Half-yearly performance reports, July to December 2013 Page 24 of 76
Therapeutic Goods Administration
Table 12 - Variations and groupings for export only medicines
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Variation and grouping applications
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
Figure 7 - Average TGA processing times (working days)
Jul-D
ec 1
1
Jan-
Jun
12
Jul-D
ec
12
Jan-
Jun
13
Jul-D
ec 1
310
15
20
25
30
35
New Applications Variations
Ave
rag
e w
ork
ing
days
Half-yearly performance reports, July to December 2013 Page 25 of 76
Therapeutic Goods Administration
Table 13 - Processing time for new applications and variations for export only medicines
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
New applications
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
Variations
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
Table 14 - Processing time for applications in progress for export only medicines
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Total outstanding at end of reporting period 28 33 19 18
Time taken to date0-4 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 26 of 76
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.
Therapeutic Goods Administration
Export certifications for medicines
Figure 8 - Average TGA processing times for export certificates (working days)
Jul-D
ec 2
011
Jan-
Jun
2012
Jul-D
ec 2
012
Jan-
Jun
2013
Jul-D
ec 2
0130
2
4
6
8
10
12
Completion of BMU processing OMA - certificate issued
Ave
rage
wor
king
day
s
Table 15 - Applications for export certifications
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Applications received 1169 805 1044 954
Certificates issued 1084 884 926 995
Applications rejected 1 0 0 0
Processing times
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%
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 27 of 76
Therapeutic Goods Administration
Non-prescription medicines – complementary medicines
Registered complementary medicines for supply in Australia
Table 16 - Applications for new registered complementary medicines
2012Oct-Dec
2013Jan-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
2012Oct-Dec
2013Jan-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)
2012Oct-Dec
2013Jan-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 28 of 76
Therapeutic Goods Administration
Figure 9 - Applications received for new listed medicine products
Jan-
Mar
200
8
Apr
-Jun
200
8
Jul-S
ep 2
008
Oct
-Dec
200
8
Jan-
Mar
200
9
Apr
-Jun
200
9
Jul-S
ep 2
009
Oct
-Dec
200
9
Jan-
Mar
201
0
Apr
-Jun
201
0
Jul-S
ep 2
010
Oct
-Dec
201
0
Jan-
Mar
201
1
Apr
-Jun
201
1
Jul-S
ep 2
011
Oct
-Dec
201
1
Jan-
Mar
201
2
Apr
-Jun
201
2
Jul-S
ep 2
012
Oct
-Dec
201
2
Jan-
Mar
201
3
Apr
-Jun
201
3
Jul-S
ep 2
013
Oct
-Dec
201
3
300
350
400
450
500
550
600
New Products
Num
ber
of a
pplic
atio
ns r
ecei
ved
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
2012Oct-Dec
2013Jan-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 29 of 76
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
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class 1 medical devices
Applications received 612 603 836 824 672
Applications finalised 612 603 836 818 671
Half-yearly performance reports, July to December 2013 Page 30 of 76
Therapeutic Goods Administration
Class 1 measuring and sterile medical devices
Table 22 - Class 1 measuring and sterile medical device application workflow
2012Oct-Dec
2013Jan-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
Class 1 sterile medical devices
Applications received 50 57 73 89 99
Applications completed 72 39 59 93 115
Applications on hand 20 48 62 42 26
Class IIa medical devices
Table 23 - Class IIa medical device application workflow
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class IIa medical devices
Applications received 315 338 387 383 350
Applications completed 355 323 302 371 464
Applications on hand 170 185 270 235 121
Half-yearly performance reports, July to December 2013 Page 31 of 76
Therapeutic Goods Administration
Class IIb medical devices
Table 24 - Class IIb medical device application workflow
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class IIb medical devices
Applications received 170 136 162 179 157
Applications completed 204 149 127 168 197
Applications on hand 101 88 123 103 63
Class III and AIMD medical devices
Table 25 - Class III and AIMD medical device application workflow
2012Oct-Dec
2013Jan-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
Class III medical devices
Applications received 81 88 89 123 148
Applications completed 220 92 48 57 137
Applications on hand 129 125 166 213 224
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
AIMD medical devices
Applications received 11 55 9 4 53
Applications completed 35 32 12 13 19
Applications on hand 17 40 37 24 58
* Notes (reference to Table 25):
Half-yearly performance reports, July to December 2013 Page 32 of 76
Therapeutic Goods Administration
The increase in applications received and applications on hand for the April to June quarter are due to the up classification of joint implants.
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
Medical device applications selected for application audit
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
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
Non
-Com
puls
ory
Audi
t Ass
essm
ent
Leve
l 1 C
ompu
lsor
y Au
dit A
sses
smen
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Leve
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ompu
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sses
smen
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0
20
40
60
80
Sponsor time TGA time
Aver
age
wor
king
day
s
Half-yearly performance reports, July to December 2013 Page 33 of 76
Therapeutic Goods Administration
Medical device (non-IVD) application outcomes
Figure 11 - Outcomes of applications completed between 1 July to 31 December 2013
Class IIb Reclas
AIMD
Class III
Class IIb
Class IIa
Class IS
Class 1M
Class I
0 200 400 600 800 1000 1200 1400 1600
Withdrawn Rejected Approved
Number of submissions
Medical device conformity assessment applications
Conformity assessment application workflow
Table 27 - Conformity Assessment application workflow
2011
Jul-Dec*
2012
Jan-Jun Jul-Dec
2013
Jan-Jun Jul-Dec
Conformity Assessments
Applications received 87 100 104 118 136
Applications completed** 115 67 91 116 121
Applications on hand 132 165 178 180 202
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 34 of 76
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
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
IVD applications
Applications received 137 130 137 139 136
Applications completed 123 137 117 164 130
Applications on hand 41 34 54 21 27
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
Cla
ss 1
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Cla
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10
20
30
40
50
60
Sponsor time TGA time
Aver
age
wor
king
day
s
Half-yearly performance reports, July to December 2013 Page 35 of 76
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
Cla
ss 1
Com
p au
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Cla
ss 2
Com
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Cla
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Non
-com
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Cla
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5
10
15
20
25
30
35
Sponsor time TGA time
Aver
age
wor
king
day
s
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
Cla
ss 1
Com
p au
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Cla
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Com
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Cla
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Non
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5
10
15
20
25
Completed Approved Rejected/withdrawn
Num
ber o
f app
licat
ions
Half-yearly performance reports, July to December 2013 Page 36 of 76
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
Cla
ss 1
Com
p au
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Cla
ss 2
Com
p au
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Cla
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Non
-com
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Cla
ss 3
Com
p au
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02468
101214161820
Completed Approved Rejected/withdrawn
Num
ber o
f app
licat
ions
In vitro diagnostic applications received by class
Figure 16 - IVD applications received by class
Oct
-Dec
12
Jan-
Mar
13
Apr
-Jun
13
Jul-S
ep 1
3
Oct
-Dec
130
10
20
30
40
50
60
70
80
Class 1 IVD Class 2 IVD Class 3 IVD Class 4 IVD
Num
ber
rece
ived
Half-yearly performance reports, July to December 2013 Page 37 of 76
Therapeutic Goods Administration
Class 1 in vitro diagnostic medical devices
Table 29 - Class 1 IVD application workflow and outcomes
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class 1 IVD applications
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
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
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class 2 IVD applications
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
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 38 of 76
Therapeutic Goods Administration
Class 3 in vitro diagnostic medical devices
Table 31 - Class 3 IVD applications workflow and outcomes
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class 3 IVD applications
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
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
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
Class 4 IVD applications
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
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 39 of 76
Therapeutic Goods Administration
In vitro diagnostic medical device application outcomes
Table 33 - IVD outcome of applications
2012Oct-Dec
2013Jan-Mar Apr-Jun Jul-Sep Oct-Dec
All classes of IVD
Approved 114 118 110 155 127
Rejected 0 1 0 0 0
Withdrawn 9 17 7 9 3
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
2012Oct-Dec
2013Jan-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 40 of 76
Therapeutic Goods Administration
Export certifications for medical devices
Table 35 - Applications for export certifications
2012Jan-Jun Jul-Dec
2013Jan-Jun July-Dec
Applications
Applications received 217 161 228 152
Export certificates issued 187 151 206 161
Applications rejected/withdrawn 3 0 0 2
Processing times (average working days)
Export certificates (target = 5 days) 3 5 4 3
Percentage processed within target time (Target >90%)
91.0% 66.0% 89% 97.5%
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
Jan-
Jun
12
Jul-D
ec 1
2
Jan-
Jun
13
Jul -
Dec
13
0
10
20
30
40
50
60
Individual permits Blood fractions Annual permits
Num
ber
of p
erm
its p
roce
ssed
Half-yearly performance reports, July to December 2013 Page 41 of 76
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)
2011Jul-Dec
2012Jan-Jun
Jul-Dec 2013Jan-Jun Jul-Dec
State
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
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)
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Phase
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
Half-yearly performance reports, July to December 2013 Page 42 of 76
Therapeutic Goods Administration
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Summary 350 343 416 326 355
Figure 18 - Total notifications and new trial notifications that include a medicine or biological
Jul-D
ec 2
011
Jan-
Jun
2012
Jul-D
ec 2
012
Jan-
Jun
2013
Jul-D
ec 2
013
0
200
400
600
800
1000
1200
1400
1600
Total Notifications Total New Trials
Tot
al n
umbe
r
Table 38 - Notifications that include a medicine or biological received by State or Territory (total number of trial sites notified)
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
State
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
Half-yearly performance reports, July to December 2013 Page 43 of 76
Therapeutic Goods Administration
Table 39- Notifications that include a medicine or biological received by phase (total number of trial sites notified)
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Phase
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
Clinical trials – medical devices
Table 40 - New trial notifications received that include a medical device
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Number of notifications received 107 130 165 168 199
Clinical trials – biologicals
Table 41 - New trial notifications received that include a biological
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Number of notifications received 3 4 9 4 6
Half-yearly performance reports, July to December 2013 Page 44 of 76
Therapeutic Goods Administration
Special Access Scheme - medicines
Figure 19 - Category A notifications and Category B applications for medicines by reporting period
Jul-D
ec 2
011
Jan-
Jun
2012
Jul-D
ec 2
012
Jan-
Jun
2013
Jul-D
ec 2
013
8000
10000
12000
14000
16000
18000
20000
Category A Notifications Category B Applications
Tot
al r
ecei
ved
Table 42 - Category A notifications and Category B applications by reporting period
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Category A notifications
Total notifications 16 570 12 948 19 795 15 790 19259
Category B applications
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
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 45 of 76
Therapeutic Goods Administration
Special Access Scheme – medical devices
Table 43 - Category A notifications and Category B applications for devices by reporting period
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Category A notifications
Total notifications 265 290 1 130 649 1561
Category B applications
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
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
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Category A notifications
Total notifications 0 3 3 9 5
Category B applications
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
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 46 of 76
Therapeutic Goods Administration
Authorised Prescribers
Table 45 - Authorised Prescriber approvals for medicines and medical devices
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Medicines
Number of approvals 252 207 402 251 221
Medical devices
Number of approvals 22 23 116 141 101
Import permits
Table 46 - Import permits issued for medicines by reporting period
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Number of approvals 344 360 344 466 672
Orphan drug designations
Table 47 - Number of orphan drug designations by reporting period
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Number of designations 14 17 23 6 11
Half-yearly performance reports, July to December 2013 Page 47 of 76
Therapeutic Goods Administration
Post-market activities
Licencing and manufacturing
Manufacturing Licences
Table 48 - Manufacturing licence applications by year
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-Dec
New licences granted 18 23 13 19 10
Withdrawn application 4 9 2 7 16
Revoked licencesVoluntarilyBy TGA
0 0 0191
100
Ceased 24 16 29 0 0
SuspendedVoluntarilyBy TGA
1NRNR
1NRNR
4NRNR
330
110
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
90%
8%
2%
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 48 of 76
Therapeutic Goods Administration
Table 49 - Licence application outcomes by year
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-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
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-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
79%
21%
Satisfactory compliance Marginal compliance Unacceptable
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Notes (reference to Figure 21): 32 certification inspections were incomplete at 31 December 2013.
Table 51 - Certification outcomes by year
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-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
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-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
2009/10Jul-Jun
2010/11Jul-Jun
2011/12Jul-Jun
2012/13Jul-Jun
2013Jul-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
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Laboratories and scientific services
Laboratory testing
Table 54 - Number of samples and products tested
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Prescription medicines Total 461 663 404 558 419
% fail 3.5 0.3 0.7 1.6 1.9
Over the counter medicines Total 70 32 31 31 62
% fail 4.3 3.1 9.7 12.9 3.2
Complementary medicines Total 95 69 54 71 42
% fail 51.6 18.8 24.1 23.9 23.8
Medical devices Total 79 243 284 100 75
% fail 16.5 16.9 21.1 23 17.3
Contract Total 34 18 12 3 2
% fail 14.7 33.3 25.0 0 0
Unregistered Total 63 62 109 91 105
% fail 74.6 33.9 61.5 67 63.8
Total samples per half year1
896 1252 1000 938 816
Total samples per half year (excluding AHQ samples)
802 1087 895 855 705
Percentage fail per half year 17% 8% 17% 13% 14%
Total number of products tested per half year2 460 464 488 394 385
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.
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Table 55 - OLSS testing: reason for fail for rejected samples between 1 July and 31 December 2013
Medical devices
OTC medicines
Prescription medicines
Unregistered products
Comp medicines
Total
Contamination 1 2 3
Formulation 1 7 64 1 73
Label and packaging deficiencies
4 1 7 12
Performance 7 1 8
Physical or mechanical properties
1 1 1 3
Unregistered product 1 1
Total 13 2 8 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.
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Table 57 - Compliance with testing timeframes this reporting period1
Priority Total PercentageMedical devices Routine 104 77%
Priority 1 100%Urgent 0 n/a
Over the counter medicines Routine 59 73%Priority 5 100%Urgent 2 100%
Prescription medicines Routine 124 77%Priority 5 100%Urgent 5 100%
Complementary medicines Routine 35 97%Priority 7 86%Urgent 1 100%
Unregistered products 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 receivedLow numbers of samples in categories may affect compliance percentages.
Table 58 - Batch release and export certification
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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.
Recalls
Medicine recalls
Table 59 - Medicine Recalls - By reporting period
2010Jul-Dec
2011Jan-Jun
Jul-Dec2012Jan-Jun Jul-Dec
2013Jan-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
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2010Jul-Dec
2011Jan-Jun
Jul-Dec2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
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
2010Jul-Dec
2011Jan-Jun Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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
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Medical device recalls
Table 61 - Medical device (including IVDs) - recalls by reporting period
2010Jul-Dec
2011Jan-Jun
Jul-Dec2012Jan-Jun
Jul-Dec2013Jan-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
Table 62 - Medical device (including IVDs) - Reason for recalls
2010Jul-Dec
2011Jan-Jun
Jul-Dec2012Jan-Jun
Jul-Dec2013Jan-Jun
Jul-Dec
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
Table 63 - Biologicals Recalls - By reporting period
2010Jul-Dec
2011Jan-Jun
Jul-Dec2012Jan-Jun
Jul-Dec2013Jan-Jun
Jul-Dec
Recalls to hospital level 0 0 3 2 0 7 0
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Adverse medicine reaction reports
Incoming adverse medicine reaction notifications
Figure 22 - Total number of incoming adverse medicine reaction notifications received
Ju
l-D
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20
11
Ja
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20
12
Ju
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20
12
Ja
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13
Ju
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138000
8500
9000
9500
10000
10500
Total number of reports received for reporting period
Nu
mb
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of
rep
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Table 64 - Source of incoming notifications
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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.
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Communications and Publications
Table 65 - Communications and publications
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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
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Listed Medicine Reviews
New and completed reviews
Table 66 - New and completed reviews
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
New reviews / investigations initiated
Targeted reviews 73 102 46 58
Random 14 2 4 19
Investigation* 51 22 42 7
Total initiated 138 126 92 84
Reviews / investigations finalised
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
Notes (reference to Table 66):*Investigations can include products not listed on the ARTGAll 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.
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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 2013Number 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 2013Number
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
2013Jul-DecNumber
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
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Notes (reference to Tables 68 and 69): Medicines may have multiple issues and actions
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Medical device post market reviews
Regulatory compliance – random reviews
Table 70 - Devices verification - random review workflow
2012Oct-Dec
2013Jan-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
2012Oct-Dec
2013Jan-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
2012Oct-Dec
2013Jan-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
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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
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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
Target2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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.
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Incident notification outcomes
Table 76 - Device incident notification report outcomes
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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.
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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
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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
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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
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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
Complainant type
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
Australian Register of Therapeutic Goods
New, variations and cancelled records
Table 84 - Number of medicine registrations processed
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Prescription medicines
New medicine entries 1098 941 958 814 1013
Changes (major and minor) 6558 7938 7554 7439 9979
Cancellations 394 302 86 332 77
Over the counter medicines
New medicine entries 134 115 140 159 89
Changes (major and minor) 181 233 182 129 176
Cancellations 56 190 13 146 9
Complementary medicines
New medicine entries 0 3 1 1 1
Changes (major and minor) 8 12 8 7 12
Cancellations 1 5 1 6 0
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Table 85 - Number of listings processed
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Medicines for supply in Australia
New medicine entries 886 836 875 872 954
Changes (major and minor) 243 304 245 183 183
Cancellations 362 1361 382 958 207
Medicines for export only
New medicine entries 47 52 155 81 76
Changes (major and minor) 29 33 40 74 22
Cancellations 139 165 143 98 19
Table 86 - Number of medical device inclusions processed
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-Jun Jul-Dec
Included medical devices
New entries 2744 2459 2584 2863 3284
Cancellations 743 2238 482 1752 639
Included medical devices for export
New entries 69 62 115 95 170
Cancellations 10 9 20 32 42
Included IVD medical devices
New entries 100 174 233 228 267
Cancellations 1 5 8 6 8
Included IVD medical devices for export
New entries 0 3 4 4 5
Cancellation 0 0 1 2 0
Other therapeutic goods
New entries 15 2 9 12 18
Cancellations 38 2 11 38 18
Other therapeutic goods for export
New entries 0 0 0 0 0
Cancellations 0 0 0 0 0
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Table 87- Number of biological inclusions processed
2013Jan-Jun Jul-Dec
Biological inclusions
New entries 1 1
Cancellations 0 0
Table 88 - Cancellation of registered and listed devices
2011Jul-Dec
2012Jan-Jun Jul-Dec
2013Jan-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
31 D
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0
10000
20000
30000
40000
50000
60000
70000
80000
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Num
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of r
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Table 89 - Number of medicine products on the Australian Register of Therapeutic Goods
201131 Dec
201230 Jun 31 Dec
201330 Jun 31 Dec
Medicine registrations
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
Medicine listings
Listed medicines 11743 11200 11697 11604 12164
Export only medicines 2755 2651 2667 2650 2706
Total medicines 28531 28447 29964 30340 31960
Table 90 - Number of medical device entries on the Australian Register of Therapeutic Goods
201131 Dec
201230 Jun 31 Dec
201330 Jun 31 Dec
Medical device inclusions
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
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
Table 91 - Number of biological entries on the Australian Register of Therapeutic Goods
201330 Jun 31 Dec
Biological entries
Biologicals 1 2
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Table 92 - Australian Register of Therapeutic Goods totals
201131 Dec
201230 Jun 31 Dec
201330 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
Figure 24 - Yearly summary of activities for medicine products
2009 2010 2011 2012 20130
5000
10000
15000
20000
25000
New registrations Variations/groupings Cancellations Yearly summary
Num
ber o
f new
pro
duct
s, v
aria
tions
and
can
cella
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Figure 25 - Yearly summary of activities for medical device products
2009 2010 2011 2012 20130
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
New registrations Cancellations Yearly summary
Num
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and
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Table 93 - Medicine products – new products, variations and groupings and cancellations by year
2009 2010 2011 2012 2013
New registrations
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
Variations and groupings
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
Cancellations
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
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Table 94 - Medical device products – new products and cancellations by year
2009 2010 2011 2012 2013
New products
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
Cancellations
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
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
2009 2010 2011 2012 2013
ARTG activity 27440 25335 30326 31728 34107
Abbreviations used in the reportACNM Advisory Committee on Non-prescription Medicines
ACPM Advisory Committee on Prescription Medicines
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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 75 of 76
PO Box 100 Woden ACT 2606 AustraliaEmail: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference/Publication R14/720365
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