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Half-yearly performance reports

Therapeutic Goods Administration

July to December 2013

May 2014

Document title of 76V1.0 Month 2012


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 <[email protected]>.

Half-yearly performance reports, July to December 2013 of 76

mailto:[email protected]

http://www.tga.gov.au/


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.



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



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



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.



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



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



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



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



Market authorisation


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


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


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


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.



Workflow of Category 1, 2 and 3 applications/submissions

Figure 1 - Category 1 workflow (no Category 2 submissions received)

Oct

-Dec

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Pre-submissions received Submissions finalised On hand at end of reporting period

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Figure 2 - Category 3 workflow

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Submissions received Submissions finalised On hand at end of reporting period

Num

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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



Category 2

Pre-Submissions received* 0 0 0 0 0



Category 3

Submissions received 324 375 300 367 427



*Includes submissions in the Pre-Submission stage**Includes submissions withdrawn or rejected at acceptance for evaluation stage



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


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*


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).


Table 3 - Submissions other than Category 1, 2 and 3 by reporting period

2012Oct-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


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




Total 6 0 5 1 4



2012Oct-Dec


Sub-total approved and rejected

Category 1 72 66 106 117 96


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


Withdrawn by sponsor

Category 1 10 11 8 10 7



Total 14 16 16 12 12

Rejected in application entry




Total 6 0 0 0 0

Sub-total Withdrawn by Sponsor and Rejected in application entry

Category 1 16 11 8 10 7



Total 20 16 16 12 12



2012Oct-Dec


Total finalised submissions

Category 1 88 77 114 127 103


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

Application Type

Wor

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Table 6 - Average Processing times for Category 1 and Category 3 submissions (working days)

Target2012Oct-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.



Non-prescription medicines – over the counter medicines

Workflow of applications

Figure 4 - Workflow of applications – totals

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Received Approved Rejected/Returned/Withdrawn

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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.



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



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



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



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

Ave

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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


Notifications

Receipt and payment to completion – target 20 working days

23 9 9 10 9




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

To

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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.



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


13 26 18 17



Table 12 - Variations and groupings for export only medicines

2012Jan-Jun Jul-Dec

2013Jan-Jun Jul-Dec

Variation and grouping applications


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


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

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ork

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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


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.


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

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day

s

Table 15 - Applications for export certifications

2012Jan-Jun Jul-Dec

2013Jan-Jun Jul-Dec


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.



Non-prescription medicines – complementary medicines

Registered complementary medicines for supply in Australia

Table 16 - Applications for new registered complementary medicines

2012Oct-Dec



Approved 1 0 1 1 0

Rejected 0 0 0 0 1


Lapsed 0 0 0 0 0


8 8 7 6 5

Table 17 - Applications for variations to registered complementary medicines

2012Oct-Dec



Approved 4 6 1 6 6

Rejected 0 1 0 0 0


Lapsed 1 0 0 0 0


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



Approved 3 1 2 0 3

Rejected 1 1 0 1 0


Lapsed 1 0 0 0 0


6 7 7 3 4



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

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009

Oct

-Dec

200

9

Jan-

Mar

201

0

Apr

-Jun

201

0

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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


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.



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


Class 1 medical devices


Applications finalised 612 603 836 818 671



Class 1 measuring and sterile medical devices

Table 22 - Class 1 measuring and sterile medical device application workflow

2012Oct-Dec


Total Class 1 measuring and sterile medical devices


Applications completed 87 48 69 103 139

Applications on hand 32 51 66 50 31

Class 1 measuring medical devices




Class 1 sterile medical devices




Class IIa medical devices

Table 23 - Class IIa medical device application workflow

2012Oct-Dec


Class IIa medical devices






Class IIb medical devices

Table 24 - Class IIb medical device application workflow

2012Oct-Dec


Class IIb medical devices




Class III and AIMD medical devices

Table 25 - Class III and AIMD medical device application workflow

2012Oct-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




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




* Notes (reference to Table 25):



The increase in applications received and applications on hand for the April to June quarter are due to the up classification of joint implants.

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


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

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Sponsor time TGA time

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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 completed** 115 67 91 116 121


Note (reference to Table 27):

*IVD applications added from Jul-Dec 2012 period.** Applications completed includes applications withdrawn post payment of application fee.



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


IVD applications




In vitro diagnostic medical device applications selected for application audit – Quarter 1, 2013/14

Figure 12 - Sponsor/TGA processing times for IVD application audits between 1 July to 30 September 2013

Cla

ss 1

Com

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Cla

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-com

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Cla

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0

10

20

30

40

50

60


Aver

age

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s




Figure 13 - Sponsor/TGA processing times for IVD application audits between 1 October to 31 December 2013

Cla

ss 1

Com

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Com

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Cla

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-com

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5

10

15

20

25

30

35


Aver

age

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Figure 14 - IVD applications selected for application audit between 1 July to 30 September 2013, outcomes

Cla

ss 1

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-com

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5

10

15

20

25

Completed Approved Rejected/withdrawn

Num

ber o

f app

licat

ions




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

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Com

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-com

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02468

101214161820

Completed Approved Rejected/withdrawn

Num

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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



Class 1 in vitro diagnostic medical devices

Table 29 - Class 1 IVD application workflow and outcomes

2012Oct-Dec


Class 1 IVD applications


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.


Table 30 - Class 2 IVD application workflow and outcomes

2012Oct-Dec




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





Table 31 - Class 3 IVD applications workflow and outcomes

2012Oct-Dec




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



Table 32 -Class 4 IVD applications workflow and outcomes

2012Oct-Dec




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




In vitro diagnostic medical device application outcomes

Table 33 - IVD outcome of applications

2012Oct-Dec


All classes of IVD

Approved 114 118 110 155 127

Rejected 0 1 0 0 0

Withdrawn 9 17 7 9 3


In vitro diagnostic medical device conformity assessment applications

Table 34 - IVD conformity assessment application workflow

2012Oct-Dec


In vitro diagnostic conformity assessment applications




Notes (reference to Table 34): Of the six applications completed in Apr-Jun 2013 one conformity assessment application lapsed.



Export certifications for medical devices

Table 35 - Applications for export certifications

2012Jan-Jun Jul-Dec

2013Jan-Jun July-Dec

Applications


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



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


http://www.tga.gov.au/newsroom/media-2013-clinical-trial-statistics-130801.htm


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

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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



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



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.



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


Total notifications 265 290 1 130 649 1561



Approved 2 261 2 805 1 542 1 142 1408

Cancelled 0 0 0 1 5

Rejected 6 2 1 0 0


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


Total notifications 0 3 3 9 5



Approved 0 13 788 964 961

Rejected 0 0 0 0 0


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.



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


Import permits

Table 46 - Import permits issued for medicines by reporting period

2011Jul-Dec

2012Jan-Jun Jul-Dec

2013Jan-Jun Jul-Dec


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



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.



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



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


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



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.



Table 55 - OLSS testing: reason for fail for rejected samples between 1 July and 31 December 2013

Medical devices

OTC 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.



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



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



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



Adverse medicine reaction reports

Incoming adverse medicine reaction notifications

Figure 22 - Total number of incoming adverse medicine reaction notifications received

Ju

l-D

ec

20

11

Ja

n-J

un

20

12

Ju

l-D

ec

20

12

Ja

n-J

un

13

Ju

l-D

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138000

8500

9000

9500

10000

10500

Total number of reports received for reporting period

Nu

mb

er

of

rep

ort

s

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.



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



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.



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


http://www.tga.gov.au/industry/cm-basics-regulation-compliance-reviews.htm


Notes (reference to Tables 68 and 69): Medicines may have multiple issues and actions



Medical device post market reviews

Regulatory compliance – random reviews

Table 70 - Devices verification - random review workflow

2012Oct-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




Reviews on hand 24 19 16 5 9

Regulatory compliance – targeted reviews

Table 72 - Devices verification - targeted review workflow

2012Oct-Dec




Reviews on hand 211 192 151 149 171



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.



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


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.



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



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



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



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


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




Complementary medicines






Table 85 - Number of listings processed

2011Jul-Dec

2012Jan-Jun Jul-Dec

2013Jan-Jun Jul-Dec

Medicines for supply in Australia



Cancellations 362 1361 382 958 207

Medicines for export only




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


Included IVD medical devices

New entries 100 174 233 228 267


Included IVD medical devices for export

New entries 0 3 4 4 5

Cancellation 0 0 1 2 0

Other therapeutic goods



Other therapeutic goods for export





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

ec 2

011

30 J

un 2

012

31 D

ec 2

012

30 J

un 2

013

31 D

ec 2

013

0

10000

20000

30000

40000

50000

60000

70000

80000

Total medicines Total medical devices Total biological entriesTotal registrations

Num

ber

of r

egis

trat

ions



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



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

tions

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

ber o

f new

pro

duct

s, v

aria

tions

and

can

cella

tions



Table 93 - Medicine products – new products, variations and groupings and cancellations by year

2009 2010 2011 2012 2013

New registrations



Registered complementary medicines 1 5 0 4 2



Yearly total 2690 3504 3856 4076 4060

Variations and groupings






Yearly total 14515 10780 15225 16549 18204

Cancellations






Yearly total 2956 2329 2626 2642 2053

Medicines activities year summary 20161 16613 21707 23267 24317



Table 94 - Medical device products – new products and cancellations by year

2009 2010 2011 2012 2013

New products



Included IVDs 0 107 225 407 495


Other therapeutic goods 80 83 32 10 26


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 IVDs 0 0 2 13 14


Other therapeutic goods 35 19 17 8 18


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



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.


PO Box 100 Woden ACT 2606 AustraliaEmail: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605

http://www.tga.gov.au

Reference/Publication R14/720365

http://www.tga.gov.au/

mailto:[email protected]

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