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Half Yearly Performance Snapshot 1 July to 31 December 2016

Therapeutic Goods Administration

Half yearly performance snapshot: July to December 2016 of 24

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Contents Half Yearly Performance Snapshot ________________ 4

Introduction ______________________________________________________________________ 4

Performance highlights _________________________________________________________ 4

Processing and approval times ________________________________________________ 7

1. Prescription medicines ______________________________________________________ 7

2. Over-the-Counter medicines ________________________________________________ 9

3. Complementary medicines ________________________________________________ 10

4. Biologicals ____________________________________________________________________ 12

5. Medical devices ______________________________________________________________ 13

6. Exports ________________________________________________________________________ 14

7. Access to unapproved therapeutic goods _______________________________ 15

8. Licensing and manufacturing _____________________________________________ 17

9. Laboratories _________________________________________________________________ 19

10. Medicine and Vaccine Adverse Event Reporting _____________________ 20

11. Medical device incident reports ________________________________________ 20

12. Regulatory compliance ___________________________________________________ 21

13. Recalls _______________________________________________________________________ 22



Half Yearly Performance Snapshot

Introduction The Therapeutic Goods Administration reports on its performance against the Regulator Performance Framework (the Framework). The Framework came into effect on 1 July 2015 and our first report, covering the period 1 July 2015 to 30 June 2016, was published on the TGA website in November 2016 (TGA key performance indicators and measures: Regulator Performance Framework).

To provide stakeholders with a progress update and assist with charting our performance, the TGA also releases a Half Yearly Performance Snapshot (the Snapshot). This Snapshot covers the period of 1 July to 31 December 2016.

Performance highlights The six months from 1 July to 31 December 2016 was a period of significant activity for the TGA. Highlights are as follows:

Medicines

Prescription medicines • A significant workload continued, with 156 Category 1 (including 23 New Chemical Entities

(NCE) and 53 new generic medicines) and 665 Category 3 applications approved. While this represents a slight decrease against the equivalent period in 2015, where 193 Category 1 and 685 Category 3 applications were approved, many applications, particularly related to cancer medicines, are increasingly more complex in nature.

• The mean and median approval times for Category 1 NCE (200 and 205 working days respectively) and Category 3 minor variation applications (between 22 and 24 working days) were well below the statutory timeframes of 255 days and 45 days respectively.

• The mean and median approval times for new generic medicines (177 and 161 working days respectively) and Product Information changes (142 and 138 working days) were below that of NCE as these application types are typically processed without referral to independent expert advisory committees.

Over-the-counter medicines • The number of new medicine applications (N1 to N5) approved during this period (77)

increased slightly compared to January to June 2016 (59) but was within the variability of previous periods.

• The percentages of applications completed within target timeframes were well above the 80% target (95% for C1 applications and 100% for all other application types). Business process reform and a streamlined submission process have led to efficiencies in completing applications within target timeframes.

https://www.tga.gov.au/tga-key-performance-indicators-july-2015-june-2016

http://www.tga.gov.au/tga-key-performance-indicators-and-measures-regulator-performance-framework

http://www.tga.gov.au/tga-key-performance-indicators-and-measures-regulator-performance-framework



Complementary medicines • The number of new ingredients permitted for use in listed medicines increased

substantially compared to the corresponding period in 2015 (from 14 to 50), largely due to new ingredients being made available for excipient use in specific circumstances in listed medicines. Two updates were made to the Permissible Ingredients Determination under section 26BB of the Therapeutic Goods Act 1989 (the Act) to enable the use of these ingredients in listed medicines.

• We increased the number of initiated targeted reviews from 89 to 235 based on the data gathered from random compliance reviews conducted in 2015-16. We identified trends in non-compliance and initiated projects targeting groups of listed medicines based on non-compliance issues. These were published on our website at a dedicated compliance page.

• Increased targeted reviews resulted in the proportion of medicines with verified compliance breaches being 80% (167) for this period, compared with 72% (136) in the corresponding period in 2015.

Medical devices • A total of 258 Level 2 compulsory audits which include the assessment of clinical evidence

were completed in this period compared to 107 in the corresponding period in 2015. Whilst during 2016 there were delays in commencing the clinical assessment component for high risk (Class III and Active Implantable Medical Devices) application audits resulting in process times of around eight to nine months, we have introduced a range of strategies to address this issue and reduce the wait time for assessments.

Licensing and manufacturing • We have revised our business practices to apply a risk-based approach to the scheduling of

inspections for the manufacture of medicines and biologicals, resulting in significant improvements in processing times. Specifically, this period has seen a 16% increase of initial inspections conducted of Australian manufacturers and a 25% increase of initial certifications of overseas manufacturers compared with the equivalent 2015 reporting period. These improvements have been achieved by focusing on initial inspections as opposed to re-inspections and taking into account any history of consistent compliance with Good Manufacturing Practice (GMP) guidelines over time.

• As at 31 December 2016, there were 252 companies holding Australian manufacturing licences covering 396 sites; and 397 overseas companies holding manufacturer certificates covering 399 manufacturing sites.

Access to unapproved therapeutic goods

Clinical trials • There was a slight reduction in the number of Clinical Trial Notifications (CTN) received

(417) compared to the corresponding period in 2015 (469).

• Ongoing modifications to the online CTNs form have been made to improve its functionality for clinical trial sponsors.

https://www.tga.gov.au/compliance-and-education-listed-medicines



Special Access Scheme • The number of completed applications and notifications under the Special Access Scheme

for Category A medical devices increased (from 1,960 to 2,832) compared to the corresponding period in 2015.

Authorised Prescriber Scheme • There was an increase in the number of authorised prescriber approvals for medicines

(from 297 to 391) and medical devices (from 121 to 177) compared to the corresponding period in 2015.

Medicine and vaccine adverse event reports • We have worked closely with stakeholders to highlight the importance of reporting adverse

events to the TGA. The National Prescribing Service (NPS) hosts an online learning module for health professionals and in April 2016 we undertook online advertising using Google and health professional publications. This resulted in increased awareness and completion rates of the NPS modules, especially in the nursing profession. There was an increase of 1,371 in notifications of medicine and vaccine adverse events compared to the equivalent 2015 reporting period.

Laboratories • Between 1 July and 31 December 2016, 1,229 samples were tested and a total of 6.9 million

doses of 53 different vaccine products were released.

Regulatory compliance • The number of products subject to investigation for compliance issues increased by 111%

from the equivalent 2015 reporting period. We attribute increased reporting of non-compliance to online educational material informing the Australian public about the dangers of importing medicines and medical devices not approved for supply in Australia and without medical supervision. We have also enhanced our relationships with government stakeholders with responsibility for law enforcement, consumer protection and the health of Australians.

• We facilitated the destruction of a total of 336,119 ‘units1’ of imported therapeutic goods. These therapeutic goods were imported outside of the TGA regulatory scheme and treated as prohibited imports under the Customs Act 1901 resulting in seizure and destruction by the Australian Border Force (ABF). Reporting on the destruction of these units commenced this reporting period and will be incorporated into subsequent reports.

• Ten products were established to be counterfeit therapeutic goods presenting a risk to public health. Safety alerts were published on the TGA website and the ABF was notified.

Recalls • Initial review of 90% of the safety related recall (i.e. Class I and II) actions for medical

devices, medicines and biologicals managed during the reporting period was undertaken within the target timeframe of two working days from the date of notification.

1 One unit equals: one tablet / one pill / one ampoule in case of injectable pharmaceutical / one litre if medicine in liquid / 1 kg in case of raw material.



Processing and approval times Processing and approval times are defined as the number of working days from the acceptance of the application until formal notification of decision, unless otherwise specified. These exclude time where we were unable to progress the application until the sponsor provided additional information or payment of fees, unless otherwise specified. Under the Act, TGA working days exclude public holidays and weekends.

1. Prescription medicines The framework for prescription medicines includes the following categories which are subject to legislated timeframes:

• Category 1 application: an application to register a new prescription medicine (other than an additional trade name) or to make a variation to an existing medicine that involves the evaluation of clinical, pre-clinical or bio-equivalence data. For example, new chemical entities, extensions of indication and new routes of administration.

• Category 2 application: an application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication.

• 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. For example, a change in the site of manufacture, a change to the synthetic route, a change in the product specifications, a change in the steps of manufacture or a change in trade name.

Figure 1: Number of approved Category 1 submissions by type for July to December 2016

Prescription medicine submissions may include a number of applications submitted at the one time. The data presented below relates to the number of submissions as this best reflects the evaluation and decision-making processes.



Table 1 Prescription medicine application approval time for July to December 2016

Approval time (TGA working days)

Application type

Submissions approved

Legislated timeframe

Mean Median Range

A: New chemical entity

Category 1 23 255 200 205 161-238

B: New fixed-dose combination

Category 1 4 255 201 204 179-218

C: Extension of indication

Category 1 20 255 199 206 147-238

D: New generic medicine

Category 1 53 255 177 161 124-253

E: Additional trade name (ATN)a

Category 1 1 255 237 237 N/A

ATN 14 45 29 30 13-42

F: Major variation

Category 1 24 255 188 195 134-224

G: Minor variationb

Category 1 N/A 255 N/A N/A N/A

Category 3 39 45 23 24 8-40

H: Minor variationc

Category 1 1 255 111 111 N/A

Category 3 626 45 23 22 1-49

J: Changes to product information requiring the evaluation of data

Category 1 30 255 142 138 65-212

a In July 2015, a legislated 45 working day process for ATN submissions commenced. During the current reporting period, submissions have been processed under both the Category 1 and ATN processes.

b The type G minor variations differ from type H minor variations in that they result in a new Australian Register of Therapeutic Goods (ARTG) entry.

c The minor variations (type H) included in the table above refer to applications to change the formulation, composition or design specification or the container for the goods or any other attribute that results in the goods being separate and distinct. These applications are typically ‘Category 3’ changes, unless the supporting scientific package contains non-clinical or clinical data in which case the application is a ‘Category 1’ application.

Further information about how prescription medicines are regulated in Australia can be found on the TGA website.

http://www.tga.gov.au/prescription-medicines-regulation-basics



2. Over-the-Counter medicines Over-the-Counter (OTC) medicine applications are categorised as new medicine (N) or change (C) applications and are further categorised by risk (N1 and C1 are lowest risk, N5 and C4 are highest risk).

Application category

Definition

N1 An application submitted as a ‘Clone’.

N2 An application which complies with an OTC medicine monograph.

N3 New application for a ‘generic’ medicine other than those ‘generic’ applications in levels N1, N2 or N4.

N4 An application for a ‘generic’ medicine where the medicine: • requires supporting safety and/or efficacy (clinical/toxicological) data

or a justification for not providing such data; and/or • requires a higher level of assessment due to the umbrella branding

segment of the product name; and/or • has not been previously registered as an OTC medicine following

down-scheduling. N5 An application for a new product that is an extension to a ‘generic category’

product or an application for a product containing a new chemical entity as an active ingredient.

C1 Quality and non-quality changes classified as ‘negligible risk’.

C2 Quality and non-quality changes classified as ‘low risk’ – no safety and/or efficacy data required; quality data may be required.

C3 Quality and non-quality changes classified as ‘low risk’ – safety and/or efficacy data required unless justified; quality data may be required. Umbrella branding segment of new name requires a higher level of assessment.

C4 Non-quality changes classified as ‘moderate risk’ – safety and/or efficacy data required unless justified.



Table 2 Over-the-Counter medicine application processing time for approved applications for July to December 2016

Total approved

Target approval

time (days)

Mean Median Range Percentage

within target

New medicine applications

N1 Lower risk

N2

N3

N4

N5 Higher risk

47 45 27 28 0-41 100

7 55 42 43 37-47 100

9 150 66 68 16-123 100

8 170 86 74 67-124 100

6 210 183 193 138-196 100

Change applications

C1 Lower risk

C2

C3

C4 Higher risk

218 20 9 8 0-29 95

121 64 18 10 0-62 100

7 120 30 14 10-107 100

1 170 86 86 86-86 100

Further information about how OTC medicines are regulated in Australia can be found on the TGA website.

3. Complementary medicines 3.1. Registered complementary medicines Table 3 Number of approved registered complementary medicine applications

2015 2016

Jul-Dec Jul-Dec

New registered medicines 2 4

Variation to registered medicines 14 11

Further information about how registered complementary medicines are regulated in Australia can be found on the TGA website.

3.2. Listed complementary medicines Table 4 Number of new ingredients permitted for use in listed medicines

2015 2016

Jul-Dec Jul-Dec

New permitted ingredients 14 50

http://www.tga.gov.au/australian-regulation-over-counter-medicines

https://www.tga.gov.au/registered-complementary-medicines



Table 5 Number of new listed medicines

2015 2016

Jul-Dec Jul-Dec

New listed medicines 919 754

Table 6 Number of listed medicine reviews by type

2015 2016

Jul-Dec Jul-Dec

Reviews initiated

Random reviews 197 0

Targeted reviews 89 235

Total 286 235

Reviews completed

Random reviews 153 83

Targeted reviews 67 168

Total 220 251

Table 7 Number of completed listed medicine reviews by outcome

2015 2016

Jul-Dec Jul-Dec

Compliance status determined

Medicines with no compliance breaches 53 43

Medicines with verified compliance breaches 136 167

Sub-total 189 210

Compliance status unable to be determined

Medicines cancelled by sponsors after request for information

20 8

Medicines not yet manufactured or information unavailable

9 33

Other 1 0

Sub-total 30 41

Product not a therapeutic good 1 0

Total completed 220 251

Further information about how complementary medicines are regulated in Australia can be found on the TGA website.

http://www.tga.gov.au/overview-regulation-complementary-medicines-australia



4. Biologicals Blood, blood components, plasma derivatives, tissue and cellular products, tissue and cell based derivatives, and other emerging biological therapies are regulated under the Therapeutic Goods Act 1989.

Table 8 Number of completed biological applications

2015 2016

Jul-Dec Jul-Dec

Technical Master File (TMF) new 0 1

TMF annual updates 2 5

TMF variations 4 7

TMF notifications 2 7

Plasma Master File annual updates 8 8

Biological Class 2 – new applications 4 0

Biological Class 3 – new applications 0 1

Biological Class 2 – variations 9 10

Biological Class 3 – variations 1 0


Further information about how biological products are regulated in Australia can be found on the TGA website.

https://www.tga.gov.au/publication/australian-regulatory-guidelines-biologicals-argb



5. Medical devices The regulatory framework for medical devices spans the life cycle of these products, including conformity assessment, inclusion on the ARTG and post-market monitoring.

Table 9 Number of completed applications and processing time for conformity assessments of medical devices (including in vitro diagnostic medical devices (IVDs))

2015 2016

Jul-Dec Jul-Dec

New devices


Percentage processed within target processing timeframes

100% 100%

Mean TGA processing time (working days) 137 118

Median TGA processing time (working days) 178 133

Changes or recertification


Percentage processed within target processing timeframes

100% 100%

Mean TGA processing time (working days) 83 100

Median TGA processing time (working days) 57 76

The TGA is required to complete conformity assessment applications within 255 working days.

Table 10 Number of completed applications for inclusion of medical devices and IVDs on the ARTG

2015 2016

Jul-Dec Jul-Dec

Class I medical devices 1,317 1,209

Class I measuring medical devices 19 25

Class I sterile medical devices 124 136

Class IIa medical devices 619 642

Class IIb medical devices 386 345

Class III medical devices 130 228

Class III Joint Reclassification medical devices 209 114

Active Implantable Medical Devices (AIMD) 7 56

Class 1 IVDs 71 41

Class 2 IVDs 94 38

Class 3 IVDs 107 21

Class 4 IVDs 20 6

https://www.tga.gov.au/medical-devices-ivds



Table 11 Number of application audits completed and processing time for medical devices and IVDs for July to December 2016

Total completed

Processing time

Mean Median

Medical devices

Auto-included applicationsa 1,209

Applications completed without audit 1,091b 4 3

Non-compulsory auditsc 172 57 22

Level 1 compulsory audits 25 12 11

Level 2 compulsory audits 258 171 175

IVDs

Auto-included applicationsa 34

Applications completed without audit 32b 5 4

IVD non-compulsory audit 5 72 54

IVD compulsory audit 35 51 40

a Class I and Class 1 IVDs are automatically included medical devices and are not subject to audits before inclusion. Separate post-market monitoring is undertaken for these goods.

b These figures do not include applications for Class I and Class 1 IVD auto-included devices. These applications are completed within 20 working days.

c Non-compulsory audit – estimate for the audit processing time does not include applications for reclassification of joint replacement medical devices received during transitional period (Class III Joint Reclassification medical devices), and applications supported by European Community certificates issued by certain notified bodies (for details see Increased application audit requirements for some medical devices applications).

6. Exports Table 12 Number of completed applications for export-only medicines and export

certifications and relevant processing time for July to December 2016

Total completed

Target processing time (days)

Mean Median

Export-only medicines

New application 117 30 24 28

Variation 36 30 22 23

Export certificates

Medicine applications 715 15 12 12

Medical device assessments 255 5 5 4

Completed applications include applications that were approved and withdrawn.

https://www.tga.gov.au/increased-application-audit-requirements-some-medical-devices-applications



7. Access to unapproved therapeutic goods 7.1. Special Access Scheme Table 13 Number of completed applications and notifications for the Special Access

Scheme

2015 2016

Jul-Dec Jul-Dec

Medicines

Category A 20,688 20,194

Category B 9,583 10,377

Medical devices

Category A 1,960 2,832

Category B 993 979

Biologicals

Category A 22 6

Category B 1,500 1,091

Further information about the Special Access Scheme can be found on the TGA website.

7.2. Authorised prescribers Table 14 Number of authorised prescriber approvals for medicines and medical

devices

2015 2016

Jul-Dec Jul-Dec

Medicines 297 391

Medical devices 121 177

Further information about authorised prescribers can be found on the TGA website.

https://www.tga.gov.au/form/special-access-scheme

https://www.tga.gov.au/form/authorised-prescribers



7.3. Clinical trials Table 15 Number of notifications for new clinical trials received by therapeutic good

type for July to December 2016

2015 2016

Jul-Dec Jul-Dec

Medicine only 244 197

Medical device only 65 71

Biological only 9 3

Medicine and medical device 132 127

Medical device and biological 5 1

Medicine and biological 9 11

Medicine, medical device and biological 5 7

Total 469 417

Table 16 Number of notifications for new clinical trials received by phases for July to December 2016

2015 2016

Jul-Dec Jul-Dec

Phase 1 98 72

Phase 1 and 2 in combination N/Aa 11

Phase 2 110 82

Phase 2 and 3 in combination N/Aa 4

Phase 3 155 113

Phase 4 71 41

Bioavailability / equivalence 16 13

Other phases in combination N/Aa 25

None specified 72 0

Device only N/Aa 56

a This information was not separately captured at this time.

It should be noted that a trial may be notified with more than one phase type.

Further information about clinical trials can be found on the TGA website.

https://www.tga.gov.au/clinical-trials



8. Licensing and manufacturing

Number of manufacturing inspections by outcome Table 17A Medicines and Blood, Tissue and Cellular Therapies

2015 2016

Jul-Deca Jul-Decb

Outcomes of inspections of Australian manufacturers

Number of inspections conducted 114 74

Satisfactory compliance (of completed inspections) 63%a 82%b

Marginal compliance (of completed inspections) 18%a 16%b

Unacceptable (of completed inspections) 1%a 2%b

Close-out in progress 18%a 16%

Processing time

Initial inspections conducted within 3 months of application 59% 75%

Re-inspections conducted within 6 months of due date 54% 70%

Outcomes of inspections of overseas manufacturers

Number of inspections conducted 35 30

Satisfactory compliance (of completed inspections) 60%a 96%b

Marginal compliance (of completed inspections) 3%a 4%b

Unacceptable (of completed inspections) 3%a 0%b

Close-out in progress 34%a 17%

Processing time

Initial certification inspections conducted within 6 months of application

25% 50%

Certification re-inspections conducted within 6 months of due date

70% 58%

a Previous reports excluded inspections that had been conducted during the reporting period but had not yet been closed out. To ensure we report on all activities conducted by the TGA the report for the July to December 2015 reporting period was adjusted. The sum of percentages in this column is 100%.

b Compliance data for this period is aligned with data reported for the 2015-16 financial year and excludes ‘Close-out in progress’ in calculation of percentages i.e. the percentages reported are limited to those inspections that are completed. Analysis of historical data shows that when these inspections are completed, the percentages tend to remain consistent.

Applicants often submit applications for GMP licences and certifications before finalising all of their systems and processes. The TGA works with the applicant to ensure an inspection is not conducted before the manufacturing facility is ready, as this may result in an adverse outcome. It is therefore not uncommon for inspections to be conducted later than the target dates.



Table 17B Devices

2015 2016

Jul-Dec Jul-Dec

Quality Management System (QMS) Audits (domestic manufacturers)

Number of audits conducted 21 18

Satisfactory compliance (of completed audits) 47% 39%

Marginal compliance (of completed audits) 5% 22%

Unacceptable (of completed audits) 0% 0%

Close-out in progress 48% 39%

Processing time

Initial audits conducted within 3 months of application 33% 33%

Re-audits conducted within 6 months of due date 22% 27%

QMS Audits (overseas manufacturers)

Number of audits conducted 9 13

Satisfactory compliance (of completed audits) 11% 69%

Marginal compliance (of completed audits) 0% 0%

Unacceptable (of completed audits) 0% 0%

Close-out in progress 89% 31%

Processing time

Initial certification audits conducted within 6 months of application

43% 43%

Certification re-audits conducted within 6 months of due date

0% 84%

The Device Conformity Assessment Section (DCAS) receives applications for Conformity Assessment Certification and conducts assessment of these applications. It may be determined that the Quality Audits and Assessment Section is required to conduct an audit of one or more manufacturers included in the Conformity Assessment Application. The timeframes used above for calculation of conduct audits are from the date of notification from DCAS.

Table 18 Number of GMP clearance applications

2015 2016

Jul-Dec Jul-Dec

Applications received 2,100 2,458

Applications completed

Approved 2,819 2,619

Rejected 156 166

Total completed 2,975 2,785

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



9. Laboratories Table 19 Number of samples tested by type of therapeutic good and percentage

which failed for the period July to December 2016

2015 2016

Jul-Dec Jul-Dec

Product type Total % fail Total % fail

Prescription medicines 408 0.5% 603 1.3%

OTC medicines 30 10% 30 23.3%

Complementary medicines 54 16.7% 41 22.0%

Medical devices 63 30.2% 112 30.4%

Contracta 7 71.4% 14 85.7%

Unregisteredb 165 84.2% 97 63.9%

Total samples (excluding AHQ samples) 727 24.2% 897 14.7%

Total samplesc 983 19.8% 1,229 11.0%

Total number of products testedd 370 - 325 -

a Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices. b Unregistered refers to products that meet the definition of therapeutic goods but are not included on the ARTG or

otherwise specifically exempted from this requirement in the legislation. This often includes adulterated complementary medicines or counterfeit products.

c Includes accreditation, harmonisation and quality control (AHQ) samples. d The TGA may test a number of samples of each product per reporting period.



10. Medicine and Vaccine Adverse Event Reporting Table 20 Source of notifications of medicine and vaccine adverse reaction

2015 2016

Jul-Dec Jul-Dec

Reports with clear causality, by reporter

Hospitals 1,178 919

Companies 4,566 4,952

General practitioners 272 270

Specialists 101 178

Pharmacists 469 489

Members of the public (consumers) 333 493

Nurses, dentists, complementary healthcare practitioners

91 74

State/Territory Health departments 1,044 1,264

Unregistered online reporters N/Aa 64

Reports rejected or without clear causality

443 1,165

Total received 8,497 9,868

Mean number of reports received weekly 326 379

Vaccine reports included in above table 1,302 1,637

a Data not reported for this period.

11. Medical device incident reports Processing time is defined as the number of working days from receipt of the notification until the incident has been investigated and resolved.

Table 21 Number of completed medical device incident reports and processing time

2015 2016

Jul-Dec Jul-Dec

Reports completed 1,969 2,100

Mean TGA processing time 6 7

Percentage processed within target timeframe 93% 94%

The target timeframe for processing of medical device incident reports is 90 working days.



12. Regulatory compliance Table 22 Number of products investigated for compliance issues by product type

2015 2016

Jul-Dec Jul-Dec

Complementary medicines 216 225

Prescription medicines 648 1,748

Medical devices 46 46

Homoeopathic medicines 2 22

OTC medicines 17 12

Biological products 30 14

Other 31 26

Total 990 2,093

Table 23 Number of completed regulatory compliance investigations by final action taken

2015 2016

Jul-Dec Jul-Dec

Warneda 353 449

No offence detected 42 20

Goods released under Personal Import Scheme 119 293

Referred to another agency or department outside Health 6 4

Referred to another Branch within the TGA 4 4

Filed for intelligence purposes 0 12

Finalised in a linked file 0 6

Import treated as abandoned goods by Customs 0 0

Recall of goods 0 1 Matters referred to the Commonwealth Director of Public Prosecutions

1 0


a The category “warned” could incorporate goods being destroyed as prohibited imports, allowed to re-export goods or compliance actions against companies or individuals.



Table 24 Number of regulatory compliance investigations by offence categorya

2016

Jul - Dec

Import 1,434

Supply 66

Claims 5

Manufacture 5

Export 2

Forgery 1

Total completed 1,513

a Reporting against these specific categories commenced in July 2016.

Table 24 shows the number of investigations by offence category. The correlation between tables 22 and 24 shows for example, an offense category of import could include multiple products captured in table 22.

13. Recalls Table 25 Number of therapeutic goods recalls

2015 2016

Jul-Dec Jul-Dec

Medicines 31 16

Medical devices (including IVDs) 291 301

Biologicals 0 2

Bloods 95 55

Total recalls 417 374

Analysis of outcomes for blood-related recalls for the previous ten reporting periods shows activity is now returning to normal levels.



Version history Version Description of change Author Effective date

V1.0 Original publication Reporting and Collaboration Services

March 2017

Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6203 1605 https://www.tga.gov.au

Reference/Publication D17-97057

mailto:[email protected]

https://www.tga.gov.au/

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