Annual performance statistics report: July 2018 to June 2019

21 October 2019
picture of report cover

About the Therapeutic Goods Administration

The Australian Government Department of Health, through the Therapeutic Goods Administration (TGA) is responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose.

Products for which therapeutic claims are made are assessed by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added during the reporting period. All therapeutic goods registered on the ARTG can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from retail outlets
  • complementary medicines, such as 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 (IVDs), such as blood tests
  • vaccines, blood products, and other biologics.

We play a regulatory role in overseeing the manufacturing process and advertising of therapeutic goods. We support compliance with the regulatory framework, working with state, territory and federal counterparts to remove unsafe/non-compliant therapeutic goods from the Australian market.

More information about how therapeutic goods are regulated in Australia can be found on our website.

Executive summary

Each year we provide information about our regulatory performance through the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance against the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.

The statistics contained within this report cover the period 1 July 2018 to 30 June 2019, and contribute to annual publications that track our progress against the priorities we have established for the financial year.

Performance highlights

Key observations for 2018-19 are summarised below, including trends and notable changes from previous reporting periods.

As part of our 2018-19 activity, we have continued to implement the Australian Government's Response to the Review of Medicines and Medical Devices Regulation (MMDR). Following the passage of amendments to the Therapeutic Goods Regulations 1990 that follow on from commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 and Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018, this reporting period now includes new data sets in relation to:

  • advertising compliance and enforcement
  • medicine shortages/discontinuations reporting
  • overseas regulator conformity assessment documents for medical devices
  • patient information leaflet and patient implant card for permanently implantable devices
  • work sharing with Comparable Overseas Regulators.

Also, new information about other reforms and programs implemented during this reporting period relate to:

  • autologous human cells and tissues (HCT) therapies
  • laboratory testing.

Reforms

Prescription medicines

  • Consistent with the intent of the MMDR, we also initiated and publicly consulted on possible reforms to the registration process for generic medicines.

Over-the-counter medicines

  • The total number of new medicine applications received was lower than in 2017-18. This was due to a significant decrease in the number of lower risk N1 applications received. There was an increase in the numbers of all other new medicines application categories (N2, N3, N4 and N5).
  • The total number of applications received to vary existing medicines increased substantially, by approximately 25%. The number of negligible risk (CN and C1) applications increased slightly and there was a significant increase in the number of low risk variation (C2) applications. This increase in the number of C2 applications was largely due to receipt of applications for changes to labelling for compliance with the Labelling Order (Therapeutic Goods Order No. 92). The numbers of higher risk variation (C3 and C4) applications were consistent with previous years.
  • Median approval times for the majority of new medicine application categories were longer than in 2017-18, but were consistent with previous years. Median approval times for higher risk variation (C2, C3, and C4) applications were longer than in 2017-18. This increase in median approval times can be attributed to the increase in numbers of N2, N3 and N4 applications and the large increase in the number of C2 applications received.
  • For all application categories, the percentage of applications processed within target time was more than 80%, with many application categories at or close to 100%.

Listed medicines

  • There was an increase in the number of new listed medicines that were entered into the ARTG this year (1,893) compared to last year (1,792).
  • Permitted indications for complementary medicines were introduced in March 2018 following the MMDR review. There were no applications finalised in 2017-18.
  • The new pathway for assessed listed medicines was introduced in March 2018 following recommendation from the MMDR review. There have been no applications received via this pathway as at 30 June 2019.
  • The number of applications for variations under section 9D(1) of the Act has significantly increased this year (from 96 in 2017-18 to 144 in 2018-19). This is likely due to sponsors reviewing a large number of existing entries in anticipation of transitioning to permitted indications.

Work sharing with overseas regulators

  • The Australia-Canada-Singapore-Switzerland (ACSS) Consortium's work sharing pilot on New Chemical Entities is a unique global collaboration between regulatory authorities and the pharmaceutical industry. The ACSS Consortium is a collaborative initiative of medium-sized regulatory authorities between the TGA, Health Canada, Singapore's Health Sciences Authority and the Swiss Agency for Therapeutic Products. Regulators undertake a single assessment for new products that will support regulatory decision-making within each jurisdiction.
  • This partnership is benefiting the community by improving access to the most recent and innovative treatment options. In 2018-19, this initiative has resulted in three new medicines - apalutamide (Erlyand®), abemaciclib (Verzenio®) and niraparib (Zejula®) receiving market approval in Australia and Canada.
  • The ACSS partnership maximises the use of up-to-date technical expertise and brings greater alignment of regulatory approaches, technical requirements, knowledge sharing and better use of resources. While also facilitating cooperation and collaboration, reductions in duplication, and increases each regulators capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

Biologicals

  • Major reforms were introduced to increase the oversight of autologous human cell and tissue, such as stem cell clinics. The number of new and variation applications for biologicals has stabilised. The first Class 4 biological product (CAR-T cells) was approved.

Medicine and vaccine adverse event reports

  • A new Adverse Event Management System was introduced in June 2018. Due to differences in the way adverse event report data is recorded in the new system, the data included in this report is not directly comparable to previous reports.
  • During this period, we received a total of 24,016 medicine and vaccine adverse reaction reports (4,225 reports related to vaccines). The mean number of reports received by the TGA weekly was 462. Of the accepted cases, 62% (13,874) were submitted by pharmaceutical companies and 20% (4,415) were made by health professionals. The most prolific reporters among health professionals were pharmacists (including hospital pharmacists) with 1,918 reports submitted.

Medical device conformity assessment

  • The target timeframes for the processing of conformity assessment applications were met, with continual focus on process improvement. The number of conformity assessment applications received decreased while the number of applications completed was comparable with the same reporting period in 2017-18.

Medical device incident reports

  • The number of medical device adverse event reports increased by 10% in 2018-19 compared to the previous year (5,874 reports). This increase can be attributed to ongoing media and public attention about medical devices, continued education of health professionals on the value of reporting adverse events, and improved sponsor reporting compliance.
  • Class I medical device reviews have increased since the introduction of fees to include these devices on the ARTG. A streamlined internal review process has resulted to ensure that the throughput is minimised.

Medicines and biologicals manufacturing

  • There was a notable increase in the number of overseas inspections being undertaken within six months of manufacturers making application for initial inspections, from 68% in 2017-18 to 86% in 2018-19; and within six months of the due date for re-inspections, from 66% to 85%. This is due to manufacturers being ready for inspection and the prioritisation of these inspections within the target timeframe. The number of both local and overseas manufacturers with an unacceptable compliance rating has reduced. Notably, no inspections of overseas manufacturers completed in this period found manufacturers that had unacceptable compliance.
  • Demand for Good Manufacturing Practice (GMP) clearances remained high with 6,628 applications received, however it is noted that a change in reporting method from 2017-18 now captures additional application types, such as extensions, which were not previously captured.

Recalls

  • Overall, the total number of recall actions remained similar to that of the last financial year.
  • There has been a significant increase (25%) for recall actions performed for in vitro diagnostic devices (IVDs).
  • Medicine consumer level recall actions have increased, from 8 to 13.
  • The new provision in the updated Uniform Recall Procedure for Therapeutic Goods (URPTG) pertaining to 'consumer recall notices' largely negates the previous mandatory requirement for costly print media advertising. This has also allowed for customisation in sponsors' communication to consumers regarding 'open seller products' via social media platforms and utilisation of their own websites, in addition to notices published by the TGA and in some cases the Australian Competition and Consumer Commission (ACCC).

Laboratory testing

  • In 2019 the TGA started the periodic publication of more detailed reports related to specific testing projects. One such report related to a survey of microwaveable grain-filled heat packs to assess the safety and performance of products available on the Australian market. Another report related to testing of a range of human insulin products to compare the quality and content of products obtained directly from sponsors against those available in pharmacies. These reports provide consumers with additional context and detail.

Medicine shortages/discontinuations

  • The Medicine Shortages Information Initiative was established to allow a more transparent and responsive approach to the management of medicine shortages and discontinuations.
  • From 1 January 2019, it has been mandatory for sponsors to report shortages or discontinuations of all prescription medicines and some over the counter medicines to the TGA. This has resulted in a very significant increase in reports.
  • All shortages deemed to be of critical patient impact are published, but sponsors are encouraged to publish information about all shortages on the TGA Medicine Shortages website.
  • The compliance framework in relation to the reporting obligations under the reporting scheme came into effect on 1 July 2019.
  • Where necessary, the TGA can work with sponsors to allow for the import and supply of overseas products to assist with a medicine shortage in Australia under Section 19A of the Therapeutic Goods Act 1989.

Processing and approval times

Processing and approval times are defined as the number of working days from the acceptance of an application until formal notification of decision, unless otherwise specified. These exclude times where we were unable to progress the application due to waiting for:

  • the sponsor to provide additional information;
  • the payment of fees was received; or
  • a 'mutual clock stop' period, agreed with the applicant or unless otherwise specified.

Under the Act, TGA working days also excludes public holidays and weekends. The timeframes applicable to many of our activities are mandated by legislation. For other activities we conduct we self-impose target timeframes, to ensure that we perform our functions efficiently and in a timely manner. Target timeframes are subject to ongoing review.

1. Prescription medicines

Applications to register new or vary existing prescription medicines are accompanied by supportive scientific data and evaluated, with timeframes underpinned by legislation and/or associated business rules.

The framework for prescription medicines includes the following categories which are subject to legislated and/or target timeframes:

Application category Description Timeframe in working days
Category 1 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.

Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment and 255 working days for the completion of the evaluation and notification of the decision.

The priority review pathway (applicable to Category 1 applications only) has the same statutory timeframe as other Category 1 applications, but the target timeframe is 150 working days.

Category 2 An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication. Legislated timeframe: 20 working days for notification of whether the application has passed preliminary assessment and 175 working days to notify the applicant of the decision.

Comparable Overseas Regulator (COR) report-based process

(from 1 January 2018)

An application accompanied by an un-redacted assessment report package from a comparable overseas regulator.

Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment. The timeframe to notify the applicant of the decision depends on the COR pathway:

  • COR-A[a]: 120 working days
  • COR-B[a]: 175 working days
Category 3

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, broader changes to the product specifications, manufacturing and labelling or a change in trade name.

Legislated timeframe: 45 working days to notify the applicant of the decision.
Correction to, or completion of, a Register entry

An application to vary the registration of a prescription medicine to correct or complete information that was inadvertently recorded incorrectly or omitted from the Register entry.

For example, errors to product information, or quality-related documentation.

No legislated timeframe: TGA processes as soon as possible.
Safety-related request (SRR)

An application to vary the registration of a prescription medicine to either:

  • reduce the patient population that can receive the medicine or
  • add a warning or precaution.
No legislated timeframe: TGA processes as soon as possible.
Notification request to vary an ARTG entry

An application to vary the registration of a prescription medicine, where the application has been determined to pose a very low risk under certain conditions.

For example, the removal of a redundant manufacture site.

No legislated timeframe: automatic approval on submission of e-form and full payment of fee.
Self-assessable request (SAR)

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 and
  • where no data are necessary or where the data can be self-assessed by the applicant.

For example, certain changes to the pack size or approved product label.

Legislated timeframe: 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.
Additional trade name An application for an additional trade name for a registered prescription medicine. Legislated timeframe: 45 working days.

Footnotes


1.1. Submission outcomes

Table 1 Number of completed prescription medicine submissions by type and outcome for July 2018 to June 2019
Number
Application Type Approved Withdrawn Rejected Total (% Approved)
Category 1
A: New chemical entity/New biological entity/Biosimilar 34 3 0 37 (92%)
B: New fixed-dose combination 6 0 0 6 (100%)
C: Extension of indication 50 4 2 56 (89%)
D: New generic medicine 77 8 2 87 (89%)
F: Major variation 72 2 0 74 (97%)
G: Minor variation[a] 3 0 0 3 (100%)
H: Minor variation[b] 2 0 0 2 (100%)
J: Changes to Product Information 101 0 0 101 (100%)
Comparable Overseas Regulator (COR) - A
C: Extension of indication 3 0 0 3 (100%)
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 1 0 0 1 (100%)
B: New fixed-dose combination 1 0 0 1 (100%)
F: Major variation 1 0 0 1 (100%)
Minor Variations
Category 3
G: Minor variation[a] 131 3 0 134 (98%)
H: Minor variation[b] 1276 17 0 1293 (99%)
Additional trade name [ATN] 36 1 0 37 (97%)
Extension of Indications - Generic 7 0 0 7 (100%)
Safety-related request [SRR] 938 15 0 953 (98%)
Self-assessable request [SAR] 945 15 0 960 (98%)
Minor editorial change [MEC] 125 5 0 130 (96%)
Correction [9D(1)] 168 9 0 177 (95%)
Notification 1471 2 0 1473 (99.9%)
Total 5548 84 4 5536 (98%)

Footnotes


In accordance with the legislation, registered medicines must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, approval may be sought to supply a product when it doesn't meet a particular standard.

Table 2 Number of other prescription medicine applications
2017-18 2018-19
July to June
Exemptions to comply with a standard [S.14] Number (% of Total)
Approved 67 (100%) 62 (98%)
Rejected 0 1 (2%)
Total (excluding withdrawals) 67 (100%) 63 (100%)
Figure 1 Submissions received 2017-18 and 2018-19 – total amount and % of total[a]
A - New chemical entity/New biological entity/Biosimilar: 2017-18 - 39 (11%); 2018-19 - 36 (10%); C - Extension of indication: 2017-18 - 58 (17%); 2018-19 - 60 (16%); D - New generic medicine: 2017-18 - 91 (27%); 2018-19 - 83 (23%).

Footnotes


Figure 1 Submissions received 2016-17 and 2017-18
Application type Jul 17 - Jun 18 Jul 18 - Jun 19
A - New chemical entity/New biological entity/Biosimilar 39 (11%) 36 (10%)
C - Extension of indication 58 (17%) 60 (16%)
D - New generic medicine 91 (27%) 83 (23%)

1.2. Approval times

Table 3 Prescription medicine application approval time for July 2018 to June 2019
Approval time (TGA working days)
Application type Legislated timeframe Mean Median Range
Category 1
A: New chemical entity/New biological entity/Biosimilar[a] 255 204 202 141 - 249
B: New fixed-dose combination 255 208 198 190 - 246
C: Extension of indication[b] 255 198 197 130 - 253
D: New generic medicine 255 181 170 96 - 254
F: Major variation 255 189 194 67 - 253
G: Minor variation 255 200 223 139 - 239
H: Minor variation 255 81 81 59 - 102
J: Changes to Product Information requiring the evaluation of data 255 134 141 4 - 249
Comparable Overseas Regulator (COR) - A
C: Extension of indication 120 50 40 36 - 74
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 175 172 172 172 - 172
B: New fixed-dose combination 175 161 161 161 - 161
F: Major variation 175 146 146 146 - 146

Footnotes


Table 4 Prescription medicine median approval time comparisons
Median approval time (TGA working days)
Application type Legislated timeframe 2017-18 2018-19
(% Change)
Category 1
A: New chemical entity/New biological entity/Biosimilar[a] 255 210 202 (▼4%)
B: New fixed-dose combination 255 192 198 (▲3%)
C: Extension of indication[b] 255 194 197 (▲2%)
D: New generic medicine 255 174 170 (▼2%)
F: Major variation 255 196 194 (▼1%)
G: Minor variation 255 250 223 (▼11%)
H: Minor variation 255 164 81 (▼51%)
J: Changes to Product Information requiring the evaluation of data 255 148 141 (▼5%)
Comparable Overseas Regulator (COR) - A
C: Extension of indication 120 n/a 40
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 175 n/a 172
B: New fixed-dose combination 175 n/a 161
F: Major variation 175 n/a 146
Minor Variations
Category 3
G: Minor variation[c] 45 39 40 (▲3%)
H: Minor variation[d] 45 32 36 (▲13%)
Additional trade name [ATN] 45 27 41 (▲52%)
Safety-related request [SRR] N/A 32 36 (▲9%)
Self-assessable request [SAR] 45 33 38 (▲15%)
Minor editorial change [MEC] 45 26 30 (▲15%)
Correction [9D(1)] N/A 56 56

Footnotes


Figure 2 Mean approval times for standard Category 1 submissions 2017-18 and 2018-19
A - New chemical entity: 2017-18 - 208; 2018-19 - 204; C - Extension of indication: 2017-18 - 191; 2018-19 - 198; D - New generic medicine: 2017-18 - 182; 2018-19 - 181
Figure 2 Mean approval times for standard Category 1 submissions 2017-18 and 2018-19
Application type 2017-18 data 2018-19 data
A - New chemical entity 208 204
C - Extension of indication 191 198
D - New generic medicine 182 181
Figure 3 Median approval times for standard Category 1 submissions 2017-18 and 2018-19
A - New chemical entity: 2017-18 - 210; 2018-19 - 202; C - Extension of indication: 2017-18 - 194; 2018-19 - 197; D - New generic medicine: 2017-18 - 174; 2018-19 - 170
Figure 3 Median approval times for standard Category 1 submissions 2017-18 and 2018-19
Application type 2017-18 data 2018-19 data
A - New chemical entity 210 202
C - Extension of indication 194 197
D - New generic medicine 174 170

1.3. Orphan drug destinations

The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to Australian patients who may not otherwise be able to access them. The program incentive is a 100% waiver of TGA fees for application and registration. Designation is a formal process that allows us to make a decision regarding whether a medicine is eligible for orphan drug designation. This precedes the registration application. The eligibility criteria aim is to focus the program on the greatest unmet need. A prescription medicine must have a valid orphan drug designation at the time of application to be eligible for a waiver of application and evaluation fees.

Table 5 Number of orphan drug designations
2017-18 2018-19
July to June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 13 (81%) 16 (67%)
C: Extension of indications 2 (12%) 7 (29%)
F: Major variation 1 (6%) 1 (4%)
Total 16 (100%) 24 (100%)

Orphan drug registrations and approval times quoted in Table 6 are also included in the total number of applications reported in each respective application category in the tables and figures below.

Table 6 Number of orphan drug registrations
2017-18[a] 2018-19
July to June
Application Type Number Approved
(% of Total)
Median approval time (TGA working days) Number Approved
(% of Total)
Median approval time (TGA working days)
A: New chemical entity/New biological entity/Biosimilar 9[b] (43%) 213 8[c] (36%) 163
C: Extension of indications 10 (48%) 198 7 (32%) 212
F: Major variation 2 (9%) 185 7 (32%) 194
Total 21[b] (100%) 197 22[c] (100%) 190

Footnotes


1.4. Priority review pathway

The priority review pathway supports patient access to vital and lifesaving prescription medicines months earlier than through the standard pathway. Priority review involves the same amount and type of evidence as the standard review process. The same standards for quality, safety and efficacy apply as under the standard process. The flexible approach we take on priority applications is much more resource intensive than the standard pathway. The pathway is reserved only for medicines that represent a major therapeutic advance. The determination process is used to assess whether a medicine is eligible for the priority pathway but does not necessarily mean that the medicine will be approved after evaluation and registered on the ARTG.

Table 7 Number of priority review determinations granted
2017-18 2018-19
July - June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 4 (29%) 6 (67%)
C: Extension of indications 10 (71%) 3 (33%)
Total 14 (100%) 9 (100%)
Table 8 Number of medicines approved through the priority review pathway[a]
2017-18 2018-19
July to June
Application Type Number Approved (% of Total) Median approval time (TGA working days) Number Approved (% of Total) Median approval time (TGA working days)
A: New chemical entity/New biological entity/Biosimilar 1 (20%) 104 3 (27%) 129
C: Extension of indications 4 (80%) 97 8 (73%) 121
Total 5 (100%) 98 11 (100%) 122

Footnotes


1.5. Provisional approval pathway

The provisional approval pathway supports patient access to vital and lifesaving prescription medicines years earlier than through the standard pathway. Time limited approval through the provisional pathway is on the basis of the evaluation of preliminary clinical data where there is the potential for a substantial benefit to Australian patients. Knowledge of the risks and benefits of these medicines is less certain than for other approved prescription medicines. Provisional approval is granted for promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

A prescription medicine must have a valid provisional determination before it can be evaluated for registration under the provisional approval pathway. The determination process is used to assess whether a medicine is eligible for the provisional pathway but does not necessarily mean that the medicine will be approved after evaluation and provisionally registered on the ARTG.

Table 9 Number of provisional determinations granted
2017-18[a] 2018-19
July - June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 1 (50%) 4 (44%)
C: Extension of indications 1 (50%) 5 (56%)
Total 2 (100%) 9 (100%)

Footnotes


1.6. Pathway comparison

Table 10 Number of medicines[a] approved via each pathway
2017-18 2018-19
July - June
Number (% of Total)
Pathway
Priority Review 5 (4%) 11 (7%)
Comparable Overseas Regulator (COR) - A 0 3 (2%)
Comparable Overseas Regulator (COR) - B 0 3 (2%)
Standard 115 (96%) 135 (89%)
Total 120[b][d] (100%) 152[c][d] (100%)

Footnotes


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 low risk, N5 and C4 are highest risk). The OTC application categorisation framework outlined on the following page defines the different OTC medicine application levels and the key application criteria.

Table 11 Categorisation of OTC medicine applications
Application category Definition Timeframe in days
N1 An application submitted as a 'clone'. 45 working days
N2 An application which complies with an OTC medicine monograph. 55 working days
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4. 150 working days
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.
170 working days
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. 210 working days
CN

'Notification' changes, where their implementation would not impact the quality, safety or efficacy of a medicine. Includes quality and non-quality changes classified as 'negligible risk'.

- Implemented 1 July 2017

N/A

(Automated validation and approval)

C1 Quality and non-quality changes classified as 'negligible risk'. 20 working days
C2 Quality and non-quality changes classified as 'low risk' - no safety and/or efficacy data required; quality data may be required. 64 working days
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.

120 working days
C4 Non-quality changes classified as 'moderate risk' - safety and/or efficacy data required unless justified. 170 working days
B1 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data. 20 working days
B3 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed. 120 working days
Requests for consent under section 14/14A of the Act Request for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. N/A

2.1. Approval times

We aim to have 80% of applications completed within target timeframes. The following target timeframes apply to OTC medicine applications:

Table 12 Median approval time for OTC medicine applications
2017-18 2018-19
July to June
New medicine applications (days)
N1 25 30
N2 35 48
N3 74 95
N4 55 97
N5 162 121
Change applications (days)
C1 4 4.5
C2 31 36
C3 72 84
C4 95 109
Table 13 OTC medicine approval time against target time by application category for July 2018 to June 2019
Application type Number completed (% of Total) Range Mean Median % within target
New medicines
N1 129 (58%) 0-66 29 30 87
N2 18 (8%) 28-55 45 48 100
N3 52 (24%) 8-188 92 95 94
N4 13 (6%) 18-217 101 97 85
N5 9 (4%) 81-198 126 121 100
Total 221 (100%)
Change applications
C1 182 (25%) 0-88 7 4.5 96
C2 549 (74%) 0-121 37 36 89
C3 8 (1%) 33-214 87 84 88
C4 2 (0.2%) 82-136 109 109 100
Total 741 (100%)

2.2. Applications

2.2.1 New OTC medicine applications

Table 14 Applications received for new OTC medicines and changes to existing medicines
2017-18 2018-19
July to June
Number (% of Total)
New medicine applications
N1 169 (60%) 100 (40%)
N2 16 (6%) 18 (7%)
N3 64 (23%) 70 (28%)
N4 23 (8%) 39 (16%)
N5 8 (3%) 23 (9%)
Total 280 (100%) 250 (100%)
Change applications
CN 171 (21%) 197 (18%)
C1 190 (24%) 197 (18%)
C2 438 (54%) 675 (62%)
C3 7 (0.8%) 7 (0.6%)
C4 3 (0.4%) 6 (0.6%)
Total 809 (100%) 1082 (100%)

2.2.2 Completed applications

Table 15 New OTC medicine applications completed and outcomes
2017-18 2018-19
July to June
Number (% of Total)
N1
Approved 144 (96%) 129 (98%)
Rejected 0 0
Withdrawn by sponsor 7 (4%) 3 (2%)
Returned/failed screening 0 0
Total 151 (100%) 132 (100%)
N2
Approved 5 (45%) 18 (82%)
Rejected 0 0
Withdrawn by sponsor 6 (55%) 4 (18%)
Returned/failed screening 0 0
Total 11 (100%) 22 (100%)
N3
Approved 37 (81%) 52 (81%)
Rejected 0 0
Withdrawn by sponsor 1 (2%) 0
Returned/failed screening 8 (17%) 12 (19%)
Total 46 (100%) 64 (100%)
N4
Approved 19 (76%) 13 (65%)
Rejected 1 (4%) 0
Withdrawn by sponsor 3 (12%) 3 (15%)
Returned/failed screening 2 (8%) 4 (20%)
Total 25 (100%) 20 (100%)
N5
Approved 8 (73%) 9 (90%)
Rejected 0 0
Withdrawn by sponsor 2 (18%) 0
Returned/failed screening 1 (9%) 1 (10%)
Total 11 (100%) 10 (100%)
Table 16 OTC change applications completed and outcomes
2017-18 2018-19
July to June
Number (% of Total)
C1
Approved 202 (99%) 182 (97%)
Rejected 0 0
Withdrawn by sponsor 2 (1%) 6 (3%)
Returned/failed screening 0 0
Total 204 (100%) 188 (100%)
C2
Approved 386 (97%) 549 (99%)
Rejected 0 0
Withdrawn by sponsor 11 (3%) 7 (1%)
Returned/failed screening 2 (0.5%) 0
Total 399 (100%) 556 (100%)
C3
Approved 5 (83%) 8 (80%)
Rejected 0 0
Withdrawn by sponsor 0 1 (10%)
Returned/failed screening 1 (17%) 1 (10%)
Total 6 (100%) 10 (100%)
C4
Approved 4 (100%) 2 (100%)
Rejected 0 0
Withdrawn by sponsor 0 0
Returned/failed screening 0 0
Total 4 (100%) 2 (100%)

2.2.3 Other applications

Other application types that we process include requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. In accordance with the legislation, registered goods must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an exemption from a particular standard for a product.

Table 17 Number of other OTC medicine applications
2017-18 2018-19
July to June
Number (% of Total)
Requests for advice for the purpose of listing a medicine as a pharmaceutical benefit
B1 0 2 (100%)
B3 0 0
Total 0 2 (100%)
Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standard
Approved 10 (100%) 21 (95%)
Rejected 0 1 (5%)
Total 10 (100%) 22 (100%)

3. Registered complementary medicines

Registered complementary medicines are considered to be of relatively higher risk than listed medicines based on their ingredients or the indications for the medicine. These medicines are fully evaluated by us for safety, efficacy, performance and quality prior to being registered on the ARTG.

Table 18 Registered complementary medicine applications by outcome
2017-18 2018-19
July to June
Number (% of Total)
New medicines
Approved 5 (83%) 5 (71%)
Rejected 1 (17%) 0
Withdrawn 0 2 (29%)
Returned/failed screening 0 0
Total new applications completed 6 (100%) 7 (100%)
Variations
Approved 19 (83%) 18 (100%)
Rejected 4 (17%) 0
Withdrawn 0 0
Returned/failed screening 0 0
Total variations completed 23 (100%) 18 (100%)
Application for consent to import, supply or export goods[a]
Approved 12 (100%) 1 (100%)
Rejected 0 0
Withdrawn N/A[b] 0
Total applications completed 12 (100%) 1 (100%)

Footnotes


4. Listed medicines

Listed medicines are considered to be of relatively lower risk than other medicines on the basis that they can only contain pre-approved ingredients and indications. Unlike registered medicines, we do not assess each listed medicine before it goes onto the market. However, we do require sponsors to certify that the medicine complies with all relevant legislation, and that they hold evidence at the time of listing (and at all times) that their medicine does what it says it will.

We may select a listed medicine for a post-market review where we require the sponsor to provide evidence of compliance with regulation. This includes assessment of evidence of efficacy and labelling. If we find the medicine does not comply with all applicable regulatory requirements, the medicine's listing may be suspended or cancelled.

4.1. New ingredients permitted for use in listed medicines

Table 19 New listed medicine ingredient applications by outcome
2017-18 2018-19
July to June
Application outcome
Approved 24 (86%) 15 (88%)
Rejected 0 1 (6%)
Withdrawn 3 (11%) 1 (6%)
Returned/failed screening 1 (4%) 0
Total completed 28 (100%) 17 (100%)

4.2. Indications permitted for use in listed medicines

Table 20 Permitted indication applications by outcome
2017-18 2018-19
July to June
Application outcome
Approved 0[a] 2 (18%)
Rejected 0[a] 5 (46%)
Withdrawn 0[a] 4 (36%)
Total completed 0[a] 11 (100%)

Footnotes


4.3. Listed medicines

Table 21 New listed medicines
2017-18 2018-19
July to June
New listed medicines 1792 1893

Subsection 9D(1) of the Act provides for variations to be made to an entry on the ARTG where information included on the ARTG is incomplete or incorrect. These variations are considered by a delegate. Other types of variations to listed medicines are applied for and processed automatically by the online application system.

Table 22 Listed medicine variations under section 9D(1) of the Act
2017-18 2018-19
July to June
Number (% of Total)
Medicine variation
Approved 91 (95%) 131 (78%)
Rejected 5 (5%) 13 (8%)
Withdrawn N/A[a] 24 (14%)
Total 96 (100%) 168 (100%)

Footnotes


Table 23 Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
2017-18 2018-19
July to June
Number (% of Total)
Application
Exemption granted[a] 9[b] (100%) 11 (85%)
Rejected 0 0
Withdrawn N/A[c] 2 (15%)
Total 9[b] (100%) 13 (100%)

Footnotes


4.3.1 Investigations

Investigations arise from notifications, complaints and referrals from internal and external stakeholders and screening of recently listed medicines on the ARTG, but can also include products not listed on the ARTG. All investigations are prioritised based on a risk management approach to provide the perceived greatest overall benefit for the Australian public. Investigations may be completed with a number of actions, such as initiating a targeted review or referral to another area of the TGA.

Table 24 Listed medicine investigations and actions undertaken
2017-18 2018-19
July to June
Number (% of Total)
Initiated investigations 56 81
Completed investigations[a] 55 36
Initiated compliance review(s) 22 (40%) 20 (55%)
Issued warning or educational letter 0 (0%) 1 (3%)
Advice provided to complainant 0 (0%) 0 (0%)
Referred to another TGA area or government organisation 4 (7%) 1 (3%)
No further action taken[b] 29 (53%) 14 (39%)
Total actions undertaken[c] 55 (100%) 36 (100%)

Footnotes


4.3.2  Compliance reviews

Listed medicines are not individually evaluated by the TGA before they are included on the ARTG. However, a proportion is reviewed post-market to check their compliance against relevant regulatory requirements. Compliance reviews may only review selected listing requirements.

Medicines may be randomly selected or targeted for a review. Medicines are randomly selected for review by a computer, based on a mathematical model. Targeted reviews can originate from a number of signals and are initiated following an investigation.

A compliance review will result in one of the following outcomes:

  • no compliance breaches are identified against selected listing requirements, the review is concluded and the medicine remains on the ARTG
  • compliance breaches are identified for the selected listing requirements
  • the review is not completed as the sponsor has cancelled the medicine
  • the review is closed due to the unavailability of information in determining its compliance status as the medicine is yet to be manufactured.
Table 25 Listed medicine reviews by type
2017-18 2018-19
July to June
Number (% of Total)
Initiated reviews
Targeted reviews 82 (36%) 127 (91%)
Random reviews 143 (64%) 12 (9%)
Total 225 (100%) 139 (100%)
Reviews on hand 173 131
Completed reviews
Targeted reviews 162 (67%) 99 (55%)
Random reviews 81 (33%) 82 (45%)
Total 243 (100%) 181 (100%)
Table 26 Completed listed medicine reviews by outcome
2017-18 2018-19
July to June
Number (% of Total)
Compliance status determined
Medicines with no compliance breaches 42 (25%) 38 (27%)
Medicines with verified compliance breaches 129 (75%) 102 (73%)
Sub-total 171 (100%)
-70%
140 (100%)
-77%
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 51 (74%) 30 (73%)
Medicines not yet manufactured 13 (19%) 11 (27%)
Other 5 (7%) 0 (0%)
Sub-total 69 (100%)
-28%
41 (100%)
-23%
Product not a therapeutic good 3 (1%) 0 (0%)
Total completed 243 (100%) 181 (100%)
Figure 4 Outcomes of compliance reviews by reason for initiation[a]
[Targeted: 70% Determined, 30% Unable to be determined; Random: 87% Determined, 13% Unable to be determined]; [Status: Determined - Targeted: 43% No breaches, 57% Verified breaches; Random: 11% No breaches, 89% Verified breaches]; [Status: Unable to be determined - Targeted 77% Cancelled by sponsor after request for information, 23% Not yet manufactured; Random 64% Cancelled by sponsor after request for information, 36% Not yet manufactured]

Footnotes


Compliance status determination
Compliance status determination Determined Unable to be determined
Targeted 70% 30%
Random 87% 13%
Status: Determined
Status: Determined No breaches Verified breaches
Targeted 43% 57%
Random 11% 89%
Status: Unable to be determined
Status: Unable to be determined Cancelled by sponsor after request for information Not yet manufactured
Targeted 77% 23%
Random 64% 36%

Of the completed compliance reviews, the following are the types of issues identified in those medicines where a compliance breach was verified. Individual medicines may have multiple issues identified.

Table 27 Types of listed medicine compliance issues identified
2017-18 2018-19
July to June
Number (% of Total)
Type of compliance issue
Information provided in ARTG entry[a] 69 (21%) 30 (12%)
Manufacturing, quality and/or formulation 27 (8%) 15 (6%)
Labelling 58 (17%) 49 (20%)
Advertising 59 (18%) 40 (16%)
Unacceptable presentation[b] 63 (19%) 52 (21%)
Evidence[c] 50 (15%) 51 (21%)
Safety[d] 0 1 (0.4%)
Non-response to a request for information[e] 5 (2%) 2 (1%)
Other[f] 2 (1%) 4 (2%)
Total 333 (100%) 244 (100%)

Footnotes


Figure 5[a] Types of compliance issues identified by reason for initiation
Advertising: 13% Targeted, 18% Random; Evidence: 18% Targeted, 22% Random; Information provided in ARTG entry: 13% Targeted, 12% Random; Labelling: 19% Targeted, 20% Random; Manufacturing, quality and/or formulation: 6% Targeted, 6% Random; Non-response: 4% Targeted, 1% Random; Other: 1% Targeted, 1% Random; Unacceptable presentation: 25% Targeted, 19% Random.

Footnotes


Figure 5[a] Types of compliance issues identified by reason for initiation
Compliance issue Targeted Random
Advertising 13% 18%
Evidence 18% 22%
Information provided in ARTG entry 13% 12%
Labelling 19% 20%
Manufacturing, quality and/or formulation 6% 6%
Non-response 4% 1%
Other 1% 1%
Unacceptable presentation 25% 19%
Table 28 Actions taken following listed medicine reviews
2017-18 2018-19
July to June
Number (% of Total)
Actions following a Request for Information
Medicines found to be compliant and review concluded 42 (25%) 38 (27%)
Medicines cancelled by the TGA without a proposal to cancel notice 0 0
Proposal to cancel notice or warning[a] sent by the TGA 129 (75%) 102 (73%)
Total 171 (100%) 140 (100%)
Actions following Proposal to Cancel notice[a] by outcome
Medicines no longer on the ARTG 55 (100%)
-43%
32 (100%)
-31%
Cancelled by the TGA 10 (18%) 3 (9%)
Cancelled by sponsors after being notified of compliance breaches 45 (82%) 29 (91%)
Medicines remaining on the ARTG 74 (100%)
-57%
70 (100%)
-69%
Reviews concluded after compliance breaches were addressed 74 (100%) 70 (100%)
Total 129 (100%) 102 (100%)

Footnotes


Figure 6[a] Outcomes of completed compliance reviews
50% Compliant after Proposal to Cancel or Warning; 21% Cancelled by sponsors after Proposal to Cancel or Warning; 27% Compliant; 2% Cancelled by the TGA after Proposal to Cancel or Warning

Footnotes


Figure 6[a] Outcomes of completed compliance reviews
Outcome Percent
Compliant after Proposal to Cancel or Warning 50%
Cancelled by sponsors after Proposal to Cancel or Warning 21%
Compliant 27%
Cancelled by the TGA after Proposal to Cancel or Warning 2%

5. Biologicals and blood components

5.1. Inclusion of biologicals

Table 29 Applications for biologicals[a] received and on hand
2017-18 2018-19
July to June
Number (% of Total)
Applications received
Technical Master File (TMF)[b] new 0 0
TMF annual updates 3 (5%) 3 (4%)
TMF variations 14 (22%) 18 (23%)
TMF notifications 8 (12%) 12 (16%)
Plasma Master File[c] annual updates 10 (15%) 12 (16%)
Biological Class 2 - new applications 1 (1%) 1 (1%)
Biological Class 3 - new applications 0 0
Biological Class 4 - new applications 2 (3%) 1 (1%)
Biological Class 2 - variations 22 (34%) 23 (30%)
Biological Class 3 - variations 5 (8%) 3 (4%)
Biological Class 4 - variations 0 4 (6%)
Total received 65 (100%) 77 (100%)
Applications on hand
TMF new 0 0
TMF annual updates 2 (10%) 1 (7%)
TMF variations 4 (19%) 5 (33%)
TMF notifications 0 0
Plasma Master File annual updates 7 (33%) 4 (27%)
Biological Class 2 - new applications 2 (10%) 1 (7%)
Biological Class 3 - new applications 1 (5%) 1 (7%)
Biological Class 4 - new applications 2 (10%) 1 (7%)
Biological Class 2 - variations 3 (14%) 2 (13%)
Biological Class 3 - variations 0 0
Biological Class 4 - variations 0 0
Total on hand 21 (100%) 15 (100%)

Footnotes


Table 30 Completed applications for biologicals
2017-18 2018-19
July to June
Number (% of Total)
Biologicals applications
Technical Master File (TMF) new 1 (2%) 0
TMF annual updates 2 (4%) 3 (4%)
TMF variations 8 (14%) 13 (19%)
TMF notifications 8 (14%) 12 (17%)
Plasma Master File annual updates 8 (14%) 9 (13%)
Biological Class 2 - new applications 3 (5%) 2 (3%)
Biological Class 3 - new applications 0 0
Biological Class 4 - new applications 0 1 (1%)
Biological Class 2 - variations 22 (39%) 23 (33%)
Biological Class 3 - variations 5 (9%) 3 (4%)
Biological Class 4 - variations 0 4 (6%)
Total completed 57 (100%) 70 (100%)

6. Medicine and vaccine adverse event reports

6.1. Adverse medicine and vaccine reaction notifications

Table 31 Source of notifications of medicine and vaccine adverse reactions[a]
2017-18 2018-19
July to June
Accepted cases total 21096 22467
Reports by health professionals 4556 4415
Patients/consumers[b] 1190 704
Pharmaceutical companies 11912 13874
Other source 3438 3474
Rejected/withdrawn cases 2603 1550
Total received 23699 24017
Mean number of reports received weekly 456 462
Vaccine reports included in this table 4554 4225

Footnotes


7. Medical devices

The Medical Devices Regulatory Framework spans the life cycle for these products, including:

  • Conformity assessment: This is the systematic examination by the manufacturer to determine that a medical device is safe and performs as intended and therefore, conforms to the Essential Principles. Certification of the manufacturer's conformity assessment procedure may (or for particular products, must) be undertaken by the TGA, or we may recognise conformity assessment certification from European notified bodies.
  • Inclusion on the ARTG: Medical devices cannot be imported, supplied in, or exported from Australia unless they are included on the ARTG or a valid exemption applies, for example custom made medical devices, importation of samples, etc. A sponsor can apply to include a medical device on the ARTG if the device complies with the Essential Principles and appropriate conformity assessment procedures have been applied to the device.
  • Post-market monitoring: Once a medical device has been included on the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.
  • Priority review of medical devices: A new pathway has been developed to allow faster processing of applications for devices that meet certain criteria for novelty and health benefits.
  • Medical device manufacturing: The TGA assesses the quality management systems of medical device manufacturers seeking TGA conformity assessment certification. This may be through onsite inspections or desktop assessment of third party inspection reports, or a combination of these methods. Surveillance inspections are also undertaken to assess continuing compliance. In addition, the TGA is a Regulatory Authority of the Medical Devices Single Audit Program (MDSAP) that assesses and recognises third party Auditing Organisations for the purposes of certifying medical device manufacturers.

7.1. Conformity assessment

7.1.1 Applications

Table 32 Number of conformity assessment applications (medical devices including IVDs)
2017-18 2018-19
July to June
Conformity assessment applications
Applications received 309 279
Applications on hand 251 252
Applications completed 273 273

7.1.2 Outcomes

Table 33[a] Outcomes of conformity assessment applications
2017-18 2018-19
July to June
New
Approved 58 63
Rejected 1 0
Withdrawn/ Lapsed 35 17
Variation (changes and re-certifications)
Approved 166 169
Rejected 1 0
Withdrawn/ Lapsed 12 24

Footnotes


7.1.3 Processing timeframes

We are required to complete conformity assessment applications within 255 working days.

Table 34 TGA processing times for new devices and variations
2017-18 2018-19
July to June
New devices
Mean TGA processing time (days) 131 160
Median TGA processing time (days) 189 196
Variations (changes and recertifications)
Mean TGA processing time (days) 110 114
Median TGA processing time (days) 95 97

7.2. Inclusion of medical devices (including IVDs)

7.2.1 Applications

Table 35 Applications for inclusion - medical devices (including IVDs)
2017-18 2018-19
July to June
Class I medical devices[a]
Applications received 4805 1545
Applications completed 4804 1631
Class I measuring medical devices
Applications received 62 46
Applications completed 64 46
Applications on hand[b] 5 0
Class I sterile medical devices
Applications received 255 198
Applications completed 240 207
Applications on hand[b] 7 1
Class IIa medical devices
Applications received 1219 1186
Applications completed 1191 1191
Applications on hand[b] 92 27
Class IIb medical devices
Applications received 650 581
Applications completed 568 589
Applications on hand[b] 132 50
Class III medical devices
Applications received 406 476
Applications completed 378 404
Applications on hand[b] 208 194
Class III Joint Reclassification medical devices
Applications received 0 0
Applications completed 88 6
Applications on hand[b] 5 0
Active Implantable Medical Devices (AIMD)
Applications received 24 37
Applications completed 34 28
Applications on hand[b] 10 18
Class 1 IVDs[c]
Applications received 74 72
Applications completed 76 72
Applications on hand[b] 2 1
Class 2 IVDs
Applications received 81 67
Applications completed 80 71
Applications on hand[b] 13 7
Class 3 IVDs
Applications received 58 53
Applications completed 60 43
Applications on hand[b] 14 20
Class 4 IVDs
Applications received 27 30
Applications completed 27 30
Applications on hand[b] 1 0

Footnotes


7.2.2 Outcomes

Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.

Table 36 Outcomes of medical device applications by classification
2017-18 2018-19
July to June
Number (% of Total)
Device Classification Approved/ Accepted Rejected/ Lapsed Withdrawn Total of applications by classification Approved/ Accepted Rejected/ Lapsed Withdrawn Total of applications by classification
Class I 4,804
(65%)
0 0 4,804
(63%)
1691
(40%)
0 0 1691
(39%)
Class I Measurement 60
(1%)
0 4
(2%)
64
(1%)
45
(1%)
0 1
(0.6%)
46
(1%)
Class I Sterile 222
(3%)
0 18
(9%)
240
(3%)
193
(5%)
0 14
(9%)
207
(5%)
Class IIa 1,138
(16%)
7
(15%)
46
(24%)
1.191
(16%)
1148
(27%)
3
(17%)
42
(26%)
1191
(27%)
Class IIb 513
(7%)
9
(19%)
46
(24%)
568
(8%)
535
(13%)
3
(17%)
51
(31%)
589
(14%)
Class III 306
(4%)
17
(35%)
55
(28%)
378
(5%)
362
(9%)
6
(35%)
36
(22%)
404
(9%)
Class III Reclassification 59
(1%)
15
(31%)
14
(7%)
88
(1%)
5
(0.1%)
0 1
(0.6%)
6
(0.1%)
AIMD 33
(0.5%)
0 1
(0.5%)
34
(0.5%)
28
(1%)
0 0 28
(0.6%)
Class 1 IVD 73
(1%)
0 3
(2%)
76
(1%)
71
(2%)
1
(56%)
0 72
(2%)
Class 2 IVD 75
(1%)
0 5
(3%)
80
(1%)
60
(1%)
1
(6%)
10
(6%)
71
(2%)
Class 3 IVD 58
(0.7%)
0 2
(1%)
60
(1%)
32
(1%)
3
(18%)
8
(5%)
43
(1%)
Class 4 IVD 27
(0.3%)
0 0 27
(0.4%)
30
(1%)
0 0 30
(0.7%)
Total of all applications by status 7,368
(97%)
48
(0.6%)
194
(3%)
7,610
(100%)
4185
(96%)
17
(0.4%)
163
(4%)
4378
(100%)

7.2.3 Processing times

A Level 1 audit may include clarification of the device classification, a conformity assessment procedure, and/or a review of packaging and labelling to ensure it meets requirements. A Level 2 audit requires the information for a Level 1 audit plus one or more of the following: clinical evidence, risk management report(s), efficacy and performance data, and/or audit reports from Notified Bodies. The target timeframe for Level 1 application audits is 30 TGA work days and for Level 2 application audits is 60 TGA work days (reflected in 'TGA days').

Table 37 Processing times for medical device application audits (including IVDs)
2017-18 2018-19
Number of applications (% of Total) Sponsor days TGA days[a] Number of applications (% of Total) Sponsor days[b][d] TGA days[a][d]
Mean Processing Time
Medical devices
Applications completed without audit 2,021 (79%) 1850 (76%)
Non-compulsory audit[c] 197 (8%) 58 58 201 (8%) 44 99
Level 1 compulsory audit 27 (1%) 23 33 156 (6%) 37 24
Level 2 compulsory audit 318 (12%) 79 83 236 (10%) 63 99
Total 2,563 (100%) 2443 (100%)
IVDs
Applications completed without audit 115 (65%) 86 (59%)
IVD non-compulsory audit 5 (3%) 34 57 8 (5%) 18 36
IVD compulsory audit 56 (32%) 29 81 53 (36%) 82 94
Total 176 (100%) 147 (100%)
Median Processing Time
Medical devices
Applications completed without audit 2,021 (79%) 1850 (76%)
Non-compulsory audit[c] 197 (8%) 33 24 201 (8%) 29 56
Level 1 compulsory audit 27 (1%) 22 23 156 (6%) 31 15
Level 2 compulsory audit 318 (12%) 54 47 236 (10%) 50 85
Total 2,563 (100%) 2443 (100%)
IVDs
Applications completed without audit 115 (65%) 86 (59%)
IVD non-compulsory audit 5 (3%) 21 23 8 (5%) 19 25
IVD compulsory audit 56 (32%) 24 64 53 (36%) 66 84
Total 176 (100%) 147 (100%)

Footnotes


Table 38 Number of priority review determinations[a] granted
2017-18 2018-19
July - June
Application type (proposed)
A: Conformity Assessment (priority applicant) determinations 0 1
B: Medical Devices (priority applicant) determinations 0 0

Footnotes


7.3. Post-market monitoring

7.3.1 Compliance reviews

As Class I medical devices are automatically included on the ARTG, we undertake post-market compliance reviews for these devices. This includes restricted word reviews, where potentially inappropriate Class I device inclusions are identified by the use of specific words indicative of risk, or listing issues relating to the inclusion of the device.

We also conduct targeted compliance reviews that are initiated on a case by case basis. These may be conducted in relation to devices of any Class.

Table 39 Restricted word Class 1 medical device and targeted compliance reviews
2017-18[b] 2018-19
July to June
Restricted word reviews
Reviews completed 122 40
Reviews commenced 122 40
Reviews on hand 9 0
Targeted compliance reviews[a]
Reviews completed 166 235
Reviews commenced 211 250
Reviews on hand 229 15

Footnotes


7.3.2 Post-market reviews

Table 40 Medical device targeted reviews
2017-18 2018-19
July to June
Post market reviews
Reviews commenced - number of ARTG entries 620 545
Reviews completed - number of ARTG entries 568 285
Reviews on hand - number of ARTG entries 315 677

7.3.3 Medical device incident reports

A medical device incident is an event associated with the use or misuse of a medical device that resulted in, or could have resulted in (near-incident): serious injury, illness or death to patient, healthcare worker or other person. Australian sponsors of medical devices must actively monitor their devices' post market performance and report incidents to the TGA. Reporting of incidents, or near-incidents, by users is voluntary.

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

Table 41 Number of medical device incident reports and processing times
2017-18 2018-19
July to June
Device incident reports
Reports received 5348 5874
Reports completed 4653 5654
Reports still in progress 283 239
Processing time
Mean TGA processing time (days) 1 14
Median TGA processing time (days) 6 9
Percentage processed within target timeframe 98% 94%
Table 42 Medical device incident report outcomes[a]
2017-18 2018-19
July to June
Incident report outcome
Reviewed and used for trend analysis purposes 4713 5129
Reviewed, no further action required 252 280
Product recall 27 55
Recall for product correction 57 72
Hazard alert 41 68
Product notification 0 0
Safety alert 2 22
Product enhancement/improvement notice 0 8
Instructions for use amended 6 8
Referral for post-market review 139 94
Refer to another TGA Branch[b] 51 24
Company warned 9 3
Product suspended from ARTG 0 4
Product cancelled from ARTG 2 16
Manufacturing process improvements 10 71
Quality system process improvements 2 3
Maintenance carried out by the hospital 0 1
Change to design 4 15
Not device related 3 2
Other 403 47

Footnotes


7.3.4 Devices manufacturing

Table 43 Outcomes of Quality Management System (QMS) audits of Australian manufacturers
2017-18 2018-19
July to June
QMS audits (Australia)
Number of audits conducted 41 35
Satisfactory compliance (of completed audits) 92% 93%
Marginal compliance (of completed audits) 8% 7%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 37% 23%
Processing time
Initial audits conducted within 3 months of application 83% 25%
Re-audits conducted within 6 months of due date 46% 57%
Table 44 Outcomes of QMS audits of overseas manufacturers
2017-18 2018-19
July to June
QMS audits (overseas)
Number of audits conducted 30 34
Satisfactory compliance (of completed audits) 100% 100%
Marginal compliance (of completed audits) 0% 0%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 60% 38%
Processing time
Initial certification audits conducted within 6 months of application 72% 48%
Certification re-audits conducted within 6 months of due date 42% 15%
Table 45 Outcomes of MDSAP
2017-18 2018-19
July to June
MDSAP Assessments (overseas)
Number of auditing organisation assessments 8 3
Number of witnessed manufacturing audits 5 5

8. Exports

8.1. Export only medicines

Export only medicines are listed under section 26 of the Act. The purpose of export only listings is to ensure that products exported from Australia comply with standards that are similar to the standards applied to products supplied in Australia.

In previous years the application number included all variations to existing export only listings as well as new listing applications. Starting from the 2018-19 financial year, new listing applications and variations to existing listings were separated to provide further data.

The target timeframe for processing export only listing applications is 30 working days.

Table 46 Approval times for export only medicines
2017-18 2018-19
July to June
New applications
Mean TGA processing time (days) 25 22
Percentage processed within target processing time 70% 87%
Variations
Mean TGA processing time (days) 19 19
Percentage processed within target processing time 91% 85%
Table 47 Applications for new and variations to export only medicines
2017-18 2018-19
July to June
Export only applications
Applications received 254 (95%) 256
Applications approved 14 (5%) 210
Grouping and variation applications
Applications received Included with applications above 154
Applications approved 103

8.2. Export certifications for medicines

The TGA provides Certificates of Pharmaceutical Product (CPP) for medicines. The CPP is based on the World Health Organisation (WHO) scheme on the quality of pharmaceutical products moving in international commerce. This is an internationally harmonised template that provides assurance about the quality of pharmaceutical products moving in international commerce. The TGA also issues Certificates of Listed Product (CLP) and Certificates of Exempt Product (CEP) that are not formally issued under the WHO scheme.

The target processing time for applications for an export certificate for a medicine is 15 working days.

Table 48 Export certification applications and processing times
2017-18 2018-19
July to June
Applications received 1799 1610
Export certificate issued 1849 1635
Processing times
Mean TGA processing time (days) 14 12
Percentage processed within target time 69% 96%

8.3. Export certification assessment for medical devices

Certificates of free sale and export certificates are documents supplied by the TGA outlining that the relevant medical device(s) are included on the ARTG and are either able to be freely supplied and sold within Australia or are able to be exported from Australia.

In September 2018, the TGA updated the process for export certification for medical devices. This resulted in the removal of country specific certificates and the introduction of an electronic certificate for medical devices. There is now less requirement to submit multiple applications, decreasing the number of export certifications provided for medical devices.

The target processing time for applications for an export certificate for a medical device is 10 working days.

Table 49 Medical device applications and processing times for export certification assessments
2017-18 2018-19
July to June
Applications received 625 401
Export certificates issued 617 410
Processing time
Mean TGA processing time (days) 8 4
Percentage processed within target time 80% 96%

8.4. Permits for the export of human substances

The TGA issues permits for the export of human substances under regulation 8 of the Customs (Prohibited Exports) Regulations 1958. There are two types of permits issued, a single-use permit generally for an individual traveling overseas and an annual permit for organisations exporting multiple times throughout the year.

Figure 7 Permits for the export of human substances
Permits issued for bone and tissue products: 79 in 2017-18, 48 in 2018-19; Permits issued for blood fraction products: 128 in 2017-18, 150 in 2018-19; Annual permits issued: 25 in 2017-18, 47 in 2018-19.
Figure 7 Permits for the export of human substances
Permit type 2017-18 2018-19
Permits issued for bone and tissue products 79 48
Permits issued for blood fraction products 128 150
Annual permits issued 25 47

9. Access to unapproved therapeutic goods

9.1. Special Access Scheme

The Special Access Scheme (SAS) refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. For this reporting period, three pathways existed under the scheme and they are categorised as follows:

  • Category A is a notification pathway which can only be accessed by medical practitioners for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
  • Category B is an application pathway which can be accessed by health practitioners for patients who do not fit the Category A definition. An approval letter from the TGA is required before the goods may be accessed.
  • Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products.

Any unapproved therapeutic good can potentially be supplied via the SAS except for drugs of abuse in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by state or territory law) which cannot be accessed through the SAS Category A process.

Table 50 SAS medicine notifications and applications
2017-18 2018-19
July to June
Number (% of Total)
Category A notifications
Total Category A notifications 36,881
(58%)
39,911[a]
(47%)
Category B applications
Approved 11641 (96%) 18388 (88%)
Cancelled 40 (0.3%) 168 (0.8%)
Withdrawn N/A 802 (4%)
Rejected 28 (0.2%) 1 (0%)
Pending at end of reporting period[b] 370 (3%) 1464 (7%)
Total Category B applications 12079 (100%)
(19%)
20823 (100%)
(24%)
Category C notifications
Total Category C notifications 14560
(23%)
24505[a]
(29%)
Total SAS notifications/applications received (all categories) 63520
(100%)
85239[a]
(100%)

Footnotes


Table 51 SAS device notifications and applications
2017-18 2018-19
July to June
Number (% of Total)
Category A notifications
Total Category A notifications 4,511 (62%) 5117[a] (60%)
Category B applications
Approved 2,466 (94%) 1,953 (90%)
Cancelled 15 (0.6%) 24 (1%)
Withdrawn N/A 51 (2%)
Rejected 9 (0.3%) 13 (0.6%)
Pending at end of reporting period[b] 143 (5%) 142 (7%)
Total Category B applications 2,633 (100%)
(36%)
2,183 (100%)
(25%)
Category C notifications
Total Category C notifications 177 (2%) 1394[a](16%)
Total SAS notifications/applications received (all categories) 7,321 (100%) 8,694 (100%)

Footnotes


Table 52 SAS biological notifications and applications
2017-18 2018-19
July to June
Number (% of Total)
Category A notifications
Total Category A notifications 110 (7%) 89[a] (4%)
Category B applications
Approved 711 (98%) 1350 (92%)
Cancelled 8 (1%) 15 (1%)
Withdrawn N/A 55 (4%)
Rejected 0 26 (2%)
Pending at end of reporting period[b] 9 (1%) 30 (2%)
Total Category B applications 728 (100%)
(44%)
1476[a] (100%)
(66%)
Category C notifications
Total Category C notifications 802 (49%) 688[a](31%)
Total SAS notifications/applications received (all categories) 1640 (100%) 2253 (100%)

Footnotes


9.2. Clinical trials

The Clinical Trial Notifications scheme provides an avenue through which unapproved therapeutic goods may be supplied for use solely for clinical trials. Unapproved therapeutic goods can include biologicals, devices or medicines or a combination of any of the three types of goods.

Table 53 Number of notifications for new clinical trials involving unapproved therapeutic goods received by therapeutic good type
2017-18 2018-19
July to June
Number (% of Total)
Therapeutic good type
Medicine 436 (45%) 466[b] (44%)
Device[a] 143 (16%) 173[b] (16%)
Biological 7 (1%) 13[b] (1%)
Medicine and device 325 (35%) 391[b] (37%)
Device and biological 1 (0.1%) 4[b] (0.4%)
Medicine and biological 5 (1%) 4[b] (0.4%)
Medicine, device and biological 3 (0.3%) 8[b] (0.8%)
Total 920 (100%) 1059[b] (100%)

Footnotes


Table 54 Number of new clinical trial notifications involving unapproved therapeutic goods received by phase
2017-18 2018-19
July to June
Number (% of Total)
Clinical trial type
Phase 1 262 (29%) 285 (27%)
Phase 2 209 (23%) 264 (25%)
Phase 3 246 (27%) 260 (25%)
Phase 4 65 (7%) 82 (8%)
Device 125 (14%) 147 (14%)
Bioavailability/equivalence 13 (1%) 21 (2%)
Total 920 (100%) 1059 (100%)
Table 55 Number of notifications for new clinical trials and variations to previously notified clinical trials, including non-fee attracting variations, involving unapproved therapeutic goods received by therapeutic good type
2017-18 2018-19
July to June
Number (% of Total)
Therapeutic good type
Medicine 1154 (39%) 1201 (38%)
Device[a] 240 (8%) 287 (9%)
Biological 12 (0.4%) 19 (0.6%)
Medicine and device 1557 (52%) 1643 (52%)
Device and biological 5 (0.1%) 9 (0.3%)
Medicine and biological 11 (0.4%) 10 (0.3%)
Medicine, device and biological 4 (0.1%) 16 (0.5%)
Total 2983 (100%) 3185 (100%)

Footnotes


The online system captures the actual number of notifications received for new clinical trials and requests to change significant details to clinical trials already notified. A variation to a previously notified clinical trial may include an addition of a site(s), change to a therapeutic good, or change in principal investigator etc.

Table 56 Number of new clinical trials and variations[a] to previously notified clinical trials involving unapproved therapeutic goods received by phase
2017-18 2018-19
July to June
Number (% of Total)
Phases
Phase 1 612 (20%) 687 (22%)
Phase 2 707 (24%) 921 (29%)
Phase 3 1280 (43%) 1196 (37%)
Phase 4 165 (5%) 123 (4%)
Device 195 (7%) 227 (7%)
Bioavailability/equivalence 24 (1%) 31 (1%)
Total 2983 (100%) 3185 (100%)

Footnotes


9.3. Authorised Prescribers

The Authorised Prescriber Scheme allows approved medical practitioners authority to prescribe a specified unapproved therapeutic good(s) to patients who are identified by their medical condition. If a medical practitioner becomes an Authorised Prescriber they may prescribe the product to patients in their immediate care, within the indication specified, without seeking further approval from the TGA.

Table 57 Authorised Prescriber approvals for medicines, medical devices and biologicals
2017-18 2018-19
July to June
Number (% of Total)
Approvals by therapeutic good type
Number of approvals for medicines 605 (60%) 694 (57%)
Number of approvals for medical devices 407 (40%) 527 (43%)
Number of approvals for biologicals 0 1 (0.1%)
Total 1012 (100%) 1222 (100%)

10. Medicines and biologicals manufacturing

10.1. Manufacturing licences issued to Australian manufacturers

Table 58 Status of manufacturing licence applications
2017-18 2018-19
July to June
Number (% of Total)
Licence status (Australia)[a]
New licences granted 23 (45%) 15 (47%)
Withdrawn application 5 (10%) 1 (3%)
Revoked licences - at request of licence holder 19 (37%) 13 (41%)
Revoked licences - TGA 2 (4%) 0
Suspended - at request of licence holder 2 (4%) 3 (9%)
Suspended - TGA 0 0
Total 51 (100%) 32 (100%)

Footnotes


Table 59 Outcomes of inspections of Australian manufacturers
2017-18 2018-19
July to June
Number (% of Total)
Inspection status (Australia)
Number of inspections conducted 229 195
Satisfactory compliance (of completed inspections) 179 (78%) 152 (78%)
Marginal compliance (of completed inspections) 21 (9%) 29 (15%)
Unacceptable (of completed inspections) 10 (5%) 8 (4%)
Close-out in progress 19 (8%) 6 (3%)
Processing time
Initial inspections conducted within 3 months of application 22 (96%) 16 (94%)
Re-inspections conducted within 6 months of due date 111 (73%) 112 (75%)

10.2. Approval (certification) of overseas manufacturers

Table 60 Manufacturing certification application by status (overseas)
2017-18 2018-19
July to June
Number (% of Total)
Applications (overseas)[a]
New applications received[b] 33 (38%) 36 (46%)
Re-inspection applications[b] 55 (62%) 42 (54%)
Total applications 88 (100%) 78 (100%)
Applications completed
Certified 85 (63%) 83 (56%)
Rejected[c] 51 (37%) 66 (44%)
Total completed 136 (100%) 149 (100%)

Footnotes


Table 61 Outcomes of inspections of overseas manufacturers
2017-18 2018-19
July to June
Number (% of Total)
Inspection status (overseas)
Number of inspections conducted 94 75
Satisfactory compliance (of completed inspections) 72 (77%) 64 (85%)
Marginal compliance (of completed inspections) 9 (10%) 11 (15%)
Unacceptable (of completed inspections) 3 (3%) 0 (0%)
Close-out in progress 10 (10%) 0 (0%)
Processing time
Initial certification inspections conducted within 6 months of application 15 (68%) 21 (85%)
Certification re-inspections conducted within 6 months of due date 41 (66%) 44 (85%)

10.3. Good Manufacturing Practice (GMP) clearances

GMP clearance is required by an Australian sponsor when a step in the manufacture of a medicine or an Active Pharmaceutical Ingredient is manufactured overseas and the manufacturing step is recorded on the ARTG.

Table 62 GMP clearance application status
2017-18 2018-19[a]
July to June
Number (% of Total completed)
Applications received 5327 6628
Applications completed
Approved 5041 (94%) 6252 (88%)
Rejected 344 (6%) 854 (12%)
Total completed 5385 (100%) 7106 (100%)

Footnotes


Table 63 Number of GMP Clearance applications received and completed by type from 1 July 2018 to 30 June 2019
Application Category Applications received Applications completed
Cancel 2 8
Extend 1966 2087
New 2459 2768
Reactivate 0 1
Variation 2201 2242
Table 64 Number of GMP Clearance applications actioned by pathway from 1 July 2018 to 30 June 2019
Pathway Applications received Applications completed Applications approved Applications not approved
Compliance Verification 3110 3573 3018 555
Mutual Recognition Agreement 3518 3533 3234 299

11. Recalls

11.1. Medicine recalls

Table 65 Medicine recalls by reason for recall
2017-18 2018-19
July to June
Number (% of Total)
Reason for recall
Adverse reactions 1 (3%) 2 (5%)
Foreign matter 5 (14%) 5 (12%)
Illegal supply 2 (6%) 2 (5%)
Impurity and degradation 1 (3%) 4 (10%)
Labelling and packaging 8 (23%) 14 (34%)
Micro-organisms 1 (3%) 2 (5%)
pH 0 0
Potency 3 (8%) 1 (2%)
Sterility 1 (3%) 0
Other[a] 13 (37%) 11 (27%)
Total 35 (100%) 41 (100%)

Footnotes


11.2. Medical device recalls

Table 66 Medical device (including IVDs) recalls by reason for recall
2017-18 2018-19
July to June
Number (% of Total)
Reason for recall
Adverse incidents 3 (0.5%) 5 (0.8%)
Diagnostic inaccuracy 3 (0.5%) 66 (11%)
Electrical defect 41 (7%) 23 (4%)
Illegal supply 2 (0.4%) 1 (0.2%)
Labelling and packaging 14 (2%) 131 (22%)
Mechanical and physical defects 202 (37%) 203 (34%)
Software defects 97 (17%) 130 (22%)
Sterility 5 (1%) 3 (0.5%)
Other[a] 187 (34%) 34 (6%)
Total 554 (100%) 596 (100%)

Footnotes


11.3. Biological recalls

Table 67 Biological recalls
2017-18 2018-19
July to June
Recalls to hospital level 25 29

12. Laboratory testing

The TGA conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

We identify and prioritise therapeutic goods for testing to fulfil its regulatory compliance and monitoring requirements, and the transparency and accountability requirements of Government. The testing program also provides flexibility and capacity to provide testing for investigations into problem reports, complaints and urgent public health concerns.

A risk management approach is used, which is consistent with ISO 31000: Risk Management principals and guidelines, to identify products with a higher risk of not complying with the required quality standards. This risk based, targeted approach to testing is reflected in the failure rates reported in the table below.

Laboratory results are made available through the Database of TGA Laboratory Testing Results, Consumers and health professionals can identify which products have been tested by the TGA, whether they passed or failed, and for those that did fail, what regulatory action was taken. Providing this information has been an important enhancement to the transparency of the Government's regulatory processes and the vital role of the TGA in ensuring the safety, efficacy, performance and quality of medicines and medical devices for Australian consumers.

Table 68 Samples and products tested by type of therapeutic good and percentage which failed
2017-18 2018-19
July to June
Therapeutic good type
Prescription medicines Total 1,106 1064
% fail 0.5 0.1
OTC medicines Total 59 20
% fail 6.8 0
Complementary medicines[a] Total 266 229
% fail 10.2 16.6
Medical devices Total 99 135
% fail 41.4 25.2
External[a] Total 70 29
% fail 8.6 13.8
Pacific Medicines Testing Program Total 21 57
% fail 14.3 21.1
Unregistered[b] Total 155 208
% fail 56.1 68.8
Total samples (excluding AHQ samples) 1776 1742
Total samples[c] 2005 2071
Percentage fail 10% 13%
Total number of products tested[d] 836 857

Footnotes


Table 69 Samples that failed laboratory testing by reason for July 2018 to June 2019
Medical devices OTC medicines Prescription medicines Unregistered products Complementary medicines External Pacific Medicines Testing Program Total (% fail)
Contamination 1 0 0 0 3 0 0 4 (0.2%)
Formulation 0 0 0 143 12 3 9 167 (10%)
Label and packaging deficiencies 21 0 0 0 21 0 0 42 (2%)
Performance 10 0 1 0 2 0 0 13 (0.7%)
Physical or mechanical properties 2 0 0 0 0 1 3 6 (0.3%)
Unregistered 0 0 0 0 0 0 0 0 (0.0%)
Total 34 0 1 143 38 4 12 232
Table 70 Batch release and export certification
2017-18 2018-19
July to June
Batch releases and certifications
Batch release[a] 432 385
Export certification[b] 34 33

Footnotes


Table 71 Target timeframes in working days for laboratory testing by priority and testing type
Priority of testing Biochemical/chemical testing Microbiological testing Medical device testing
Urgent[a] 20 (95% of target times to be met) 40 (95% of target times to be met) 20 (95% of target times to be met)
Priority 40 (80% of target times to be met) 50 (80% of target times to be met) 40 (80% of target times to be met)
Routine 50 50 50

Footnotes


Table 72 Compliance with testing timeframes for July 2018 to June 2019
Priority Number (% of Total)
Therapeutic good type
Medical devices Routine 82 (23%)
Priority 20 (20%)
Urgent 0
OTC medicines Routine 17 (88.2%)
Priority 3 (100.0%)
Urgent 0
Prescription medicines Routine 215 (62%)
Priority 14 (57%)
Urgent 22 (36%)
Complementary medicines Routine 206 (18%)
Priority 23 (35%)
Urgent 0
Unregistered products Routine 2 (0.1%)
Priority 195 (34%)
Urgent 11 (91%)

13. Regulatory compliance

The TGA conducts compliance and enforcement activities against a risk based compliance framework. A range of tools are utilised to encourage compliance and address non-compliance including education and guidance, warnings, the issue of infringements, or product suspensions or cancellations. Investigations may also result in criminal or civil court proceedings. All compliance activities have the purpose of protecting public health.

Due to changes in the IT data capture process in December 2017 the categories against which data is presented has been altered. The tables below have been updated to reflect these changes.

Table 73 Number of compliance actions taken against completed investigations
2017-18 2018-19
July to June
Number (% of Total)
Completed investigations
Criminal prosecution 2 (0.1%) 1 (0.1%)
Infringement notices 0 (0%) 9 (0.3%)
Warning letters issued[a] 2173 (73%) 2489 (72%)
Goods released under Personal Import Scheme 324 (11%) 534 (15%)
Referred to external agency 58 (2%) 86 (3%)
Referred to the Commonwealth Director of Public Prosecutions 3 (0.1%) 5 (0.1%)
Referred internally 28 (1%) 91 (3%)
No offence identified 397(13%) 248 (7%)
Total[c] 2985 (100%) 3463 (100%)
Units of goods referred to ABF for destruction[b] 850514 1069946

Footnotes


Table 74 Regulatory compliance investigations by number
2017-18 2018-19
July to June
Compliance cases[a]
Cases received 3574 3658
Cases active 17 400
Cases finalised 3976 3271

Footnotes


Table 75 Number of different products investigated
2017-18 2018-19
July to June
Number (% of Total)
Therapeutic good type
Prescription medicines (Schedule 4 and Schedule 8) 1319 (56%) 1650 (51%)
Schedule 9 medicines 8 (0.4%) 10 (0.3%)
Schedule 10 medicines 18 (0.8%) 20 (0.6%)
Medical devices 27 (1%) 40 (1%)
Complementary and homoeopathic medicines 400 (18%) 353 (11%)
OTC medicines 98 (4%) 75 (2%)
Biological and blood products 11 (0.5%) 14 (0.4%)
Other[a] 472 (21%) 1074 (33%)
Total[b] 2353 (100%) 3236 (100%)

Footnotes


Table 76 Regulatory compliance investigations by special interest categories
2017-18 2018-19
July to June
Number (% of Total)
Compliance investigation category
Unregistered 3851 (95%) 3544 (96%)
Registered 14 (0.3%) 11 (0.3%)
Counterfeit product 173 (4%) 121 (3%)
Other 25 (0.6%) 17 (0.5%)
Total[a] 4063 (100%) 3693 (100%)

Footnotes


Table 77 Number of offence types related to completed cases
2017-18 2018-19
July to June
Number (% of Total)
Offence type
Import 5720[a] (90%) 4388 (87%)
Export 6 (0.1%) 5 (0.1%)
Manufacture 32 (0.5%) 63 (1%)
Supply 542 (9%) 605 (12%)
Total completed[b] 6300 (100%) 5061 (100%)

Footnotes


Table 78 Location of alleged offence by referral type for July 2018 to June 2019
Origin ACT NSW NT QLD SA VIC WA TAS Total
Australian Border Force 31 423 173 521 288 1268 97 60 2861
External Agencies, Other Regulatory Body, State Health Department 0 3 1 1 0 4 38 0 47
General public 0 18 0 14 2 15 224 1 274
Sponsor/client, Patient/Practitioner 0 1 1 2 0 6 55 0 65
TGA internal[a] 0 23 0 13 3 8 70 1 118
Total 31 468 173 551 293 1301 484 62 3671

Footnotes


14. Pharmacovigilance inspection program (PVIP)

Table 79 Pharmacovigilance Inspection Program inspections undertaken and deficiencies identified
2017-18[a] 2018-19
July to June
Compliance investigation category
Total inspections completed 5 10
Total with completed findings 5 7
Critical deficiencies[b] 0 1
Major deficiencies[c] 25 34
Minor deficiencies[d] 12 24
Average deficiencies per inspection

0 critical

5 major

2 minor

0 critical

5 major

3 minor


Footnotes


15. Reporting of medicine shortages

Table 80 Number of medicine shortage reports[a] by shortage reason
2017-18 2018-19
July to June
Number (% of Total)
Shortages reported
New - Commercial changes 9 (3%) 237 (16%)
New - Discontinuation 24 (9%) 63 (4%)
New - Manufacturing related 141 (52%) 676 (47%)
New - Other 66 (24%) 237 (16%)
New - Product recall 0 (0%) 18 (1%)
New - Unexpected increase in demand 34 (12%) 224 (15%)
Total 274 (100%) 1455 (100%)

Footnotes


Table 81 Number of medicine shortage notifications processed
2017-18 2018-19
July - June
Notifications processed
New 274 1455
Update[b] 799 2605
Total 1073 4060

Footnotes


Version history

Version history
Version Description of change Author Effective date
V1.0 Original publication Reporting and Collaboration Services 21 October 2019