Annual performance statistics report: July 2018 to June 2019
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: |
| 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:
|
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
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
| [a] | Under COR-A, the TGA regulatory decision will be based on a critical review of the COR assessment reports and an evaluation of the Australian label, Product Information (PI) and where required, the Risk Management Plan (RMP). Under the COR-B approach, the TGA regulatory decision will still be mostly based on a critical review of the COR assessment reports. The amount and type of any additional data requiring evaluation, as well as the age of the assessment report, will determine whether the application is best processed under the COR-B approach or as a standard Category 1 application. |
|---|
1.1. Submission outcomes
| 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
| [a] | The type G minor variations differ from type H minor variations in that they result in a new ARTG entry. |
|---|---|
| [b] | The minor variations (type H) 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. |
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.
| 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%) |
Footnotes
| [a] | Total Category 1 and Comparable Overseas Regulator (COR) submissions received in each period. |
|---|
1.2. Approval times
| 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
| [a] | Application type A figures do not include three submissions processed via the priority review pathway. |
|---|---|
| [b] | Application type C figures do not include eight submissions processed via the priority review pathway. |
| 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
| [a] | Application type A figures do not include three submissions processed via the priority review pathway. |
|---|---|
| [b] | Application type C figures do not include eight submissions processed via the priority review pathway. |
| [c] | The type G minor variations differ from type H minor variations in that they result in a new ARTG entry. |
| [d] | The minor variations (type H) 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. |
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.
| 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.
| 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
| [a] | Includes orphan drugs designated under the previous orphan drug program (where the designation application was lodged) and the current program. |
|---|---|
| [b] | One new biological entity was registered under the new orphan drug program during 2017-18. This product also had a priority review determination. |
| [c] | Two new biological entities were registered under the new orphan drug program and the priority review pathway, one new chemical entity was registered under the new orphan drug program and the COR-B review pathway. |
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.
| 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%) |
| 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
| [a] | The target timeframe for the priority review pathway is 150 working days. |
|---|
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.
| 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
| [a] | The 2017-18 data is provided for the period March to June 2018 only, since the provisional approval pathway was implemented in March 2018. |
|---|
1.6. Pathway comparison
| 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
| [a] | Medicine types that utilise these pathways (New chemical entity, New biological entity, Fixed dose combination, extension of indication, major variation). |
|---|---|
| [b] | A new biological entity was processed as both an orphan drug and under the priority review pathway. |
| [c] | Two new biological entities were processed as both an orphan drug and under the priority review pathway, one new chemical entity was processed as both an orphan drug and under the COR-B pathway. |
| [d] | No new provisional medicines were approved in these periods. |
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.
| 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:
|
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:
| 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 |
| 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
| 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
| 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%) |
| 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.
| 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.
| 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
| [a] | Applications can be made for consent to import, supply or export goods under section 14/14A of the Therapeutic Goods Act 1989. |
|---|---|
| [b] | This figure has not been reported on previously. |
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
| 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
| 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
| [a] | This data was not reported in 2017-18 as there were no completed applications. |
|---|
4.3. 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.
| 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
| [a] | This figure was not reported in 2017-18. |
|---|
| 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
| [a] | Sponsors can apply for certain exemptions under Section 14 of the Therapeutic Goods Act 1989. Applications seek consent to import, export or supply a listed medicine that does not comply with the applicable standards. |
|---|---|
| [b] | The data for 2017-18 was incorrectly reported as 5 in the Annual Performance Statistics Report 2017-18. |
| [c] | This figure was not reported in 2017-18. |
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.
| 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
| [a] | Investigations with ensuing actions completed. The values for 2017-18 shown here differ from those provided in the Annual Performance Statistics Report 2017-18, which included 9 investigations completed with action still pending (prioritised for targeted review). |
|---|---|
| [b] | The outcome 'no further action taken' includes examples where the investigation was resolved by other means such as the product has been or is currently under review; or the complaint was not justified and did not warrant further action. The values for 2017-18 shown here differ from those provided in the Annual Performance Statistics Report 2017-18 (10) because 19 investigations that had been prioritised for targeted review in 2017-18 were subsequently deemed to require no further action. |
| [c] | An investigation may give rise to more than 1 action. |
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.
| 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%) |
| 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%) |
![[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]](http://www.tga.gov.au/sites/default/files/annual-performance-statistics-report-july-2018-june-2019-fig4.png)
Footnotes
| [a] | In this period, of the medicines for which we were able to determine a compliance status, 89% had verified compliance breaches when initiated by random selection, which is consistent with the non-compliance rate from the previous period (88%). For medicines that were targeted for review and the compliance status was determined, a markedly lower percentage (57%) were found to have compliance breaches; this was attributable to a significant number targeted of reviews to specifically check compliance with a requirement for label warning statements, for which many medicines were compliant. |
|---|
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.
| 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
| [a] | 'ARTG information' broadly refers to situations where the information on the ARTG is incorrect, including indications that are not eligible for listing and ingredients that do not comply with listing requirements. |
|---|---|
| [b] | 'Unacceptable presentation' means that aspects such as name, labelling, packaging, advertising or other material state or suggest that the medicine has ingredients, components or characteristics that it does not have. |
| [c] | 'Evidence' means the evidence held by the sponsor does not support the claims relating to the medicine. |
| [d] | 'Safety' means that the medicine is not safe for the purposes for which it is to be used. |
| [e] | In previous reports 'other' included non-response to a request for information. However this is now being reported separately. |
| [f] | 'Other' compliance issues may include the sponsor failing to comply with a condition that the medicine is subject to. |
Footnotes
| [a] | Reviews are either randomly selected or targeted for a particular issue. Multiple breaches may be identified for each medicine that is found to be non-compliant; for example, 44% of all randomly-selected non-compliant medicines were found to have insufficient evidence to support the medicine indication, yet this breach accounted for 22% of the total breaches identified across all randomly-selected non-compliant medicines. These figures are not corrected for the nature of information assessed during a review. For example, of those randomly-selected non-compliant medicines for which evidence was assessed, 92% were found to have an 'Evidence' breach. |
|---|
| 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
| [a] | In some targeted review projects, sponsors are sent a 'warning' letter instead of a 'proposal to cancel' letter. A proposal to cancel or warning letter is considered the same for reporting purposes. |
|---|---|
| [b] | The figures provided under 'Actions following a Proposal to Cancel notice by outcome' are a breakdown of the corresponding figures provided for the same under 'Actions following a Request for Information'. |
Footnotes
| [a] | A significant proportion of listed medicine reviews are concluded after the sponsor has adequately addressed the compliance breaches identified by us. Under the Therapeutic Goods Act 1989 sponsors are given an opportunity to respond to issues raised during a compliance review. There was a slight decrease in the number of listed medicines cancelled by the TGA following a Proposal to Cancel or warning letter (2%) compared with the previous period (5%). |
|---|
5. Biologicals and blood components
5.1. Inclusion of biologicals
| 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
| [a] | The Australian Regulatory Guidelines for Biologicals (published on our website) define the different biological classes. |
|---|---|
| [b] | Technical Master Files (TMF) contain information from manufacturers that demonstrate how product safety and quality standards have been met for Blood, Blood Components and Haematopoietic Progenitor Cells. |
| [c] | Plasma Master Files contain control strategies that ensure the quality and safety of plasma, from collection through to plasma pooling prior to fractionation and including donor selection criteria and testing, which are part of medicinal products or medical devices. |
| 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
| 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
| [a] | Data is subject to change due to receipt of further information related to individual reports resulting in their amendment, or further case processing. |
|---|---|
| [b] | In 2018-19 the increased number of reports submitted by the pharmacists from the NPS MedicineWise phone service – a service for consumers to report adverse events and seek clinical advice from pharmacists - may explain the decreased number of reports submitted by consumers. |
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
| 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
| 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
| [a] | The table has been broken down into 'New' and 'Variation' assessment application to provide additional transparency. In reviewing the changes in the reporting, the final total was increased by one. |
|---|
7.1.3 Processing timeframes
We are required to complete conformity assessment applications within 255 working days.
| 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
| 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
| [a] | Class I medical devices are automatically included (i.e. these applications are completed within 24 hours). There are no applications for this classification of device 'on hand'. Differences in the number received and finalised relate to those applications received on the last day of the reporting period and/or data migration processes. |
|---|---|
| [b] | Applications on hand – figures shown are correct as of the date when the data was extracted. There may also be delays between the date of the decision and the time when the system is updated due to administrative and/or data migration processes. |
| [c] | The number of applications for Class 1 IVD includes auto-included devices and applications completed with or without audit. |
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.
| 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').
| 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
| [a] | TGA time starts when the application is selected for audit, is based on working days, and excludes the time when we wait for information or payment from the sponsor. |
|---|---|
| [b] | Days taken for sponsor to provide further information/pay fees etc. |
| [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). |
| [c] | Due to technical and data migration issues the timeframes calculated for this reporting period may have some minor inaccuracies. |
| 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
| [a] | Priority designation is a formal decision by the TGA to assign priority to the assessment of an application to include a medical device in the ARTG. Granting of priority designation does not guarantee approval for the application itself. Designation decisions lapse after six (6) months, unless an application for either TGA conformity assessment or ARTG inclusion is received during this time. |
|---|
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.
| 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
| [a] | The number of targeted reviews includes the number of compliance reviews undertaken in relation to all classes of medical devices. |
|---|---|
| [b] | Due to technical and data migration issues the numbers calculated for this reporting period may have some minor inaccuracies. |
7.3.2 Post-market 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.
| 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% |
| 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
| [a] | Outcomes are not mutually exclusive. |
|---|---|
| [b] | The Incident report (DIR) may be referred onto another section for their action. These areas include but are not limited to Recalls, Regulatory Compliance, Clinical Trials and Advertising. Generally these reports are closed off in the DVM database unless there is more than one issue noted within the report. It may also still be investigated by DVM depending on this issue. |
7.3.4 Devices manufacturing
| 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% |
| 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% |
| 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.
| 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% |
| 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.
| 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.
| 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.
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.
| 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
| [a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
|---|---|
| [b] | Pending applications are waiting on additional information to be supplied by the applicant. |
| 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
| [a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
|---|---|
| [b] | Pending applications are waiting on additional information to be supplied by the applicant. |
| 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
| [a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
|---|---|
| [b] | Pending applications are waiting on additional information to be supplied by the applicant. |
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.
| 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
| [a] | 'Device' includes both medical device and therapeutic device categories. |
|---|---|
| [b] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
| 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%) |
| 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
| [a] | Device includes both medical device and therapeutic device categories. |
|---|
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.
| 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
| [a] | A variation may include any change to a previously notified clinical trial such as an additional site, change to a therapeutic good, or change in principal investigator. |
|---|
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.
| 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
| 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
| [a] | As at 30 June 2019, there were 254 Australian companies holding manufacturing licences covering 396 sites. |
|---|
| 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
| 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
| [a] | As at 30 June 2019, there were 141 overseas manufacturers covering 164 manufacturing sites that were subject to TGA inspection and approximately 2,600 overseas manufacturing sites that relied on evidence from recognised regulators. |
|---|---|
| [b] | Refers to applications that generated an inspection, undertaken by the TGA. However, this does not correlate with completed applications, as the certification process may be continuing across financial years. |
| [c] | Rejections include withdrawn applications. |
| 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.
| 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
| [a] | A change in the reporting method from 2017 now captures additional application types (e.g. extensions, variations etc.). It followed updates to the GMP Clearance application e-forms in September 2017 and has resulted in variations to some figures when comparing the two reporting periods. |
|---|
| Application Category | Applications received | Applications completed |
|---|---|---|
| Cancel | 2 | 8 |
| Extend | 1966 | 2087 |
| New | 2459 | 2768 |
| Reactivate | 0 | 1 |
| Variation | 2201 | 2242 |
| 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
| 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
| [a] | 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product, disintegration/dissolution, GMP non-compliance and transport/storage. |
|---|
11.2. Medical device recalls
| 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
| [a] | 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences. |
|---|
11.3. 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.
| 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
| [a] | Performed on request for overseas regulators, 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] | We may test a number of samples of each product per reporting period. |
| 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 |
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Batch releases and certifications | ||
| Batch release[a] | 432 | 385 |
| Export certification[b] | 34 | 33 |
Footnotes
| [a] | Evaluation of batch release documentation for vaccines, biotechnology and blood products. |
|---|---|
| [b] | Certification of biological products being exported from Australian manufacturers to overseas markets. |
| 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
| [a] | Testing on products linked to potential public safety concerns are assigned to the 'Urgent' testing category. Urgent testing may impact on the timeframes for priority and routine testing. Priority is given to testing of products with the highest risk of a quality deficiency. |
|---|
| 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.
| 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
| [a] | The category 'warning letters issued' can include goods destroyed as prohibited imports and goods re-exported. |
|---|---|
| [b] | Units refers to single dosage unit e.g. 1 tablet, 1 capsule, 1 tub of powder or a single device. |
| [c] | There can be multiple actions per case resulting in a higher total figure than shown in finalised cases below. |
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Compliance cases[a] | ||
| Cases received | 3574 | 3658 |
| Cases active | 17 | 400 |
| Cases finalised | 3976 | 3271 |
Footnotes
| [a] | These figures are based on case numbers and not actions taken or offence types. |
|---|
| 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
| [a] | Due to system technical issues, some investigations were unable to be categorised by therapeutic good type. |
|---|---|
| [b] | Multiple therapeutic goods types may appear in a single case. |
| 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
| [a] | There can be multiple special interest categories in a single case. |
|---|
| 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
| [a] | There was a spike in cases in the second quarter of 2018 due to targeted action by Australian Border Force. |
|---|---|
| [b] | There can be multiple offences in a single case. |
| 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
| [a] | Referred from within the TGA for investigation as a result of other work, e.g. Conformity assessments, advertising complaints. |
|---|
14. Pharmacovigilance inspection program (PVIP)
| 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
| [a] | Inspections commenced in January 2018, so the 2017-18 figure represents a half-year of data. |
|---|---|
| [b] | A deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines. Deficiencies classified as critical may include a pattern of deviations classified as major. A critical deficiency also occurs when a sponsor is observed to have engaged in fraud, misrepresentation or falsification of data. |
| [c] | A deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines. Deficiencies classified as major may include a pattern of deviations classified as minor. |
| [d] | A deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients. A deficiency may be minor either because it is judged as minor or because there is insufficient information to classify it as major or critical. |
15. Reporting of medicine shortages
| 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
| [a] | New reports only, does not include updates of previously reported shortages. Mandatory reporting of all shortages of prescription medicines and select over-the-counter medicines commenced 1 January 2019. |
|---|
| 2017-18 | 2018-19 | |
|---|---|---|
| July - June | ||
| Notifications processed | ||
| New | 274 | 1455 |
| Update[b] | 799 | 2605 |
| Total | 1073 | 4060 |
Footnotes
| [a] | Updates of previously reported shortages, including updates to 'Resolved' status. All reports submitted voluntarily, with mandatory reporting of all shortages of prescription medicines and select over-the-counter medicines commencing 1 January 2019. |
|---|
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Reporting and Collaboration Services | 21 October 2019 |