Version 1.0, August 2015
As a part of the Department of Health, the Therapeutic Goods Administration (TGA) safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989. Through the TGA, the Australian Government aims to:
During January to June 2015 we have been guided by the TGA Strategic Statement 2012-2015 in delivering these outcomes.
Our performance against our broad strategic intent for this period is measured through eight key performance indicators (KPIs):
The KPIs and the specific measures that are used to report against each KPI have been endorsed by the Australian Therapeutic Goods Advisory Council, following consultation with the TGA Industry Consultative Committee.
This KPI report covers aspects of our performance between January and June 2015.
Progress has been made in a number of areas since the last KPI report. In particular, in the number of manufacturing clearances issued, and work sharing arrangements with international regulators. There was a steady rise in stakeholder engagement with the TGA website, and progress towards the Australian Government's Digital Transition Policy is increasing and on target to reach 100 per cent by December 2015.
The Australian Government has developed a framework to assist regulators to measure their performance. The Regulator Performance Framework (RPF) comprises six outcomes-based KPIs that reflect the Australian Government's overarching expectations of regulator performance.
The RPF KPIs came into effect on 1 July 2015, and will replace the TGA's KPI framework. The January to June 2015 report will be the final KPI report to be published in the current format.
The first report against the new RPF will cover the period July 2015 to June 2016 and the TGA's performance against the RPF KPIs will be published on the TGA website following Ministerial approval. Further information on the TGA key performance indicators and measures: Regulator Performance Framework is available on the TGA website.
Version | Description of change | Author | Effective date |
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V1.0 | Original publication | TGA | August 2015 |
Version 1.0, August 2015
We demonstrate our performance against this KPI in three different areas, as described below.
For this reporting period, website statistics are split into two separate time periods because we upgraded our reporting software in November 2014. There is a difference between how the reporting software captures and analyses the data and therefore there is not a direct correspondence between the new metrics and visitor numbers reported in previous periods.
Number of visitors engaged with the TGA website (new reporting software) | Jan - Jun 2015 | Nov - Dec 2014 |
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Sessions - a period of active engagement by a user with the website | 1,284,287 | 370,204 |
Users - the total number of unique website visitors | 799,364 | 242,987 |
Page views - a view of a single web page on our website | 3,313,113 | 992,786 |
Number of visitors to the TGA website (previous software) | Jul - Oct 2014 | Jan - Jun 2014 |
Number of visitors to the TGA website | 1,196,493 | 1,665,669 |
Top 5 web pages viewed (2015) | Jan - Jun 2015 | |
Home page | 332,320 | |
Australian Register of Therapeutic Goods | 44,465 | |
The Poisons Standard | 40,330 | |
Prescribing medicines in pregnancy database | 28,660 | |
Recommended Paracetamol doses | 27,186 | |
These web pages represent about 14% of total page views. | ||
Top 5 web pages viewed (2014) | Jul - Dec 2014 | Jan - Jun 2014 |
Home page | 433,976 | 371,264 |
Children's Panadol 1-5 years Colourfree suspension | 39,608 | N/A |
Recommended paracetamol doses | 29,427 | 43,275 |
Latest news & updates | 27,729 | 37,082 |
Australian Register of Therapeutic Goods | 24,233 | 35,886 |
N/A = not applicable. This webpage was created during the current reporting period.
TGA participation in stakeholder forums | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
---|---|---|---|
Number of TGA participations in key stakeholder forums, either as speakers or through exhibits | 191 | 28 | 22 |
Consumers, health professionals and industry are surveyed annually to measure whether there are improvements in stakeholder understanding of our role. The next survey will be conducted in late 2015 and therefore no new data is available for this period.
TGA stakeholder engagement | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
---|---|---|---|
Number of new consultations completed during the reporting period | 5 | 4 | 1 |
Median number of submissions received for consultations | 36 (range 21–67) |
11 (range 5–80) |
9 |
Submissions and TGA responses published on the TGA website in target timeframes1,2 | 100% | 100% | 100% |
Number of subscribers to all TGA email lists | 9570 | 9648 | 9169 |
Number of subscribers to consultation email list | 780 | 647 | 592 |
Number of stakeholders who were satisfied or very satisfied with our consultative processes | 66% | N/A | 75% |
Stakeholder satisfaction with TGA consultation processes decreased during this reporting period due to shorter timeframes provided for consultation responses, and reduction in advanced notice of consultations due to the unavailability of the consultation forecast during the conduct of the Expert Review of Medicines and Medical Devices Regulation.
The Regulatory Assistance Section (RAS) is our first point of contact for enquirers approaching the TGA. Under the TGA's customer service standards, the RAS aims to respond to voicemail messages within two working days, and to respond to emails (either through a direct response or referral to regulatory areas for appropriate action) within five working days.
Enquiries received by the RAS are separated into levels depending on how the enquiry is managed:
There were 1955 voicemail messages received during this period. This is an increase from the previous period as a result of staff turnover and training, however the RAS responded to 100 per cent of email and voicemail enquiries within the specified timeframes during the reporting period.
Time taken to respond to complaints | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Number of complaints received by email Median time taken to respond (days) |
1 2 |
0 N/A |
5 5 |
Complaints received by telephone Time taken to respond (days) |
1 1 |
0 N/A |
2 0-2 |
The TGA customer service standards specify that feedback will either be answered or acknowledged within 5 working days and, where feedback requires further investigation by the TGA, the acknowledgement will provide notification of this and associated timeframes for response.
Version 1.0, August 2015
The TGA makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. This KPI provides evidence about whether we are enabling timely access to therapeutic goods for the Australian public.
We aim to ensure that all of the applications for market authorisation of therapeutic goods are processed within target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good. Some of these targets are specified in the legislation. Timeframes exclude 'hold times' where the TGA is awaiting a response from an applicant following a request for information, and includes any time for committee consideration.
Pre-market business operations | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Prescription medicines | |||
Applications lodged under the prescription medicines registration process ('Category 1' applications) processed within the legislated timeframe (255 working days) | 177 (99%) | 164 (100%) | 206 (99.5%) |
Quality related evaluations ('Category 3' applications) processed within the legislated timeframe (45 working days) | 723 (98%) | 737 (100%) | 754 (100%) |
Non-prescription medicines: new applications1 | |||
N1 (target timeframe = 45 working days) | 56 (100%) | 116 (94%) | 131 (98%) |
N2 (target timeframe = 75 working days) | 1 (100%) | 8 (100%) | 2 (100%) |
N3 (target timeframe = 150 working days) | 16 (100%) | 21 (100%) | 38 (100%) |
N4 (target timeframe = 170 working days) | 15 (100%) | 58 (100%) | 18 (100%) |
N5 (target timeframe = 210 working days) | 7 (100%) | 17 (100%) | 1 (100%) |
Non-prescription medicines: change applications1 | |||
C1 (target timeframe = 20 working days) | 268 (91%) | 261 (97%) | 184 (84%) |
C2 (target timeframe = 64 working days) | 136 (100%) | 134 (99%) | 169 (98%) |
C3 (target timeframe = 120 working days) | 2 (100%) | 3 (67%) | 6 (100%) |
C4 (target timeframe = 170 working days) | 5 (100%) | 02 | 3 (100%) |
Complementary medicines | |||
Registered complementary medicines (mean approval time; working days) | 4233 | 1604 | 02 |
New substances for listed medicines (mean approval time; working days) | 1273 | 239 | 225 |
Medical devices | |||
Conformity assessments processed within the target timeframe (255 days) | 53 (100%) | 95 (100%) | 137 (100%) |
Non-compulsory application audits processed within the target timeframe5 (30 working days)6 | 156 (72%) | 133 (54%) | 478 (38%)7 |
Level 1 application audits processed within the target timeframe5 (30 working days) | 11 (100%) | 13 (77%) | 16 (60%) |
Level 2 application audits processed within the target timeframe5 (60 working days) | 155 (46%) | 156 (18%)8 | 205 (60%) |
In vitro diagnostic medical devices | |||
Conformity assessments processed within the target timeframe (255 days) | 12 (100%) | 25 (100)% | 24 (100%) |
Non-compulsory application audits processed within the target timeframe (60 working days) | 4 (100%) | 8 (50%) | 6 (33%) |
Mandatory technical file reviews processed within the target timeframe (60 working days) | 71 (100%) | 78 (83%) | 69 (91%) |
Version 1.0, August 2015
This indicator demonstrates whether TGA's work supports the continued availability of therapeutic goods on the Australian market that are safe, effective and of high quality. The success of many of these measures is underpinned by reporting of adverse events by consumers, health professionals and industry.
The number of listed medcines cancelled in the July-December 2014 reporting period is higher than comparative periods due to a single sponsor of 36 products failing to comply with a notice requiring information about the goods.
Due to the complex nature of some investigations, it is not expected that all investigations would be completed within the 90 day target. For example, delays can occur while waiting on input from third parties.
Post-market business operations | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Regulatory compliance | |||
Outcomes of completed investigations of alleged offences: | |||
Warning issued | 399 | 509 | 371 |
Goods released under Personal Import Scheme | 46 | 42 | 33 |
Referred to another part of TGA | 3 | 4 | 8 |
Referred to another department or agency | 4 | 8 | 8 |
Import treated as abandoned goods by Customs | 0 | 0 | 0 |
No offence detected | 59 | 148 | 100 |
Cases of deliberate non-compliance referred to the Commonwealth Director of Public Prosecutions for criminal prosecution | 1 | 2 | 3 |
Decisions in relation to complaints about advertising of therapeutic goods1 | 02 | 02 | 11 |
Public information on unlisted therapeutic goods | 26 | 18 | 40 |
Percentage of TGA actions that took place within target timeframes | |||
Percentage of priority laboratory testing, identified as a result of safety issues, completed within target timeframes | 95% | 96% | 96% |
Class I and II recalls when they are indicative of a safety concern for3: | |||
|
95% | 100% | 92% |
|
95% | 98% | 97% |
|
04 | 04 | 100% |
Non-compliance of listed medicines, where a safety issue has been identified through targeted or random review | 05 | 100% | 05 |
Safety signals identified through adverse event reporting and other surveillance activities for6: | |||
|
100% | 96% | 95% |
|
100% | 100% | 100% |
Version 1.0, August 2015
This indicator measures whether we are able to attract, develop and retain a professional workforce that can respond to current and emerging regulatory needs.
Performance against measures of organisational health | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Attracting staff: our success in recruiting the right staff to vacant positions | |||
Number of positions unfilled 90 days after advertising | 01 | 5 | 0 |
Developing our staff: the training we provide to develop and maintain the skills of our people, and activities undertaken to keep them informed | |||
Number of corporate training days per number of full-time equivalent positions | 0.9 | 1.0 | 1.0 |
Percentage of medical staff that attended at least one professional development activity in the last six months | 100% | 100% | 100% |
We keep staff informed through two primary internal communication channels: the TGA Daily and the TGA Weekly2 | |||
Percentage of TGA Weekly disseminated (weekly for 24 weeks during this reporting period)3 | 100% | 100% | 100% |
Percentage of TGA Daily disseminated (five days/week) | 100% | 100% | 100% |
TGA staff are surveyed annually. The previous indicator titled "percentage of staff that agree that the work they do is important for public health" is no longer measured in the staff survey and therefore has been removed from this report.
*Of the 506 survey respondents in 2015, 29% of TGA staff provided a neutral response to this survey question.
Version 1.0, August 2015
TGA's activities are primarily cost recovered from industry. However, the TGA received appropriation funding in 2014-15 for aligning Australia's and New Zealand's regulation of therapeutic goods. The function of administering compliance frameworks for controlled drugs was transferred to the TGA Group of the Department of Health in August 2014 and continues to be funded from the departmental appropriation. As a result, TGA now has multiple funding sources for its activities. These activities contribute to Outcome 7 'Health infrastructure, regulation, safety and quality' and Outcome 9 'Biosecurity and emergency response' in the Department of Health's Portfolio Budget Statements.
This indicator on our financial performance shows that we are within the target budget range when compared to budget.
5. Financial performance | Total revenue | Total expenditure | ||||
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Time period | Actual ($'000) | Budget ($'000) | Variance (%) | Actual ($'000) | Budget ($'000) | Variance (%) |
Jul 2014 - Jun 2015 | 139,546 | 138,922 | 0% | 134,905 | 139,231 | -3% |
Jan - Jun 2015 | 71,042 | 68,850 | 3% | 66,860 | 68,900 | -3% |
Jul - Dec 2014 | 68,504 | 70,072 | -2% | 68,045 | 70,331 | -3% |
Jul 2013 - Jun 2014 | 132,564 | 133,161 | -1% | 133,065 | 133,470 | 0% |
Jan - Jun 2014 | 64,369 | 65,880 | -2% | 69,011 | 65,914 | 5% |
Note: target budget variance is ±5%.
Revenue for the full year was in line with budget overall although annual charges were below budget due to the transition arrangements for the new Annual Charges Exemption scheme and a higher rate of Low Value Turnover applications received during the year. Offsetting this were above-budget application fees and additional appropriation for administering compliance frameworks for controlled drugs.
Expenditure was below budget, mainly in employee expenses due to lower than budget staffing levels and no change in staff pay rates from last financial year.
Version 1.0, August 2015
Performance in addressing audit findings | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Financial audits | |||
Outcome of the financial audit | N/A | Unmodified1 | N/A |
Percentage of category 'A', 'B' and 'C' findings addressed within target timeframes | N/A | 100% | N/A |
Percentage of management responses completed prior to publication of audit report | N/A | 100% | N/A |
Performance audits | |||
Percentage of management responses completed prior to publication of audit report | No performance audits | No performance audits | 100% |
Performance in meeting other statutory obligations | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
---|---|---|---|
Compliance with on time payment policy for small business: Relevant invoices paid within 30 days | 96% | 99% | 93% |
Compliance with freedom of information legislation: Requests processed to completion within legislated timeframes1 | 100% | 100% | 100% |
Progress towards the Australian Government Digital Transition Policy: applications and submissions received by the TGA that are available in an electronic form2 | 72% | 70% | 62% |
Percentage of compliant regulation impact statements3 completed by the TGA | N/A | 100% | N/A |
Percentage of compliant cost-recovery impact statements completed by the TGA4 | 100% | 100% | 100% |
Version 1.0, August 2015
TGA has strong active working relationships with most major overseas regulators. These relationships help us safeguard public health in Australia through harmonisation, information sharing and cooperation.
Many of our efforts towards international cooperation are achieved by collaboration with international regulators through formal forums and consortia.
Good Manufacturing Practice inspections |
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Contributed to a review of Pharmaceutical Inspection Cooperation Scheme (PIC/S) strategies and policies, as the basis for mutual recognition of decisions on Good Manufacturing Practice (GMP) inspections. Continued regular sharing of inspection schedules with the United States of America's Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada, with a view to identifying opportunities for joint inspections. Conducted nine joint GMP inspections with other regulatory agencies, including the EMA, European Union (EU) member state regulators, the European Directorate for the Quality of Medicines and Healthcare (EDQM), the US FDA, Medsafe New Zealand, Health Canada and the Medicines Control Council of South Africa. |
International Medical Devices Regulators Forum (IMDRF) |
National Competent Authorities Report Exchange Program: In March 2015 updated guidance was published on the exchange of reports about serious public health issues between IMDRF members. Regulated Product Submission: Comprehensive Tables of Contents (ToC) have been established for in vitro diagnostic (IVD) market authorisation and non-IVD market authorisation. Planning for further piloting of the ToCs is underway, with a focus on the development of supporting documents. The pilot plan was publicly released as an IMDRF information document. Software as a Medical Device (SaMD): Draft guidance was released for consultation on the application of existing, standardised and generally accepted quality management system practices to SaMD. Medical Device Single Audit Program (MDSAP): An assessment and decision process for the recognition of MDSAP Auditing Organisations has been developed. Two guidance documents are currently under development-guidance on regulatory authority assessment methods of auditing organisation's processes and medical device regulatory authority audit reports. The TGA is actively participating in the MDSAP pilot, including the auditing organisation assessment process. Medical Device Patient Registries: Work commenced on work items for integrating device registries, Unique Device Identification and innovative tools for medical device evaluation. Adverse event coding for medical devices: Work commenced on the development of common terminology and code related to adverse events involving medical devices. |
International Generic Drug Regulators Programme (IGDRP) |
Continued participation in the pilot IGDRP-EU Decentralised Procedure and EU Centralised Procedure for the evaluation of generic medicine applications. Incorporated the IGDRP evaluation templates for TGA assessment of Biopharmaceutics Classification System-based biowaivers and Active Substance Master Files/Drug Master Files. The working groups are now reviewing their mandates and workplans for the next direction in work sharing. As the IGDRP Secretariat, the TGA developed a website for the IGDRP's public face, finalised the Terms of Reference for the next two years of the group and established a new working group to address IT business needs for the IGDRP and its working group. |
International Coalition of Medicines Regulatory Authorities (ICMRA) |
Participated as a member of the ICMRA Interim Management Committee where, among other things, regulators established a clear strategic framework to clarify the role of the ICMRA and better articulate its value-add across global initiatives. As the project lead, finalised the draft protocol for sharing information between ICMRA partners to allow for worksharing, particularly in relation to the pre-market authorisation for generic medicines and data requirements for mutual recognition of GMP inspections. |
Direct collaboration with other regulators |
Generic Medicines Continued collaboration with Health Canada, the Health Sciences Authority of Singapore and Swissmedic to develop simplified information sharing programmes to facilitate work sharing for assessment of Drug Master Files (DMF) in each country. Finalised DMF quality assessment report template, which is currently being used by all four agencies. Facilitated communication with selected generic companies for a pilot project to support genuine worksharing between the four agencies, which is based on the EU Decentralised Procedure. Project likely to begin in March 2016 (based on available submissions that meet the criteria). Continued information sharing with Health Canada in the area of pre-market assessment of generic medicines as business-as-usual through the routine exchange and utilisation of evaluation reports. Orphan Medicines Continued to monitor opportunities to enhance collaboration and information sharing regarding assessment of orphan medicines with other regulators. Collaborative arrangements Finalised new collaborative arrangements with Medsafe (New Zealand) and the Paul Ehrlich Institut (Germany) that allow for sharing of a broad range of confidential information to support our regulatory functions and underpin future collaborative activities. Continued work to finalise new collaborative arrangements with Swissmedic, the French Agency for the Safety of Health Products (ANSM) and US FDA to enhance collaboration and information sharing, including the exchange of information such as assessment reports on orphan drugs. Continued discussions with European regulators to enhance confidence in medical device assessments completed in Europe. |
Collaboration and work-sharing with other regulators | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
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Exchange of bioequivalence reports1 to support generic prescription registration | 12 | 17 | 0 |
Number of monographs developed with Health Canada to support non-prescription medicines registration2 | 2 | 0 | 0 |
Number of desktop clearances for manufacturers undertaken in place of inspections, taking into consideration regulatory decisions by other comparable regulators.3 | 2144 | 1941 | 1481 |
Work sharing and single inspections under the Medical Devices Single Audit Program (Pilot MDSAP). As it is still in pilot phase, inspections under the MDSAP are yet to commence.4 |
N/A | N/A | N/A |
Number of post-market signals for prescription medicines received from international regulators during the reporting period to trigger appropriate early warnings. | 0 | 1 | 0 |
Version 1.0, August 2015
Internal reviews are undertaken when someone affected by a decision requests a review of the decision by the TGA under Section 60 of the Therapeutic Goods Act 1989. In some cases, external review of TGA decisions by the Administrative Appeals Tribunal (AAT) is requested.
Internal and external review of TGA decisions | Jan - Jun 2015 | Jul - Dec 2014 | Jan - Jun 2014 |
---|---|---|---|
Internal review1 | |||
We make more than 34,000 regulatory decisions every year. Internal reviews are usually only sought on a small number of these decisions (less than 1%). | |||
Number of requests for internal review processed during the reporting period | 13 (100%) | 18 (100%) | 25 (100%) |
Regulatory decisions subject to internal review, for which the original decision is: | |||
|
9 (69%) | 9 (50%) | 15 (56%) |
|
4 (31%) | 6 (33%) | 7 (32%) |
|
0 (0%) | 2 (11%) | 0 (0%) |
|
0 (0%) | 1 (6%) | 3 (12%) |
External review | |||
Number of matters referred to the AAT, where the outcome is indicative of an issue about quality of the initial decision.3 | 0 (0%) | 1 (25%) | 0 (0%) |