Publication of the 2016-17 TGA Stakeholder Survey results
The 2016-17 Stakeholder Survey report has now been published.
This annual survey aims to measure our performance in a range of areas and informs part of our KPI report.
During the process of preparing the survey findings for publication, we identified some minor discrepancies in the survey data, however these were already published in the KPI report in late 2017.
The discrepancies were as follows:
- We reported that invites were sent to 20,214 stakeholders to complete the survey, however the correct figure is 21,214.
- We reported that 51% of health professionals found consultations very useful, however the correct figure is 42%. This does not impact on the KPI rating of 'met' (KPI 6).
We have amended the KPI report to reflect the correct information.
On this page: About the Therapeutic Goods Administration | Regulator Performance Framework
About the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is part of the Department of Health and is responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose. Approved therapeutic goods can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.
The TGA is responsible for ensuring that 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 2017 there were 87,258 therapeutic goods on the ARTG.
The TGA regulates the supply of:
- medicines prescribed by a doctor or dentist
- medicines available in the pharmacy
- medicines available from other 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
- other products that make therapeutic claims.
We also play a regulatory role in overseeing the manufacturing and advertising of therapeutic goods.
More information about how therapeutic goods are regulated in Australia can be found on our website.
Overview for 2016-17
In 2016-17 we continued to deliver world-class regulation of therapeutic goods, contributing to better health outcomes for Australians[1]. We began implementing the response to the Review of Medicines and Medical Devices Regulation (MMDR), announced in the 2016-17 Budget. The first legislative changes to implement the reforms were enacted in June 2017. A major challenge was commencing the implementation of regulatory reform, while maintaining core activities associated with providing high quality regulation of therapeutic goods in Australia. This challenge is expected to continue in 2017-18 as implementation of regulatory reform continues.
Regulator Performance Framework
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The Australian Government has developed a framework to measure the performance of regulators. The Regulator Performance Framework (the Framework) comprises six outcomes-based key performance indicators (KPIs) to articulate the Government's overarching expectations of regulator performance:
- Regulators do not unnecessarily impede the efficient operation of regulated entities
- Communication with regulated entities is clear, targeted and effective
- Actions undertaken by regulators are proportionate to the regulatory risk being managed
- Compliance and monitoring approaches are streamlined and coordinated
- Regulators are open and transparent in their dealings with regulated entities
- Regulators actively contribute to the continuous improvement of regulatory frameworks.
These KPIs are supported by measures of good regulatory performance to assist regulators in assessing their achievement against the KPIs.
The Framework aims to encourage regulators to undertake their functions with the minimum impact necessary to achieve regulatory objectives and to effect positive ongoing and lasting change within regulators. The Framework allows regulators to report objectively on the outcomes of their efforts to administer regulation fairly, effectively and efficiently.
The Framework has applied since 1 July 2015, with the first assessment period being the 2015-16 financial year. Our reports are published annually on the TGA website. Further information on the Government's Framework is available at: Regulator Performance Framework - external site.
Self-assessment against the Framework
Each year, regulators are required to undertake a process of self-assessment against the KPIs provided in the Framework. The Framework also includes a series of measures that assist in explaining how regulators may assess themselves against the KPIs. Underneath the measures, we have developed further metrics that detail how we interpret the KPIs and measures.
We are required to align some of these against our legislated requirements under the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.
At the conclusion of this year's reporting period we gathered evidence in support of the metrics and measures that represent our performance against the KPIs. This evidence was gathered from multiple data sources including published advice on our website, market research, public consultations, and international and domestic stakeholder forums.
Using the evidence collected, we assessed ourselves against the KPIs, giving ourselves a rating of met, substantially met or not met.
We provided our draft self-assessment report to our external validator, the TGA Industry Forum (comprised of industry peak bodies) to provide their assessment of our performance during the reporting period. We examined their feedback in detail.
We then finalised and published this report, identifying both our self-assessment rating, the feedback provided by our external validator and opportunities for improvement in the next reporting period.
In this way, we continually improve as a regulator and enhance our responsiveness to our regulated entities. process benefits both the therapeutic goods industry and the Australian public.
Self-assessment rating at a glance in 2016-17
Using the following performance ratings, we have self-assessed against the KPIs provided in the Regulator Performance Framework.
Performance rating key
![]() KPI met Strong performance against all of the measures under the KPI. |
![]() KPI substantially met Strong performance against most of the measures under the KPI. |
![]() KPI not met Poor performance against all of the measures under the KPI. |
![]() External validation Comments received from our external validators (TGA Industry Forum). |