On this page: About the Therapeutic Goods Administration | Overview for 2017-18 | Regulator Performance Framework | Self-assessment against the 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.
Products for which therapeutic claims are made are entered on the Australian Register of Therapeutic Goods (ARTG).
Some examples of goods that the TGA regulates the supply of include:
- medicines prescribed by a doctor or dentist
- medicines available from supermarkets, the general pharmacy or from behind the pharmacy counter
- vaccines
- complementary medicines, including vitamins, herbal and traditional medicines
- medical devices, from simple devices like bandages to complex technologies like heart pacemakers
- tampons and disinfectants
- products used to test for various diseases or conditions (in vitro diagnostic devices (IVDs)), such as blood tests
- blood, blood components and biologicals (cells and tissues).
We also play a regulatory role in overseeing manufacturing processes in Australia and overseas, and advertising of therapeutic goods.
More information about how therapeutic goods are regulated can be found on our website.
Overview for 2017-18
In 2017-18 we continued to progress the implementation of the Australian Government's response to the Review of Medicines and Medical Devices Regulation (MMDR) as announced in the 2016-17 Budget, and have enacted multiple changes to our legislation to enable this transition.
Balancing the demands of regulatory reform while maintaining our core business of providing high quality regulation of therapeutic goods in Australia continues to be both a challenge and a priority. Some highlights from this reporting period include reforming our orphan drug program, creating a new Special Access Scheme (SAS) pathway, implementing new provisional approval and priority review pathways for prescription medicines, and improving our international synergy and cooperation activities with overseas regulators.
Regulator Performance Framework
The Australian Government has developed a framework to measure the performance of regulators. The Regulator Performance Framework - external site (the Framework) comprises six outcomes-based key performance indicators (KPIs) as listed below 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 will allow 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.
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 includes a series of measures 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 the reporting period we gather 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 this evidence, we assess ourselves against the KPIs, giving a rating of met, substantially met or not met.
We provide our draft self-assessment report to our external validator, the TGA Industry Forum (TIF), comprised of industry peak bodies, to provide their assessment of our performance during the reporting period. All feedback is considered in detail.
The report is then finalised and published on the TGA website, identifying our self-assessment rating, the feedback provided by our external validator, and opportunities for improvement in our next reporting period.
In this way, we continually improve as a regulator and enhance our responsiveness to our regulated entities. This process benefits both the therapeutic goods industry and the Australian public.
Self-assessment rating at a glance in 2017-18
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). |