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TGA key performance indicators and measures: Regulator Performance Framework
Introduction
Regulator Performance Framework
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 of 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 new Framework will apply from 1 July 2015 - with the first assessment period being the 2015-16 financial year. Further information on the Framework is available at: Cutting Red Tape: Regulator Performance Framework.
Assessing our achievement of the KPIs
In consultation with the TGA Industry Consultative Committee (TICC) and the Australian Therapeutic Goods Advisory Council, we have developed a series of qualitative and quantitative outputs and evidence to assess our achievement of the six KPIs and associated measures.
The first report assessing our achievement of the KPIs will be available following completion of the first assessment period (2015-16 financial year), and then annually thereafter. These annual reports will replace the previous TGA KPI reports published twice yearly.
These reports will focus on our performance as a regulator and our engagement with stakeholders. We will, however, continue to produce other reports with more detailed information about our regulatory and corporate activities, including:
- The half-yearly performance reports
- The TGA annual business plan
These are available on the TGA website and can be read in conjunction with the reports that will be produced against the Framework KPIs.
Our role and our stakeholders
We are a partner in the National Medicines Policy with a major role in ensuring the quality, safety and efficacy of medicines. We are committed to working with our partners under the policy towards better health outcomes for the Australian population. Consumers and health professionals are key stakeholders, as well as the members of the therapeutic goods industry.
In addition to this, our overarching mission is to:
...safeguard and enhance the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989.
As part of the Department of Health we work collaboratively with a number of other areas of the department towards achieving our collective vision of better health and wellbeing for all Australians.
While the purpose of the Framework is to encourage regulators to minimise the impact of carrying out their regulatory objectives, with a particular focus on the regulated industry, we have a broader remit, as outlined above. Therefore, we have developed outputs and activity-based evidence as required by the Framework, as well as additional outputs to demonstrate that we are fulfilling our public health and safety obligations.
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- The best evidence for this measure is reporting on possible issues with individual regulatory decisions made at the TGA, which are usually identified through legislative review processes.
- Substantive regulatory decisions include decisions:
- to not include products on the Australian Register of Therapeutic Goods (the Register)
- to remove products from the Register
- to grant or revoke a manufacturing licence or conformity assessment certificate.
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Version | Description of change | Author | Effective date |
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V1.0 | Original publication | Regulatory Engagement, Education and Planning Branch | May 2015 |