TGA key performance indicators: July 2015 to June 2016

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14 November 2016

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) as listed below to articulate the Government’s overarching expectations of regulator performance:

  1. Regulators do not unnecessarily impede the efficient operation of regulated entities
  2. Communication with regulated entities is clear, targeted and effective
  3. Actions undertaken by regulators are proportionate to the regulatory risk being managed
  4. Compliance and monitoring approaches are streamlined and coordinated
  5. Regulators are open and transparent in their dealings with regulated entities
  6. 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 Framework has applied since 1 July 2015, with the first assessment period being the 2015-16 financial year. Our reports will be published annually on the Therapeutic Goods Administration (TGA) website. Further information on the Government's Framework is available at: Regulator Performance Framework.

Assessing our achievement of the KPIs

In consultation with our stakeholders through the TGA Industry Consultative Committee (TICC) and the Australian Therapeutic Goods Advisory Council, an agreed set of TGA specific qualitative and quantitative outputs and evidence against the Government's KPIs were developed to assess our achievement. These KPIs were endorsed by the then Assistant Minister and published on our website in June 2015. The evidence metrics are specified under each of the KPIs and form the basis of our self-assessment.

In preparing our self-assessment against the KPIs multiple data sources were utilised, including:

  • published advice on our website
  • stakeholder surveys
  • public consultations
  • market research
  • business improvement activities
  • international and domestic stakeholder forums.

Our self-assessment was externally validated in September 2016 by the TICC, which comprises industry and consumer representatives.

General feedback from TICC members was positive, supporting our self-assessment overall and agreeing there is sufficient evidence to support our performance ratings for KPIs 2 to 6. In relation to KPI 1, some members suggested that a performance rating of substantially met would be more appropriate, as the evidence did not adequately demonstrate the performance rating of met.

Members noted their appreciation of our efforts in stakeholder engagement, communication and ongoing business improvements.

In terms of feedback on whether the self-assessment process provided sufficient, reliable and current evidence to support our overall performance rating of met, TICC members either agreed or somewhat agreed. Members noted that this is the first report of its kind, and although the majority of the evidence matrices are appropriate and an effective tool for assessing our compliance against the KPIs, the matrices should be subject to continuous improvement to ensure relevance.

Summary of our performance in 2015-16

Self-assessed rating of overall performance

Overall we met the requirements of the Framework through meeting KPIs 1, 3, 5 and 6 with 'strong performance' against these measures and through substantially meeting KPIs 2 and 4. A brief summary is provided blow.

Self-assessment rating and summary of overall performance
KPI Performance rating Comments
KPI 1. Regulators do not unnecessarily impede the efficient operation of regulated entities Met

The performance rating of met is supported by successful participation in formal stakeholder forums and participation at industry events. This has led to smaller face-to-face workshops and increased opportunities for our staff to improve their knowledge of emerging technologies and provide industry with an opportunity to increase understanding of our regulatory requirements.

Additionally, we have implemented a number of initiatives under the Business Improvement Program aimed at reducing compliance costs to industry.

KPI 2. Communication with regulated entities is clear, targeted and effective Substantially met The performance rating of substantially met is based on medical device timeframes for application audits not being met, although these timeframes are not mandated in legislation. The legally-mandated timeframes for medical device conformity assessment were met in 100% of cases.
KPI 3. Actions undertaken by regulators are proportionate to the regulatory risk being managed Met

The performance rating of met is supported by our risk management approach in regulating therapeutic products, including identifying entities at risk of unintentional or deliberate non-compliance, and the collection of intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

Evidence of actions undertaken by regulators that are proportionate to the regulatory risk is also outlined in our laboratories targeted testing of medicines and medical devices according to the risk they pose to the public, monitoring of the market for signals of potential non-compliance and the scheduling of manufacture inspections based on compliance records.

Additionally, we can communicate regulatory requirements and compliance expectations quickly and directly to market-entry applicants.

KPI 4. Compliance and monitoring approaches are streamlined and coordinated Substantially met The performance rating of substantially met is because we do not yet have a fully mature compliance and enforcement framework with graduated sanctions and penalties. While we have a sound compliance structure in place, we do not yet have a range of regulatory tools which allow us to use the full range of compliance approaches.
KPI 5. Regulators are open and transparent in their dealings with regulated entities Met

The performance rating of met is demonstrated through our continued efforts towards raising awareness of our regulatory framework through industry workshops and the publication of educational material, as well as maintaining telephone and email based information lines.

We also publish regular performance activity reports on our website.

KPI 6. Regulators actively contribute to the continuous improvement of regulatory frameworks Met The performance rating of met is supported by our stakeholder engagement through market research, continued business improvements and interactions with other regulators.

Additional reporting

The reporting provided through these KPIs focuses on our performance as a regulator and our engagement with our stakeholders, however we will continue to produce other reports with more detailed information about our regulatory and corporate activities. These reports include the:

These reports are publicly available and can be read in conjunction with the KPIs.

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