Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017

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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 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

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:

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 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.

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.

Self-assessment rating and summary of overall performance

KPI	Comments	Our ongoing focus for 2017-18
KPI 1 Met Regulators do not unnecessarily impede the efficient operation of regulated entities	This rating is based on extensive formal and informal consultation and participation in industry events. We implemented business improvements based on the feedback we received through consultation with industry, resulting in less impost on industry in meeting regulatory requirements. We implemented a number of initiatives associated with business improvement and in response to MMDR recommendations that have been co-designed and influenced through engagement with key stakeholders.	We will continue to focus on providing extensive informal and formal consultation opportunities for regulated entities to ensure that we do not unnecessarily impede their efficient operation. We will ensure that our consultation is appropriately targeted and that industry comments on changes to regulatory practice are appropriately considered.
KPI 2 Substantially met Communication with regulated entities is clear, targeted and effective	While the majority of our deliverables under this KPI were met we did not meet all our timeframes for application audits on medical devices. The timeframes are not mandated through legislation but are self-imposed. The legislated timeframes for medical device conformity assessments were met in all cases.	We will continue to strive to process applications (including auditing of medical devices) within target timeframes while providing consistency in decision making. We will continue to deliver regulatory information in a clear, targeted and effective manner through consultations or online publications and other means.
KPI 3 Met Actions undertaken by regulators are proportionate to the regulatory risk being managed	This rating is based on our risk based approach to the regulation of therapeutic products. We have continued to develop risk based frameworks aimed at enhancing voluntary compliance by regulated entities. Our approach to risk is proportionate to the risk regulated. We monitor signals of non-compliance and base our intervention on compliance history.	We will continue to provide transparency with respect to our regulatory compliance activities by publishing the outcomes of the activity undertaken. Internal system improvements will reduce our reliance on requests for information where we already hold information relevant to an application.
KPI 4 Substantially met Compliance and monitoring approaches are streamlined and coordinated	This rating is based on our maturing compliance and enforcement framework. We have established an intelligence team, and are improving our investigations and enforcement capability. To support this, new compliance and enforcement powers are proposed in Bill 2 which was introduced into Parliament on 14 September 2017.	We will embed the strategic policies developed over 2016-17 that relate to our monitoring and compliance activities. We will prioritise our activities in accordance with our Regulatory Compliance and Enforcement Plan and continue to collaborate with Commonwealth, state and territory regulators as well as our international counterparts.
KPI 5 Met Regulators are open and transparent in their dealings with regulated entities	This rating is based on our provision of clear and accurate regulatory guidance and education about our regulatory activity. We report extensively about the activity we undertake. Guidance and education activity included the launch of SME Assist, a program that supports small to medium enterprises and researchers to better understand our regulatory environment and their obligations.	We will continue to revise published regulatory guidance, including through SME Assist, to ensure it is clear, practical and useful to industry. We will provide more targeted guidance around over-the-counter and complementary medicines.
KPI 6 Met Regulators actively contribute to the continuous improvement of regulatory frameworks	This rating is based on our stakeholder engagement and self-evaluation through market research, continued improvements through MMDR and other reforms as well as interactions with other regulators.	Cooperation across the department as well as with other agencies will continue as will consultation through Regulatory Impact Statements. We will look for opportunities to improve our engagement with consumers and other stakeholders, including our international counterparts, in order to ensure confidence in the efficacy, safety and quality of therapeutic goods in Australia.

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