Regulator Performance Framework: Self-assessment Report, July 2018 to June 2019
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 behind the pharmacy counter
- medicines available in the general pharmacy
- medicines available from retail outlets
- complementary medicines, including 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 biologicals (cells and tissues).
We also play a regulatory role in overseeing the manufacturing process and advertising of therapeutic goods in Australia.
More information about how therapeutic goods are regulated can be found on our website.
Overview for 2018-19
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.
In 2018-19 we continued to progress the implementation of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR) as announced in the 2016-17 Budget. Implementing the Government's reforms provides a number of opportunities for improving therapeutic goods regulation and reducing regulatory burden for industry.
Key program milestones achieved in the 2018-19 financial year include: the commencement of the new Therapeutic Goods Advertising Code; the TGA commencing as the single body responsible for handling advertising complaints; an integrated system for acceptance, administration and evaluation of all ingredient applications for listed medicines; commencement of a review of the marketing authorisation process for generic prescription medicines; and establishing the medicine shortages information initiative.
Regulator Performance Framework
The Australian Government is committed to reducing the cost of unnecessary or inefficient regulation imposed on business, community organisations and individuals. The Regulator Performance Framework (RPF) establishes a common set of performance measures for the comprehensive assessment of regulator performance and their engagement with stakeholders. The way regulators administer regulations can have a major effect on the burden imposed, and therefore the framework aims to encourage regulators to undertake their functions with the minimum impact necessary to achieve regulatory objectives.
The RPF comprises six outcomes-based Key Performance Indicators (KPIs) and associated measures. The KPIs articulate the Government's overarching expectations of regulator performance, namely that:
- 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 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.
Under the RPF, regulators are required to undertake an annual self assessment of regulatory performance against the six KPIs.
The metrics used to assess performance are a mix of qualitative and quantitative measurements that have been agreed through a ministerially approved stakeholder consultation mechanism, and approved by the Minister.
External validation
The results of this self-assessment are required to be validated by the TGA Industry Forum (TIF) as the approved stakeholder consultation mechanism.
The TIF is comprised of industry peak bodies. They provide assessment of our performance during the reporting period and all feedback is considered in detail.
Certification by the Accountable Authority
The self assessment is required to be certified by the Secretary of the Department of Health as the Accountable Authority under the Public Governance, Performance and Accountability Act 2013 and the Therapeutic Goods Act 1989.
| Met | Substantially met | Not met |
| Strong performance against all of the measures under the KPI | Strong performance against most of the measures under the KPI | Poor performance against all of the measures under the KPI |
| Regulator Performance Framework KPIs | Ratings for 2018-19 | |
|---|---|---|
| KPI 1 | Regulators do not unnecessarily impede the efficient operation of regulated entities. | Met |
| KPI 2 | Communication with regulated entities is clear, targeted and effective | Met |
| KPI 3 | Actions undertaken by regulators are proportionate to the regulatory risk being managed. | Met |
| KPI 4 | Compliance and monitoring approaches are streamlined and coordinated. | Met |
| KPI 5 | Regulators are open and transparent in their dealings with regulated entities. | Substantially met |
| KPI 6 | Regulators actively contribute to the continuous improvement of regulatory frameworks. | Met |
Overall assessment
Using the above performance ratings, targets have been met for most measures under the six KPIs.
Our performance and activities continue to be reported through various publications available on the Health and TGA websites. We also raised awareness of our regulatory framework with stakeholders through meetings, workshops, webinars, publication of materials on our website, social media promotion and improved response times to email and phone enquires. Our commitment to the TGA Customer Service Standards is an ongoing project. We have not yet reached 100% in terms of timeliness of our responses which has resulted in our self-assessment for KPI 5 being maintained as 'Substantially met'.
We have engaged with stakeholders at all levels, providing information and assistance for the ongoing operation of their relevant regulated entities. We expanded our engagement with Small to Medium Enterprises (SMEs) with SME Assist, allowing more opportunities for sponsor understanding and input to be provided into TGA processes.
The establishment of the TGA Facebook page has expanded the way we communicate, and helped us emphasise our commitment to being open and transparent as a regulator. During the reporting period we also hosted webinars, targeted and public consultation, and provided eLearning and contemporary guidance material through our website to assist our stakeholders to navigate changes to regulations. We also continued to publish the results of consultations on the TGA website.
We have utilised risk-based models in areas such as advertising, recalls and product testing, to minimise impact on regulated entities. We continued to monitor potential non-compliance, and considered emerging trends and compliance history when undertaking intervention.
Our ongoing collaboration with international regulators, as well as various state and territory bodies, has streamlined our compliance and monitoring activities in areas such as breast implants, manufacturing inspections, and medicine shortages.
We supported and educated our stakeholders by working collaboratively with the industry through business improvements and the implementation of new reforms. Our annual stakeholder survey had an increased response rate from medical professionals and the industry, the results of which help us provide better regulatory advice and services in the future.
In 2018-19, the annual bilateral meetings with peak industry bodies to consult on fees and charges were extended to four additional peak bodies. In addition, a consultation paper on proposed fees and charges for 2019-20 was also released publicly to provide opportunity for wider industry and other stakeholders' comments.
Opportunities for improvement
The self assessment process highlighted areas of ongoing focus for continuous improvement in our regulatory performance.
In 2019-20 we will continue to increase our engagement and strengthen our relationships with regulated entities and peak industry bodies. To remain competitive globally and to reduce duplication in the regulatory review of products, we will also continue to collaborate with our international regulatory counterparts on information, work sharing, and work collaboration activities.
We will continue to implement regulatory reforms, as well as maintaining our core activities associated with providing high quality regulation of therapeutic goods in Australia.