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

26 April 2018

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KPI 5 Regulators are open and transparent in their dealings with regulated entities

KPI met The self-assessment rating of met is based on our continued provision of clear and accurate regulatory guidance and education about our regulatory activity. We report extensively about the activity we undertake.
External validation Our external validators mostly agreed that we provide clear and accurate regulatory guidance and education, citing the clinical evidence guideline and the SME portal as positive examples.
KPI 5.1 Regulators' risk-based frameworks are publicly available in a format which is clear, understandable and accessible.


Strong internal governance framework to support our risk and compliance activity.

Review of the Scheduling Policy Framework in consultation with the Commonwealth, states and territories.

KPI 5.2 Regulators are open and responsive to requests from regulated entities regarding the operation of the regulatory framework, and approaches implemented by regulators.

Addressing approximately 180,000 public and industry enquiries through our information lines.

Launch of SME Assist.

KPI 5.3 Regulators' performance measurement results are published in a timely manner to ensure accountability to the public.

Publication of performance reports for 2016-17 including:

Annual Performance Statistics Report

Half Yearly Performance Snapshot

Regulator Performance Framework Self‑Assessment (KPI) Report

Continuous improvement 2017-18

We will continue to provide transparency through our annual reporting.

We will provide regulatory assistance and improve our capacity to respond to enquiries. As we strengthen our regulatory guidance we anticipate greater compliance with regulatory requirements.

KPI 5.1 Regulators' risk-based frameworks are publicly available in a format which is clear, understandable and accessible

5.1a Refer to KPI 3.2 – Information on the TGA's risk framework published on the TGA website.

We support an open and transparent regulatory framework and continuous improvement as a regulator by providing ample opportunity for industry to provide feedback on our processes. We publish extensively on our website, making guidance and support available to assist with voluntary compliance as well as reporting our performance against regulatory performance timeframes and internally set targets.

We publish specific information detailing how we apply a risk based framework to compliance activity. Internally, we govern risk through our Regulatory Practice Committee and Regulatory Compliance Committee. We also provide regular updates on regulatory risk to the Department of Health Audit and Risk Committee. We continue to invest in providing education and transparency about the regulatory framework through our website, social media profile, industry workshops, hotlines and the publication of educational material.

The Scheduling Policy Framework (SPF) governed by the Australian Health Ministers' Advisory Council provides guidance on the factors to be considered in a risk/benefit analysis for decision-makers within the Department of Health in the scheduling processes. The SPF is published on our website and is being reviewed as part of MMDR reforms.

Our therapeutic product vigilance activities are increasing as part of MMDR reforms. In February 2017 we introduced Therapeutic Product Vigilance Guidelines, which are available on the TGA website. The guidelines clearly outline our processes relating to product vigilance and the interaction of risk throughout the product lifecycle to support health product vigilance and benefit-risk management.

During 2016-17 we developed an Orphan Drug Framework which laid the foundations for an improved Orphan Drug Program. The objectives of the program are to provide incentives to sponsors to bring medicines for a small population to market and make medicines available to patients who would not otherwise be able to access them.

5.1b Information on the TGA's regulatory compliance framework published on the TGA website, with evidence of systems for regular review and updates.

We publish our Regulatory Compliance Framework on the TGA website. We also publish the following types of compliance information:

  • Compliance undertakings
  • Court actions
  • Cancellations
  • Suspensions
  • Complaints about advertisements
  • Regulatory decisions and notices.

We employ a combination of monitoring strategies post-market to support our compliance program, which enables us to apply flexible and proportionate responses to non-compliance, as well as proactively encouraging compliance and managing emerging issues. This is achieved through our continued communication strategies, ongoing publication of safety updates and workshops with industry on effective risk minimisation activities to improve the quality of risk management plans submitted with their applications for high risk medicines or vaccines.

Our regulatory compliance environment has been subject to extensive consideration through the review of Medicines and Medical Devices Regulation resulting in improvements to our regulatory framework. We have consulted extensively with stakeholders on proposed legislative reforms. With the passage of amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 our compliance system will be given greater rigour, providing more certainty to our regulated industry.

More information about our regulatory compliance framework is provided in KPIs 3.2 and 3.3.

KPI 5.2 Regulators are open and responsive to requests from regulated entities regarding the operation of the regulatory framework, and approaches implemented by regulators

5.2a Adherence to quantitative standards of service commitments and agreed performance measures in relation to responding to enquiries received through the TGA's public information lines.

We maintain a number of telephone and email based information lines that receive enquiries from industry stakeholders. Together, these information lines have dealt with approximately 180,000 enquiries during 2016-17. Although approximate, these numbers demonstrate our high level of responsiveness to industry and the Australian public.

Our Regulatory Assistance Section manages telephone, email, fax and letter enquiry lines. During the reporting period 28,658 enquiries were received by the Section, of which 27% were from industry. Where responses were provided by the Section, 10 from industry were not responded to within the timeframes outlined in the TGA Customer Service Standards, i.e. to acknowledge letters and emails within five working days and respond to voice mail messages within two working days. This was due to emails being quarantined as possible spam resulting in a delay in the response.

SME Assist, a new service to help small and medium enterprises (SMEs) better understand and navigate therapeutic goods regulation in Australia, was launched on 9 June 2017. A key barrier for small to medium enterprises entering the industry is a lack of understanding as to what the pathways and requirements are for market authorisation and post market monitoring for therapeutic goods. SME Assist provides web-based tools, support materials and training workshops specifically targeted at SMEs and research and development groups developing new medicines and devices to help them understand their regulatory obligations.

Small to Medium Enterprise (SME) Assist

In the first three weeks of operation SME Assist received 95 registrations from small and medium businesses across the medicines and medical devices sector, as well as 1,291 visits to the new SME Assist entry-point.

The top three issues of interest have been medical devices (69), complementary medicines (55) and Over the Counter medicines (35). During the month of June, the SME Assist front page received 1,291 page views with 1,006 of these being from unique users.

The new SME Assist service has been well-received by the sector – in particular the introduction of 'decision-trees' which help small and medium business to identify and understand whether their product is considered a therapeutic good, and steps to achieve market authorisation. There was an engagement rate of 56.5% and 50.1% with the 'Is my good a therapeutic good?' and 'What classification is my medical device?' decision trees respectively. This percentage represents the number of people who landed on the page and clicked through the decision tree.

In the first three weeks of the tools becoming available, they have been used in over 200 cases to help companies understand whether therapeutic goods legislation and regulations apply to them, and point them in the right direction for further information and advice.

As part of the launch, education and training sessions were announced, the first of which is to help small and medium business to understand their regulatory obligations.

This initiative addressed issues raised as part of the MMDR review, and will directly contribute to reducing regulatory burden through helping small and medium business understand the requirements and obligations they need to meet for health products used in Australia.

Our Manufacturing Quality areas managed in excess of 10,000 enquiries in relation to GMP and requests for support or assistance from stakeholders in meeting their regulatory obligations.

We also manage a TGA Business Services (TBS) Helpdesk and a Product Billing Helpdesk. Between these two helpdesks we answered more than 50,000 enquiries.

5.2b Information on interactions with industry.

Please refer to KPIs 1.1a and 1.1b, which provide detailed information on the extensive formal and informal interactions with industry stakeholders undertaken during the reporting period.

KPI 5.3 Regulators' performance measurement results are published in a timely manner to ensure accountability to the public

5.3a Information on ongoing reporting activities including applicable timeframes.

We report on our performance and activity, in compliance with Australian Government reporting requirements, the Public Governance and Accountability Act 2013 and the interests and needs of our stakeholders through the following documents:

These reports are published on our website, or the Department of Health website. Where possible, we include an interactive component to our reporting through infographics to ensure our data is easily comprehensible.

Through these reports, stakeholders can assess our performance against government objectives, our responsiveness to industry and our efficacy against regulatory requirements.

We manage a number of advisory committees with external participants, including the:

General details of the matters considered by the Committees at each meeting are made available after the meeting through statements published on our website.

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