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Regulator Performance Framework: Self-assessment Report, July 2018 to June 2019

2018-19 Performance Reporting

20 December 2019

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

Measures/metrics Evidence (performance in 2018-19)

KPI 5.1

Regulators' risk‑based frameworks are publicly available in a format which is clear, understandable and accessible.

We publish specific information detailing how we apply a risk-based framework to compliance activity. We continually review and update the content available on our website to ensure readability and understanding.

We have targeted information available on our website for SMEs, start-ups, researchers and those unfamiliar with therapeutic goods regulation. The SME Assist web resources are designed to assist these industry stakeholders in navigating regulatory requirements and meeting their compliance obligations. New resources added over the reporting period include educational decision tools such as 'What do I require to have a listed medicine in the ARTG'.

We have also made adopted international ICH/EU guidance more transparent by providing a searchable database, as well as improving the accessibility by reformatting prescription medicines registration guidelines.

Self‑assessed rating: Met

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.

We utilise a number of different media for communicating with regulated entities including email, website information, Facebook and offering a first contact point Regulatory Assistance Section (RAS) that manages our central enquiry lines. We are looking to enhance the enquiry management system used by RAS to improve the stakeholder experience.

During the reporting period, RAS managed 24,220 telephone and email enquiries; 27% from industry and regulated entities, 22% from health professionals, 41% from the public and the remainder from other stakeholders.

94% of all enquiries received by RAS during the reporting period met the timeframes outlined in the TGA Customer Service Standards, i.e. to acknowledge emails within 5 working days and respond to voicemail messages within two working days. The failure to meet response timeframes in all cases was due to staffing shortages in the last quarter of 2018, and is why we have rated ourselves as only 'substantially met' against this KPI. 81% of enquiries received over the period October to December 2018 met timeframes. This issue was resolved and over 98% of enquiries received between January to June 2019 met timeframes.

SME Assist responded to 150 emails enquiries, in addition to those relating to specific events - a 65% increase from the previous reporting period.

There were 79,000 visitors to the SME Assist web pages (up 11% from 2017-18). These pages provide tailored information to those new to therapeutic goods regulation.

Formal and informal stakeholder interactions are detailed in KPI 1.1.

Self‑assessed rating: Substantially met

KPI 5.3

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

We publish a number of reports annually detailing our performance and activities. These reports meet the Australian Government reporting requirements and provide transparency of our activities. The following reports are available on the Health and TGA websites:

  • July to December Half Yearly Performance Snapshot (March)
  • Database of TGA Laboratory Testing Results (May and November)
  • Annual Health Portfolio Budget Statements (May)
  • July to June Annual Performance Statistics Report (October)
  • Department of Health Annual Report (October)
  • Annual Stakeholder Survey (December)
  • Annual Regulator Performance Framework Self-Assessment Report (December)

Self‑assessed rating: Met

External validators agreed that we have consistently been open and transparent through all forms of communication, and agreed with our self-assessed rating of 'substantially met'. Stakeholder feedback encouraged us to be more proactive in communicating changes in milestone dates, which would assist industry more broadly.

Identified opportunities for improvement

We will continue to publish performance and activity reports, as well as regularly revise and update guidance material, to enable transparency to our stakeholders. We will also review our reporting activities to examine if we can provide more specific detail relevant to industry, such as milestone data.

We will also to continue to uphold our Customer Service Standards, including the timely management of telephone and email enquiries, and ensuring that our responses are clear and easy to understand. We will continue to review our Customer Service Standards and consult with industry to resolve these issues for future interactions.

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