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TGA key performance indicators: July 2015 to June 2016
KPI 5 Regulators are open and transparent in their dealings with regulated entities
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 publish detailed and user friendly information on the way we apply our risk-based frameworks and this information is updated in response to emerging issues. KPI 3.2a outlines how our risk framework is made available to the public.
We have continued to direct efforts towards raising awareness of our regulatory framework through activities such as industry workshops and publication of educational materials.
5.1b Information on the TGA's regulatory compliance framework published on the TGA website, with evidence of systems for regular review and updates.
Our Regulatory Compliance Framework outlines to stakeholders how we manage our compliance function under legislation.
We employ a combination of monitoring strategies to support our compliance program, which enables us to apply flexible and proportionate responses to non-compliance, as well as proactively encourage compliance and manage 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.
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, with our Regulatory Assistance Section (RAS) managing the central telephone, email, fax and letter enquiry lines. During the reporting period 28,035 enquiries were received by the RAS, of which 40% were from industry. Where responses were provided by the RAS, all enquiries from industry were responded to within the timeframes outlined in our customer service standards, i.e. to acknowledge letters and emails within five working days and respond to voice mail messages within two working days.
5.2b Information on interactions with industry.
Please refer to KPIs 1.1a and 1.1b, which provide detailed information on the formal and informal interactions with industry stakeholders 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 regularly report on performance activities through:
- Half Yearly Performance Snapshot - July to December 2015
- Performance Statistics Report (annual)
- Regulator Performance Framework KPI report (annual) from 2016
- input to the Health Portfolio Budget Statements (annual)
- input to the Department of Health Annual Report (annual)
- Prescription Medicines Annual Summaries (annual)
- reports for statutory advisory committees (as required).
During the reporting period we commenced a review of our reporting framework, including consultation with industry, to gather a holistic view of the reports that are provided. The aim of this review was to develop a reporting framework that aligns with relevant Australian Government reporting requirements as well as the interests and needs of our stakeholders, and to ensure that the effort required to produce the report is a valuable investment of resources.
Through the review of our reporting framework, we now publish the Half Yearly Performance Report Snapshot - July to December 2015 in digital format. The new digital format offers animation and interactivity to provide users with an improved understanding of the content through the use of plain language.
We have also established a framework of program and project reporting governed by program and project boards to ensure appropriate oversight of key business improvement projects. These reports are delivered on a weekly, monthly, six-monthly and annual basis.
|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|