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Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018

19 December 2018

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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 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 supermarkets, the general pharmacy or from behind the pharmacy counter
  • vaccines
  • complementary medicines, including vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • tampons and disinfectants
  • products used to test for various diseases or conditions (in vitro diagnostic devices (IVDs)), such as blood tests
  • blood, blood components and biologicals (cells and tissues).

We also play a regulatory role in overseeing manufacturing processes in Australia and overseas, and advertising of therapeutic goods.

More information about how therapeutic goods are regulated can be found on our website.

Overview for 2017-18

In 2017-18 we continued to progress the implementation of the Australian Government's response to the Review of Medicines and Medical Devices Regulation (MMDR) as announced in the 2016-17 Budget, and have enacted multiple changes to our legislation to enable this transition.

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. Some highlights from this reporting period include reforming our orphan drug program, creating a new Special Access Scheme (SAS) pathway, implementing new provisional approval and priority review pathways for prescription medicines, and improving our international synergy and cooperation activities with overseas regulators.

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) as listed below 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 will allow 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.

Self-assessment against the Framework

Self-assessment steps: KPIs, Measure, Evidence, Self assessment, External validation, Review based on feedback, PublicationEach year, regulators are required to undertake a process of self-assessment against the KPIs provided in the Framework. The Framework includes a series of measures 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 the reporting period we gather 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 this evidence, we assess ourselves against the KPIs, giving a rating of met, substantially met or not met.

We provide our draft self-assessment report to our external validator, the TGA Industry Forum (TIF), comprised of industry peak bodies, to provide their assessment of our performance during the reporting period. All feedback is considered in detail.

The report is then finalised and published on the TGA website, identifying our self-assessment rating, the feedback provided by our external validator, and opportunities for improvement in our next reporting period.

In this way, we continually improve as a regulator and enhance our responsiveness to our regulated entities. This process benefits both the therapeutic goods industry and the Australian public.

Self-assessment rating at a glance in 2017-18

Using the following performance ratings, we have self-assessed against the KPIs provided in the Regulator Performance Framework.

Performance rating key

Icon: KPI met

KPI met

Strong performance against all of the measures under the KPI.

Icon: KPI substantially met

KPI substantially met

Strong performance against most of the measures under the KPI.

Icon: KPI not met

KPI not met

Poor performance against all of the measures under the KPI.

Icon: External validation

External validation

Comments received from our external validators (TGA Industry Forum).

Self-assessment rating and summary of overall performance

KPI Comments Our ongoing focus for 2018-19

KPI 1

Met

Regulators do not unnecessarily impede the efficient operation of regulated entities

Icon: KPI met

We held regular formal stakeholder forums and participated in industry events as well as senior executive meetings with peak bodies such as:

  • the Australian Self Medication Industry
  • Medical Technology Association of Australia
  • CMA and stakeholder meetings with technical working groups.

We hosted a workshop for small to medium businesses 'Meeting Your Obligations' at the Good Manufacturing Practice (GMP) Forum, and implemented a number of initiatives through the Business Improvement Program.

We will continue to work with industry to improve the efficiency and transparency of processes through formal stakeholder engagement and other appropriate forums.

KPI 2

Met

Communication with regulated entities is clear, targeted and effective

Icon: KPI met

We communicated through webinars and other forums, delivery of changes to the therapeutic goods advertising framework through extensive targeted and public consultations, and changes to the regulation of autologous human cell and tissue products.

We will continue to work towards processing applications within specified timeframes while providing effective communication through

  • update of guidance documents to improve clarity of the regulatory requirements
  • educational activities to improve awareness and understanding of the therapeutic goods advertising requirements
  • ongoing support to providers during the transition period for changes to the regulation of autologous human cell and tissue products.

KPI 3

Met

Actions undertaken by regulators are proportionate to the regulatory risk being managed

Icon: KPI met

We took a risk-based approach which was proportionate to the therapeutic products we regulate.

We continued to monitor signals of non-compliance and considered compliance history when undertaking intervention.

We continued to triage and prioritise advertising complaints based on the risk that the advertising could pose to public health and safety.

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

Met

Compliance and monitoring approaches are streamlined and coordinated

Icon: KPI met

We have built a Case Categorisation and Prioritisation Model to ensure consistent triaging and risk based responses to alleged breaches of the Therapeutic Goods Act 1989.

A new notifications process for very low risk variations to biologicals and to the registered medicines was introduced, allowing the use of a single electronic form to request certain types of changes to a medicine.

We will continue to consult with our stakeholders on improvements relating to reporting medical device adverse events.

We will continue to collaborate with our international colleagues and explore opportunities to utilise existing information. We will align our processes with international best practice whenever possible.

KPI 5

Substantially met

Regulators are open and transparent in their dealings with regulated entities

Icon: KPI substantially met

We continued to raise awareness of our regulatory framework through our various interactions with industry and other stakeholders through workshops, publication of educational material, engaging with the TGA Industry Forum, and maintaining our telephone and email enquiry lines.

In addition, we published monthly and annual performance reports on our website.

We have rated ourselves as 'substantially met' against this KPI because we did not meet the TGA Customer Service Standards in all cases when responding to email and telephone enquiries. This was partly due to the transition to a new enquiry management system, which resulted in some enquiry data being lost during the July-September 2017 period.

To provide transparency to our stakeholders, we will continue to publish performance and activity reporting on our website, as well as revise and update regulatory guidance material.

We will continue to develop our enquiry management system to ensure timely management of telephone and email enquiries.

KPI 6

Met

Regulators actively contribute to the continuous improvement of regulatory frameworks

Icon: KPI met

We maintained high levels of stakeholder engagement through market research, continued business improvements as well as interactions with other Government Departments and comparable regulators.

We have implemented a number of reforms, including streamlining the advertising framework.

A new electronic notifications process for very low risk variations to prescription medicines was introduced in late 2017. This followed the earlier introduction of a similar process for non-prescription registered medicines. TGA approval for these variations is made automatically, if the application passes electronic validation and payment is received, reducing compliance costs and approval times.

We implemented an improved streamlined and coordinated approach to the implementation of the new provisional approval pathway for the registration of prescription medicines, providing earlier access to certain new medicines.

We will continue to provide ongoing support and education to providers during the transition period for changes to regulations, for example, autologous human cell and tissue products.

We will continue to improve our engagement with consumers and other stakeholders to ensure confidence in the efficacy, performance and quality of therapeutic goods in Australia. This will include actively responding to feedback provided in our annual stakeholder survey.

We will continue to review and update the Case Categorisation and Prioritisation Model to align with best practice compliance and monitoring approaches.

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