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TGA key performance indicators: July 2015 to June 2016

14 November 2016

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KPI 6 Regulators actively contribute to the continuous improvement of regulatory frameworks

KPI 6.1 Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework.

6.1a Market research conducted on an annual basis to measure consumer, health professional and industry trust in - and engagement with - the regulatory framework.

The information retrieved from our market surveys is utilised to ensure that we help stakeholders make more informed decisions about therapeutic goods and comply with our regulatory requirements.

During the reporting period we surveyed 449 health professionals, 65 consumers and 1,628 members of industry via a public survey to gauge each group's:

  • level of awareness of therapeutic goods regulation, the TGA and specific regulatory activities
  • perceptions and support for us
  • preferred sources of information about the regulatory system
  • previous contact with us and use of existing information services.

Key findings in relation to trust in the regulator, based on cooperative and collaborative relationships, for the three major stakeholder groups are outlined below.

Consumers Health Professionals Industry
Trust to perform role ethically and with integrity 71% 83% 87%
Provide safeguards for the health of Australians 58% 74% 77%

Stakeholders were mainly satisfied or very satisfied with our communication and consultation processes, however, overall only 50% of stakeholders felt that the TGA consulted them on relevant issues.

Consumers Health Professionals Industry
Satisfaction with communicating with the TGA 59% 57% 64%
Dissatisfaction with communicating with the TGA 22% 18% 15%
Satisfaction with consultations with the TGA 64% 63% 62%
Dissatisfaction with consultations with the TGA 0% 22% 12%

Between February and April 2016, 40 in-depth one hour interviews were conducted with industry stakeholders, including representatives from large companies as well as small to medium enterprises, to find out more about their experience of dealing with the TGA online. Interviews were conducted with people from prescription medicines, complementary and OTC medicines, devices, and manufacturing sectors.

6.1b Stakeholder engagement and satisfaction with TGA consultative processes.

Percentage of stakeholders who were satisfied or very satisfied with our consultative processes 67%
Percentage of stakeholders who were dissatisfied with our consultative processes 10%

The data for this output was obtained through the annual program of market research reported under KPI 6.1(a).

KPI 6.2 Regulators engage stakeholders in the development of options to reduce compliance costs. This could include industry self-regulation, changes to the overarching regulatory framework, or other strategies to streamline monitoring and compliance approaches.

6.2a Evidence of continuous compliance with our practice of engagement with industry before a RIS is finalised.

Industry was consulted on the two RISs finalised during the reporting period. This minimised the potential for unintended impacts on regulated entities and product supply. Refer to KPI 1.2a for more information on RIS consultation during this period.

We also engage with regulated entities prior to minor or machinery changes that may not require a RIS, such as updates to guidelines, and improvements to forms and systems used to conduct business. These consultative processes are consistent with our commitment to minimise the potential for unintended financial or resource impacts on regulated entities and product supply consultation. Refer to KPI 2.2a for information about our formal consultations during the reporting period.

Detailed information on our consultations can also be found on our website.

6.2b Progress of business improvements and other projects aimed at reducing compliance costs.

We aim to reduce compliance costs to our regulated entities by regularly engaging with our stakeholders and maintaining a cycle of continuous business improvements, including:

  • launch of the TGA Business Services website
  • transition to eCTD technical files for prescription medicines
  • introduction of the ACE scheme
  • introduction of the pre-submission pilot pathway for prescription medicines applications
  • implementation of electronic lodgement of CTN
  • ongoing development of an online application form for minor variations relating to prescription medicine applications
  • introduction of regulatory reforms to the IVD Framework (in particular, regulation of in-house IVD tests) with a transition period until 30 June 2017 for in-house IVDs.

During the period, there was progress in implementing digital prescription and OTC medicine submissions and monitoring systems including a new fee model for OTC medicines.

For more information, refer to KPIs 1.3b and 4.2a.

KPI 6.3 Regulators regularly share feedback from stakeholders and performance information (including from inspections) with policy departments to improve the operation of the regulatory framework and administrative processes.

6.3a Information on cooperation and collaboration with policy areas of our Department.

These activities included:

  • collaboration with representatives from the Office of Health Protection and Jurisdictional Immunisation Coordinators from the states and territories regarding vaccine safety issues
  • liaison with the Medical Benefits Division to support the activities of the Prostheses List Advisory Committee, including alignment of ARTG inclusions and the Prostheses List following the reclassification of joint replacement prostheses
  • working with the Best Practice Regulation Branch to provide input on regulatory reform activities, including the Review of Medicines and Medical Devices Regulation
  • representation on the World Health Organisation International Non-proprietary Names Consultations. The outcomes of the consultations and implications of the adoption of the biological qualifier were conveyed to the Pharmaceutical Benefits Division
  • collaboration with the Pharmaceutical Benefits Division and Medical Benefits Division to utilise datasets to establish mechanisms for effective post-market monitoring
  • collaboration with the Preventative Health Policy Branch on the Food-Medicine Interface Protocol
  • collaboration, in conjunction with the Pharmaceutical Benefits Division, on improving a mechanism to share information regarding prescription medicines submitted under the TGA-Pharmaceutical Benefits Advisory Committee Parallel Process. This information sharing is intended to minimise requests for information from sponsors.

6.3b Information on interactions with other Australian government departments, regulators and statutory authorities.

As part of the Health Department, we collaborate with other Australian government agencies on a range of regulatory issues to ensure a consistent approach. During the period we engaged with:

  • Food Standards Australia New Zealand, on health claims and novel ingredients
  • state and territory food authorities, regarding enquiries on products at the food-medicine interface
  • the ACCC, on safety related recalls
  • the Department of the Environment, on the rapid evaluations templates they use for chemical assessments
  • HealthPACT, reviewing new and innovative devices
  • the Department of Immigration and Border Protection, to develop targeted approaches to prevent the import and/or export of illegal therapeutic goods
  • the Department of Agriculture and the Department of Immigration and Border Protection to collaborate and share information technology design, systems and learnings
  • the Productivity Commission, on its public inquiry into Australia's Intellectual Property Arrangements
  • the Department of Foreign Affairs and Trade, prior to the Trans-Pacific Partnership negotiations in 2015
  • the National e-Health Transition Authority, on Australian medicines terminology and specifically changes to medicines ingredient names
  • the National Health and Medical Research Council, to update guidance documents relating to conduct of clinical trials in Australia
  • state and territory jurisdictions represented on our committees, e.g. Advisory Committee on Chemicals Scheduling and Advisory Committee on Medicines Scheduling.
Self-assessed rating of performance against KPI 6 for 2015-16
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

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