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TGA business plan 2013-2014

Therapeutic Goods Administration

19 December 2013

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Operating environment

Portfolio budget statements deliverables and performance indicators

2013-14 Portfolio budget statements
Deliverables Performance indicators
Ensure that therapeutic goods are safe, effective and of high quality

Percentage of evaluations and appeals regarding the entry of therapeutic goods onto the Australian Register of Therapeutic Goods made within legislated timeframes (target: 100%)

Percentage of licensing and surveillance inspections completed within target timeframes (target: domestic 100%, overseas 90%)

Percentage of prescription medicine evaluations completed within target timeframes (target: 100%)

Implement the TGA Reform Blueprint

Implement reforms that enhance TGA's current regulatory processes (target: reforms implemented in accordance with the published plan Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future)

Number of blueprint recommendations implemented
(target: 12 for 2013-14)

Health will support industry to implement reforms that strengthen self-regulation of the promotion of therapeutic goods
(target: shared information and complaints systems established by June 2014)

Establish the Australia New Zealand Therapeutic Products Agency

Further progress a program of work sharing and joint operations

Commence public consultation on draft Health Rules by February 2014.

Other performance indicators

During 2013-14, in conjunction with key stakeholders, we will finalise and publish agreed Key Performance Indicators to provide quantitative and qualitative information on our organisational effectiveness and operational efficiency. The proposed key performance indicators were presented to the Australian Therapeutic Goods Advisory Council (ATGAC) and TGA-Industry Consultative Council (TICC) in June 2013 for their consideration and advice. These measures of performance will include the monitoring and reporting of:

  • stakeholder communication, education and satisfaction
  • premarket business operations
  • postmarket business operations
  • organisational health
  • financial performance
  • statutory obligations
  • international cooperation
  • decision making.

Workforce planning

The development of a workforce planning framework and plan was completed in early 2013. It will help us in:

  • categorising the different roles undertaken by our workforce
  • forecasting supply and demand
  • identifying areas of key risk to workforce capacity through utilising a range of people metrics
  • developing strategies with priorities for human resource capacity and capability planning.

The TGA Workforce Plan 2013-15 adopts a risk based approach to analysing our current and future workforce to develop and maintain a capable workforce that is able to meet current and future objectives.

The key strategies from the plan are to:

  • integrate workforce planning into the annual business planning process
  • actively manage our workforce profile
  • focus capability development activities in alignment with our job family profile
  • mature the workforce planning processes
  • actively manage risks to maintaining a capable workforce and the risks of staff losses in the establishment of ANZTPA
  • reduce reliance on ICT contractors
  • actively manage critical job roles to maintain a critical talent pool.

Information and Communication Technology (ICT)

image of a social network of people

TGA is undertaking a comprehensive program to develop and progressively implement an integrated information environment and business systems upgrade to support our regulatory and business operations. This upgraded environment will facilitate:

  • business performance management and optimisation
  • enterprise reporting and business intelligence
  • collaboration and co-operation across business areas
  • risk management and compliance
  • strategy and governance
  • integrated business processes and methods
  • modernisation of the Electronic Business Services (eBS) System.

Some of the business drivers for the environment come from the transition to ANZTPA and the changes introduced through the Blueprint Reforms Program.

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