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TGA business plan 2014-2015

Therapeutic Goods Administration

25 November 2014

Book pagination

Attachment 1: Strategic statement

Print version of the TGA strategic statement 2012-2015 (pdf,153kb)

TGA strategic statement 2012-2015

Strategic direction

To maintain the community's trust in the safety, quality and efficacy/performance of therapeutic goods, the TGA aims to consistently deliver scientific, clinical and regulatory excellence. We strive to be:

  • Transparent by clearly communicating our risk management approach to regulation and decision making processes and by supporting decisions with evidence.
  • Visible through helping consumers and the community to better understand the role of the TGA.
  • Empowering through assisting stakeholders in accessing relevant, meaningful and reliable information.
  • Consistent through an equitable and reliable approach to risk management and decision making.
  • Effective by taking appropriate and timely action in relation to regulatory decisions.
  • Efficient by continually improving quality and productivity in the delivery of all our functions.
  • Influential through informing scientific and clinical debate to support the safe and effective use of therapeutic goods.
  • Responsive to emerging local and global regulatory issues.

Priorities

TGA's priorities have been developed in the context of the Department's Portfolio Budget Statements, corporate plan and related strategies. The TGA's priorities are to:

  • continue to regulate therapeutic goods for safety, effectiveness/performance and quality.
  • pursue international regulatory convergence and work sharing.
  • continue a program of quality improvement in regulatory processes and reform in key areas, according to government priorities.

Key strategies

In implementing and balancing our efforts across our priorities the TGA will focus on the following key strategies:

Refining our regulation

  • Maintaining an effective regulatory framework that is contemporary with international best practice.
  • Redeveloping major industry guidance documents and providing more information - in a simple to access style - about regulatory decisions and processes.

Engaging with our stakeholders

  • Developing, enhancing and maintaining relationships with consumers and health professionals and maintaining appropriate relationships with industry.
  • Enhancing international regulatory cooperation through better exchange of information, work sharing and capacity building.
  • Minimise duplication of effort through stronger collaboration with overseas regulators and assessment bodies.

Managing key relationships

  • Promoting and enhancing collaborative and cooperative relationships with the rest of the Department of Health.
  • Proactive monitoring and management of emerging issues and strong communication with the Assistant Minister and Minister.

Enhancing our business capability

  • Implementing cohesive policies, management and processes that:
    • utilise the highest quality scientific and clinical methods, governance and management skills, and
    • integrate across our organisational groups.
  • Manage major strategic, financial and operational risks.
  • Improve business processes and systems to improve client services.
  • Contribute to the Government's deregulation and red tape reduction agenda by identifying and progressing opportunities to better regulate according to product risk.

Delivering through our people

  • Maintaining a capable workforce that adapts flexibly to changes introduced through regulatory reform, deregulation initiatives and other priorities of government.
  • Maintaining effective levels of performance and provide for continuous learning to improve our capability.
  • Implementing human resource management policies, procedures and systems that promote the APS Code of Conduct, support the reform agenda of the Australian Public Service and the Department's People Strategy 2010-2015.

Indicators of performance

Measurement of performance will include the monitoring and reporting of:

  • Improved community and industry understanding of TGA's regulatory role and decision-making.
  • High stakeholder satisfaction and participation with our consultative processes.
  • Adherence to timeliness and performance commitments made under the TGA customer service standards.
  • Pre- and postmarket business operations are consistent and meet agreed service/timeliness standards.
  • Non-compliance and safety issues identified by TGA at an early stage and appropriate, effective responses implemented.
  • Indicators of organisational health including attraction, development and retention of staff who can respond appropriately to both current and emerging regulatory needs.
  • Financial performance aligns with financial targets.
  • Compliance with statutory reporting obligations and government accountability frameworks.
  • International co-operation demonstrated to enhance regulatory harmonisation and improve TGA efficiency.
  • Evidence from internal reviews and Administrative Appeals Tribunal decisions that TGA is regulating consistently with the legislation.

Risk mitigation

The TGA will focus on:

  • Reliability and consistency in regulatory decision making and effective monitoring of the safety of products on the market.
  • Meeting our stakeholder expectations to foster community confidence.
  • Maintaining alignment with relevant legislation of our processes, regulatory practices and guidance documents.
  • Retaining and recruiting capable staff.
  • Improving our systems and processes to build and maintain corporate memory.
  • Effectively continuing the therapeutic goods reform process.

Book pagination