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TGA business plan 2012-2013

Therapeutic Goods Administration

7 November 2012

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Strategic considerations


As part of the Department of Health and Ageing (DoHA) the TGA safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989. By working with our stakeholders (consumers, health professionals, government, industry and international counterparts), we will enhance our processes to ensure that the regulatory framework within which we operate is able to adapt to new scientific developments and emerging community expectations.

Photo of a medical practitioner and a patient looking at a laptop

The TGA's main contribution is to Outcome 1 - Population Health of the Department of Health and Ageing's Portfolio Budget Statement. The Australian Government aims to "ensure that therapeutic goods manufactured or supplied in, or exported from, Australia are of high quality, and are safe and effective to use for their intended purpose, and to implement further reforms to Australia's regulatory framework".

The TGA Business Plan 2012-13 is part of the governance framework that guides the TGA's work and identifies continuing responsibilities and major project initiatives. TGA's Business Plan is also guided by the TGA Strategic statement 2012-15 (Attachment A) which outlines our strategic direction, priorities, performance indicators and how we will mitigate risk.

To maintain the community's ongoing trust in the safety and quality of therapeutic goods, the TGA strives to be:

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

Key roles, responsibilities and priorities


The role of the TGA is to regulate therapeutic goods. The TGA does this by applying scientific and clinical expertise to an assessment of the evidence of the risks compared to the benefits of use of therapeutic goods. The TGA applies this risk-based regulatory process to therapeutic goods before they are marketed and monitors products once they are on the market. Additionally, it assesses the suitability of medicines and medical devices for export from Australia.

The TGA regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.


The Australian Government, through the TGA, will continue to regulate therapeutic goods under a national framework to ensure their quality, safety and efficacy. Thus there are a large number of "Business as Usual" responsibilities to be undertaken during the coming year. In 2012-13, the TGA will implement a comprehensive reform agenda outlined in "TGA reforms: A Blueprint for TGA's future" and based on an action plan published in July 2012. The reforms will:

  • Improve the way that the TGA communicates with the public about the benefits and risks of therapeutic goods
  • Improve and publicly clarify the TGA's processes used to assess different types of therapeutic goods
  • Increase the level of evaluation of higher risk medical devices
  • Strengthen the response to unsubstantiated advertising and other breaches of the requirements for advertising of therapeutic goods.
Photo of a medical practitioner taking a woman's blood pressure

The Australian and New Zealand Governments have agreed to proceed with a trans-Tasman scheme for the regulation of therapeutic goods. A three-stage approach over the next four years will be implemented to create a single regulatory framework to provide health benefits for consumers, reduced regulatory costs for industry and greater efficiency for governments.


During 2012-13, TGA will need to balance the delivery of our ongoing regulatory program with the development and implementation of a significant program of reform. Priorities comprise:

The regulation of therapeutic goods for safety, effectiveness and quality

The TGA safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989.

Implement the TGA Reform Blueprint

On 8 December 2011, the Parliamentary Secretary for Health and Ageing, the Hon Catherine King announced her plan to reform the TGA to ensure that it remains adaptable to community and industry expectations. The plan, outlined in "TGA reforms: A Blueprint for TGA's future", will improve the Australian community's understanding of the TGA's regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.

The table below provides an overview of the implementation of the 2012-13 Blueprint reforms.

Streams Work to be completed in 2012-2013
Governance & Management: Managing and governing projects to deliver an integrated program of reform
  • Governance
  • Program Management
  • Annual Reviews
Communication & Stakeholder Engagement: Projects that deliver on recommendations for better communications and stakeholder engagement
  • Australian Therapeutic Goods Advisory Council
  • Consultation principles and Communication strategy
  • Application processing review
  • Regulatory Risk Framework
  • Evaluate post-market risk communication scheme
  • Public access to adverse event data
  • Publicise compliance outcomes
Advertising: Projects that deliver on recommendations for reform of Advertising
  • Consult and provide advice to government
Complementary Medicines: Projects that deliver on recommendations for reform of Complementary Medicines
  • Improved guidelines and information
  • Post market compliance reforms
  • Procedures for investigating advertising breaches
Medical Devices: Projects that deliver on recommendations for reform of Medical Devices
  • Consult on improved device information
  • Consult and provide advice to government on proposals for increased pre-market scrutiny and third party assessment bodies
Organisation Change: Projects and activities that support reform and deliver sustainable outcomes, including engaging TGA staff to understand, support and adopt reform changes
  • Implement organisational change and staff engagement strategy
  • Identify IT system requirements
  • Assess implications for regulatory framework and legislation
Progress establishment of the Australia New Zealand Therapeutic Goods Agency (ANZTPA)

The Governments of Australia and New Zealand have agreed to a phased approach to implementing a trans-Tasman regulatory scheme for therapeutic goods. The first stage of implementation will result in more efficient processes for the approval of therapeutic goods through the implementation of the following agreed business to business projects between the TGA and Medsafe:

  • Development of a publicly available data base with information on adverse reactions to medicines and medical devices.
  • Delivery of a common recalls portal for therapeutic goods.
  • A common early warning system will also be delivered to inform the public of potential safety issues concerning therapeutic goods.
  • Reform of the business process for the evaluation of over the counter medicines.
  • Finalising shared capability to conduct audits to assess good manufacturing practice (GMP).

Areas of particular emphasis

In delivering the 2012-13 priorities, the TGA will put particular emphasis on:

1. Cohesion

Fundamental to cohesion is improved strategy and planning, such that our business-as-usual activities are efficiently integrated with the Blueprint reform process and the move to becoming the Australia New Zealand Therapeutic Products Agency. This will include strengthening of internal communication so that important issues are escalated in a timely manner. A strong effort will be made to improve cohesion among the Executive, so that we operate not just as mangers of our individual areas of responsibility but as a close-knit team carrying out joint planning and leadership. This principle will be applied at all levels of TGA's management structure.

2. Delivery

The Blueprint reforms address five areas:

  • governance and management
  • communication and stakeholder management
  • advertising
  • complementary medicines, and
  • medical devices

The three-phased plan details how the reforms will be rolled out through to December 2015. The TGA understands that it is essential to demonstrate real improvements because with an increase in fees comes an increase in expectations. We have to show value for money to industry, at least in the medium term. Consumers and health professionals too have performance expectations; this will be especially important as we strive to become more transparent.

TGA's Organisation Chart is shown in Attachment B.

3. Communications and strong stakeholder engagement

While the TGA (and the rest of DoHA) will continue to work through specialist media managers for issues management, an overall communication and education strategy will be developed in late 2012 to enable TGA to better address high-profile topics. TGA will place a greater focus on education, explaining clearly how we regulate with an emphasis on effective risk communication so that people understand, for instance, that medical devices will and do fail no matter how well we do our job.

4. Supporting regulatory reform

The TGA will make greater efforts to provide more consistent regulatory decisions under our Act and will assess options for proposal to Government to adjust levels of regulation in different areas according to the level of risk.

5. Strengthening our relationships with the rest of the Department and with the Parliamentary Secretary and Minister

It is important that the TGA see itself in the broader departmental and government policy context. This will require TGA staff to develop closer relationships at all levels with key DoHA areas, involvement in policy discussions where they are relevant to the broader contest of regulation, and exploring further opportunities in coordination areas of common concern. Stronger and more frequent communication will take place with our Parliamentary Secretary, Minister and their staff.

Photo of a woman holding a piece of paper and looking at a laptop screen

6. Making the TGA a great place to work

Many medical, scientific, legal and administrative staff see the TGA as an attractive place to work, and the TGA will increase its communication with sources of potential staff to enable that reputation to be spread further. The 2012 Staff Survey showed that while many people are happy working at TGA, some issues that were specific to the TGA will be addressed through a specific plan.

Approach to priorities

In implementing and in balancing our effort across our priorities during 2012-13, TGA will focus on the following strategies:

1. Refining our Regulation

  • Maintaining an effective regulatory framework which is contemporary and coherent with international best practice.
  • Redeveloping key guidance documents and providing better information about regulatory decisions and processes.

2. Engaging with our Stakeholders

  • Developing and enhancing key partnerships with consumers, healthcare professionals and other regulatory agencies.
  • Maintaining appropriate relationships with industry.
  • Enhancing international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region.

3. Managing Key Relationships

  • Promoting and enhancing collaborative and cooperative relationships with the rest of the Department.
  • Proactive monitoring and management of emerging issues and enhanced relationships with the Secretary and the Parliamentary Secretary.

4. Enhancing our Business Capability

  • Implementing cohesive policies, management and processes that utilise the highest quality scientific methods, governance and management skills, and integrate seamlessly across our organisational groups.
  • Maintaining a robust risk management approach to all strategic and key operational risks.
  • Maintaining sound financial performance.
  • Investing in emerging technology to improve our capability.

5. Delivering through our People

  • Maintaining a sustainable and capable workforce.
  • 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 that provides for effective performance and continuous learning.

Significant changes and challenges

The work program planned for 2012-13 is substantial, as it incorporates business as usual, implementation of the Blueprint reforms and progression of the establishment of the Australia New Zealand Therapeutic Products Agency. TGA is fully cost recovered from fees and charges imposed on industry. Activity based costing ensures that the fees and charges imposed on industry remain appropriate. The TGA is facing some significant challenges in maintaining quality business as usual regulatory services while also embarking and delivering on a wide ranging and complex reform program.

It is critical to the delivery of our work program that the TGA develops a disciplined approach to the planning, resourcing and implementation of all of its business activities. Key mechanisms in ensuring that the TGA will meet this challenge will be to enhance our governance and to deliver operational and financial efficiencies. Given the fee and charge increase to industry, TGA in consultation with key stakeholders will develop a set of meaningful measures to assess performance and delivery of this work program.

The TGA has responded to the 2012 Staff Survey results through a range of TGA-wide initiatives that have been developed to improve leadership and management, career development and planning, and workplace behaviours. The action plan for the 2012 staff survey has focussed around four areas:

  • Senior management team jointly planning and implementing a TGA wide work program.
  • A focus on strategy and planning with clarity regarding priorities and deliverables.
  • Engaging with Section Heads and managers.
  • How we manage change.

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