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TGA business plan 2014-2015

Therapeutic Goods Administration

25 November 2014

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Strategic considerations


As part of the Department of Health the TGA safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989.

Our regulatory activities also contribute towards the Health Department's delivery of outcomes. They are carried out under a national framework and using a risk management approach.

Assessment and monitoring are carried out to ensure that therapeutic goods available in Australia are of an acceptable standard, and manufactured in accordance with the standards applicable to the type of product. At the same time, we continue to ensure that the community has access, within a reasonable timeframe, to therapeutic advances.

Key roles

The role of the TGA is to regulate therapeutic goods through the effective and timely administration of the Therapeutic Goods Act 1989 (the Act). The objects of the Act are to:

  1. provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy (performance) and timely availability of therapeutic goods that are:
    1. used in Australia, whether produced in Australia or elsewhere; or
    2. exported from Australia.
  2. provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.

We undertake this role by applying scientific and clinical expertise to assessments of the evidence of risks compared to the benefits of use of therapeutic goods. We apply this risk-based regulatory process through premarket assessment before therapeutic goods are marketed and through postmarket monitoring and compliance strategies once products are on the market. We also assess the suitability of medicines and medical and therapeutic devices for export.

TGA also regulates manufacturers of therapeutic goods to enable them to meet acceptable standards of manufacturing quality.

We work with consumers, health professionals, industry, technical and scientific specialists and our international regulatory counterparts.

Our Business Planning is guided by the TGA Strategic Statement 2012-15 (Attachment 1), which outlines an overarching approach to our directions, priorities, performance and risk mitigation.


In maintaining the community's trust in the safety, quality and efficacy/performance of therapeutic goods, 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 actions 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 enable the safe and effective use of therapeutic products
  • Responsive to emerging local and global regulatory issues.

Priorities for 2014-15

Our priorities for the next 12 months comprise:

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

Regulating therapeutic goods for safety, effectiveness/performance and quality

Critical to application of risk-based processes for therapeutic goods assessment is the work of TGA's premarket and postmarket Divisions: the Market Authorisation Group (MAG) and the Monitoring and Compliance Group (MCG).

The MAG is responsible for undertaking evaluations of applications to approve new therapeutic goods for supply in Australia. The MAG makes decisions whether to approve or reject market authorisation of medicines, medical and therapeutic devices and blood and tissues that are imported, exported, manufactured and/or supplied in Australia.

The MCG is responsible for ongoing monitoring of therapeutic products supplied in Australia to ensure they continue to maintain an appropriate level of quality, safety and efficacy/performance throughout their lifecycle. The MCG is also the division responsible for the regulation of the manufacture of therapeutic goods. Australian and international manufacturers must operate in a manner that allows products to meet specified standards if they are to be supplied in Australia.

The Regulatory Support Group (RSG) is the TGA Division that provides the regulatory support services that enable us to undertake our regulatory responsibilities. This support includes the delivery of legal, financial, information technology and information management, project and change management, communications, committee support, parliamentary and human resource management services.

In undertaking our core business of risk-based market authorisation and monitoring and compliance and continuing to meet the objectives of safeguarding and enhancing the health of the Australian community, we will also look for opportunities for reducing regulatory burden on industry and health professionals.

We will continue to publish a six-monthly report detailing measures of business performance and a six-monthly report against Key Performance Indicators (KPIs).

International regulatory convergence and work sharing

We need to engage with regulatory counterparts internationally, as well as with regional and international organisations, to support the implementation of science-based standards that ensure the safety and quality of products throughout the supply chain.

The TGA participates in international harmonisation, regulatory convergence and work sharing activities with international agencies and overseas regulators. These activities will help to reduce effort in premarket evaluation of therapeutic goods, while timely exchange of information on products that are already on the market enables us to make more informed and consistent regulatory decisions about the safety, quality, efficacy and performance of therapeutic goods available in Australia.

Successful relationships with our international regulatory counterparts require the investment of time and other resources. The major return on this investment is a reduction in duplication of effort, leading to a more efficient and effective regulatory system. Other benefits include a better understanding of emerging trends and access to the latest regulatory science developments, more informed regulatory decisions for industry and better safeguards for the Australian public.

Continuing the quality improvement and regulatory reform process

In 2014-15, the TGA will continue to implement a quality improvement program around regulatory processes and reforms in key areas. Consistent with the Government's deregulation and red tape reduction agenda, the main focus will be an examination of premarket processes for different categories of medicines and devices to ensure that TGA targets its regulatory efforts and level of regulatory oversight according to the risk of the products being regulated.

In addition, we will continue to improve the way we communicate with the public about the benefits and risks of therapeutic goods and will optimise a range of regulatory processes in the premarket area. Finally, we will enhance postmarket surveillance capacity:

  • through new initiatives to stimulate adverse event reporting for medicines from pharmacists, general practitioners and consumers
  • through a collaborative program with the states and territories on enhanced reporting of adverse events following immunisation (AEFI)
  • through collaboration in the establishment of clinical quality registers for cardiac devices and breast implants and sentinel reporting sites.

We will continue publishing a half-yearly report on the progress of these improvements and reforms.

Further, we will support the Government's review of medicines and medical devices, and commence work to implement the review panel's recommendations on the following:

  • ensuring there is an appropriate balance between risk and benefit in the regulation of prescription, over-the-counter, complementary medicines and medical devices, as well as access for individuals to unapproved medicines and medical devices
  • simplifying and streamlining the approval processes undertaken by TGA. This will include recommendations on:
    • fast tracking approvals processes for medicines and medical devices
    • opportunities for working together with trusted regulators in other jurisdictions, including the potential for work-sharing assessments for products marketed in multiple countries; and
    • exploring how risk assessments, standards and determinations of trusted regulators can be used more extensively by Australian regulators when approving the supply of medicines and medical devices
  • ensuring regulatory arrangements are sufficiently flexible to accommodate developments in medicines and medical devices, including exploring opportunities to streamline approvals that cross regulatory categories
  • improving the processes that assist industry, researchers and consumers to navigate the regulatory system for medicines and medical devices
  • supporting work underway on medical device reforms and clinical trial approval arrangements in Australia
  • any other matters that the review committee regards as important and relevant to the safe and efficient supply of effective medicines and medical devices to the Australian people.

Significant changes and challenges

In the work program planned for 2014-15, we need to be able to maintain high quality 'business as usual' regulatory services while also identifying opportunities for deregulation and delivering on an extensive reform program.

As a technically-based regulator, we can face challenges in recruiting specialist scientific and medical staff, particularly in a competitive market with the medicines and devices industry. Recruitment must also be carried out in accordance with Australian Public Service (APS)-wide recruitment policies.

We also need to ensure that we have the capacity and capabilities to meet emerging challenges in relation to:

  • our premarket evaluation of risks and harms of products remaining contemporary and continuing to reflect international best practice
  • having the capacity and capability to investigate problems and complaints with therapeutic goods
  • having the capacity and capability to appropriately evaluate emerging technologies
  • meeting increasing patient demand for early access to novel therapies, where greater uncertainties about the benefits and risks of products exist
  • improving our readiness for a wider roll out of personalised medicine
  • improving our pharmacovigilance of medicines and postmarket monitoring of medical devices, including signal detection and analysis
  • improving quality of therapeutic goods through wider use of risk-based approaches to manufacturing inspections
  • applying social science and market research to better target information to help consumers and health professionals make informed decisions about therapeutic goods.

Management of changes and challenges

Strategies used in implementing and balancing our effort across our priorities during 2014-15 will be to:

1. Refine our regulation

Maintain an effective regulatory framework that is contemporary and in line with international best practice and redevelop major guidance documents and provide more information-in a simple to access style-about regulatory decisions and processes.

2. Engage with our stakeholders and manage key relationships

Develop, enhance and maintain relationships with consumers and healthcare professionals and maintain appropriate relationships with industry. Enhance 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.

Promote and enhance 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.

3. Enhance our business capability

Implement 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.

4. Deliver through our people

Maintain a capable workforce that adapts flexibly to changes introduced through regulatory reform, deregulation initiatives and other priorities of Government.

Maintain effective levels of performance and provide for continuous learning to improve our capability.

Implement human resource management policies, procedures and systems that promote the APS Code of Conduct, support the reform agenda of the APS and TGA's People Strategy 2012-2015.

In addition to these strategies, we are also responding to the 2014 APS Employee Census results through the implementation of an action plan that includes a range of organisation-wide initiatives that focus on major survey outcomes.

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