TGA Group of Regulators corporate plan 2003-2005

Message from the Parliamentary Secretary to the Minister for Health and Ageing

This Government is committed to promoting, developing and funding world class health services for all Australians. Where our health policies affect business, we will also work with industry to minimise the impact of regulations and Government requirements, without compromising the high standard of our health system.

The Therapeutic Goods Administration, the Office of the Gene Technology Regulator and the Office of Chemical Safety have an integral role to play in realising the Government's vision of a community well served by a health system that promotes and protects the health of the public and one which leads the world in the area of evidence based medicine, best practice health care and public health.

In all walks of life we have a reliance on the quality of medicines, medical devices and chemicals we use. The regulation of blood, blood products, tissues and gene technology are critical to protecting the health of Australians.

As a result of the world leading work of these Regulators, Australians - the vaccinated child, the person self-medicating to alleviate the symptoms of the common cold, the accident victim receiving a blood transfusion, the older Australian recovering from a hip-replacement operation, the person painting their house and the farmer planting genetically modified crops - can all have confidence in the product being used.

I look forward to working with the staff of these important health regulatory bodies to advance and protect public health through scientific and regulatory excellence.

Trish Worth
Parliamentary Secretary
to the Minister for Health and Ageing

Who we are

We are a unit within the Department of Health and Ageing. We administer the Therapeutic Goods Act 1989 and Industrial Chemicals (Notification and Assessment) Act 1989 and support the Gene Technology Regulator in administering statutory responsibilities under the Gene Technology Act 2000.

This Corporate Plan sets out our strategic directions and serves as a link between the Department of Health and Ageing Corporate Plan and the activities we administer. It also establishes the basis for Business Plans within the TGA Group of Regulators that include key performance indicators, targets and performance measures.

Our role

We develop and implement appropriate national policies and controls for medicines, medical devices, chemicals, gene technology, blood, blood products and tissues.

Our vision

We aim to be recognised as a world leader in advancing and protecting public health and the environment through scientific and regulatory excellence.

Our mission

We will develop and implement appropriate national regulatory policies and controls for medicines, medical devices, blood, blood products, tissues, chemicals and gene technology.

In doing so we will:

• provide expert policy, technical advice and analysis to Government;
• provide risk based national regulation and monitoring of the standard of medicines, medical devices, chemicals, gene technology, blood, blood products and tissues;
• represent and promote Australia's contribution and capabilities in the area of policy and controls for medicines, medical devices, chemicals, gene technology, blood and blood products in the international community;
• work with governments, industry and consumer representatives to ensure the delivery of high quality, cost-effective policies and controls designed to meet the needs of consumers; and
• ensure that we perform our regulatory role sensitively, objectively, effectively and efficiently.

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Our staff and our commitment to achievement

We recognise that the skills and experience of the staff are the key to effective performance. We promote high performing teams supported by a focus on staff development, opportunities for challenging and interesting work, job satisfaction and a rewarding work environment.

We are committed to achievement by:

• effectively managing our staff performance development scheme;
• ensuring staff are provided with opportunities for professional development;
• promoting and encouraging the sharing of knowledge;
• recognising the professionalism, skills and experience of our staff;
• empowering staff to make decisions at an appropriate level;
• being accountable to each other for our actions and behaviour;
• involving staff in changes which will impact on them;
• supporting flexibility and innovation in the way in which we achieve our goals;
• encouraging effective communication with stakeholders and each other; and
• providing an appropriate working environment.

Our values

We hold important:

• professionalism through integrity, diligence, objectivity, excellence, commitment and consistency;
• accountability through open and transparent processes;
• achievement through professionalism and effective, efficient and flexible work practices which are focussed on delivering timely outcomes; and
• respect for each other and our stakeholders through open and effective communication and quality service.

Our outputs

We will effectively and efficiently regulate through:

• timely pre-market assessment of new therapeutic goods;
• audit and licensing/certification of therapeutic goods manufacturers;
• post-market monitoring of therapeutic goods available in Australia;
• licensing of the collection, processing and testing of fresh blood collected in Australia;
• administering schemes for access to experimental and unapproved therapeutic goods;
• satisfying obligations under international drug treaties;
• pre-introduction assessment of new industrial chemicals;
• reviewing of priority existing chemicals (including for health and environmental risk); and
• identifying and managing risks posed by or as a result of gene technology.

Our performance

We recognise that our performance is subject to the scrutiny of stakeholders, including the Minister, the Parliament, consumers, industry, health service providers, government agencies and international organisations.

The APS Code of Conduct sets the principles on which we model our behaviour for delivering service to consumers and the therapeutic goods, gene technology and chemical industries.

We will ensure...

...there is organisational capability...

• Strategies, structures and processes will be clear and aligned to the achievement of Government objectives and priorities;
• Staff will have appropriate skills and competencies to meet the evolving challenges facing us; and
• Systems will be in place to collect and analyse the information necessary to measure our performance.

...we effectively manage our responsibilities...

• High quality outcomes will be achieved across programs that reflect the priorities of Government;
• Staff will be well equipped for their roles and responsibilities through effective sharing of information, development and management of performance;
• We will consult with stakeholders;
• We will respond in a professional and timely way to all enquiries in accordance with our Customer Service Charters;
• There will be continuous improvement of business practices; and
• We will acknowledge the contribution of our staff.

...there is capacity to contribute to and manage a changing environment...

• Our approach will be based on effective strategic planning, risk management and project management;
• There will be clear communication and consultation with staff and stakeholders;
• There will be effective communication amongst staff of shared goals, values and future directions;
• We will consider innovative solutions; and
• We will represent Australia's interests in the international arena.

Our strategic planning framework is as follows

	Corporate Plan Who we are What we do
Business Plans Key Performance Indicators		Supporting Plans Communications Plan Customer Service
	Work Plans PDS Agreements

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