Therapeutic Goods Administration strategic plan 2006-2008
The TGA Strategic Plan sets the organisation's strategic direction and identifies its key priorities for 2006-2008. The Plan also describes the TGA's strategic objectives, high-level strategies for achieving those objectives and measures that will be used to monitor performance.
National Manager's message
Regulation is neither static nor staid. Good regulation is both a science and a skill.
Good regulation is using regulation only where and how necessary. The Therapeutic Goods Administration (TGA) has been a leader in the risk managed approach to regulation where the level of regulation is commensurate with the risk.
Good regulation is operating in a manner that reflects the global markets especially through harmonising and cooperating with overseas counterparts.
Good regulation benefits all affected parties. The TGA protects public health and safety and at the same time provides benefits to industry through assisting good research, helping exporters, supporting the reputation of the industry and providing high quality services.
Good regulation is operating in a transparent manner where people, whether consumers or industry, know why and how decisions are made, can influence these and have access to necessary information.
Good regulation requires common sense, by having a clear understanding of the outcomes but realising there may be different ways to reach those outcomes.
Good regulation takes account of the full life cycle of products.
Good regulation means having excellent staff, strong business like approaches, a very clear understanding of our role and environment and effective communication.
The TGA has a well deserved reputation for being among the best in the world for good regulation of therapeutic products. We are now poised to move into our next stage of evolution, the joint regulatory scheme with New Zealand.
This document provides a clear statement of the TGA's strategic objectives for the period 2006-2008 and I commend it to you. It will be supplemented by a more detailed annual Business Plan in each financial year.
Dr David Graham
National Manager
About us
The TGA, a business unit of the Australian Government Department of Health and Ageing, is responsible for the regulation of therapeutic products in Australia. The TGA carries out regulatory activities consistent with the objectives of Therapeutic Goods Act 1989 (the Act) and provides advice to Ministers in relation to the operation of the current regulatory system for therapeutic products, as well as possible changes to the system to meet future needs of the Australian population. The TGA fully recovers the cost of all regulatory activities that fall within the scope of the Act.
The TGA regulates therapeutic products through:
- pre-market assessment;
- post-market monitoring and enforcement of compliance with standards; and
- licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.
In undertaking its regulatory role, the TGA adopts a risk management approach by:
- identifying, assessing and evaluating the risks posed by therapeutic products;
- applying any measures necessary for treating the risks posed; and
- monitoring and reviewing risks over time.
The TGA's key stakeholders include governments, consumers, industry and health professionals.
Our mission
Why we are here
To safeguard public health in Australia through administration of a national framework for the regulation of therapeutic products, which is consistent with international best practice and ensures the timely availability of therapeutic products in Australia that are of good quality and safe for their intended purpose.
Our vision
What we want to achieve
To be recognised nationally and internationally as a best practice regulator of therapeutic products with the confidence and respect of governments, the community and the regulated industry.
Our values
What is important to us
We uphold the Australian Public Service Values.
In our work, we will be:
- responsive
- accountable
- transparent
In our people and our relationships, we value:
- integrity
- professionalism
- commitment
- mutual respect and trust
Key priorities for 2006-2008
- To contribute to public health and safety by implementing regulatory arrangements that:
- ensure that therapeutic products available in Australia are of good quality and safe for their intended purpose;
- minimise the regulatory burden on industry; and
- are consistent with public health policy in Australia.
- To achieve an appropriate balance between pre-market and post-market regulatory controls.
- To implement successfully the merger of the TGA and New Zealand's Medsafe to form the Australia New Zealand Therapeutic Products Authority (ANZTPA).
- To ensure an organisational infrastructure and financial arrangements appropriate to the TGA's immediate needs and the needs of the ANZTPA.
- To work strategically and effectively with comparable international regulatory agencies to implement regulatory standards that are consistent with international best practice, recognising the increasingly global market and the efficiencies to be gained.
- To operate within the available resources to provide efficient and effective services for the Australian community and to the industry. The TGA fully recovers the cost of all regulatory activities that fall within the scope of the Therapeutic Goods Act 1989. This requires it to provide quality services to its customers whilst maintaining its independence as a regulator.
- To be as transparent as possible in our processes and decisions.
Key result areas
To meet our statutory and other obligations and to achieve our key priorities we will focus on four key result areas:
- our service delivery
- our stakeholders
- our business capability
- our people
Our service delivery
Provide and manage regulatory services which are efficient, effective and responsive to the needs of our stakeholders.
Our objectives are:
- Products regulated throughout their lifecycle commensurate with the assessed level of risk to the community.
- Implementation of regulatory standards and requirements for therapeutic products, which are consistent with international best practice.
We will achieve these by:
- Regulatory decision-making that is timely and supported by contemporary scientific and other relevant evidence.
- Post market monitoring and enforcement of compliance with regulatory requirements.
- Making effective use of expert advisory committees for the provision of high standard, independent expert advice on regulatory matters.
- Monitoring, responding to and managing emerging regulatory issues, technological developments and external reviews that impact on the TGA.
- Fostering relationships that facilitate cooperation with comparable international regulatory agencies.
- Contributing to the development of and, where appropriate, implementing internationally harmonised regulatory standards.
We will measure our performance by monitoring:
- The number of applications processed and regulatory actions taken within statutory or agreed target timeframes.
- The balance between pre and post market regulatory controls.
- The level of industry compliance with regulatory requirements.
- The extent of and benefit from cooperation with key international regulatory agencies.
Our stakeholders
Engender confidence in our stakeholders that our dealings will be professional, responsible, timely and transparent.
Our objective is:
- Effective communication and consultation with our stakeholders to facilitate understanding, information sharing and appropriate outcomes.
We will achieve this by:
- Communicating with stakeholders to improve awareness of our regulatory role and understanding of our processes and requirements.
- Engaging with stakeholders on proposed regulatory change.
- Acknowledging and responding to stakeholder input.
- Ensuring transparency and timeliness in our dealings with stakeholders.
We will measure our performance by monitoring:
- The level of stakeholder satisfaction with our consultative processes.
- The extent of stakeholder participation in our consultative processes.
- The level of stakeholder support for our regulatory approaches.
- The level of our compliance with the TGA Service Charter.
Our business capability
Continuously improve our operations by monitoring outcomes and creating opportunities to achieve better results.
Our objectives are:
- Continuous improvements in internal operational effectiveness and process efficiencies.
- A robust risk management approach to all strategic and key operational risk.
- Sound financial performance.
We will achieve these by:
- Maintaining effective corporate governance arrangements.
- Implementing information management systems and business infrastructure to support the TGA and meet the needs of the ANZTPA.
- Reviewing and, where necessary, amending or supplementing internal procedures to support the TGA and meet the needs of the ANZTPA.
- Identifying and treating new and emerging significant business risks.
- Operating in line with budget forecasts.
We will measure our performance by monitoring:
- The effectiveness of risk mitigation strategies to address business risks.
- The level of compliance with statutory reporting obligations and government accountability frameworks.
- The extent to which non-compliance issues are identified at an early stage and appropriate responses implemented.
- Financial results relative to financial targets.
Our people
Attract and retain appropriately qualified and skilled people by providing an environment that supports and values them and recognises their contribution
Our objectives are:
- Strong and effective leadership and management.
- Staff who are appropriately qualified, skilled and experienced and who are highly committed to the achievement of organisational objectives.
We will achieve this by:
- Clearly articulating the strategic and business objectives for the organisation and its people.
- Ensuring staff understand their roles, responsibilities and accountabilities.
- Creating an environment where staff feel challenged in their work, their contribution is valued and their diverse needs and interests are supported.
- Implementing human resource management policies, procedures and systems that align with organisational objectives and support effective performance and continuous learning.
We will measure our performance by monitoring:
- The nature of comments from staff surveys.
- Indicators of organisational heath such as effective targeting of learning and development opportunities; staff turnover and absenteeism; performance management and attraction and retention strategies.
Our planning and monitoring framework
