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TGA business plan 2013-2014
Therapeutic Goods Administration
As part of the Department of Health (Health) the TGA safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989.
This mission is delivered through our contribution to Health outcomes.
Through our work, the Australian Government aims to:
- ensure that therapeutic goods manufactured, supplied in or exported from, Australia are of high quality, and are safe and effective to use for their intended purpose
- implement further reforms to Australia's regulatory framework.
Our regulatory activities also contribute towards the Department's delivery of:
- access to Pharmaceutical Services - particularly access to cost effective medicines.
- access to Medical Services - particularly access to medical devices, and to cost-effective medical and allied health services.
- biosecurity and emergency response - preparedness to respond to national health emergencies and risks, including through better surveillance, regulation, prevention and detection.
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:
- provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:
- used in Australia, whether produced in Australia or elsewhere; or
- exported from Australia.
- 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 pre-market assessment before therapeutic goods are marketed and through post-market monitoring and compliance strategies once products are on the market. We assess the suitability of medicines and medical devices for export.
We also regulate manufacturers of therapeutic goods to ensure they 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 our decisions with appropriate evidence
- Visible through helping consumers and the community to 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 to enforce regulatory decisions
- Efficient by continually improving quality and productivity in the delivery of all our functions
- Influential through having a strong role in informing scientific debate and participating in creation of relevant national and global standards 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
Priorities for 2013-14
Our priorities for the next 12 months comprise:
- Ensuring timely access to therapeutic goods that are safe, effective and of high quality
- Continuing the implementation of the TGA Blueprint Reforms
- Continuing the work to establish the Australia New Zealand Therapeutic Products Agency (ANZTPA).
Ensuring timely access to therapeutic goods that are safe, effective and of high quality
Critical to the application of risk-based processes for therapeutic goods assessment is the work of the TGA's pre-market and post-market 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 products for supply in Australia. The MAG decides whether to approve or reject market authorisation of medicines, medical 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, efficacy and performance throughout their lifecycle. The way our medicines, medical devices and blood and tissue products are manufactured is also regulated by the TGA. 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 and financial services, information technology and information management, communications, committee support, and parliamentary and human resource management services.
Continuing the implementation of the TGA Blueprint Reforms
We are committed to working collaboratively with our external stakeholders - consumers, health professionals and industry - to ensure the Blueprint reforms are implemented effectively, and that stronger relationships are established for the future.
The Blueprint reforms began in January 2012 and will be implemented over four years, in accordance with the published plan Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future.
Continuing the work to establish ANZTPA
On 20 June 2011, the Australian and New Zealand Prime Ministers signed a "Statement of Intent" to establish ANZTPA and to progressively implement the joint regulatory scheme for therapeutic products over five years.
Development of regulatory rules ahead of ANZTPA is only part of the development of a Common Regulatory Framework. A parallel priority is to look at how TGA and Medsafe business and regulatory processes, administration, expertise and datasets can be aligned ahead of the establishment of ANZTPA.
Building on the experience from the five "Business-to-Business" projects completed in mid 2013, TGA and Medsafe have identified and agreed on six further activities that will deliver increased regulatory alignment:
- Pre-market business processes for prescription medicines
- Pre-market business processes for non-prescription medicines
- Medicine ingredients
- Medicines safety
- Support for a common regulatory framework for medical devices
- Biological and blood products.
The work is being staged to manage workloads as well as to accommodate interfaces with linked activities occurring under the Blueprint Reforms program.
Significant changes and challenges
The work program planned for 2013-14 is substantial, as it incorporates business as usual, implementation of the Blueprint reforms and progression of the establishment of the ANZTPA. We need to address the challenge of maintaining quality business as usual regulatory services while also delivering on a wide ranging and complex reform program.
The TGA is fully cost recovered from fees and charges imposed on Industry. Some monies have been appropriated to fund work to establish ANZTPA. A challenge to fully developing a framework ahead of ANZTPA is in dealing with uncertainty about ANZTPA governance arrangements, similarly our ability to actively manage all major risks in the establishment of ANZTPA is impacted by uncertainty about ANZTPA employment arrangements.
As a regulatory science based organisation, the TGA can face challenges in relation to recruiting specialist staff, including, recruitment for these roles in a competitive market with the medicines and devices industry.
To ensure that we regulate according to risk we also need to ensure that we have the capacity and capabilities to meet emerging challenges in relation to:
- our pre-market evaluation risk management remaining contemporary and continuing to reflect international best practice
- having the capacity to appropriately evaluate emerging technologies
- improving our readiness for a wider roll out of personalised medicine
- improving our use of post-market pharmacovigilance signals
- improving manufacturing quality through new approaches to audit and inspection process
- utilising social science and market research to help consumers and healthcare practitioners make informed decisions about therapeutic goods.
Management of changes and challenges
Strategies used in implementing and balancing our effort across our priorities during 2013-14, will be to:
1. Refine our regulation
Maintain an effective regulatory framework that is contemporary and coherent with international best practice and redevelop major guidance documents to provide better information about regulatory processes.
2. Engage with our stakeholders and manage key relationships
Develop and enhance partnerships with consumers and healthcare professionals. Maintain appropriate relationships with industry and enhance international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building.
Promote and enhance collaborative and cooperative relationships with the rest of the Department and proactive monitoring and management of emerging issues. Ensure communication is strong with the Parliamentary Secretary and Minister.
3. Enhance our business capability
Implement cohesive policies, management and processes that utilise the highest quality scientific methods, governance and management skills, and enhance integration across our organisational groups.
Manage major strategic, financial and operational risks. Initiate a major technology investment and change program to improve our capability. Support electronic health reform outcomes.
4. Deliver through our people
Maintain a capable workforce that adapts flexibly to changes introduced through the Blueprint reforms, the development of ANZTPA 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, and support the reform agenda of the Australian Public Service and TGA's People Strategy 2012-2015.
In addition to these strategies we are also responding to the 2013 Staff Survey results through the implementation of an action plan that includes a range of organisation wide initiatives that focus on major survey outcomes.