TGA business plan 2013-2014

Therapeutic Goods Administration

19 December 2013

Picture of the cover of this publication

The TGA Business Plan 2013-2014 provides an overview of the organisation's strategic considerations including our:

  • mission
  • key roles and responsibilities
  • priorities, and our approach to these
  • areas of particular emphasis
  • significant changes and challenges.

A full copy of the TGA Business Plan 2013-2014 is also available for download in pdf format.

Strategic considerations

Therapeutic Goods Administration

19 December 2013

Mission

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.

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 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.
Photo of a masked medical practitioner looking through a scope

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.

Objectives

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:

  1. Pre-market business processes for prescription medicines
  2. Pre-market business processes for non-prescription medicines
  3. Medicine ingredients
  4. Medicines safety
  5. Support for a common regulatory framework for medical devices
  6. 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.

health professional working from her laptop

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.

image of customs employee searching hand luggage

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.

Operating environment

Therapeutic Goods Administration

19 December 2013

Portfolio budget statements deliverables and performance indicators

2013-14 Portfolio budget statements
Deliverables Performance indicators
Ensure that therapeutic goods are safe, effective and of high quality

Percentage of evaluations and appeals regarding the entry of therapeutic goods onto the Australian Register of Therapeutic Goods made within legislated timeframes (target: 100%)

Percentage of licensing and surveillance inspections completed within target timeframes (target: domestic 100%, overseas 90%)

Percentage of prescription medicine evaluations completed within target timeframes (target: 100%)

Implement the TGA Reform Blueprint

Implement reforms that enhance TGA's current regulatory processes (target: reforms implemented in accordance with the published plan Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future)

Number of blueprint recommendations implemented
(target: 12 for 2013-14)

Health will support industry to implement reforms that strengthen self-regulation of the promotion of therapeutic goods
(target: shared information and complaints systems established by June 2014)

Establish the Australia New Zealand Therapeutic Products Agency

Further progress a program of work sharing and joint operations

Commence public consultation on draft Health Rules by February 2014.

Other performance indicators

During 2013-14, in conjunction with key stakeholders, we will finalise and publish agreed Key Performance Indicators to provide quantitative and qualitative information on our organisational effectiveness and operational efficiency. The proposed key performance indicators were presented to the Australian Therapeutic Goods Advisory Council (ATGAC) and TGA-Industry Consultative Council (TICC) in June 2013 for their consideration and advice. These measures of performance will include the monitoring and reporting of:

  • stakeholder communication, education and satisfaction
  • premarket business operations
  • postmarket business operations
  • organisational health
  • financial performance
  • statutory obligations
  • international cooperation
  • decision making.

Workforce planning

The development of a workforce planning framework and plan was completed in early 2013. It will help us in:

  • categorising the different roles undertaken by our workforce
  • forecasting supply and demand
  • identifying areas of key risk to workforce capacity through utilising a range of people metrics
  • developing strategies with priorities for human resource capacity and capability planning.

The TGA Workforce Plan 2013-15 adopts a risk based approach to analysing our current and future workforce to develop and maintain a capable workforce that is able to meet current and future objectives.

The key strategies from the plan are to:

  • integrate workforce planning into the annual business planning process
  • actively manage our workforce profile
  • focus capability development activities in alignment with our job family profile
  • mature the workforce planning processes
  • actively manage risks to maintaining a capable workforce and the risks of staff losses in the establishment of ANZTPA
  • reduce reliance on ICT contractors
  • actively manage critical job roles to maintain a critical talent pool.

Information and Communication Technology (ICT)

image of a social network of people

TGA is undertaking a comprehensive program to develop and progressively implement an integrated information environment and business systems upgrade to support our regulatory and business operations. This upgraded environment will facilitate:

  • business performance management and optimisation
  • enterprise reporting and business intelligence
  • collaboration and co-operation across business areas
  • risk management and compliance
  • strategy and governance
  • integrated business processes and methods
  • modernisation of the Electronic Business Services (eBS) System.

Some of the business drivers for the environment come from the transition to ANZTPA and the changes introduced through the Blueprint Reforms Program.

Outputs to deliver

Therapeutic Goods Administration

19 December 2013

Regulation of therapeutic goods for safety, effectiveness and quality

Strategies underpinning this priority

pharmacist talking to clients about medicine
  • Use a benefit to risk management approach to carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.
  • Ensure that the Australian community has access, within a reasonable time, to therapeutic advances.
  • Maintain an effective regulatory framework that is contemporary and coherent with international best practice.
  • Enhance international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region.
  • Implement cohesive policies, management and processes that utilise the highest quality scientific methods, governance and management skills, and integrate seamlessly across our organisational groups.
  • Maintain a robust risk management approach to all strategic and key operational risks.
  • Maintain and build a sustainable and capable workforce and invest in emerging technology to improve our capability.
  • Maintain adequate expertise on the TGA's statutory advisory committees to ensure the committees continue to effectively assist the TGA's regulatory decision making processes.
  • Redevelop key guidance documents and provide better information about regulatory decisions and processes.
Lead TGA group: Market Authorisation Group (MAG)
Activity Outputs
Undertake market authorisation for medicines, medical devices, biological and blood and tissue products, together with the exports regulatory function

Complementary medicines

  • Rationalise and expand the number of coded indications available to sponsors of listed medicines
  • Subject to Government approval of legislative changes, eliminate the use of free text in the ELF (electronic medicines listing) system
  • Implement risk profiles to inform the compliance program
  • Implement of a workflow system to support regular reporting on progress of investigations and trends in non-compliance
  • Update guidelines for levels and kinds of evidence in light of consultations
  • Consider any needed regulatory outcomes/reforms following the CMO's review of homeopathic and other therapies
  • Develop policy, consult and implement changes in relation to proprietary ingredients for listed medicines
Reducing regulatory burden
  • Identify and investigate potential regulatory changes to more closely align assessment with risk in the areas of OTC medicines and medical devices
  • Identify and investigate potential regulatory changes to more closely align assessment with risk in the areas of OTC medicines and medical devices
  • Implement coded indications and provide clearer regulatory guidance in relation to evidence guidelines for complementary medicines
  • Increase our use of reports from international regulators to support Australian regulatory decisions
Regulatory science

Modernisation of pre-market evaluation

  • More clearly embed benefit-risk methodology and assessments in medicine and device assessments
  • Explore better use of clinical trial data for assessment of medical devices
  • Ensure that we have the capacity to appropriately evaluate innovative emerging technologies, focusing on:
    • rapidly evolving areas of medical therapy (e.g. oncology)
    • emerging technologies such as nanotechnology
    • device development that is heavily dependent on software and regulation of medical apps as devices

Improve our readiness for a wider roll out of personalised medicine

  • Ensure we have a good understanding of the genetics and diagnostics behind the technologies to enable their appropriate evaluation
Medicines labelling and packaging
  • After consultation, implement regulatory changes to improve patient safety outcomes for labelling and packaging of medicines
Medicine shortages
  • Develop and implement information sharing approaches for better managing shortages of medicines through agreeing roles between industry and government, providing industry guidance and establishing a website for reporting and tracking shortages
Medicines compounding
  • Following consultation, develop RIS and implement the Government's preferred options for reform
Lead TGA group: Monitoring and Compliance Group (MCG)
Activity Outputs
Undertake post-market monitoring and regulatory activities for medicines, medical devices and blood and tissue products, together with the recalls and advertising regulatory functions
  • Provide access to adverse drug reaction and device incidents data, therapeutic goods early warnings and alerts, and more detailed information regarding therapeutic goods recalls
  • Undertake inspections and assessments of manufacturers, nationally and internationally
  • Explore the concept of manufacturer based rather than individual sponsor based inspections of manufacturing facilities
  • Reduce the number of inspections carried out in countries where other major regulators have also been inspecting the same manufacturing facilities
  • Undertake monitoring and compliance laboratory testing, investigation and reviews
  • Explore the feasibility for opportunities to use electronic health including potential for linkages to the PCEHR (personally controlled electronic health record) in relation to enhancing adverse event and incident reporting
  • Increase our use of post-market signals received from international regulators to trigger appropriate early warnings for the Australian public
Reducing regulatory burden
  • Introduce advertising reforms that streamline and clarify advertising requirements
Regulatory science
  • Better use of post-market/pharmacovigilance signals
  • Integrate feedback loops from recent initiatives such as enhanced reporting
  • TGA having input into to the identification of international drug and device safety research topics
  • Input to whole of government efforts for assessing vaccine safety
Device registries
  • Together with RPGD and other stakeholders, undertake developmental work leading to the introduction of patient contact registers for high risk implantable devices and clinical quality registers for implantable cardiac devices and breast implants to systematically track the performance of these devices and improve clinical practice in their use
  • Undertake consultation and develop a Cost Recovery Impact Statement (CRIS) for device registries
  • If required, draft legislative amendments required to support levies for the ongoing administration of each registry
Advertising reform project
  • Subject to government approval, continue to develop a more effective advertising complaint handling process and operating procedure for investigating advertising
Lead TGA group: Regulatory Services Group (RSG)
Activity Outputs
Provide support services that enable the TGA to more effectively undertake its regulatory responsibilities

Regulatory compliance

  • Focus compliance efforts to areas of greatest risk
  • Continue to develop appropriate responses to target falsified medicines and illegal internet sales of therapeutic goods
  • Continue co-operation with the Australian Customs Service in the development of targeted approaches to prevent the importation and or export of illegal therapeutic goods

Finance

  • Review of activity based costing and low value turnover (LVT) exemptions. Develop policy options for government consideration.
Reducing regulatory burden
  • Ensure that simpler and more targeted information is available and readily accessible on our website to save phone calls, email and other enquiries
  • Explore new opportunities for expanding international engagement that leads to international regulatory harmonisation and work sharing projects
Regulatory science

Utilise market research to help consumers and healthcare professionals make more informed decisions about therapeutic goods

  • Underpin research to drive prioritisation and development of TGA communication and education activities and content

Strengthen domestic and international collaboration

  • Strengthen the collaborations with Australian universities who are funded through Government (e.g. by NH&MRC, Australian Research Council), to undertake regulatory science research
  • Work to better mobilise external expertise and regulatory science initiatives led by other regulators (who have the mandate and financial resources to drive these initiatives)

Implementation of TGA Blueprint reform

Strategies underpinning this priority

health professional taking patient's blood pressure
  • Develop and enhance key partnerships with consumers, healthcare professionals and other regulatory agencies.
  • Develop and enhance engagement with consumers and healthcare professionals.
  • Maintain appropriate relationships with industry.
  • Maintain an effective regulatory framework that is contemporary and consistent with international best practice.
  • Maintain a robust risk management approach to all strategic and key operational risks.
  • Maintain a sustainable and capable workforce.
  • Enhance international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region.
  • Invest in appropriate technology to improve our capability.
  • Redevelop key guidance documents and provide better information about regulatory decisions and processes.
Lead TGA group: Market Authorisation Group
Activity Outputs
Complementary medicines business process review
Improve the integrity of the self-assessment process for listing complementary medicines on the Australian Register of Therapeutic Goods (ARTG)
  • Work finalised on development of coded indications project so as to limit the use of inappropriate claims and indications on the ARTG
  • Subject to Government approval, RIS and legislative amendments drafted for introduction into Parliament
Analyse and develop risk profiles of products and sponsors to better inform the selection of products for post-market reviews
  • IT system changes to workflow management implemented to enable data collection and key automated reporting requirements
Medicines labelling and packaging
Implement revised medicines labelling and packaging requirements to assist consumers and health practitioners to make informed decisions about the quality use of medicines and to improve safety outcomes
  • Revised TGO subjected to industry and broader public consultation to help inform the Regulatory Impact Statement and obtain policy approval
  • Final TGO registered as a legislative instrument
Regulatory framework and guidelines
Provide user-friendly information on the risk based framework under which we operate, including detailed explanations of how this framework operates for different classes of therapeutic goods
  • Development and implementation of a communication and educational plan to communicate our risk based framework more broadly
Explore mechanisms for providing explanations on TGA's regulatory processes, and adopt publication principles on the outcomes of application assessments
  • Usability testing of new webpage format for the updated guidelines and format and content refined in response to feedback, prior to publishing the final guidelines
Online applications
Report on the feasibility of developing an online system for the submission and tracking of all applications for assessment, to enable the sponsor to ascertain the progress of an application
  • Complete the evaluation of eCTD systems and selection of appropriate system
  • After initial improvements to OTC medicines tracking extension to other therapeutic products
Lead TGA group: Monitoring and Compliance Group
Activity Outputs
Recalls
Promote the distribution of therapeutic goods safety information, and examine mechanisms for improving the timely communication of alerts and recalls to health practitioners and consumers
  • Complete a review and update of uniform recall procedures, consultation with stakeholders and development of a draft revised instrument
  • Implement the early warnings system and notification system for medical and medical device recalls
Enhancing post-market compliance
Explore mechanisms to maintain the currency of Consumer Medicines Information (CMI) and approved Product Information (PI)
  • Complete public consultation on options to maintain currency of PI and CMI to inform the development of these proposals
  • Policy approval on proposals requiring regulatory change will be provided and approved changes will be implemented
Advertising

Improve access and quality of information on the processes for regulation of advertising of therapeutic goods, including the complaint process and the outcomes of complaints

Enhance sanctions and penalties for repeated breaches of non-compliance (as well as strengthening sanctions and penalties for advertising)

Apply, enforce and publicise sanctions and penalties, including for advertising breaches and recalling products from the market

  • Feedback assessed on consultation RIS and policy approval obtained for proposals for the future regulatory framework for the advertising of therapeutic products
  • Regulatory changes drafted and submitted for policy approval for implementation
Lead TGA group: Regulatory Services Group
Activity Outputs
Strategic engagement and information accessibility

Work transparently with other key providers of information to enhance the information available to the public (consistent with the principles of the quality use of medicines)

Ensure the TGA website is current, accurate, relevant, timely and up to date, and meets the needs of its audiences

  • Feedback from Australian Therapeutic Goods Advisory Council (ATGAC) deliberations used to shape TGA's stakeholder and communication activities
  • Following the development of a partnership strategy, partnering with organisations and participate in existing conferences and events.
  • Schedule of events developed and published
  • Outcomes of stakeholder research used to develop educational materials targeted to consumers, health professionals and industry
  • Invite key external organisations to link to information on the TGA website and vice-versa
  • Functionality of the TGA website improved by introducing a new way of presenting, searching and managing content
  • Continue to manage enquiries to the TGA through the Public Contact Team
Develop and publish agreed Key Performance Indicators to provide quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency
  • Develop processes for systematic reporting of agreed KPIs and reporting commenced
Develop and publish a policy on the disclosure of commercially confidential information
  • Seek feedback from stakeholders prior to finalising implementation

Implementation of ANZTPA

Strategies underpinning this priority

herbal medicines and stethescope
  • Develop a responsive and cost-effective scheme for regulating therapeutic products that is consistent with international best practice. Such a scheme aims to:
    • Apply a level of regulation that is commensurate with the potential risks to public health and safety posed by therapeutic products and balance the risks and the potential benefits to be obtained by users from the availability of these products in Australia and New Zealand
    • Ensure consumers and health professionals have sufficient, accurate information to enable them to select and use therapeutic products safely and effectively
    • Assist New Zealand and Australian states and territories to adopt a uniform approach to controlling consumer access to therapeutic products
    • As far as possible, harmonise requirements with overseas regulators of equivalent standard.
  • Maintaining a sustainable and capable workforce.
  • Enhancing international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region.

Major activity or projects underpinning these responsibilities

Activity Outputs
Harmonisation of regulatory business towards a common regulatory framework
Completion of implementation of the business to business projects

Undertake other regulatory harmonisation projects, as follows:

  • OTC medicines:
    • implementation of integrated business processes, common sets of guidelines, workflow management systems, advisory label statements
    • undertake confidence building activities between evaluation teams
  • Prescription medicines:
    • alignment of pre-market evaluation processes between Australia and NZ
    • alignment of orphan drugs assessment policy and administrative practice
    • harmonise the format requirements for Medicines PI and CMIs
  • Medicine ingredients:
    • harmonise scope and names for proprietary ingredients
    • harmonise terminology for ingredient names
    • develop common list of colouring substances allowed for use in medicines
  • Medicine safety:
    • harmonise required label warning statements for medicines
    • harmonise paediatric dosages for paracetamol and ibuprofen

Develop a harmonised recalls code.

  • Medical devices regulation:
    • scope and identify overlap between the Class III and AIMD devices on the NZ database (WAND) and the ARTG
    • review manufacturers' evidence requirements
    • identify issues and concerns with transferring WAND entries to DEAL and issuing single market licences
  • Biologicals and fresh blood components regulation:
    • harmonise GMP Codes for Blood and Blood Products/Components
    • harmonise Site Master File requirements
    • assess the results of the NZ cell and tissues therapies review
  • Liaison with Medsafe and the Australian (and as appropriate New Zealand) industry on regulatory issues
Health rules development
  • Development and drafting of "health" Rules in relation to
    • medicines, medical devices and biologicals (initially)
    • fees and charges, administration, advertising, scheduling, transitional arrangements, interpretation (subsequently, with some work continuing into 2014/15)
Facilitate the progression to a joint agency
  • Participation in Australia/New Zealand policy working groups covering governance, information law and intellectual property, regulatory sanctions, enforcement
A single entry point - e-Business web portal for ANZTPA
  • Progress the development of a single entry point for business, to streamline processing by progressively covering all business engagement applications for industry

Alliances and shared responsibilities

Therapeutic Goods Administration

19 December 2013

Role of state offices

Most TGA employees (95%) are based in the ACT. There are currently 18 staff located in Sydney, 23 in Melbourne, 6 staff in Brisbane, and 2 staff in Adelaide. Our Melbourne office staff relocated to the Department's Victorian State Office in August 2013.

Staff located outside the ACT primarily focus on medicines and devices authorisation (clinical roles and some nonclinical roles) and GMP inspection and support roles.

Cooperative work with other Australian Government agencies

The TGA collaborates closely with several of the regulators within the Health Portfolio and the Agriculture Portfolio on common issues. This includes:

  • Food Standards Australia and New Zealand (FSANZ), on regulatory issues at the food-medicines interface
  • Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) on radiopharmaceuticals and diagnostic technologies
  • National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on chemicals and cosmetics
  • Office of the Gene Technology Regulator (OGTR) on gene technology in therapeutic goods
  • The Department of Agriculture on bio-security issues
  • Australian Pesticides and Veterinary Medicines Authority (APVMA) on veterinary medicines.

A Regulators' forum of the heads of these agencies, including the TGA National Manager, meets regularly and facilitates collaboration on harmonised training and exchange of best practice approaches for regulation in relevant food, agriculture and health areas.

In addition the TGA works closely with the following other government departments and agencies:

  • APVMA in relation to chemical and veterinary medicines scheduling issues
  • Departments of the Prime Minister and Cabinet, Finance, Treasury and Attorney-General's Department on the formation of ANZTPA
  • Ombudsman's office in relation to provision of information and determination of complaints
  • Australian Customs and Border Protection Service in relation to importation and export of therapeutic goods
  • Australian Competition and Consumer Commission in relation to fair trading and consumer issues relating to promotion and use of therapeutic goods and health services.

Aboriginal and Torres Strait Islander activities

Health is committed to having a diverse workforce. Targets have been set for all APS agencies to have 2.7% indigenous workforce by 2015.

Funding, capital expenditure and anticipated revenue

Therapeutic Goods Administration

19 December 2013

Our finances are managed through the Therapeutic Goods Special Account (under Section 21 of the Financial Management and Accountability Act 1997).

The Portfolio Budget Statements includes expenses totalling $148.428 million for the TGA for 2013-14. The appropriations include funding of the new budget measure on High Risk Implantable devices of $3.577m and interest equivalency. ANZTPA departmental and administered funding is held by Health Central Office and not by the TGA.

2013-14 Portfolio budget statements

Budgeted expenses
2012-13
Actual expenditure
2013-14
Estimated expenditure
TGA Special Account $131,310,000 $148,428,000
Budgeted increase in expenditure (including capital) comprises:
Estimated Actual 2012-13 $131,310,000
Employee expenses increase (2.5% per Health Enterprise Agreement) $2,175,000
Business improvement and general increase (e.g. rent) $2,976,000
New Policy Proposal (NPP) - High Risk Implantable Device Registers* $3,577,000
Business Systems Upgrade (reallocation of funding from TGA reserves)† $8,390,000
Budgeted expenses 2013-14 (including capital) $148,428,000

* The funding for registers is mainly for work done by other parts of Health, and for contracting groups developing the registers. The TGA expects to retain only a small amount of the funding for its work program

† Funds allocated from cash reserves held in the TGA special account. This allocation was approved in the 2013-14 Budget for the development of new business systems to support the future requirements of the TGA and its industry stakeholders. The new systems will improve efficiency and transparency and be consistent with transition to ANZTPA.

Approved capital expenditure
2013-14
Proposals
2014-15
Out year 1
2015-16
Out year 2
2016-17
Out year 3
Therapeutic Goods
Approved internally funded projects‡ $5,052,500 $6,507,900 $5,355,900 $6,939,000

Note: Excludes the Business Systems Upgrade project as a business case has not yet been endorsed.

Anticipated revenue movements
2013-14 2014-15 2015-16
Anticipated revenue $133,601,000 $134,916,000 $139,233,000

Risk

Therapeutic Goods Administration

19 December 2013

The TGA has identified the following risks as its highest rated.

Risk Risk mitigation strategies
Insufficient capacity to absorb changes across the organisation and maintain effective business operations
  • Closely monitoring progress of TGA Blueprint for reforms
  • Adoption of an appropriate change management framework
  • Workforce plan in place
  • Redevelopment of IT infrastructure and information management systems
  • Communications and education framework and strategies for management of stakeholder expectations
Failure to meet major stakeholders' expectations
  • Implementation of public contact strategy
  • Framework for customer, health professional and industry stakeholder engagement
  • Standard procedures in place to address responses for enquiries and customer service and provision of timely and accurate advice to stakeholders, in accordance with Customer Service Standards
  • Clearer articulation of Regulatory guidelines
  • Development of wider sponsor access to eBusiness
  • Monitoring of international best practice
  • Risk based review and implementation of Audit schedule
  • Risk based review and implementation of Laboratory testing program
Misalignment between law, processes and guidance documents
  • Regular review of processes to ensure alignment with legislation and proper administrative good practice
  • Regular review and update of regulatory guidelines
  • Review of regulatory guidance documents and SOPs
  • Adequate allocation of resources for decision making and training for decision makers
  • Finalise legal elearning modules
  • Information on the TGA website updated and reviewed regularly
  • Use of Business Process Management to align process with legislation
Inability to retain and recruit capable staff
  • Review of learning and development
  • Regular review of the recruitment model in meeting the TGA's business
  • Proactive approaches to making the TGA a good place to work
  • Adoption of an appropriate change management framework
Lack of appropriate preparation for ANZTPA
  • Adequate implementation of agreed projects for which TGA is responsible
  • Contribute to development of options about governance and employment structure
  • Adequate staff consultation and effective communication
  • Adoption of an appropriate change management framework
  • Ensure appropriate expertise is available to the implementation team

Attachment 1: Strategic statement

Therapeutic Goods Administration

19 December 2013

Print version of the TGA strategic statement 2012-2015 (pdf,252kb)

TGA strategic statement 2012-2015

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

Working with our stakeholders we fulfil this mandate and meet the challenges of protecting public health in Australia through a robust regulatory framework that provides for reliability in regulatory decision making and effectiveness in monitoring ongoing safety of products on the market.

Strategic direction

To maintain the community's trust in the safety and quality of therapeutic goods, the TGA aims to consistently deliver scientific, clinical and regulatory excellence. 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 action in relation to 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 and clinical debate to support the safe and effective use of therapeutic products.
  • Responsive to emerging local and global regulatory issues affecting the Government and the community.

Priorities

TGA's priorities have been developed in the context of Health and Ageing Portfolio Budget Statements and the Department's corporate plan and related strategies. The TGA's priorities are to:

  • Regulate therapeutic goods for safety, effectiveness and quality.
  • Implement the TGA Reform Blueprint.
  • Establish the Australia New Zealand Therapeutic Products Agency (ANZTPA).

Key strategies

In implementing and balancing our efforts across our priorities the TGA will focus on the following key strategies:

Refining our regulation
  • Maintaining an effective regulatory framework which aligns with international best practice.
  • Redeveloping key guidance documents and providing better information about regulatory decisions and processes.
Engaging with our stakeholders
  • Developing and enhancing relationships with consumers, healthcare professionals, industry and other regulatory agencies.
  • Enhancing international regulatory cooperation through better exchange of information, work sharing and capacity building.
Managing key relationships
  • Promoting and enhancing collaborative and cooperative relationships with other parts of the Department.
  • Proactive monitoring and management of emerging issues and enhanced relationships with the Secretary and with the Parliamentary Secretary and Minister (where appropriate).
Enhancing our business capability
  • Implementing cohesive policies, management and processes that:
    • utilise the highest quality scientific and clinical methods, governance and management skills, and
    • integrate 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.
Delivering through our people
  • Maintaining a 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.

Indicators of performance

Measurement of performance will include the monitoring of:

  • Meeting milestone delivery targets and target dates for "Blueprint for TGA's future", including ANZTPA joint agency projects.
  • Evidence from Section 60 reviews, Administrative Appeals Tribunal decisions, audits and legal advice that risks are managed well in decision making.
  • Compliance with statutory reporting obligations and government accountability frameworks.
  • High stakeholder satisfaction and participation with our consultative processes.
  • International co-operation demonstrated to enhance regulatory harmonisation and improve capacity of TGA staff.
  • Non-compliance and safety issues identified by TGA at an early stage and appropriate, effective responses implemented.
  • Improved community and industry understanding of TGA's regulatory role through close management of media issues and public awareness.
  • Business operations are consistent and meet agreed service/timeliness standards.
  • Financial performance aligns with financial targets.
  • Indicators of organisational health including low staff absenteeism, attraction and retention of staff in critical areas, evidence that performance management enhances individual development and contribution to TGA outcomes.
  • Adherence to timeliness and performance commitments made under the TGA customer service standards.

Risk mitigation

The TGA will focus on:

  • Reliability and consistency in regulatory decision making and effective monitoring of the safety of products on the market.
  • Meeting our key stakeholder expectations to foster community confidence.
  • Maintaining alignment with relevant legislation of our processes, regulatory practices and guidance documents.
  • Retaining and recruiting capable staff.
  • Improving our systems and processes to build and maintain corporate memory.
  • Effectively preparing for the implementation of ANZTPA.