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TGA business plan 2012-2013
Therapeutic Goods Administration
Outputs to deliver
1. The regulation the therapeutic goods for safety, effectiveness and quality (ongoing business requirements)
Strategies underpinning this priority:
To ensure therapeutic goods available in Australia are of an acceptable standard, and manufactured in accordance with the principles of Good Manufacturing Practice:
A. Appropriate use of risk management to carry out a range of assessment and monitoring activities. At the same time, enabling the Australian community to access therapeutic advances within a reasonable time.
- Undertake market authorisation activities for biological, complementary, prescription and non-prescription medicines, together with the exports regulatory function.
- Complete assessment of prescription medicines applications within statutory timeframes.
- Implement business improvements to reduce the backlog of non-prescription medicines and medical devices applications.
- Undertake market authorisation activities for medical devices, including managing the transition of hip, knee and shoulder implants from Class II to Class III.
- Encourage a greater number of registration applications for newly-regulated therapeutic goods, including biologicals and in vitro diagnostics.
- Implement a comprehensive risk-based laboratory testing and batch release program.
B. Maintaining an effective regulatory framework which is contemporary and aligned with international best practice.
- Undertake post-market monitoring and regulatory activities for prescription and non-prescription medicines, devices, and complementary medicines, together with the recalls and advertising regulatory functions.
- Undertake audits and assessments of therapeutic product manufacturers, nationally and internationally.
- Undertake surveillance, enforcement and related activities, including investigations into import and export, manufacture and supply of unauthorised and counterfeit therapeutic goods.
- Develop standard operating procedure for investigating advertising breaches and communicate timeframes for completing investigations.
- Rationalise and expand the number of coded indications available for listed complementary medicines through the assessment of common indications. Develop policy options for further steps, such as eliminating the free text field, requiring sponsors to use only the available coded indications or to apply for a new coded indication for consideration by government.
- Provide on-line access for reporting of adverse events for medical devices and promote the role of TGA to healthcare professionals, industry and the public in monitoring and assessing adverse events to medicines and medical devices.
- Provide access to Australian adverse drug reaction data through the release of a publicly-searchable database.
- Develop options for the regulation of pharmacy compounding.
C. Enhancing international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region
- Opportunities explored for expanding international regulatory harmonisation through development of a 2012-15 International engagement strategy and work plan.
- Co-ordination of work sharing projects with international regulators in relation to generic medicines, new chemical entities and associated GMP activities.
- Participate in the development of a medical devices single audit program with the US, Canada and Brazil.
- Stong participation in regulatory harmonisation fora such as the International Medical Device Regulators Forum.
- Implement harmonised ingredient names for medicine components.
D. Implementing cohesive policies, management and processes that utilise the highest quality scientific methods, governance and management skills, and integrate seamlessly across our organisational groups
- Develop a TGA-wide monitoring and compliance strategy.
E. Maintaining a sustainable and capable workforce
- Finalise and implement strategic workforce plan for the TGA, in consultation with the broader Department of Health and Ageing.
- Investigate and develop the use of shared services for delivery of TGA HR requirements.
F. Investing in emerging technology to improve our capability
- Provide the business systems and support services that enable the TGA to undertake its regulatory responsibilities, including development of systems for electronic lodgement of variations to prescription medicine registrations.
- Review the capability of TGA's systems to provide sponsors with access to an on-line system for submission and tracking for all applications for assessment.
- Enhancements to TGA's application processing systems including an evaluation of an electronic Common Technical Document review tool capable of allowing dossiers to be lodged by applicants electronically, validation of electronic submissions to occur and provide evaluators with the capability to review submissions on line.
G. Redeveloping key guidance documents for industry and providing better information about regulatory decisions and processes
- Update the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) and the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) using a new format proposed for all TGA regulatory guidelines. Release after taking stakeholder feedback into account.
- Develop and release 'Guidelines for levels and kinds of evidence' for Complementary medicines for public consultation prior to finalisation.
- Propose and implement, after consultation, regulatory requirements for labelling and packaging of medicines.
2. Implement the TGA Reform Blueprint (reform initiatives)
Many of the reforms will be managed as discrete projects.
- MAG1: Medical Devices Reform, MAG2: Complementary Medicines Reform, MAG6:Regulatory Framework and Guidelines, MAG7: Labelling and Packaging
- MCG1: Adverse Events, MCG2: Early Warning (ANZTPA B2), MCG3: Recalls (ANZTPA B3), MCG5: Post Market Business Process Reform, and MCG6: Advertising
- RSG2: Strategic Engagement, RSG3: Information Accessibility, RSG5: On-line Applications.
Further detail is provided in the Blueprint implementation plan.
Strategies underpinning this priority:
A. Developing and enhancing key partnerships with consumers, healthcare professionals and other regulatory agencies
Communication and partnerships
- Establish the Australian Therapeutic Goods Advisory Council to enable more effective stakeholder input into future directions and program implementation.
- Develop a consistent approach to providing information on the work of TGA statutory advisory committees, including outcomes of meetings.
- Develop and implement a comprehensive communication strategy to better inform consumers, industry and healthcare professionals.
- Make more information available to the public through the TGA website and other channels.
- Conduct a pilot project to trial more effective public contact management.
- Work in partnership with other information providers to develop ways to achieve wider public understanding that listed medicines are not evaluated for effectiveness by the TGA prior to market.
- Work with the National Prescribing Service and other information providers to establish agreement on the provision of information to the public consistent with the principles of the quality use of medicines.
- Consult further with stakeholders on the recommendations for advertising reform including more effective approach to sanctions and penalties and provide advice to Government.
- Develop a strategy to increase consumer and health professional awareness of, and participation in, the adverse event reporting system.
- Review the notifications system and consult consumers and health professionals on potential improvements.
- Consult stakeholders on options to amend labelling of complementary medicines to provide consumers with clear information, particularly in relation to explaining the meaning of the listed medicine ('AUST L') category.
- Implement a risk-based approach to undertaking complementary medicines post-market reviews, and include the development and application of risk profiles to inform the selection of post-market reviews.
- Provide the public with information on the complementary medicines that have been subject to post-market reviews and the outcomes of reviews.
B. Maintaining appropriate relationships with industry
- Develop consultation principles to guide regulatory transparency and accountability following consideration and feedback from the Australian Therapeutic Goods Advisory Council and other key stakeholders.
- Public consultation on the disclosure of commercially confidential information, to inform the development of TGA policy and a plan on commercially confidential information.
- Work with stakeholders to develop a proposal to provide device product names.
- Publish all hazard alert and recall notices on the TGA website.
- Examine the feasibility of developing a system to allow public searching of TGA regulatory actions.
C. Maintaining a robust risk management approach to all strategic and key operational risks
- Provide more detailed explanations of TGA's risk framework as it applies to different classes of therapeutic goods, initially focusing on listed complementary medicines.
- Actively promote the distribution of therapeutic goods safety information, and examine mechanisms for improving the timely communication of alerts and recalls, to health practitioners and to consumers.
- Conduct an evaluation of an early post-market risk communication scheme for new prescription medicines coming onto the market with consideration of international models.
- For prescription medicines, consider processes and regulatory changes that would help maintain the currency of Consumer Medicines Information (CMI) and approved Product Information (PI). Following public consultation, examine options for improving access to and information about CMIs and PIs, and if appropriate develop regulatory change proposals for Government consideration.
- For medical devices regulation, following industry and public consultation provide advice to Government on options around: recognition processes for third party assessment bodies including potential use for Australian manufacturers and levels of pre-market scrutiny for implantable medical devices.
D. Maintaining a sustainable and capable workforce
- Identify and publish key performance information, to provide quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency.
E. Enhancing international regulatory cooperation through better exchange of information, work sharing and regulatory capacity building in our region
- Conduct an evaluation of an early post-market risk communication scheme for products coming onto the market with consideration of international models.
F. Investing in emerging technology to improve our capability
- Release an improved TGA website search engine.
3. Progress establishment of the Australia New Zealand Therapeutic Products Agency
Strategies underpinning this priority:
A. Implementing the agreed Australia New Zealand Therapeutic Products Agency (ANZTPA) business to business projects with a view to establishing the ANZTPA joint therapeutic regulatory agency.
- Establish a Database of Adverse Event Notification to release publicly accessible information on adverse event reports to medicines.
- Develop a joint early warning system to inform the public of potential safety issues concerning therapeutic products.
- Investigate the feasibility of a common recalls portal to inform the public of recalls of therapeutic products.
- TGA and Medsafe will establish an integrated capability to conduct audits to assess good manufacturing practice.
- TGA and Medsafe to reform the business process for the evaluation of over the counter medicines, forming the basis for a common approach to lodgement of applications, assessment, evaluation and registration.
B. Enhancing international regulatory cooperation with New Zealand through better exchange of information, work sharing and regulatory capacity building
- Work with the ANZTPA task force central agencies and the Attorney-General's Department and New Zealand Counterparts to implement a program of work sharing and joint operations.
- Commence development and implementation of a Common Regulatory Framework for therapeutic goods regulation between Australia and New Zealand.
- Commence development of a Single Entry Point for business, initially as a source of information on ANZTPA regulatory developments.
The recruitment of appropriately skilled and experienced staff will continue to challenge the TGA especially in areas requiring medical, project management and legal expertise. While the TGA anticipates an increased demand on resources for business as usual activities such as applications, variations and evaluations, a noted upward trend in FOI requests, S60 reviews and litigation over the last financial year indicates that a further increase in specifically skilled staff will be required to meet the demand. There is also the need to manage succession planning for medical officers who intend to retire or leave the organisation within the next two years.
The program of Blueprint reforms and ANZTPA activities will deliver long term organisational change in the TGA. As a result change management and performance development will continue to be an important priority over the coming year.
There is a strong commitment to the ongoing development of our people through active use of the Performance Development Scheme and broadening of our capabilities through our learning and development programs. The TGA will undertake projects to improve and reform our people management approaches. Human resource priorities will include:
- Develop and implement a TGA People Strategy using the results of the 2012 staff survey as a guide.
- Completion of the implementation of changes introduced in the Work Health and Safety Act (C'wealth) 2011.
- Review of recruitment and learning and development frameworks, and implementation of revised approaches.
- Development of TGA's first formalised Workforce Plan, and establishment of a workforce planning framework.
The 2012 Staff Survey demonstrated a strong commitment and satisfaction of staff to their job and to the TGA more broadly. There was a noted improvement since the 2010 Staff Survey in staff views about internal communication, bullying and harassment and learning and development opportunities.
A number of other results however, highlight areas where improvement is needed. These areas relate to:
- improving leadership and management
- career development progression and planning
- improving workplace behaviours
- balancing workloads.
TGA has developed a 2012-2015 ICT Strategic Plan. The plan incorporates all major initiatives to be undertaken or supported by the TGA over the next several years. The plan takes account of the demands of operational support that arise from major reforms process over the next 12 months, ANZTPA and technology drivers.
A major task for the organisation over the next year is to make significant inroads towards the reduction of the number of systems in use. The aspiration is to move to a single workflow system which is used to support all product types throughout the pre and post market phases of the product lifecycle.
Alliances and shared responsibilities
Role of State and Territory Offices
The TGA has a small number of staff located in Brisbane, Sydney, Melbourne and Adelaide, and a second site in Fyshwick under the direction of Offices (branches) in TGA Symonston.
Cooperative work with other divisions or Australian Government agencies
The Australian Government continues to work on a range of reforms of the health system. As part of that system, the TGA is an active participant in the overall health reform agenda. Whilst the TGA works cooperatively with all divisions of DoHA it works most closely with the following divisions and portfolio agencies:
|Division or Portfolio Agency||Business Activity|
|Chief Medical Officer and Office of Health Protection||Medical and public health advice relating to therapeutic goods and therapeutic goods governance.|
|Regulatory Policy and Governance Division||Collaboration on therapeutic goods regulation including advertising and implementation of device registries and the formation of the ANZTPA.|
|Medical Benefits Division||Collaboration on medical devices policy, adverse events and public awareness.|
|Pharmaceutical Benefits Division||Collaboration with the Pharmaceutical Benefits Advisory Committee, QUM and in dealing with medicines shortages.|
|Population Health Division||Collaboration on vaccination policy, adverse events reporting and monitoring and working with the ANZTPA taskforce.|
|People, Capability and Communications||People Strategy and TGA staff capability development and workforce planning.|
|Australian Commission on Safety and Quality in Health Care (ACSQHC)||Collaboration on QUM issues in relation to safe and appropriate use of therapeutic goods including packaging and labelling.|
|Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)||Collaboration on assessment and therapeutic use of radionuclides.|
|Food Standards Australia New Zealand (FSANZ)||Collaboration on the Food-Medicine interface, particularly dietary supplements and therapeutic claims.|
|National Blood Authority (NBA)||Collaboration on regulation of blood and plasma.|
|National Health and Medical Research Council (NHMRC)||Regulation of clinical trials and issues related to clinical practice guidelines|
|Office of the Gene Technology Regulator (OGTR)||Collaboration on the regulation of genetically modified therapeutic goods.|
|Industrial Chemicals Notification and Assessment Scheme (NICNAS)||Collaboration on the cosmetics therapeutics interface, nanotechnology issues and interface issues and scheduling of industrial chemicals.|
The TGA also participates in the Regulators' forum, involving the Department of Agriculture, Fisheries and Forestry; FSANZ, ARPANZA; NICNAS, Australian Pesticides and Veterinary Medicines Authority (APVMA); and OGTR. The forum collaborates on harmonised training and exchange of best practice approaches for regulation in food, agriculture and health.
In addition the TGA works closely with the following other government agencies:
- APVMA in relation to medicines and Poisons Scheduling Committees.
- Central Agencies and Attorney General's Department on the formation of the ANZTPA.
- Ombudsman's office in relation to provision of information and determination of complaints.
- Australian Competition and Consumer Commission in relation to fair trading and consumer issues relating to promotion and use of therapeutic goods and health services.
International cooperation and collaboration
Therapeutic goods are developed and manufactured internationally and sold locally and internationally. The TGA needs to have collaborative arrangements with other international for the whole lifecycle of therapeutic goods to ensure that Australians have access to quality therapeutic goods in the shortest time possible.
The TGA will continue to explore opportunities for expanding international regulatory cooperation, particularly in relation to information exchange and inspection of manufacturing facilities. In 2012-13 The TGA will progress engagement strategies with key international regulatory agency stakeholders. In particular TGA will:
- Develop a framework for international engagement for 2013-15 which aligns our priorities for engagement with our business objectives.
- Develop a strategy for building (regulatory) capacity in our region, in consultation with other areas of the Department and the World Health Organization.
- Develop and implement a strategy for the review and maintenance of TGA's collaborative arrangements with overseas regulatory agencies, including guidelines for the exchange of confidential (regulatory) information.
- Implement the collaborative work program developed by the consortium of four regulators (TGA, Swissmedic, Health Canada and Singapore's Health Sciences Authority).
- Progress bilateral work sharing program developed with Health Canada, in the areas of approval of generic medicines, new prescription medicines, over-the-counter medicines and inspections of manufacturing facilities.
In addition, the significant co-operative effort with colleagues at Medsafe in New Zealand will continue with business to business projects, and a further program of work, to implement a trans-Tasman regulatory scheme for therapeutic goods.
Employees and suppliers
A summary of the TGA's proposed work program and resources allocated for 2012-13:
|Average Staffing Level||Staff Costs ($)||Suppliers Costs ($)|
|Market Authorisation Group||254.9||33,844,000||5,066,000|
|Monitoring and Compliance Group||226.7||27,925,000||5,011,000|
|Regulatory Support Group||178.3||22,245,000||29,176,000|
|TOTAL 2012-13 OPERATIONAL ALLOCATION||$127,870,000|
A summary of the TGA's proposed cost recovery revenue for 2012-13 is shown below:
|Annual Charges & Licences||51,126,000|
|Conformity Assessment Fees||4,763,000|
|Desktop & Application Audits||2,602,000|
|TOTAL 2012-13 COST RECOVERY REVENUE||$127,570,000|
The following summarises the strategies TGA will follow to mitigate our exposure to enterprise risks:
- 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.
- Retaining and recruiting capable staff.
- Maintaining alignment with relevant legislation of our processes, regulatory practices and guidance documents.
- Improving our systems and processes to build and maintain corporate memory.
- Effectively preparing for the implementation of ANZTPA.