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TGA business plan 2014-2015

Therapeutic Goods Administration

25 November 2014

Book pagination

Outputs to deliver

Regulation of therapeutic goods for safety, effectiveness/performance and quality

Strategies underpinning this priority

  • Use a risk management approach to carry out assessment and monitoring to ensure therapeutic goods available in Australia are of an acceptable standard.
  • Support the Australian community in having timely access to therapeutic advances.
  • Maintain an effective regulatory framework that is contemporary and in line with international best practice.
  • Implement policies, management and processes that utilise the highest quality scientific methods, governance and management skills, and integrate seamlessly across our organisational groups.
  • Manage significant strategic and key operational risks.
  • Maintain and build a sustainable and capable workforce and invest in emerging technology to improve our capability.
  • image of pharmacistMaintain adequate expertise on the TGA's statutory advisory committees to ensure they continue to effectively assist our regulatory decision making process.
  • Provide more information to stakeholders about regulatory decisions and processes.
  • Contribute to the Government's deregulation and red tape reduction agenda by identifying and progressing opportunities to regulate according to product risk.
Lead TGA Group: Market Authorisation Group (MAG)
Activity Expected outputs
Undertake market authorisation for medicines, medical devices, biological and blood and tissue products, together with the exports regulatory function

Complementary medicines

  • Continued market authorisation activities for listed medicines, registered complementary medicines and new substances.
  • Continued work to update regulatory guidance material to assist product sponsors.
  • Development of processes and systems commenced to support streamlined registered complementary medicine and new substance applications.

Over-the-Counter (OTC) medicines

  • Evaluation/assessment of applications completed within target timeframes.
  • The reformed OTC premarket evaluation business process finalised and support systems improved.
  • Improved guidance developed for 'acceptable presentations' of OTC medicines.

Prescription medicines

  • Evaluation/assessment of applications completed within legislated timeframes.
  • Continued streamlining of systems to support market authorisation of new medicines and variations to existing products.
  • Faster and more efficient processes developed for the evaluation of generic medicines.
  • Continued work to update Regulatory Guidelines, taking stakeholder feedback into account.
  • Potential antimicrobial resistance strategies considered during assessment of antimicrobials.

Medical devices

  • Market authorisation activities for medical devices and in vitro diagnostic medical devices (IVDs)completed within target or legislated timeframes.
  • Continued implementation of the transition for reclassification of joint replacement implants from class IIb to class III medical devices.
  • Transition to the IVD Framework continued and regulatory reforms for IVDs developed and implemented.
  • Continued refinement of medical device conformity assessment and application for inclusion processes, as part of the Business Improvement Program.


  • Market authorisation activities for biologicals undertaken.
  • Processes developed and implemented for varying ARTG entries for biologicals.
  • Implementation of the Biologicals transition strategy progressed.


  • Market authorisation activities for export-only therapeutic goods undertaken.
  • Appropriate access to therapeutic goods provided to health professionals and consumers, through the Special Access Scheme and other related frameworks.
  • Opportunities from eHealth initiatives explored.
  • Delivery of evaluation capability continued in the areas of clinical, toxicology, pharmaceutical chemistry and biological science.
  • The Drug Control Section from the Office of Chemical Safety integrated within TGA to facilitate continued effective management of import-export processes for controlled and reportable substances and greater alignment with TGA processes for access to unapproved medicines.
  • Medicines scheduling processes, including the Advisory Committee on Medicines Scheduling, integrated into TGA activities in response to the Review of Medicines Scheduling.
Reducing regulatory burden
  • Implementation progressed for digital prescription and OTC medicines submissions and monitoring systems.
  • Potential regulatory changes identified and investigated to more closely align assessment with risk in the areas of OTC medicines and medical devices.
  • Electronic lodgement of clinical trial notifications (CTN) and clinical trial exemption (CTX)applications implemented
Regulatory science
  • Consultation on options, and standard protocols developed for requirements for clinical data for premarket assessment of medical devices.
  • TGA's capacity to appropriately evaluate innovative emerging technologies assured, focusing on:
    • rapidly evolving areas of medical therapy (e.g. oncology) and personalised medicine
    • emerging technologies such as nanotechnology
    • device development that is heavily dependent on software.
International Harmonisation of Ingredient Names
  • Following-consultation, RIS developed and the preferred options for reform implemented.
Medicine shortages
  • Implementation of the agreed approach continued for communicating and better managing shortages of medicines. Success of the protocol's implementation monitored.
Medicines compounding
  • Following consultation, RIS developed and the preferred options for reform implemented.
Lead TGA Group: Monitoring and Compliance Group (MCG)
Activity Expected 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
  • Postmarket monitoring and surveillance activities undertaken across all product types to ensure they remain compliant with regulatory requirements.
  • Activities relating to recalls and advertising regulatory functions undertaken.
  • Surveillance, enforcement and related activities undertaken.
  • Adverse event reporting by consumers and health professionals improved through education and awareness raising activities and improved reporting interfaces implemented.
  • Public access provided to therapeutic goods adverse event data, early warnings and alerts, and more detailed information provided about therapeutic goods recalls.
  • Inspections and assessments of manufacturers undertaken, nationally and internationally, while utilising good manufacturing practice (GMP)clearances from international partners to the maximum feasible extent for overseas manufacturers.
  • Monitoring and compliance laboratory testing, investigation and reviews undertaken in response to quality or safety concerns.
  • Advertising complaints responded to in a timely manner using a risk based approach.
  • Continued streamlining of administrative processes for handling of advertising complaints.
  • Lot release program for vaccines conducted.
Regulatory science
  • Early assessment of and response to potential safety signals identified through postmarket monitoring.
  • Effective triage processes in place to keep pace with an increased flow of adverse event reports as a result of increased rates of reporting.
  • Input provided to whole of government efforts for assessing vaccine safety by providing timely information on national rates of adverse events following immunisation.
  • Proactive risk assessment strategies applied for the planning of manufacturing quality inspections.
  • A risk based laboratory testing program conducted to monitor compliance with required standards.
Device registries
  • Together with the Department's Acute Care Division and other stakeholders, work commenced to develop patient contact registers for high risk implantable devices and clinical quality registers for implantable cardiac devices and breast implants.
  • Consultation undertaken and a Cost Recovery Impact Statement (CRIS)developed on the preferred option for cost recovery for registries.
  • Legislative amendments prepared if required to support levies for the ongoing administration of each registry.
Regulatory compliance
  • Compliance efforts focused to areas of greatest risk.
  • Information published about decisions made to cancel therapeutic goods for non- compliance with regulatory requirements.
  • Continued development of appropriate responses to target falsified medicines and illegal internet sales of therapeutic goods.
  • Continued cooperation with the Australian Customs Service and Border Protection Service in the development of targeted approaches to prevent the importation and/or export of illegal therapeutic goods.
Lead TGA Group: Regulatory Services Group (RSG)
Activity Expected outputs
Provide support services that enable the TGA to more effectively undertake its regulatory responsibilities

Program and Change Management

  • Continued implementation of business improvements to provide a streamlined approach for regulatory case management, reporting and client services, including:
    • consistent, easy to use and streamlined application processes for conformity assessment
    • readily accessible and 'real time' information on the status of conformity assessment applications for industry and TGA staff
    • development of a single source of consistent information available across TGA so that stakeholders do not receive conflicting advice
    • a customer self-service initiative
    • rollout of the eCTD facility for prescription medicines.
  • A delivery strategy for the implementation of business change through projects.
  • A 'centre of excellence' for change and project management service delivery maintained.
  • Timely and accurate information provided on project status, issues, risks and critical decision points.
  • Delivery of TGA reforms,the Business Improvement Program and the deregulatory agenda supported

TGA Advisory Committees

  • Continued administrative support provided to TGA's advisory committees, subcommittees and working groups.
  • Recruitment processes undertaken for critical 2014-2015 statutory advisory committee vacancies.
  • Continued targeted use of the committees and associated advice to assist TGA decision making.
  • More comprehensive and timely public reporting of committee outcomes.
  • Review undertaken of nature and number of committees, to reduce administrative burden.
  • Advisory Committee for Medicines Scheduling integrated into TGA committee support processes.

Human Resources

  • Continued HR support provided to the TGA for recruitment, learning and development, payroll,work health and safety and performance management activities.
  • TGA's workforce plan updated.
  • Continued refinement of recruitment processes in line with whole of government processes to improve TGA ability to define and fill critical job roles.
  • Continued refinement of the work health and safety management system in alignment with the overall Departmental system and strategies.
  • 2014-15 training plan developed and implemented.
  • Strengthened support for active manager assistance in case management of underperformance and of compensation cases.

Information management

  • Continued provision of information technology support and communication systems and solutions to support business processes.
  • Continued development and implementation of an integrated information environment and system.

Parliamentary support

  • Timeliness and provision of accurate and appropriate information in parliamentary support activities.


  • Continued provision of internal and external corporate communications for the TGA.
  • Further development of education materials and social media content targeted to areas of demand.
  • Migration to a new Content Management System to improve searching and content structure on the TGA website.
  • Simpler and more targeted information provided and redundant, out-dated and trivial content archived or removed from our website.
  • High quality and timely responses provided to stakeholder enquiries via email and telephone through the Public Contact Team.


  • Continued provision of financial, procurement and property support to the TGA.
  • Financial management policy relevant to TGA financial frameworks documented and communicated.
  • Alignment of business planning with budgeting at the branch and section and project level progressed.
  • Strengthened financial governance of programs and projects.
  • Investment funding supported for 2014-15initiatives on international collaboration, Australia-New Zealand regulatory alignment and implementation of regulatory reforms.
  • A new activity based costing tool implemented and a report prepared on fees and charges.
  • TGA is compliant with the Cost Recovery Framework issued by the Department of Finance in July 2014.
  • Business improvements in financial operations implemented.
  • Review of the LVT exemption scheme completed with options proposed for Government.
  • Decision made on the TGA's long-term accommodation requirements in Canberra.

Risk Management and Business Continuity Framework

  • Executive kept informed of progress of treatments identified in the TGA Enterprise Risk Plan.
  • Robust business continuity framework further developed, including regular testing of the framework.

Legal services

  • Legal advice and assistance to the TGA.
  • Continued improvements to awareness and knowledge within TGA of the legal environment in which we operate.
  • Assistance provided with the implementation of TGA's reforms and the deregulation agenda.
Regulatory science
  • Market research utilised to help stakeholders make more informed decisions about therapeutic goods and comply with our regulatory requirements.
  • Research applied to drive prioritisation and development of TGA communication and education activities and content.
  • Effective use made of external expertise and regulatory science initiatives led by other regulators.

image of medicine manufacturing plant

International harmonisation and work sharing

Strategy underpinning this priority

Lead TGA Group: Market Authorisation Group (MAG)
Activity Expected outputs
Enhance cooperation and work sharing with international regulators in the premarket assessment of medicines and medical devices

Generic medicines

  • Increased exchange of, and reliance on, the evaluation reports of trusted international regulators to support Australian regulatory decision making.
  • Improved understanding of international regulators processes to increase opportunities for harmonisation and work sharing.
  • Implementation of harmonised processes and protocols for work sharing with Health Canada and opportunities identified for work sharing with other trusted international regulators.
  • Participation in the European Directorate for the Quality of Medicines and HealthCare's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia.

New chemical entities (including orphan drugs)

  • Program developed for exchange of evaluation reports for new chemical entities (NCEs), including orphan drugs, with Health Canada and opportunities identified for exchange of information and work sharing with trusted international regulators.
  • Exchange of full assessment reports related to marketing authorisations of orphan medicines with the European Medicines Agency.

OTC medicines

  • Opportunities identified for work sharing with Health Canada to support the registration process for OTC medicines, including the development of further OTC monographs.

Complementary medicines

  • Opportunities identified for work sharing with Health Canada to support the evaluation of registered complementary medicines and ingredients for use in listed medicines.
  • Greater use of evaluations of new substances performed by overseas regulators explored.

Medical devices

  • Phased program of confidence building with European Notified Bodies completed.
Influence the international regulatory harmonisation agenda through participation in key multilateral fora
  • Contribution made to the development of new international regulatory standards in the areas of vaccines, immunisations, medical devices, sterilization, GMP, and non-propriety names through participation in standard setting bodies such as the World Health Organization (WHO) and the International Organisation for Standardization (ISO).
  • Contribution made to the harmonisation of existing international standards in the areas of evaluation of Active Drug Substance Master Files/Drug Master Files;granting of "biowaivers", and medical devices through participation in multilateral initiatives of international regulators.
  • Influence the international regulatory harmonisation agenda through membership of the Executive Committee of the International Coalition of Medicines Regulatory Authorities.
Lead TGA Group: Monitoring and Compliance Group (MCG)
Activity Expected outputs
Engage in activities to reduce duplication and improve efficiencies in inspection of manufacturing sites
  • Protocols and criteria developed for exchange of manufacturing inspection information with trusted international regulators.
  • Reduced number of inspections carried out in countries where other regulators have also been inspecting the same manufacturing sites.
  • Work sharing with Health Canada increased on GMP inspections and desk top assessments and opportunities for work sharing with other trusted international regulators identified.
  • Internationally consistent manufacturing quality standards applied.
Enhance postmarket monitoring
  • Increased use of risk communication received from other regulators to trigger safety investigations and appropriate regulatory action if required.
  • Work sharing with Health Canada on postmarket monitoring-evaluations undertaken of Periodic Safety Update Reports and Risk Management Plans where products are common to both jurisdictions.
  • Database for collecting and analysing adverse events upgraded to allow more effective international sharing of information and improved signal detection.
Influence the international regulatory harmonisation agenda through participation in key multilateral fora
  • Contribution to the development of new international regulatory standards and regulatory requirements through participation in initiatives of regulators (for example,Medical Device Single Audit Program)and standard setting bodies such as the WHO, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the ISO.
  • Contribution to regional capacity building through participation in forums such as the Regional Alliance Steering Committee for National Regulatory Authorities for Vaccines and potentially through greater involvement in regulatory capacity development for medicines in the Mekong region.
Lead TGA Group: Regulatory Support Group (RSG)
Activity Expected outputs
Coordinate TGA's participation in international activities
  • TGA's contribution to influencing the development and harmonisation of international regulatory standards supported through the strategic planning of bilateral and multilateral work sharing and harmonisation activities supported.
  • Implementation of TGA's International Engagement Strategy 2013-2015 continued.
  • New opportunities identified for expanding international engagement leading to international regulatory harmonisation and work sharing projects.
  • TGA's participation in the International Coalition of Medicines Regulatory Agencies (ICMRA) Management Committee and GMP Inspections Project supported; leading in the implementation of the ICMRA generic drugs work plan and sub-projecton GMP data requirements.
Coordinate the development of revised collaborative arrangements with trusted international regulators
  • Strengthened collaboration and formalised work sharing arrangements in place with overseas-regulators.
Provide support services that enable the TGA to effectively participate in international collaboration and work sharing initiatives
  • IT architecture and supporting protocols developed for sharing confidential information with trusted international regulators that incorporate appropriate security measures to protect information from unauthorised use or accidental modification, loss or release.
Continued trans-Tasman cooperation between the two national regulators and the degree of harmonisation between regulatory schemes
  • Enhanced information-sharing in relation to pre- and postmarket regulatory functions performed by each regulator, such as:
  • regulatory compliance and pharmacovigilance
  • laboratory tests
  • investigations into quality defects or manufacturing errors
  • evaluation reports
  • medicines scheduling.

Premarket process for medicines

  • Continued implementation of a common approach to OTC medicine premarket business processes.
  • Common electronic platform shared for OTC and prescription medicine applications.
  • Guidance information developed for industry about requirements for making changes to approved medicines in Australia and New Zealand.
  • Further mutual recognition of TGA and Medafe GMP audits of manufacturers in their respective jurisdictions or those located in third countries.


  • Common adverse events/pharmacovigilance database facilities strengthened.

Continuing the therapeutic goods reform process

Strategies underpinning this priority

  • Develop and enhance key partnerships with consumers, healthcare professionals and other regulatory agencies.
  • Maintain appropriate relationships with industry.
  • Maintain an effective regulatory framework that is contemporary and in line with international best practice.
  • Maintain a robust risk management approach to all strategic and key operational risks.
  • Maintain a sustainable and capable workforce.
  • image tablets in a blister packet 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.
  • Contribute to the Government's deregulation and red tape reduction agenda by identifying and progressing opportunities to reduce red tape.
Lead TGA Group: Market Authorisation Group (MAG)
Activity Expected 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.
  • RIS and legislative amendments drafted for introduction into Parliament, subject to Government policy approval.
Enhancing postmarket monitoring so as to more efficiently focus postmarket resources towards problem areas.
  • Data collected from listing compliance reviews performed by the TGA analysed to inform risk profiles and prioritisation of subsequent reviews.
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.
  • Proposed Therapeutic Goods Order designed to address poor labelling and the associated public health implications subjected to public consultation to help inform the final RIS and decision. Implementation through a new Therapeutic Goods Order.
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.
  • A communication and education plan developed and implemented to communicate our risk based framework more broadly.
Explore mechanisms for providing explanations of 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.
Electronic submissions
Replace paper dossiers for prescription medicines registrations with electronic submissions that meet international standards.
  • Worked with internal stakeholders and industry to implement eCTD format submissions.
Medical device reforms
Develop regulatory definition of hip, knee or shoulder joint replacement implants to clarify the range of medical devices captured by the reclassification.
  • RIS developed to support government decision making on options, including appropriate consultation.
  • Appropriate regulatory amendments sought.
Provide advice to Government on a modified package of medical device reforms,building on previous proposals and consultation, and taking into account the Government's deregulation policy.
  • RIS developed to support government decision making on options, including appropriate consultation with stakeholders.
Assess approaches for the regulation of autologous stem cells, including aspects related to advertising. Consult publicly on regulatory options and consider whether changes to current regulatory frameworks are warranted.
  • Discussion paper developed that considers issues and potential options to address them. Subject to Government endorsement, public consultation on regulatory options.
Experimental products
Reform regulations and processes surrounding access to unapproved therapeutic products through the Special Access Scheme, including development of electronic submissions.
  • Internal policy paper developed on options for reforming regulations and processes.
  • RIS developed to support Government decision making on options, including appropriate consultation with stakeholders.
  • Implementation of preferred options commenced, including systems for electronic applications and/or notifications.
Review the way in which the TGA undertakes regulatory toxicology to ensure that priorities, approaches and staffing resources are aligned with contemporary international standards and commensurate with risk.
  • Review of the toxicology section completed.
Reducing regulatory burden
Contribute to the Government's deregulation agenda by identifying and progressing opportunities to reduce red tape.
  • Subject to government approval, this could include work towards the following activities:
  • providing greater flexibility of pathways to market authorisation for prescription medicines, medical devices and breakthrough therapies
  • considering allowing notification and/or self- certification for some processes:
    • minor variations to existing approved products and export-only medicines
    • health professional authorisation for use of medicines and medical devices not yet approved in Australia
  • reviewing the regulatory requirements for certain low-risk medicines and medical devices, including through possible alignment with comparable food, cosmetic or other consumer product regulatory regimes.
Lead TGA Group: Monitoring and Compliance Group (MCG)
Activity Expected outputs
Promote the distribution of therapeutic goods safety information, and examine mechanisms for improving the timely communication of alerts and recalls, to health professionals and to consumers.
  • Review completed and update of Uniform Recall Procedure for Therapeutic Goods, including consultation with stakeholders and development of a draft revised instrument.

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.

  • Subject to Government approval, revised RIS developed and approval sought for proposals for the future regulatory framework for the advertising of therapeutic goods that streamline and clarify advertising requirements and provides for penalties that are proportionate to the nature of the offence committed.
  • Subsequent regulatory changes drafted and submitted for policy approval for implementation.
  • Subject to Government approval, continued development of a more effective advertising complaint handling process and operating procedure for investigating non-compliance with advertising requirements.
Reducing regulatory burden
Contribute to the Government's deregulation agenda by identifying and progressing opportunities to reduce red tape.

Subject to government approval, this could include work towards the following activities:

  • reviewing the advertising requirements for non- prescription medicines, including the need for pre- approval of advertisements
  • reviewing certain fee structures and administrative processes to ensure barriers are removed for businesses to maintain contemporary and effective product registrations and corresponding information for health professionals and consumers.

various icon images of medicines and medical devices

Lead TGA Group: Regulatory Services Group (RSG)
Activity Expected outputs
Strategic engagement and information accessibility

Work transparently with other key providers of information to enhance the information available to the public.

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

  • Functionality of the TGA website improved by introducing new ways of presenting, searching and managing content, including Product Information and Consumer Medicine Information documents.
  • Feedback from Australian Therapeutic Goods Advisory Council deliberations used to shape TGAs stakeholder and communication activities.
  • Participation in conferences and events continued, including plenary presentations, as well as other educational activities with key stakeholders and partnered organisations.
  • Continued dissemination of communication and education materials and testing new materials that are audience-centred,based on outcomes of research into the needs of major stakeholders.
Implement agreed Key Performance Indicators (KPIs)to provide quantitative and qualitative information on the TGAs organisational effectiveness and operational efficiency.
  • Implementation of KPI reporting completed with the publication of the full set of reporting measures in the January to June 2014 report.
  • KPI reporting continued as a business-as-usual activity.
Complete changes to reflect TGA's approach to disclosure of commercially confidential information.
  • Update of TGA forms and guidance documents to reflect the approach.
Reducing regulatory burden
Contribute to the Governments deregulation agenda by identifying and progressing opportunities to reduce red tape.

Subject to government approval, this could include work towards the following activities:

  • implementing a new business environment to improve engagement with business and other regulators:
    • electronic submission using pre-populated forms
    • review of information requirements
    • applicant access to milestone dates and expected completion dates
  • enabling streamlined data sharing to make TGA information directly available to the Pharmaceutical Benefits Scheme.

Book pagination