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TGA business plan 2013-2014

Therapeutic Goods Administration

19 December 2013

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Outputs to deliver

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

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