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TGA business plan 2017-18

20 November 2017

Book pagination

Regulatory reform

In 2016-17 we began implementing the Australian Government Response to the Review of Medicines and Medical Devices Regulation. The Review assessed the regulatory framework for medicines and medical devices in Australia and made a number of recommendations to improve the availability of high quality, safe and efficacious products in a timely way to the community. In addition we have implemented reforms in other areas such as orphan medicines and autologous cells.

Implementation of the Government Response to the Review will continue throughout 2017-18 building upon the reforms already implemented, such as further amendments to the Therapeutic Goods Act 1989 and supporting regulations, which came into effect on 1 July 2017. Key reforms from these amendments include:

New regulatory pathway for medicines and medical devices

A new priority review pathway for prescription medicines was implemented on 1 July 2017 and first applications are being assessed during 2017-18. The priority review pathway provides consumers and health professionals with up to three months faster access to eligible medicines and sponsors with a predictable and transparent pathway. The flexible priority review business process has a target timeframe of 150 working days. Implementation of a new provisional approval pathway for prescription medicines is subject to legislative changes introduced into Parliament in September 2017.

Medical devices reforms include changes to enable implementation of a priority assessment pathway for medical bodies from 1 January 2018 and the potential for Australian bodies to be designated by the TGA to undertake conformity assessment of medical devices.

Variations to registered medicines

A notification process for low risk variations to registered medicines, where these changes do not affect safety, quality or efficacy, is being implemented. Under this process, the sponsor notifies the TGA of the variation and the request is electronically validated allowing a computer program to inform the sponsor that the variation can be implemented.

The notification process for over-the-counter and registered complementary medicines, and the first step in the implementation for prescription medicines - a new e-form - were launched in July 2017. Notifications for prescription medicines will be in place before the end of 2017.

Access to unapproved therapeutic goods

A new 'Category C' notification became available under the SAS from July 2017 for certain unapproved therapeutic goods. These therapeutic goods are for patients that are not terminally ill and are available based on health practitioner notifications rather than requiring an application to be made under the Category B SAS scheme. More products will be considered for Category C over time, based on evidence of safe use.

A new online management system for SAS and the Authorised Prescriber scheme is also under development, and practitioners will be encouraged to submit forms online. The Authorised Prescriber process has been simplified and from 1 July 2017 is based on approval by an ethics committee or specialist college.

Further work

Work during 2017-18 will focus on further reforms (many are subject to passage of legislation) to:

  • establish a provisional approval pathway that will provide earlier access to certain promising new medicines that do not yet have a full dossier of data (in particular clinical data), where there is the potential for a substantial benefit to Australian consumers through the earlier availability of these medicines.
  • change the regulation of complementary medicines that will allow consumers to make more informed product choices, including a new assessment pathway for efficacy-assessed listed complementary medicines. Reforms include the establishment of a list of permitted indications and an exclusivity period for new ingredients. Consultation will occur in late 2017 on recommendations to support the use of a new efficacy-assessed assessment pathway with a pilot of the assessed listed medicines pathway to occur in 2018.
  • introduce significant reforms to streamline the advertising framework for therapeutic goods, including establishing a single, centralised complaint handling system managed by the TGA from 1 July 2018 with external review of the complaints model after three years. Consultation will occur in late 2017 on principles to be adopted in a new Therapeutic Goods Advertising Code from mid-2018 and the Code itself will be consulted on in early 2018. An education program to support compliance will be undertaken in early 2018 and will cater to different audiences including sponsors, health practitioners and the community through guidance and other material.
  • strengthen and broaden the range of investigation and enforcement powers relating to compliance and monitoring. These amendments will standardise monitoring, investigation, infringement notices and injunctions to align with comparable Commonwealth regulators and government policy.

Timeframes for implementation are subject to Parliamentary processes and anticipated passage of the proposed amendments.

Stakeholder consultation will continue throughout 2017-18, through both targeted and public consultations, to inform options for implementation. Additionally, guidance material and industry workshops will be developed to support understanding of the changes to the regulatory framework and regulatory requirements.

A significant program of IT work is supporting implementation of the reforms, focusing on improvements to supporting software and the development of new IT capabilities.

There are a range of other reforms forecast for delivery in 2017-18 to support better health outcomes for Australians and to reduce regulatory burden. An overview of our 2017-18 activities is provided in the table below.

Regulatory reform activities for 2017-18
Outcome Activities
Prescription medicine reforms
  • Develop and implement expedited pathways (priority review and provisional approval) for the registration of novel prescription medicines that address unmet clinical needs
  • Undertake priority review designations and assessments of certain new prescription medicines
  • Develop supporting IT systems for provisional medicines registration applications
  • Implement a revised risk-based process for evaluating variations to registered medicines, specifically the introduction of a notification process for low risk variations
  • Expand the list of variations approved for processing as notifications to include biologicals and additional registered medicines
  • Re-format Product Information documentation
Complementary and over-the-counter medicine reforms
  • Implement the permitted indications reforms for listed complementary medicines
  • Implement the new assessed listed medicines pathway including development of:
    • evidence guidelines to support the new pathway
    • a claimer for assessed complementary medicines
  • Introduction of a market exclusivity period for new ingredients approved for use in listed medicines
Biologicals reforms
  • Enhance our regulatory framework for biologicals to align with changes made to medicines regulation including publishing guidance on Risk Management Plans for biologicals
Medical device reforms
  • Commence a priority review pathway for medical devices
  • Establish a process for Australian designated bodies to undertake conformity assessments of medical devices
  • Implement criteria to identify comparable overseas regulators for the approval of medical devices
  • Propose initial regulatory amendments to harmonise medical devices regulation, focused on safety concerns, with the European Union regulatory framework
  • Undertake a review of the range of products currently classified as Class I medical devices
Post-market monitoring reforms
  • Update guidance on pharmacovigilance requirements of medicine sponsors for products on the ARTG and identify mechanisms for enhancing compliance
  • Upgrade the database for collecting and analysing adverse events to allow more effective international sharing of information and improved signal detection
  • Incorporate expanded classification of adverse events, via work on the International Medical Devices and Regulators Forum working groups, to improve international sharing of information
  • Implement the Black Triangle Scheme for new medicines
  • Implement a new Adverse Event Management System
  • Access linked datasets including Prescription Sequence Symmetry Analysis and 45 and Up projects
Access to unapproved therapeutic products reforms
  • Implement policies, processes and systems for electronic applications and/or notifications
  • Undertake compliance assessments of the new SAS Category C notification pathway
  • Develop an external application portal for the SAS and Authorised Prescriber scheme
Scheduling Policy Framework and advertising of pharmacist only medicine reforms
  • Revise Scheduling Policy and companion handbook to improve the efficiency and transparency of the scheduling process
  • Update guidelines and reform the advertising of S3 (pharmacist only medicines) substances
Advertising of therapeutic goods reforms
  • Introduce a new Advertising Code for therapeutic goods
  • Establish a single complaints management process
  • Design and implement a new IT system for advertising complaints management
  • Develop and implement a sponsor education program to support compliance
  • Work towards revised compliance and monitoring powers in the Therapeutic Goods Act 1989
International cooperation and work sharing reforms
  • Develop frameworks to support increased use of overseas reports and work-sharing arrangements in making regulatory decisions and criteria to identify comparable overseas regulators for prescription medicines
  • Make effective use of external expertise and regulatory science initiatives led by other regulators
  • Improve understanding of international regulators' processes to increase opportunities for collaboration, for example:
    • collaborate through the Australia-Canada-Singapore-Switzerland Consortium, particularly on the generic medicines work sharing trial
    • greater use of safety evaluations for new complementary medicine ingredients performed by overseas regulators, including with Canada, Singapore and Switzerland
    • progress work sharing opportunities for medicines, including with Health Canada, through the Regulatory Cooperation Initiative
  • Continue the Trans-Tasman cooperation between regulatory schemes through:
    • enhanced information sharing in regulatory compliance and pharmacovigilance, laboratory tests, investigations into quality defects or manufacturing errors and recall actions undertaken
    • continued sharing of a common approach to over-the-counter medicine pre-market business processes
    • further mutual recognition of TGA and Medsafe GMP inspections of manufacturers

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