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TGA business plan 2017-18
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.
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.
|Prescription medicine reforms||
|Complementary and over-the-counter medicine reforms||
|Medical device reforms||
|Post-market monitoring reforms||
|Access to unapproved therapeutic products reforms||
|Scheduling Policy Framework and advertising of pharmacist only medicine reforms||
|Advertising of therapeutic goods reforms||
|International cooperation and work sharing reforms||