You are here
TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2014
Progress to 31 December 2014
Forty-eight (48) recommendations were proposed for implementation by the TGA during the four year program.
- Thirty eight recommendations have been implemented by 31 December 2014.
- A further ten (10) recommendations are planned for implementation by 31 December 2015.
Appendix A provides information on TGA's progress against each of the recommendations including progress to 31 December 2014 and activity planned for the next six months (until 30 June 2015).
Appendix B provides a planned schedule for implementation of recommendations in the period from 1 January 2015 to 31 December 2015 (remainder of Phase 3).
The term "implemented" indicates that the recommendation has been materially addressed. In some cases, it does not mean that work in a particular area is complete.
For example, Transparency Review Recommendation 10 has been described as implemented as reporting against a full set of agreed Key Performance Indicators (KPIs) has occurred. Ongoing publication of quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency will continue. Further work will also be undertaken to ensure the KPIs address the common set of performance measures required as part of the Government's Regulator Performance Framework.
In many cases, further activity will be undertaken to embed the outcomes of these recommendations into the business-as-usual functions of TGA, and planned activity for the six months to 30 June 2015 is shown against each recommendation in Appendix A. This appendix also shows recommendations which have been implemented and those on track.
Progressing implementation: 2014-15
One recommendation has been implemented in the six month period to 31 December 2014 (Transparency Review Rec 10):
- The TGA, in conjunction with key stakeholders, develop and publish agreed Key Performance Indicators to provide quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency.
It is anticipated that a further recommendation will be implemented in the six months to 30 June 2015 (Transparency Review Rec 16):
- The TGA 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.
We will continue consultation processes, preparing regulation impact statements (where required), seeking policy approval for changes and drafting regulations or legislation (where regulatory or legislative change is required). Planned activity for the January - June 2015 period against each Blueprint recommendation is shown in Appendix A.
Review of medicines and medical devices regulation
On 24 October 2014 the Government announced an Expert Review of Medicines and Medical Devices Regulation (the Review) would be undertaken. The Review will examine specific aspects of the regulatory framework for medicines and medical devices administered by the Therapeutic Goods Administration with a view to identifying:
- areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and
- opportunities to enhance regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
The Review will provide recommendations on the regulatory frameworks for prescription and over the counter medicines and medical devices by 31 March 2015. The Review of the regulatory framework for the complementary medicines sector will be undertaken during the second quarter of 2015.
Progress of some reforms proposed in the "Blueprint for TGA's future" is dependent on the outcome of the Expert Review and the Government's response to the Review's findings. This includes areas where the Review intersects with reforms such as limitation of "free text claims" for complementary medicines, reforms to advertising and further changes to the regulation of medical devices.
Other aspects of the TGA's work programme fall outside the remit of the Review and work will continue in these areas. These include:
- the ongoing programme of publication of guidance documents;
- improvements to TGA internal business processes; and
- TGA process reform that does not involve potential regulatory change (for example, confidence building work with European Notified bodies that assess and certify medical devices for the Australian market).
Material variations to delivery
The announcement of the Expert Review of Medicines and Medical Devices Regulation has required a revision to the delivery schedule for some Blueprint recommendations. As outlined above, the nature of possible reform to complementary medicine regulation, therapeutic goods advertising and further changes to the regulation of medical devices in particular are dependent on the Review's findings and the Government's subsequent response. Therefore, five recommendations will not be implemented as forecast during 2014-15:
- The TGA 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 (Transparency Review Rec 9)
- To improve the integrity of the self-assessment process for listing complementary medicines on the Australian Register of Therapeutic Goods, the ANAO recommends that Health seeks to finalise work on the 'coded indications' project so as to limit the use of inappropriate claims and indications on the ARTG (Auditor-General's Report Rec 2)
- Modify Electronic Listing Facility system, to include restriction or elimination of access by sponsors to 'free text' (Informal Working Group Rec 2a)
- Review current 'coded indications' project based on the document 'Guidelines for levels and kinds of evidence' and either restrict or eliminate access by sponsors to 'free text' in the Electronic Listing Facility (Informal Working Group Rec 4)
- Publication of device product information on the TGA Website (Medical Device Reforms - Proposal 4)