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TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2013
Progress to 31 December 2013
Forty-eight (48) recommendations will be implemented by the TGA during the four year program:
- Four (4) recommendations were implemented by 30 June 2012 (as planned).
- A further twenty-four (24) recommendations have been implemented by 30 June 2013.
- A further twenty (20) recommendations will be implemented by 31 December 2015. Three of the twelve (12) recommendations forecast for delivery in 2013-14 have been implemented in the first half of the financial year. The remaining 9 recommendations are on track for implementation by 30 June 2014. One recommendation forecast for delivery in 2014-15 has also been implemented.
Appendix A provides information on TGA's progress against each of the recommendations including progress to 31 December 2013 and activity planned for the next six months (until 30 June 2014).
Appendix B provides a planned schedule for implementation of recommendations in the period from 1 July 2013 to 31 December 2015 (Phase 3).
As at 31 December 2013, thirty-two recommendations have been implemented.
Three recommendations relating to complementary medicines have been implemented in the first half of 2013-14. Information from compliance reviews is being used to develop risk profiles of sponsors and characteristics of medicines to inform the targeted compliance review program. This addresses Auditor-General’s Recommendations 4a and 4b.
In response to Auditor-General's Recommendation 5b, an IT reporting system has been developed to enable provision of regular reports to the TGA executive on progress with investigations and trends in non-compliance.
Transparency review recommendation 4 which relates to working with key information providers has also been implemented. This recommendation was forecast to be implemented in 2014-15.
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 Recommendation 8 has been described as "implemented" because the role of advisory committees in the context of TGA's regulatory decisions has been described publicly, including on the TGA website. Further work will occur in 2013-14 to finalise principles for publishing committee meeting information. A further example is Transparency Recommendation 13. The recommended assessment into the feasibility of developing an on-line system for the submission and tracking of all applications is complete, as is the process to procure a new system for electronic lodgement of supporting industry application data. The commissioning phase for new systems will involve wide-ranging changes to work practices and opportunities for efficiencies in processes for industry. Introducing these changes will require consultation with industry, and revision of TGA work practices over the next two years.
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 2014 is shown against each recommendation in Appendix A. This appendix also shows recommendations which have been implemented and those on track.
Progressing implementation: 2013-14
There are nine remaining recommendations forecast to be implemented by June 30, 2014. Delivery of these recommendations is on track. The TGA will continue tasks such as undertaking consultation processes, preparing regulation impact statements (where required), seeking policy approval for changes and drafting legislation (where legislative change is required). Planned activity for the Jan -June 2014 period against each Blueprint recommendation is shown in Appendix A.