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Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future
On 8 December 2011, the Parliamentary Secretary for Health and Ageing, the Honourable Catherine King MP, released a package of reforms for the TGA outlined in TGA reforms: A blueprint for TGA's future (the Blueprint).
The Blueprint incorporates reforms arising from major reviews in 2010 and 2011 including:
- the review to improve transparency of the TGA;
- the Working Group on Promotion of Therapeutic Products;
- public consultations on the regulatory framework for advertising therapeutic goods;
- the Auditor-General's report on Therapeutic Goods Regulation: Complementary Medicines;
- the informal working group examining the regulation of complementary medicines and reasons for low compliance rates with particular regulations;
- public consultations on the medical devices regulatory framework; and
- the Australian Government Health Technology Assessment Review.
The TGA is responsible for implementing the Blueprint recommendations, with the exception of the recommendations made by the Working Group on Promotion of Therapeutic Products (the Working Group). Those recommendations involve matters of broader health policy and are the responsibility of the Regulatory Policy and Governance Division of the Department of Health and Ageing. In the 2012 Budget, the Australian Government provided $1.4 million over four years to further assist industry to respond to recommendations by the Working Group and support stronger self-regulation, better communication and shared systems for complaints reporting.
In addition to the Blueprint reforms, there is additional significant reform activity already underway within the TGA. There is also an ongoing program of work being jointly delivered by the TGA and Medsafe NZ in the lead up to the creation of the Australia New Zealand Therapeutic Products Authority (ANTZPA).
The objectives of the Blueprint reforms, and this implementation plan, are to:
- enhance the TGA's current processes to ensure that the regulatory framework in which it operates can be readily adapted to new scientific developments and emerging community expectations;
- improve the Australian community's understanding of the TGA's regulatory processes and decisions;
- enhance public trust in the safety and quality of therapeutic goods; and
- ensure the TGA effectively implements plans to inform the community of its role in providing timely access to the therapeutic goods that Australians need, and that these goods meet appropriate standards of quality, safety and efficacy.
Implementing the Blueprint reforms will require the TGA to:
- deliver outcomes that respond to the Government's Blueprint recommendations (see Attachment 1: Correlation of recommendations);
- achieve operational reforms needed to deliver benefits from those recommendations; and
- ensure that concurrent reform activities underway at the TGA in addition to the Blueprint reforms (ANZTPA and other activities) are achieved in a coordinated way.
Effective engagement with external stakeholders is a priority in the implementation of the Blueprint reforms. Consistent with the Government's commitment to openness and transparency, the TGA is adopting a strong focus on enhancing its communication and engagement with consumers, health professionals and the therapeutic goods industry throughout the Blueprint implementation projects and other concurrent reforms.
Where possible, the TGA will use its existing communication forums and channels to engage with consumers, health professionals and the therapeutic goods industry, but will investigate and develop other communication channels, including stakeholder engagement methods, to support the effective delivery of wide ranging reform projects as required.
By engaging external stakeholders effectively, the TGA will:
- raise consumer, health professional and the therapeutic goods industry awareness about the program of Blueprint reforms;
- engage external stakeholders with an interest in or affected by individual reforms in reform activities; and
- provide support throughout the implementation.