TGA reforms: A blueprint for TGA's future
On 8 December 2011 TGA reforms: a blueprint for TGA's future was released. The Blueprint aims to improve the Australian community's understanding of the TGA's regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.
The blueprint was released in response to several major reviews of therapeutic goods regulation that were undertaken in 2010 and 2011. These reviews include
- the review to improve the transparency of the Therapeutic Goods Administration
- public consultations on the regulatory framework for advertising therapeutic goods
- the Auditor-General's report on Therapeutic Goods Regulation: Complementary Medicines
- an informal working group examining the regulation of complementary medicines and reasons for low compliance rates
- public consultations on the medical devices regulatory framework
- the Working Group on Promotion of Therapeutic Products
- the Health Technology Assessment Review.
In July 2012 the TGA released its plan for delivering the blueprint. Implementing the Blueprint reforms will require the TGA to:
- deliver outcomes that respond to the Government’s Blueprint 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.
Reform in each of these areas will be achieved incrementally over four years, in three phases. The priorities are:
- better managing our communication;
- better managing our practice; and
- mature and sustainable performance.
Further information is available in the document, Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future.
To assist in the delivery of this program of work the TGA has developed the 'Program Implementation Guide for TGA Staff'. It will provide a single integrated view of the activities and control measures necessary to achieve the objectives of the program. The Guide also provides a baseline for the measurement and tracking of project progress, and the control of changes to the project.