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TGA reforms
The TGA mandate is to regulate medicines, medical devices and biological products throughout their lifecycle. The TGA is focusing on implementing changes to ensure a greater emphasis on transparency of regulatory decision-making processes, a continuing focus on business process reform and a more strategic approach to the use of information technology to support regulatory operations.
- Expert review of medicines and medical devices regulation
The Review was conducted by a panel of three independent experts: Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO - The Business Improvement Program
The TGA introduced the Business Improvement Program (BIP) to make our information and communications technologies better - TGA Reforms: a blueprint for TGA's future
The blueprint was released on 8 December 2011 in response to several major reviews of therapeutic goods regulation that were undertaken in 2010 and 2011- Advertising regulatory framework - options for reform
In June 2010, a review of the advertising arrangements for therapeutic goods other than prescription medicines was initiated - Complementary medicines regulatory reforms
These reforms are part of the TGA reforms: A blueprint for TGA's future and address the recommendations of the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Medical devices reforms
A series of medical device regulatory reforms increasing the rigour of pre-market assessment of higher risk medical devices, to assure the quality, safety and performance of these devices - Medicine labelling and packaging review
Consultation on recommendations to change the presentation of information on the labels and packages of medicines - Streamlined Submission Process project (prescription medicines)
In early 2009, the TGA commenced a significant program of business process reforms (BPR program) for the regulation of prescription medicines in Australia
- Advertising regulatory framework - options for reform