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TGA external communication and education framework
Priorities and projects 2013-2015
Overarching communication and education priorities
The TGA has two overarching communication and education priorities:
- explaining the role and responsibilities of the Australian Government in regulating therapeutic goods
- describing the benefits versus risks approach the TGA takes to regulating therapeutic goods.
The TGA will provide information about:
- what the TGA is and how it works with other parts of DoHA, the national healthcare system, and international therapeutic goods regulators
- what the TGA does—its roles and responsibilities as the therapeutic goods regulator—including:
- what therapeutic goods TGA evaluates
- how therapeutic goods are evaluated (including the differences between registered, listed and included therapeutic goods, and their processes of evaluation)
- what is involved in the TGA's approval of therapeutic goods - including providing an appropriate level of information on manufacturing inspections, as well as the information on the work of the different TGA statutory advisory committees
- how therapeutic goods are monitored for safety and for compliance with the regulatory system, and how compliance is enforced
- the regulatory actions TGA is empowered to take under the Act
- how its work contributes to the quality use of therapeutic goods, for example, the role it plays in providing Consumer Medicines Information and Product Information
- what the TGA is not able to do, such as:
- research, develop or manufacture new therapeutic goods
- provide clinical advice on medication and prescription management for individual patients
- undertake laboratory testing for every batch of a therapeutic good authorised for supply
- manage the supply of therapeutic goods (noting that during product shortages the TGA may assist sponsors to provide alternative versions of the therapeutic good)
- compare different therapeutic goods for cost-effectiveness
- subsidise provision of therapeutic goods
- protect the intellectual property of therapeutic goods
- test low risk complementary medicines and medical devices for efficacy
- regulate the conduct of medical practitioners or healthcare practitioners more broadly.
- how the TGA is funded, and how it remains impartial and avoids conflicts of interest
- how and when to contact the TGA.
The TGA will provide information to help stakeholders understand the benefits versus risks approach it takes in the regulation of therapeutic goods, including:
- risks associated with therapeutic goods that are subject to safety alerts, recalls or cancellations, or other regulatory action
- the role of scientific evidence in demonstrating the safety and quality of therapeutic goods
- the application of different regulatory requirements for approval depending on the nature and level of risk for different therapeutic goods
- what is required of individuals and companies to ensure compliance with the therapeutic goods regulations
- the TGA's compliance framework.