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TGA external communication and education framework

Priorities and projects 2013-2015

21 December 2012

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Overarching communication and education priorities

Photo of several hands overlapping in the centre of a group of peopleThe 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.

Communicating and educating on the role and responsibilities of the TGA

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.

Photo of a medical practitioner talking to a smiling womanCommunicating the benefits versus risks approach to regulating therapeutic goods

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.

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