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Health Technology

Expert Review of Medicines and Medical Devices Regulation

The Academy recommends that Australia must retain an individual regulatory body to ensure continued safety of the Australian population and grow and promote globally competitive medicine and medical device industries in Australia.

Australia’s medicines and medical device regulator, the Therapeutic Goods Administration (TGA), is a high quality and strong first line regulator of therapeutic goods for inclusion on the Australian market. Regulation is through a risk-based approach that ensures Australians have access to medicines and medical devices that meet acceptable levels of safety and efficacy.

The Australian Government, through its Industry Innovation and Competitiveness Agenda, has outlined its plan to reduce regulatory and administrative burdens. If applied to the TGA, this could see the TGA accepting products that have been approved by other global regulators that have not been evaluated in the Australian context, with the risk of diminishing the high quality regulatory system that exists in Australia.

Assessment, approval and regulation of medical products must remain the responsibility of the Australian TGA to protect the health and safety of Australians and to ensure that the Australian medical device, biotechnology, and clinical trial industries are the target of strengthened investment.

ATSE’s submission highlights several domestic benefits gained from the operational systems and reputation of the TGA (making it an organisation that must remain independent to best protect the Australian population), states areas of the TGA’s regulatory framework that should be protected, and offers recommendations for change that can further strengthen aspects of the TGA.

This submission briefly discusses:

  • The need for continued support to the Clinical Trial Exemption and Clinical Trial Notification schemes;
  • Current TGA resourcing and the need for public funds to cover public good activities;
  • The adoption of support measures for small to medium enterprises, similar to those undertaken by other international regulators;
  • The need for greater dissemination of information to the community;
  • The introduction of fast-track approval processes in Australia that are based on clear evidence for benefit to patients and unmet clinical need;
  • Recent and continuous development of regulations for emerging technologies;
  • The TGA’s leadership in undertaking international collaboration to reduce regulatory burden and duplication;
  • Current TGA approval timeframes; and,
  • The adoption of online systems.
Published December 2014
Pages 14
Format PDF
Size 1.9MB
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  • The Australian Academy of Technology and Engineering is the business name of
    the Australian Academy of Technological Sciences and Engineering (company name).
    The acronym ATSE is used for both.
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