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
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
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:
Enhancing Australia's prosperity through technology and innovation