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.