TGA Review Panel to Review Medicines and Medical Device
The Australian Government announced on 24 October 2014 that a
panel of three experts would conduct an independent review of the
regulation of medicines and medical devices, to examine specific
aspects of the regulatory framework administered by the Therapeutic
Goods Administration (TGA).29
The Review conducted by Emeritus Professor Lloyd Sansom AO, Mr
Will Delaat AM and Professor John Horvath AO will, focus on
areas of unnecessary, duplicative or ineffective regulation
that could be removed or streamlined without undermining the safety
or quality of therapeutic goods available in Australia;
opportunities to enhance the regulatory framework so that
Australia will remain well positioned to effectively respond to
global trends in the development, manufacture, marketing and
regulation of therapeutic goods.
According to the Terms of Reference30, the Review
will make recommendations to:
ensure there is an appropriate balance between risk and benefit
in the regulation of prescription, over-the-counter, complementary
medicines and medical devices, as well as access for individuals to
unapproved medicines and medical devices;
simplify and streamline the approval processes undertaken by
the TGA, including recommendations on:
fast tracking approvals processes for medicines and medical
opportunities for working together with overseas regulators;
exploring how risk assessments, standards and determinations of
regulators can be used more extensively by Australian regulators
when approving the supply of medicines and medical devices;
ensure regulatory arrangements are flexible to accommodate
developments in medicines and medical devices, including
streamlining of cross-category regulatory approvals;
improve processes that assist industry, researchers and
consumers to navigate the regulatory system;
support work underway on medical device reforms and clinical
trial approval arrangements; and
any other matters that the review committee regards as
important and relevant to the safe and efficient supply of
effective medicines and medical devices to the Australian people.
However, the Review will not make recommendations in relation
any aspect of the Pharmaceutical Benefits Scheme;
work by the Department of Health on the reimbursement
National Health and Medical Research Council arrangements
relating to research and development; or
work currently underway by the Department of Health and the
Department of Industry on ethics processes for clinical trials
The Panel held a forum on 12 November 2014 for peak consumer,
health professional and industry bodies to brief them on the
process for the Review and opportunities to engage with the
Panel31. On 21 November 2014, the Panel called for
submissions from interested parties in response to its Discussion
Paper32, which closed on 5 January 2015.
The Review report is scheduled to be provided to the Minister
for Health, Prime Minister, Assistant Minister for Health, and the
Parliamentary Secretary to the Prime Minister responsible for
deregulation, by 31 March 2015.
29 The Hon Peter Dutton MP and Senator The Hon
Fiona Nash, Joint Media Release 'Expert Panel to Review
Medicines and Medical Devices Regulation' (24 October
>. 30 The Department of Health, 'Review of Medicines
and Medical Devices – Terms of Reference' <
Version.pdf >. 31 The Department of Health, 'Expert Review of
Medicines and Medical Devices Regulation' (20 January 2015)
>.. 31 Emeritus Professor Lloyd Sansom AO, Will Delaat AM
and Professor John Horvath AO, 'Review of Medicines and
Medical Devices Regulation Discussion Paper' (November
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