Expert Panel to Review Medicines and Medical Devices Regulation

The Australian Government has announced an independent review of the regulation of medicines and medical devices.

Page last updated: 24 October 2014

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Joint Media Release

The Hon Peter Dutton MP
Minister for Health

Senator The Hon Fiona Nash
Assistant Minister for Health

24 October 2014

The Australian Government today announced an independent review of the regulation of medicines and medical devices.

Health Minister Peter Dutton and Assistant Minister for Health Fiona Nash announced they had appointed an Expert Panel Review of Medicines and Medical Device Regulation.

The landmark review of the ways in which the Therapeutic Goods Administration (TGA) regulates medicines and medical devices will be led by Emeritus Professor Lloyd Sansom AO who will be assisted by Mr Will Delaat AM and Professor John Horvath AO.

Mr Dutton said medical technology was constantly evolving.

“We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner,” he said.

Senator Nash said the review was a key step in efforts to remove ineffective regulation and encourage greater competition and innovation in the medicines and medical devices sectors.

“This Review will identify ways to assist medicine and medical device producers and suppliers struggling with complex and costly regulatory pathways, while upholding the safety and efficacy of therapeutic goods available in Australia," she said.

Emeritus Professor Sansom AO is a distinguished educator, researcher and policy adviser on health and pharmaceutical matters.

He has extensive experience in the pharmaceutical sector, played a major role in the development of Australia’s National Medicines Policy and is a former long standing chair of the Pharmaceutical Benefits Advisory Committee.

Mr Delaat has over 40 years of experience in the global pharmaceutical industry.

Professor Horvath is a distinguished specialist renal physician, researcher and teacher. He has contributed to Australian health policy through many roles, including as the Australian Government’s Chief Medical Officer from 2003 to 2009.

Their Review will examine Australia's regulatory framework for therapeutic goods, with a view to identifying:
    • 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 continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
Senator Nash said the Review complemented the Government's Innovation and Competitiveness Agenda.

The Expert Panel will release a discussion paper in the near future and is encouraging interested people to contribute their ideas. It will also be actively consulting with peak health professional, industry and consumer groups.

It will provide recommendations on the regulatory frameworks for prescription and over the counter medicines and medical devices by 31 March 2015.

A review of the regulatory framework for the complementary medicines sector will be undertaken during the second quarter of 2015.

Further information is available at on the Department of Health Website.

Media contacts: John Wiseman - 0401 776 108 (Mr Dutton)
Kay McNiece - 0412 132 585 (Senator Nash)

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