Independent Review of Medicines and Medical Devices Regulation

Health Minister Peter Dutton and Assistant Minister for Health Fiona Nash have appointed an Expert Panel Review of Medicines and Medical Device Regulation, to take place in the second quarter of 2015.
The independent review will look at the ways by which the Therapeutic Goods Administration (TGA) regulates medicines and medical devices. It will be led by Emeritus Professor Lloyd Sansom AO and assisted by Mr Will Delaat AM and Professor John Horvath AO.
Emeritus Professor Sansom AO is a distinguished educator, researcher and policy adviser on health and pharmaceutical matters who has extensive experience in the pharmaceutical sector.
Senator Nash said the review was an important move in reducing any ineffective regulation and encouraging 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," Senator Nash said.
Mr Dutton said, “We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner".
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.

The Expert Panel will release a discussion paper in the near future and is encouraging interested people to contribute their ideas. Ultimately, the review will provide recommendations on the regulatory frameworks for prescription and over-the-counter medicines and medical devices by March 31, 2015.