Expert review of medicines and medical devices regulation - second report released

The Review of Medicines and Medical Devices: Stage Two Report examines the regulation of complementary medicines and the advertising framework for therapeutic goods.

If you have questions on the Stage Two Report, please contact the Review Taskforce via: MMDReviewTaskforce@health.gov.au.

Previous information

Expert review of medicines and medical devices regulation - first report released

24 June 2015

The Minister for Health, Sussan Ley, Assistant Minister for Health, Fiona Nash, and Parliamentary Secretary to the Prime Minister, Christian Porter, have released the Review of Medicines and Medical Devices: Stage One Report which covers recommendations on the regulatory frameworks for medicines and medical devices.

The Review was conducted by a panel of three independent experts: Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO.

The Panel is reporting in two stages. The Government is currently considering the first report, and the second report, addressing the regulatory frameworks for complementary medicines and the advertising of therapeutic goods, is due to be delivered to the Minister for Health in the coming months.

The Review examined specific aspects of the regulatory framework for medicines and medical devices administered by the Therapeutic Goods Administration 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; and
• 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.

If you have questions on the Stage One Report, please contact the Review Taskforce via: MMDReviewTaskforce@health.gov.au

Expert review of medicines and medical devices regulation

24 October 2014

On 24 October 2014 the Australian Government announced a review of the regulation of medicines and medical devices. The Review will be carried out by a panel of three experts: Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO.

The Review will examine specific aspects of the regulatory framework for medicines and medical devices administered by the Therapeutic Goods Administration 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; and
• 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.

As part of the Review, the panel will be consulting with health professionals, industry, consumers and other stakeholders. Further details on the Review can be found on the Department of Health website.

If you have any questions about the Review or the submission process, please contact the Review Secretariat at medicines.review@health.gov.au.