Federal government announces Expert Review of Medicines and Medical Devices Regulation

Further to the recent launch of the Industry Innovation and Competitiveness Agenda, the federal government has announced the establishment of an independent panel to undertake a review of medicines and medical devices regulation in Australia. The panel comprises Emeritus Professor Lloyd Sansom AO (Chair), Will Delaat AM and Professor John Horvath AO.

The review will examine the Therapeutic Goods Administration’s (TGA) regulatory framework and processes 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 panel said it is aware that there have already been a number of reviews or inquiries that have looked at aspects of the regulation of medicines and/or medical devices in Australia. So as not to duplicate this work, it is the intention of the panel to develop a discussion paper which summarises:

• concerns that have been expressed by stakeholders in the past about the regulation of medicines and medical devices;
• options put forward by stakeholders to address these concerns.

This discussion paper, once available, will be released on the Department of Health’s website and interested organisations and individuals will be invited to provide submissions addressing the issues and options raised in the paper. Stakeholders will also have an opportunity through this process to raise additional issues or options for reform that fall within the panel’s terms of reference but which have not been addressed in the paper.

The terms of reference and further information can be found here