The Review of Medicines and Medical Devices Regulation was undertaken by an Expert Panel made up of Emeritus Professor Lloyd Samson AO (Chair), Mr Will Delaat AM, and Professor John Horvath AO.
The Review aimed to identify areas of unnecessary, duplicative, or ineffective regulation that could be streamlined and opportunities to enhance the regulatory framework, so that Australia continues to be well positioned to respond to emerging global trends.
The Review made recommendations that provide options to harmonise Australia’s regulatory system for therapeutic products with international regulatory frameworks, and allow for greater flexibility in approval pathways for medicines and medical devices.
The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released on 15 September 2016. The response addresses each of the 58 recommendations made by the review.
The Government’s response supports the majority of the recommendations and identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia.