05 December 2016
Legislation has been introduced to Parliament to amend the Therapeutic Goods Act 1989, supporting the Expert Panel Review of Medicines and Medical Devices Regulation (Sansom Review) to amend restrictive regulations.
Health Minister, The Hon Sussan Ley MP, introduced the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 on 1st December 2016—the first action taken towards implementation of the Medicines and Medical Devices Review which was released in September 2016.
The Sansom Review found that the TGA is well respected, though could provide greater flexibility and more timely pathways to market for the benefit of the sector and patients, as well as increased collaboration with international counterparts to further reduce regulatory burden.
The bill supports the introduction of two new expedited pathways for the marketing approval of certain medicines and medical devices, by providing a regulation-making power to set out the details of the new pathways for priority review.
The industry and relevant stakeholders will be consulted in the review of regulations, which are set to include details such as the criteria for goods to utilise pathways, how to apply, and what fees may be involved.
The amendments to processes—approval, registration and listing times—will result in faster access to medicines and medical devices, while maintaining Australia’s high standards of safety and efficacy and decreasing the regulatory burden on industry and on medical practitioners.
MTPConnect CEO Sue MacLeman welcomed the announcement: “MTPConnect has been charged with vigorously tackling barriers to success, and we are delighted to see measures put in place that are set to further encourage and support the thriving medtech, biotech and pharmaceutical sector in Australia.”