Submission to the Senate Inquiry Regarding the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

This letter submission to the Senate Community Affairs Committee supports the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR), and recommends the Committee to recommend that the Senate pass it. Research Australia maintains that faster Therapeutic Goods Administration (TGA) approvals, with less administrative burden and no loss of safety, would give consumers earlier access to new medicines and devices and help Australian companies reach profitability and international markets sooner. It notes that implementation depends on thorough consultation on the regulations that follow, and that new Australian third-party bodies approving medical devices will need rigorous accreditation.