The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 (the Bill) is part of the Government’s response to the recommendations of the review of Medicines and Medical Devices Regulation (MMDR), and the legislation is supported by Research Australia’s submission to the inquiry by the Senate Standing Committees on Community Affairs.
The aim of the Review’s recommendations is to improve the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration. Together the regulatory reforms are expected to reduce the administrative burden on applicants and make the approval process faster without jeopardising the safety of consumers.
Achieving this aim will provide consumers with earlier access to potentially lifesaving new medicines and devices. It is also an effective means of supporting Australia’s medical device and medicines industries; by accelerating their pathway to market it will enable them to become profitable more quickly, providing them with more resources to pursue the international markets needed to be truly successful and profitable.