Following extensive consultation with stakeholders including consumers, healthcare professionals and industry, the Government, for the most part, supports the recommendations of the Review of Medicines and Medical Devices Regulation.
Of the Review's 58 recommendations, 56 are supported by the Government. The majority of these recommendations are supported in full, while for some, the Government supports the intention of the recommendation but proposes to implement them in a different manner to that suggested by the Review.
Of the 56 supported recommendations, the Government has decided to defer two recommendations namely the:
- establishment of registries for all high-risk medical devices (recommendation 22);
- review of the Therapeutic Goods Administration's (TGA) funding arrangements (recommendation 32).
The two recommendations that the Government has rejected relate to the decision-making and governance arrangements of the regulator (recommendations 29 and 30). These recommendations were primarily rejected due to widespread stakeholder concerns that they would result in significant approval delays for new medicines and medical devices. In addition, the intention of these recommendations can be achieved through the implementation of the broader suite of reforms recommended by the Review.
The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released on 15 September 2016.
Word version: Australian Government Response to the Review of Medicines and Medical Devices Regulation (Word 190 KB)
PDF version: Australian Government Response to the Review of Medicines and Medical Devices Regulation (PDF 305 KB)