The Australian Government has released its response to the Review of Medicines and Medical Devices Regulation, with reforms to be progressively rolled out over the next 2 years.
Background and scope of review
An independent review of medicines and medical devices regulation by an expert panel was announced in October 2014. The expert panel reports on Medicines and Medical Device Regulation were published in July 2015 (available here), including 58 recommendations for reform.
The scope of the review was to benchmark TGA regulatory requirements against international authorities, to ensure there is an appropriate balance between risk and benefit in the regulation of prescription, over-the-counter, complementary medicines and medical devices and to simplify and streamline the approval processes undertaken by the TGA.
The Review did not concern any aspect of the Pharmaceutical Benefits Scheme or reimbursement or subsidy of medicines and medical devices.
The Government released its response to the expert panel reports on 15 September 2016 (available here) and, for the most part, has accepted the recommendations made by the expert panel.