Australia's regulatory framework for therapeutic goods has undergone many changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). These reforms ensure the availability of therapeutic goods that meet the Australian standards for safety, quality and efficacy. The MMDR implementation hub brings together information on implemented and partially implemented reforms (where work continues to progress).
The implementation of the Australian Government response to the MMDR review has been a carefully managed process, with a staged approach, to ensure there is minimal effect on the TGA's operations and outputs. For information about the program's status, visit: Overview of program status for the MMDR reforms.
We have implemented most of the reforms, including a number of changes to legislation, new assessment pathways to bring medicines and medical devices to market earlier, and utilising assessments from comparable overseas regulators. Some longer-term reforms are still progressing, including particular reforms that commenced later in the implementation. This was to permit other influencing elements (for which TGA had no control) to be in place but allow adequate transition times to safeguard the continued availability of therapeutic goods on the Australia market. For further information on the program's achievements to April 2020, see: MMDR program achievements.