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.
There has been a slowing in the implementation this year. This reflects the challenges identified by the therapeutic goods industry and healthcare professionals to redirect their efforts to respond to the pandemic. The delays have allowed the TGA to undertake further consultation that will assist in developing more comprehensive guidance materials and refining implementation details relating to the reforms. For further information on the program's achievements to November 2020, see: MMDR program achievements.