Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). These reforms aim to ensure the availability of products that meet the Australian standards for safety, quality and efficacy. The MMDR hub brings together information on the completed, ongoing and future reforms.
Implementation of the Australian Government response to the MMDR review has involved a significant program of work. To maintain business-as-usual activities, reforms are in the process of being rolled out in a staged approach. For information on which reforms have been completed and which are upcoming, visit: Overview of program status for the MMDR reforms.
We have already implemented a number of reforms, including changes to legislation and new assessment pathways to bring medicines to market quicker. Some longer term reforms are still progressing and some reforms are scheduled to commence at a later date to allow time for transition processes to be put in place. For information on what was achieved between September 2016 and September 2018, see: MMDR program achievements as at September 2018.