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Medicines and Medical Devices Regulation Review hub

14 November 2018

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.

Program achievements

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.

The prescription medicines regulatory reforms include changes that will bring medicines to market sooner in Australia, while maintaining a robust framework for safety, quality and efficacy.

The medical devices regulatory reforms include changes that will provide Australians with earlier access to new medical devices and enhance post-market surveillance.

The complementary medicine regulatory reforms include changes that will create a new approval pathway for listed complementary medicines and increase availability of information to support consumer decisions.

The advertising reforms include changes that will streamline complaints handling, enhance sanctions and penalties available for addressing non-compliant advertising, and abolish the requirement for certain advertisements to be pre-approved.

The post-market monitoring reforms include changes to enhance monitoring and compliance of therapeutic products that are released to market.

Reforms relating to accessing unapproved products include modifications to the Special Access Scheme and Authorised Prescriber scheme to allow streamlined access to certain unapproved therapeutic products.

Reforms to TGA advisory committees include changes that provide greater efficiencies and a reduction in the number of statutory advisory committees that provide independent advice to the TGA.

Further reviews include a review of the regulatory framework for low-risk products and a review of the Scheduling Policy Framework for medicines.

Cross cutting initiatives include developing a support function for small and medium sized enterprises and research institutions to support the growth of the medical technologies, biotechnologies, and pharmaceuticals sector.

Further information

Up-to-date information about the reforms and their status.

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.

All consultations related to the Medicines and Medical Devices Regulation Review