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Implementation of the Review of Medicines and Medical Devices Regulation

6 May 2020

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).

Program achievements

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.

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.

Information on consultations related to the Medicines and Medical Devices Regulation Review.