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MMDR: Cross-cutting initiatives

15 December 2020

The Australian Government Response to the Review of Medicines and Medical Devices Regulation supported adoption of a broad range of reforms aimed at improving transparency and engagement with sponsors.

The changes 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.


Support for Small and Medium Enterprises

The SME Assist scheme provides targeted tools and content to support small and medium enterprises and R&D groups developing new medicines and medical devices to understand the key issues around the regulation of therapeutic goods in Australia.

Cost-recovery processes

The Therapeutic Goods Administration (TGA) routinely prepares cost recovery implementation statements (CRIS).

The CRIS provides information on how the TGA implements cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices, including in vitro diagnostic (IVD) devices, and biologicals onto the Australian Register of Therapeutic Goods (ARTG) and the ongoing monitoring and surveillance of them.

Any changes to fees and charges (required to support the reforms) are captured in the relevant CRIS.

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.