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MMDR program achievements as at April 2020
The Therapeutic Goods Administration (TGA) has undertaken a significant program of work to implement the 56 supported recommendations from the Review of Medicines and Medical Devices Regulation (MMDR).
The TGA worked closely with stakeholders to determine the best way to implement the reforms. Feedback from over 30 public consultations and additional targeted stakeholder consultations have informed our policy position and shaped what the reforms look like.
The reforms have focused on:
- providing greater flexibility in approving both medicines and medical devices
- aligning the level of regulation with the risk level of a product and creating options for notification pathways
- reducing regulatory burden and removing duplicative processes
- greater collaboration with international regulators and harmonising regulation
- increasing consumer protections and creating additional provisions for compliance action
- increasing the availability of consumer information and improving transparency of processes for industry
To enable the program of work major legislative and regulatory reforms have included:
- the first legislative changes enacted in June 2017 focused on expedited pathways for medicines and medical devices. We made supporting regulatory amendments in both June and November 2017.
- the next set of legislative amendments enacted in March 2018 focused on additional assessment pathways and reforms to the regulation of complementary medicines and the advertising of therapeutic goods.
- the Therapeutic Goods Advertising Code (No.2) 2018 (the Code) was made on 31 October 2018, and came into effect on 1 January 2019 with subsequent minor amendments made in July 2019.
- other regulatory amendments made supported the rationalising the number of statutory Advisory Committees and aligned aspects of the regulatory framework for medical devices in Australia with that in the European Union.
What has been achieved?
We have delivered a raft of reforms, in addition to maintaining core business activities that ensure the high quality regulation of therapeutic goods in Australia. Underpinning the reforms are a range of educational resources and guidance material to support consumers, industry and health professionals. Some of the major reforms delivered to date include:
- Priority review pathway for prescription medicines
- Priority review pathway for medical devices
- Provisional approval pathway: prescription medicines
- Assessed listed medicines pathway for complementary medicines
- Permitted indications for listed medicines
- Comparable overseas bodies (COBs) for complementary medicines
- Proposed new notification process: registered medicines
- Greater use of overseas assessments - Comparable overseas regulators (CORs) for prescription medicines
- Support for small and medium enterprises - SME Assist
- Changes to the Special Access Scheme (SAS)
- Simplified and improved arrangements for handling therapeutic goods advertising complaints
- Enhanced post-market monitoring of medicines - Black Triangle Scheme
Remaining reforms currently being progressed include:
- Commercial bodies in Australia, designated by the TGA, to undertake conformity assessments of medical devices
- Mechanisms to incentivise innovation for the Australian Complementary medicines sector to improve the competitiveness – data protection for assessed listed medicines.
- Review the range of low risk products currently listed in the ARTG (including products currently classified as Class I medical devices)
- More comprehensive post-market monitoring scheme (for Medical Devices), including better integration and analysis of available datasets, alerts that a drug is newly registered, electronic reporting of adverse events and collaboration with overseas regulators
- Regulation of medical devices by the TGA is, wherever possible, aligned with the European Union framework
For more information on the completed and upcoming reforms, visit the overview of program status for MMDR reforms.
General information relating to the review and the implementation can be found at: Implementation of the Review of Medicines and Medical Devices Regulation.