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MMDR program achievements as at November 2020
In 2016 the Therapeutic Goods Administration (TGA) embarked on a significant reform program to implement the 56 supported recommendations from the Review of Medicines and Medical Devices Regulation (MMDR). The majority of the reforms were delivered by the end of 2019 and while it was anticipated that the remaining reforms would be delivered by mid-2020 this could not be achieved as globally, governments, the therapeutic goods sector, and healthcare professionals all respond to the COVID-19 pandemic.
Those medical device reforms that have a longer lead-time, such as Essential Principles, they will be implemented from 2023 (medical devices) and from 2024 (in vitro diagnostic medical devices), while others, such as the review of the Class I medical devices are being implemented in parallel to other reforms. The implementation of Australian conformity assessment bodies is anticipated to be implemented by mid-2021.
The implementation of the remaining two reforms to complementary medicines regulation (the development, or adoption from Comparable Overseas Regulators of monographs for commonly used active ingredients and the introduction of mechanisms to incentivise innovation for the Australian Complementary medicines sector to improve the competitiveness) will be closed on 31 March 2021 and 30 June 2021, respectively.
The TGA continues to work closely with stakeholders to determine the best way to implement the remaining 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 was passed and commenced (in most part) on 6 March 2018. Supporting regulation amendments commenced (in most part) on 20 March 2018. As a result of concerns outlined in the Senate during the second reading debate, the Government delayed commencement of provisions relating to the removal of advertising pre-approvals for two years until 1 July 2020). This has now been implemented.
- Additionally, regulation amendments in 2019 and 2020 supported the implementation of the reforms through (in 2019) the reclassification of a number of kinds of medical devices to more closely align the regulation of devices in Australia with the European Union (EU) and (in 2020) the updating of a number of device-related definitions to more closely align with the EU approach.
- The commencement dates for the amendments to regulations made in July 2020 were deferred for several measures. These amendments reflected the delays in the European Union Medical Device Regulation implementation resulting from the challenges the medical device industry faced as they directed efforts to supporting the pandemic.
- The amendments to principal legislation that commenced in June 2020 also supported the implementation of the reforms through the introduction of a data protection scheme for assessed listed medicines to help improve the competitiveness of the Australian complementary medicines industry by providing incentives for innovation. Further legislative amendments to facilitate the scheme were introduced to Parliament on 9 December 2020.
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
- Permitted indications for listed medicines
- Comparable overseas bodies (COBs) for listed medicines, assessed listed medicines and registered 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
Work continues to progress the remaining reforms, including:
- Commercial bodies in Australia, designated by the TGA, to undertake conformity assessments of medical devices
- Mechanisms to incentivise innovation and improve competitiveness within for the Australian Complementary medicines sector by introducing a to improve the competitiveness – data protection scheme for assessed listed medicines
- Draft efficacy monographs, which sponsors can use as evidence to support the indications for their listed medicine. Two pilot monographs will be initially published and their usefulness and uptake by industry assessed before further monographs are developed.
- 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.