MMDR program achievements

In 2016 we embarked on a significant reform program. 

We are implementing 56 supported recommendations from the Review of Medicines and Medical Devices Regulation (MMDR).

By the end of 2019, most reforms had been delivered. 

We had hoped the remaining reforms would be delivered by mid-2020. As governments, the therapeutic goods industry, and healthcare professionals responded to COVID-19, this couldn't be done.

Those medical device reforms that have a longer lead-time, such as Essential Principles, will be implemented from 2024 (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.

Collaboration with stakeholders will complete 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 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.
• Regulation amendments in 2019 and 2020 supported the implementation of the reforms through (in 2019) the reclassification of several kinds of medical devices to align the regulation of devices more closely 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.

Achieved

We have delivered a raft of reforms. We have done this while maintaining core business activities.

The reforms are backed by a range of education resources and guidance material. These will support consumers, industry, and health professionals. 

Some of the major reforms delivered to date include:

• Priority review pathway: 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)
• Notifications process: registered medicines
• Comparable overseas regulators (CORs) for prescription medicines
• Support for small and medium enterprises with SME Assist
• Changes to the Special Access Scheme (SAS)
• Enhanced post-market monitoring of medicines with the Black Triangle Scheme
• Determinations for Australian conformity assessment bodies
• Benchmarking against international assessment timeframes
• Comparable overseas regulator marketing approvals for medical devices
• Consumer/patient information materials requirements

Work continues to progress on:

• 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. This 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
• Establishment of a Unique Device Identification System