TGA is currently seeking feedback on some far reaching regulatory reforms, including proposals to introduce local third party assessment arrangements and direct recognition of regulatory approvals from “comparable” overseas regulatory agencies. TGA currently only recognises European certifications. These reforms could see Notified Bodies operating directly in Australia and TGA recognising decisions from agencies such as the US FDA, Health Canada or the Japanese PMDA.
The last quarter of 2016 has been an extremely busy one for the Australia Therapeutic Goods Administration (TGA) with an unprecedented number of consultations being circulated for feedback from industry.
Notably of these consultations are some that may have significant impact to not only Australian manufacturers, but also overseas manufacturers. More importantly, some manufacturers are at risk if their sponsor is not aware of potential implications of some of these consultations if they are to come to fruition.
For those closely monitoring the Australian landscape for the regulation of Medical Devices and diagnostics in Australia (and for the pharmaceutical industry), they will recognise these consultations as direct outcomes of the Expert review of medicines and medical devices regulation. March 2015 saw the independent Expert Panel provide the Government with its first report on the review of medicines and medical devices regulation in Australia. This saw the panel make 32 recommendations. July 2015 saw the second (and final) report from the Expert Panel to Government, making a further 26 recommendations.
Two current consultations appear to be high priority for TGA and will have a substantial impact to industry:
- Accelerated assessment of medical devices – Priority Review pathway – Implementation
- Designation of Australian conformity assessment bodies for medical devices – implementation
These reforms have been debated by TGA and its stakeholders for some time. The discussion has always involved speed to market for higher risk devices. This has been a careful balancing act between the industry need to provide quality innovative technology to the market quickly, and the regulators need to effectively manage the public expectation of safe and effective products.
Giving Innovators a Hand – Expedited Pathways
The TGA appear to be making a realistic approach of implementing a system for priority pathways for clearance of novel technology. The trick will be deciding what’s novel and the consideration given to clinical need. We’ve seen similar approaches from the US FDA, and most recently with the China FDA implementation of the “Green Channel” expedited review pathway, both of which allow additional support and/or focus for innovative devices coming to market. This can only be a good thing not only for industry but for the community at large. The shape of any expedited pathway will be very dependent on how this is implemented, what type of feedback is received by the regulator from industry and the legislative changes that may need to go through parliament before these changes can be adopted. Depending on the priorities of Federal Parliament, it could be some time before we actually see results.
Australian Conformity Assessment Bodies
This idea of having TGA step away from direct conformity assessments has been in play for a long time. The current reliance on European (CE) certificates as the basis or the bulk of ARTG registrations s really a key strategic risk for Australia. Essentially we have hitched our wagon to Europe and are thus potentially at risk if Europe introduces changes which effect the TGA use of CE certificates. For example the current changes in European classifications may introduce disparities with Australia which complicate assessments. Furthermore, public perceptions of weaknesses in European assessment (whether justified or not)have potential to undermine confidence in TGA. It’s likely that any Australian Conformity Assessment Bodies will be local offices of the larger European Bodies already operating in Australia (and which also operate as local assessors in Canada, Japan, the USA and many emerging markets).
So what does this mean for industry? Well, we very much need to carefully consider what is being proposed and more importantly provide feedback to the TGA. Written submission are public, are considered by the legislators and have a surprising amount of weight. SO be sure your voice is hears. It’s no use complaining later if you didn’t speak out. The consultations close early January 2017.
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