ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

TGA Medicines & Medical Device Reforms —

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The independent review of medicines and medical devices regulation (the MMDR review) was announced by the Australian Government on 24 October 2014. The Review examined Australia's medicines and medical devices regulatory framework and processes with a view to identifying areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia. It was also tasked with reviewing opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

A panel chaired by Emeritus Professor Lloyd Sansom AO, with Mr Will Delaat AM and Professor John Horvath AO as members undertook the MMDR and engaged a wide number of stakeholders from across the healthcare professions and patient groups in addition to the medicines and medical device sector. The Australian Dental Industry Association (ADIA) was engaged throughout the panel's review process and continues to work with the Australian Government as the resulting reforms are introduced.

On 4 June 2015, the (then) Minister for Health, Sussan Ley MP, released the first stage of the MMDR review report. When coupled with the second state report released later that year, the result was a series of recommendations to the regulatory framework for the approval of medical devices that are significant in scale and scope.

MMDR Key Outcomes For The Dental Industry —

Expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances;
identifying comparable overseas regulators using transparent criteria;
enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements for products in the Australian Register of Therapeutic Goods; and
improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products.
improving and clarifying the interface and synergies between the market approval of therapeutic goods and advertising requirements that ensure consumer protections are balanced with the availability of information for consumers and health professionals to make informed spending and health decisions; and<
enhancing and streamlining the advertising framework to facilitate and maximise compliance and the management of complaints.

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On 15 September 2016 the Australian Government Response to the MMDR review was released. It identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red-tape for industry whilst maintaining the safety of therapeutic goods in Australia.

MMDR Review Key Documents —

Medicines & Medical Device Regulatory Review - Stage One Report [PDF]
Medicines & Medical Device Regulatory Review - Stage Two Report [PDF]
Medicines & Medical Device Regulatory Review - Australian Government Response [PDF]

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Following consultation with stakeholders including consumers, healthcare professionals and industry, the government has supported the majority of the recommendations of the Review.

As the peak business organisation representing dental product manufactures and supplier, the views of ADIA have been keenly sought by the TGA as it works with the medical devices sector to implement the reforms.

Member Engagement —

ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. To ensure that the advice and guidance ADIA provides the TGA on matters associated with medical device regulation members determine ADIA policy through the ADIA-DRC Dental Regulation Committee.

Further Information —

If you have an interest in ADIA's work at a parliamentary and departmental level to secure the policy reforms that support businesses in the dental industry, for updates subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at policy@adia.org.au or by telephone on 1300 943 094.

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