ADIA's Policy Advocacy Delivers New Approval Pathway
30th Jan 18
More expedient Australian market approval for new dental products is what legislative reforms before the parliament will achieve, something made possible as a result of the Australian Dental Industry Association's (ADIA) policy advocacy over a number of years.
Key Issues For The Dental Industry —
Australian dental product suppliers have often faced prolonged delays in obtaining market approval for new dental products that offer new and innovative patient treatment and diagnostic options. It’s for this reason that the ADIA has been a long-standing advocate for the ability of third-party conformity assessment bodies, other than the Therapeutic Goods Administration (TGA), to operate in Australia. The great news for Australia’s dental industry is that this is to be the outcome of legislation currently before the parliament.
The Therapeutic Goods (2017 Measures No 1) Bill 2017 (Cth) will provide the TGA with the powers to designate third-party conformity assessment bodies. ADIA has continuously argued that doing so will create efficient competitive conformity assessment pathways that will lower assessment costs and times.
The Therapeutic Goods (2017 Measures No 1) Bill 2017 (Cth) is currently being reviewed by the Senate’s community affairs legislation committee. Also being review by the Senate is the Therapeutic Goods (Charges) Amendment Bill 2017 (Cth) which provides the TGA with the power to set fees for new third-party conformity assessment bodies. In a detailed submission to the committee, ADIA has argued that the bill should pass without amendment as it supports the outcome of these reforms.
In developing the criteria for third-party conformity assessment body designation, the TGA must consult with industry and prospective third-party conformity assessment bodies. A detailed assessment of the Bill and ADIA's advice to the government can be found in the ADIA senate inquiry submission reviewing the legislation.
There are multiple benefits associated with this amendment for patients, healthcare professionals, and industry. The presence of multiple third-party conformity assessment bodies would create competition in the delivery of prompt and high-quality product assessments in Australia and reduce the cost of assessment. Patients, dental healthcare professionals, and industry alike will benefit from a more efficient product approval framework for medical devices that will broaden the range of medical devices, and therefore clinical options, that are available in Australia.
This reform arises from the expert review of medicines and medical device regulation that has been endorsed by the Australian Government. This reform came about after ADIA, along with other stakeholders in the therapeutic products sector, successfully argued for improvements in the regulatory framework for the approval of medicines and medical devices. As a result of ADIA’s advice to the panel, the Australian Government recognised that streamlining access to medical devices, including access to novel and life-saving therapies, offers significant benefits to consumers, health professionals and industry. The resulting reforms reflect the Government's plan to boost competitiveness and lessen unnecessary regulatory burden.
ADIA will have the opportunity to restate its support for the legislation when it meets with the Minister for Health, the Hon. Greg Hunt MP, later this week.
Member Engagement —
The association's policy advocacy on medical device regulation is undertaken by the team within the ADIA whom receive advice and guidance from employees of member businesses serving on the ADIA-PRPC Product Regulation Policy Committee. Member updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
For further information on ADIA's market research activities send an email to firstname.lastname@example.org or telephone 1300 943 094. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 30 January 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
|A —.. A D I A . .S T R A T G E G I C . .A L L I A N C E S
|* To download these files you'll need ADIA Member Plus access.
6th Nov 18
Given the impact that the Minamata Convention on Mercury has on the use of dental amalgam, its capture and storage, the Australian Government is facing renewed calls to expedite its ratification by the dental industry.
10th Sep 19
The Therapeutic Goods Administration (TGA), in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for Consumer Medicine Information (CMI).