TGA Consultation on Low Risk Product Regulation
24th Apr 17
The Australian Dental Industry Association (ADIA) is seeking advice from dental product manufactures and suppliers on proposed options for future regulation of ‘low risk products’ by the Australian Government.
Key Issues For The Dental Industry —
As a result of advocacy by ADIA and other stakeholders in the therapeutic goods sector, the Australian Government undertook an expert review of medicines and regulation which made three three recommendations in relation to performing further reviews of the regulation of ‘low risk’ products.
These recommendations were accepted by Government in its response released on 15 September 2016. In conducting these further reviews, the Therapeutic Goods Administration (TGA) met with other product regulators, industry associations (including ADIA) and some individual companies, to understand the product types that are considered ‘low risk’ in the context of these recommendations. Having developed candidate product types, the purpose of this paper is to enable broader public consultation on possible regulatory options for different product types. This is set out in the following discussion paper:
TGA Consultation Paper —
Options for the future regulation of low risk products [PDF]
In consolidating the expert opinions and tool outcomes, options for reform to the regulation of a range of products and options has been identified by the TGA. The regulator has argued that it is believed that many of these options could be implemented without a detrimental impact on public health and safety. Indeed, by reforming the regulatory approach around certain products, it would allow sponsors and TGA to better focus on the areas of risk with these products as well as on other, higher-risk products. This general approach is supported by ADIA.
ADIA’s preliminary assessment is that the TGA’s intent not to fundamentally change the definition of a medicine or medical device under the Therapeutic Goods Act (Cth) 1989 is sound; however, it would be possible to change the regulatory approach taken for particular groups of products regulated under the Act.
The ADIA-DRC Dental Regulation Committee is currently reviewing the paper and as part of this work advice and guidance from member businesses is valued. Any comment can be forwarded to the ADIA Advocacy team via email at firstname.lastname@example.org and should be received by Friday, 5 May 2017.
Member Engagement —
Businesses that manufacture and supply dental products drive ADIA's policy advocacy priorities and, with respect to issues associated with therapeutic product regulation members convene under the auspices of the ADIA-DRC Dental Regulation Committee to provide advice and guidance to ADIA staff responsible for negotiating outcomes with the Australian Government, with updates provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.
Further Information —
For further information on ADIA's efforts to reform the dental product regulatory system, and this issue in particular, send an email to email@example.com 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 24 April 2017 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 publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.
26th Apr 18
Australia’s innovative dental product manufacturers are invited to join the Australian delegation to the US MedTech Conference to be held in the United States over 23-26 September 2018.
14th Jun 18
A new series of reports that provide unique insights into the market for dental products is under development and you have the opportunity to get involved, offering a great opportunity to understand the structure of the industry.