TGA Publishes Draft Advertising Guidance
15th Aug 18
The dental industry is playing a lead role in supporting the Therapeutic Goods Administration (TGA) develop industry guidance on the 2018 TGA Therapeutic Goods Advertising Code, a document that sets clear standards for advertising medical devices to consumers.
Key Issues For The Dental Industry —
The Australian Dental Industry Association (ADIA) has been asked by the TGA to coordinate the dental industry's views on documentation to assist industry compliance with the 2018 TGA Therapeutic Goods Advertising Code. In this document, that will come into effect from 1 January 2019, the Australian Government has set out a framework for the advertising of medicines and medical devices that seeks to promote the safe and effective use of therapeutic goods by minimising misuse, overuse or under-use of the goods.
The 2018 TGA Therapeutic Goods Advertising Code also ensures that advertising to the public is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance and therefore supports informed health care choices.
The advertising of medicines and medical devices to the public was an issue canvassed extensively in the 2015 Review of Medicines and Medical Devices Regulation. This resulted in an outcome, broadly endorsed by the Australian Dental Industry Association (ADIA), for the Therapeutic Goods Administration (TGA) being designated as the centralised complaints management body for the advertising of therapeutic products to the public. This represents a significant simplification and clarification relative to the existing system of multiple different bodies which will make it easier for manufacturers and suppliers of innovative dental products to comply with advertising requirements.
Earlier this year, the dental industry worked with ADIA to support the TGA in finalising the 2018 TGA Therapeutic Goods Advertising Code. While supporting the overall direction of the 2018 TGA Therapeutic Goods Advertising Code, representatives of the dental industry serving on the ADIA-PRPC Product Regulation Policy Committee made a number of comments which were included in ADIA's submission to the TGA. These recommendations sought to ensure that businesses in the dental industry are not subjected to unintended outcomes of unreasonable compliance obligations, particularly with respect to internet advertising.
Following on from this, ADIA has been invited by the TGA to provide further advice regarding the latter’s refinements to the guidance documentation for the above 2018 TGA Therapeutic Goods Advertising Code. The guidance document is important as it will be relied upon by businesses to interpret and implement in practical terms the requirements of the new Code. The revised draft guidance document can be downloaded below:
ADIA, based on advice from the ADIA-PRPC Product Regulation Policy Committee, will prepare a submission response on behalf of manufacturers and suppliers of innovative dental products to ensure that the guidance provides adequate clarity and support for businesses seeking to comply with the new 2018 TGA Therapeutic Goods Advertising Code when it comes into effect from 1 January 2019.
Member engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to policy advocacy efforts to reduce the red-tape associated with the manufacture and supply of innovative dental products, the team in the ADIA national office receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date with the latest therapeutic goods advertising requirements 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 email@example.com or by telephone on 1300 943 094.
Currency & Disclaimer —
This update was issued on 15 August 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 publication 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.
26th Aug 18
With the new federal Cabinet having been announced, ADIA has set about working with the new Ministers to ensure their focus is on making cuts to red-tape to support manufacturers and suppliers of dental products.
29th Nov 17
The dental industry is preparing for a new edition of the ADIA Code Of Practice that seeks to ensure the dental industry's promotional activities do not inappropriately a healthcare professional's decision on patient treatment planning