TGA Plan To Achieve Global Regulatory Harmonisation
28th Sep 18
The Therapeutic Goods Administration (TGA) has released its operations plan to harmonise Australia’s regulatory framework for therapeutic products with that of comparable overseas jurisdictions, which will cut red-tape and make it easier for businesses to import and export dental products in Australia.
Key Issues For The Dental Industry —
The TGA, the Australian Government agency responsible for regulating therapeutic products and, therefore, the majority of dental products supplied in Australia, has released its 2018-19 operations plan for engagement with overseas regulators. This plan underpins the TGA’s activities that will ensure that Australia’s regulatory framework for therapeutic products is consistent with that of comparable jurisdictions around the world.
This is important for businesses that manufacture and supply dental products, as increased harmonisation between Australia’s framework and that of overseas regulators will reduce the amount of unique documentation required to achieve conformity, minimise unjustified unique Australian requirements, and reduce the amount of unnecessary duplication.
Specific projects that the TGA will undertake over 2018-19 for medical device harmonisation include:
■. Work towards a standard format for medical device regulatory submissions that supports electronic transmission (i.e. make submission forms look the same and contain the same information requirements);
■. Develop a globally consistent approach to regulatory pathways for personalised medical devices, including the majority of products manufactured and supplied by dental laboratories;
■. Develop a common set of requirements for regulatory reviewers to improve consistency of regulatory reviews across jurisdictions;
■. Participate in a globally consistent approach for the implementation of the Global Medical Device Nomenclature (GMDN); and
■. Strengthen the performance of regulatory authorities in the Indo-Pacific region (more consistent and clearly defined regulations will make it easier for Australian dental product manufacturers to export to these markets).
The TGA’s international engagement strategy holds benefits for businesses beyond regulatory harmonisation. The TGA will, over 2018-19, enhance its interoperability with overseas regulators to combat illegal online supply and reduce the transit of counterfeit products; specifically from the UK, China, India, Singapore, and Thailand.
You may download TGA’s 2018-19 operations plan for international engagement below:
TGA’s International Engagement Strategy: operations plan 2018-19 [PDF]
The 2018-19 operations plan supports the TGA’s broader international engagement strategy which can be downloaded via the link below:
TGA’s International Engagement Strategy 2016-20 [PDF]
The Australian Dental Industry Association (ADIA), the peak business body that represents dental product manufacturers and suppliers, supports efforts undertaken to align Australia’s dental product regulatory framework with international standards. If a dental product has been approved under a trusted international standard or risk assessment, then Australian regulators should not impose any additional requirements for approval in Australia, unless a good reason to do so is demonstrated.
Further Information —
To keep up to date with how ADIA is working to help reduce red-tape and support businesses that import and export dental products subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the ADIA policy team via email at firstname.lastname@example.org or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 28 September 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, images and where 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
11th Dec 17
The dental industry is leading the charge in development of new regulatory standards for 3D printed medical devices with the aim of allowing the sector to adopt this pioneering new technology as it evolves.
6th Jul 18
The Shadow Assistant Minister for Medicare, Mr Tony Zappia MP, will meet the dental industry’s senior leadership when the annual Dental Industry Parliamentary Roundtable event convenes in Canberra in October 2018.