TGA Cost Recovery Guidelines Updated
9th Apr 18
The Australian Government has released new guidance as to how the Therapeutic Goods Administration (TGA) implements cost recovery activities associated with the regulation of medicines and medical devices.
Key Issues For The Dental Industry —
Since the 1997 Australian Government budget the nation’s regulator of dental products, the TGA, operates on a cost-recovery model where the funding for its activities is derived from the fees and charges it levies on businesses seeking market access approval.
The TGA recovers its costs via annual charges, application and evaluation fees, conformity assessment fees and inspection fees which are imposed on sponsors and manufacturers of medicines and medical devices. The Therapeutic Goods Act 1989 (Cth) provides a legal authority for the TGA to charge for its regulatory activities within the scope of the Act. The Therapeutic Goods (Charges) Act 1989 (Cth) provides a legal authority to levy annual charges on sponsors and manufacturers of medicines and medical devices. Applicable fees and charges are prescribed in the subordinate regulations made under these Acts.
To provide guidance to those within the Australian Government, and to external stakeholders, the TGA publishes the TGA Cost Recovery Implementation Statement that implements cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices in addition to ongoing surveillance of the Australian market. The TGA Cost Recovery Implementation Statement has been updated and can be downloaded at:
As the peak business organisation representing dental product manufacturers and suppliers the Australian Dental Industry Association (ADIA), has maintained for a number of years the policy position that as the TGA’s regulatory activities could be considered a core function of government the cost-recovery model is not appropriate. However, in circumstances where across the political spectrum it is thought appropriate that the TGA operate on a cost-recovery model, the focus of ADIA is on ensuring that the TGA operates cost effectively (so as to avoid imposing unnecessary costs on industry and with the utmost transparency.
ADIA is currently negotiating with the TGA concerning the fees and changes it will levy on business during FY2018-19 and these negotiations are ongoing. At a broader level, ADIA is strongly advocating for a wholesale independent review of the TGA’s fees and charges regime.
Member Engagement —
On matters associated with medical device regulation and the work of the TGA the team in the ADIA National Office responsible for policy advocacy receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date on matters associated with how TGA fees and charges affect the dental industry 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 firstname.lastname@example.org or by telephone telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 9 April 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.
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11th Apr 18
As the TGA acts to introduce an application fee for placing Class 1 medical devices on the ARTG, ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.
23rd May 18
The nation’s regulatory of medical devices has proposed to place a new cost on businesses wanting to supply dental products – what does this mean for industry?