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New guidance explaining how Australia’s new priority-review pathway for novel devices works clarifies that designation application fees are not refundable.





Medtech companies hoping to enter the Australian market faster by applying to use the country’s new priority-review pathway for novel medical devices and IVDs will be charged $9,660 (US$7,573) to have their applications for designation under the scheme assessed.



The Therapeutic Goods Administration will not refund fees for designation applications that are withdrawn before the decision is made, or are assessed as ineligible for designation, the agency clarifies in a guidance document published on Jan. 2, a day after the new pathway went live.



In addition, securing a priority designation, which allows marketing applications to jump to the front of the queue of submissions under review by the TGA, does not guarantee approval for the product, the guidance says. Also, the application designation fee is additional to the fees for conformity assessment or inclusion in the Australian Register of Therapeutic Goods.



To qualify for priority-review designation, applicants must “make a concise, persuasive argument” that their product meets three eligibility criteria: serious condition, unmet needs and major therapeutic advantage.



Development of the priority-review pathway for devices and IVDs follows Australia’s landmark Medicine and Medical Devices Regulation (MMDR) review, which was conducted by an expert panel and published in 2014. The panel made 58 recommendations for reform, including how best to allow TGA to speed access to devices and drugs.



To qualify for priority-review designation, applicants must “make a concise, persuasive argument” that their product meets three eligibility criteria: serious condition, unmet needs and major therapeutic advantage.



The guidance document explains in detail how applicants should go about demonstrating eligibility. It also contains practical information on submitting applications for designation.



The document points out that applicants can include several new medical devices of the same type in one application for priority review if they all fulfil the eligibility criteria and are not currently assessed under a routine pathway. Medical devices of the ‘same type’ can be devices in the same product family, or multiple devices designed to be used together.



Following anapplication, companies can expect to be notified of TGA’s decision within four weeks (20 working days) of the agency receiving their application (excluding any additional time taken for applicants to respond to TGA requests).



A designation decision will lapse after six months, unless TGA receives an application for either TGA conformity assessment or ARTG inclusion during this time. Applicants who are denied a designation will receive a statement of the reasons for TGA’s decisions.



Designation decisions will be published on the TGA’s website after the applicant has been notified, a move that industry had warned during a public consultation last year would introduce a competitive disadvantage for manufacturers.



TGA will not publish details of designation applications that are assessed as not eligible, or those that are withdrawn before it makes a decision.

The guidance document notes that companies planning to seek both regulatory approval and reimbursement may wish to indicate whether they agree that all documents provided to TGA or developed during TGA assessment can be shared with the relevant committee, i.e. the Medical Services Advisory Committee, or the Prostheses List Advisory Committee.

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