As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the requirements for the new Priority review designations For Medical devices (including IVDs). The TGA had discussed the availability of this process as a result of the review conducted in 2015. And finally, it’s here!
Priority designation devices go to the front of the queue – this should dramatically improve time to market.
To be eligible, devices must meet 3 specific criteria.
1. Serious condition
The device addresses a life threatening or seriously debilitating condition;
2. Unmet need
i. no devices are already approved for the same purpose in Australia, OR
ii. the new device has substantially better safety or performance than approved devices;
3. Breakthrough technology OR clinical advantage OR public health (IVD only) – at least one of the following applies:
i. the new device is a breakthrough technology with substantially better safety or performance than existing devices; or
ii. there is evidence that the device offers a major clinical advantage over existing alternatives included in the Register; or
iii. the new device is an IVD which will provide a major public health benefit.
In summary – a device which addresses an unmet need for a serious condition, using either new or existing technology, and has substantially better safety or performance than what’s already available. (Incremental improvements won’t make the grade.)
TGA’s guidance sets all this out in detail including suggested content of a submission to address the specific criteria. The applicant will need to make a concise, persuasive argument against all three criteria. The TGA will also allow for pre-submission meetings to take place prior to the submission of your priority designation application is made.
TGA recovers all of its costs from fees and there is no exception here. As of 1 January 2018, the fee for a Priority Review designation application is $9,660. Once application has been made, the application will be sent an invoice for the fee which must be paid before review commences. The TGA fee is not refundable, so be sure to make a strong case!
The anticipated timeframe for TGA’s assessment and decision making on your designation application is up to 20 working days and the decision is only valid for 6 months, so you’ll need to be prepared to submit your application.
To learn more about Australian Priority Review, or overall Australian regulations, be sure to register for the Asia Pacific Device Summit. Learn directly from leading experts from APAC including Australia, Greater China, India, ASEAN and Japan about what it takes to succeed in these fast-growing markets. Early bird ends February 28, 2018. Register NOW