Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs
EMERGO KEY POINTS:
- New Australian TGA guidance establishes a priority review designation pathway for cutting-edge and novel medical devices and IVDs.
- Qualifying devices must meet criteria pertaining to serious diseases or conditions, unmet clinical needs and breakthrough technologies.
- TGA decisions on priority review designation applications will take no more than 20 business days.
The Australian Therapeutic Goods Administration (TGA) has adopted guidance establishing a priority review designation process for qualifying medical devices and IVD products.
According to the guidance, priority review designation may apply either to TGA conformity assessments or listings of devices in the Australian Register of Therapeutic Goods (ARTG). Products qualifying for priority review designation will move to the front of the line for TGA premarket assessments or ARTG listings.
Priority review qualifications for medical devices and IVDs
In order to achieve priority review designation from TGA, a device must meet three key criteria:
- The device’s intended purpose is to monitor, treat, prevent or diagnose a serious disease or condition;
- No other device with the same intended purpose is listed in the ARTG, or the new device demonstrates superior safety and/or performance characteristics compared to ARTG-listed products with the same intended purpose;
- An IVD product includes a breakthrough technology, provides a significant clinical advantage, or will result in a major public health benefit in Australia.
How Australian market applicants can demonstrate eligibility
TGA registration applicants seeking priority review designation will have to demonstrate how their devices meet the three criteria listed above.
For the “serious condition” criterion, applicants must use “objective and quantifiable” medical data to identify their targeted diseases or conditions.
To address the “unmet need” criterion, applicants should describe how their devices provide state-of-the-art treatment of targeted diseases or conditions, or how they will address urgent or unmet clinical needs. Applicants should provide details regarding any similar devices, or attestations that no similar devices are currently listed in the ARTG. Furthermore, applicants should identify targeted patient populations and submit evidence of how their devices will provide clinical advantages over alternative treatments.
For the “breakthrough technology/clinical advantage/public health” criterion, applicants should summarize evidence supporting the magnitude of their devices’ improved safety and/or performance; impact on patient outcomes; and advances compared to similar devices listed in the ARTG.
The TGA priority review application process
Medical device and IVD companies interested in applying for TGA’s priority review designation must first obtain a TGA client ID number and then complete and submit their application forms to the agency. Once TGA receives a priority review application, the regulator will send an invoice with the application fee to the registrant; fees must be paid prior to application review.
The regulator expects concise summaries of supporting evidence--not full technical files or clinical reports--in priority review designation applications.
Application review timeframes
According to TGA, reviews of priority review designation applications will take up to 20 business days. In instances where companies' priority review designation applications are approved, those firms will then have six months to submit full market authorization applications to TGA.