Australia – TGA releases new fee schedule and announces reform delays

Australia’s Therapeutic Goods Administration (TGA) published its new fee schedule for the upcoming year and announced delays to a series of regulatory reforms.

2020-21 fee schedule released

The TGA’s fee schedule for the 2020-2021 fiscal year, which begins on July 1, includes the general 1.95% increase that had been identified in a proposal published in January. The schedule also features a new tiered fee structure for consent to import, supply, or export non-compliant devices (including IVDs).

One noteworthy addition is a discounted schedule of annual Australian Register of Therapeutic Goods (ARTG) listing fees for devices on the July 2020 Prostheses List, which is applicable for this fiscal year only due to the impact of elective surgery cancellations during the COVID-19 pandemic. This reflects a discount of 50% from the standard annual ARTG fees. There is no need for medical device companies to submit a request for the discount to the TGA; instead it will be automatically applied to eligible ARTG entries.

The IVD variation application fee appears to have been omitted from the schedule, which may have been an oversight. If so, it has likely increased to AUD $470, in line with the medical device variation application fee…