Therapeutic Goods Administration Cost Recovery Stakeholder Engagement Effectiveness Survey

Closed 28 Oct 2020

Opened 14 Oct 2020

Overview

The Therapeutic Goods Administration (TGA) cost recovers the cost of activities associated with the registration and listing of medicines and inclusion of medical devices, including in vitro diagnostic (IVD) devices, and biologicals onto the Australian Register of Therapeutic Goods (ARTG) and the ongoing monitoring and surveillance of them. The TGA's regulatory activities also cover the licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.

The TGA’s cost recovery stakeholder engagement strategy is set out in its Cost Recovery Implementation Statement (page 33). In the past two years the TGA has adjusted consultative arrangements in response to stakeholder feedback obtained through its current consultation process.

In order to further enhance its consultation process and provide industry with adequate opportunity to engage with the TGA in relation to cost recovered fees and charges, the TGA would like to seek feedback for last year’s consultation through an online survey. Your feedback could include comments in relation to interactions with TGA about the proposed fee and charges for 2020-21:

  • the meetings conducted with 13 industry bodies in December 2019
  • the Public consultation which was open between 20 January and 28 February 2020, and
  • any other correspondence or interactions with the TGA about the proposed fees and charges for 2020-21.

As this is the TGA’s first survey of this kind, you may also wish to provide feedback in relation to prior years’ consultations on fees and charges.

Your feedback will be anonymous. We look forward to hearing your feedback about the consultation process.

** The survey distribution list includes sponsors who paid fees or charges to TGA in last two years and who have provided their email address.

Audiences

  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Medical Devices & IVDs
  • Biogicals
  • Other

Interests

  • Management review