Skip to content
An official website of the OECD. Find out more
Created by the Public Governance Directorate

This website was created by the OECD Observatory of Public Sector Innovation (OPSI), part of the OECD Public Governance Directorate (GOV).

How to validate authenticity

Validation that this is an official OECD website can be found on the Innovative Government page of the corporate OECD website.

The Australian Therapeutics Goods Administration expedites assessments of COVID-19 diagnostic kits.

Innovative response

Australia's Therapeutic Goods Administration (TGA) has created a number of new regulations to accelerate the production and supply of COVID-19 test kits, through an expedited assessment procedure.

In some cases, for example point of care tests, due to limited information at the time of application, regulatory approval is granted, with strict conditions that follow-up data and studies including stability shelf-life is provided to the TGA. In addition, a number of exemptions for complying with normal regulatory processes and approvals are in place to facilitate faster access and supply for some tests and PPE medical devices.

Specific issues addressed and anticipated impact

The speed of typical assessments for therapeutic goods is typically very slow within the TGA. This would mean that equipment which is needed imminently might be slowed down due to regulatory red tape and administration, thus resulting in adverse medical outcomes.
This solution should help partially redress this problem.

Organisations/institutions involved

Australian Government, Department of Health - Therapeutic Goods Administration

Level(s) of government:
  • National/Federal government

Issues being addressed:

  • Resource management and mobilisation
  • Crowdsourcing solutions

Response tags:

Date Submitted:

15 April 2020