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.
Australian Government, Department of Health - Therapeutic Goods Administration
- National/Federal government
Issues being addressed:
- Resource management and mobilisation
- Crowdsourcing solutions
15 April 2020