3 July 2017 - The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes to the Authorised Prescriber Scheme that will streamline the application process and improve access to required unapproved therapeutic goods.

From 3 July 2017, medical practitioners will not be required to submit their clinical justification to the TGA for evaluation as this will have already been approved by a human research ethics committee or endorsed by a relevant specialist college.

Applications to become an Authorised Prescriber of therapeutic goods which are deemed to have an established history of use will be eligible for a longer duration of authorisation, at the discretion of the Delegate. The maximum duration of approval will increase from one year to two years for medical devices and from two years to five years for medicines and biologicals.

Read TGA news article