Posted by Michael Wonder on 20 Mar 2018
Provisional approval pathway: prescription medicines
20 March 2018 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation, the TGA is implementing a pathway for the provisional registration of prescription medicines.
Approval through the provisional pathway will be on the basis of preliminary clinical data where there is the potential for a substantial benefit to Australian patients.
The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods. It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
