Abstract

Australia is considered a highly regulated market for therapeutic goods, featuring some of the most stringent regulatory requirements in the world. The governing body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA). There are four main categories of therapeutic goods in Australia: medicines, biologicals, medical devices and other therapeutic goods. To supply a therapeutic good to the Australian market, the applicant must obtain pre-market approval from the TGA before the medicine can be registered.

This article covers the pathways that can be followed to register a prescription medicine in Australia: the standard registration pathway, the priority review pathway, the provisional determination pathway, the comparable overseas regulators report-based pathway, the Access Consortium pathway and Project Orbis. It examines each registration pathway, including scope and evaluation time.