Pharmacuetical Drug Products Approval Procedure in Australia

This article is written only for the educational purposes. The objective of this article is to guide the industry about the Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. TGA is the administrator for approval of medicines and devices in Australia. As per the TGA act all the medicines are classified in to prescription, non-prescription medicines and export only medicines. Prescription medicines are classified in to three categories like, Category-1; Category-2 and Category-3 type applications.