Process Involved for Registration of Generic Medicines and Format of Drug Dossiers in Australia

Rajkiran Kolakota¹ & K.V.S.L. Kavya*^2
1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP.

A  B  S  T  R A C T
Therapeutic Goods Administration (TGA) guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The format for applications is the Common Technical Document (CTD). These guidelines are not intended to replace the CTD guidelines but to provide explanation that complements the CTD. These are guidelines, and not legally binding. The TGA guidelines assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The format for applications is the Common Technical Document (CTD). These guidelines are not intended to replace the CTD guidelines but to provide explanation that complements the CTD. These are guidelines, and not legally binding. The application for marketing approval of a generic chemical pharmaceutical, unlike that for new compound, does not require pre clinical data from animal studies and clinical data from human clinical studies to establish the generic chemical pharmaceutical’s safety and effectiveness.
Keywords: Therapeutic Goods Administration, Common Technical Document, existing medicine, Generic Medicine etc.