Issn  2249-7579
e Issn  2249-7579
Publisher JOURNAL OF PHARMACEUTICAL BIOLOGY
Title

REGULATORY REQUIREMENTS FOR THE APPROVAL OF GENERIC DRUGS AND COMPILATION OF DOSSIER FOR AUSTRALIA (TGA)

Authors
Raghucharan Y
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhrapradesh, India
Lokesh Reddy M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhrapradesh, India
Vamseedhar Naik Bukke
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhrapradesh, India
Alagu Sundaram M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhrapradesh, India
Jayachandra Reddy P
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhrapradesh, India
Keywords
TGA ,Category Applications ,Streamlined submission process ,

Abstract

The present Thesis determines the Regulatory requirements for Generic drug registration process in Australia. Therapeutic Goods Administration (TGA) is the regulatory authority for Australia and is responsible for regulating medicines and medical devices. Prescription drugs are evaluated by the Drug Safety and Evaluation Branch (DSEB). There are three categories of applications. Category 1: Applications include new chemical entities, new biological entities, new combination products, extension of indications, major and minor variations, and new generics. Category 2: Applications supported by previous approvals and independent evaluation reports, from two acceptable countries. Category 3 : Applications involving changes to the quality data of medicines already included on the ARTG which, in the opinion of the TGA, do not need to be supported by clinical, non-clinical or bioequivalence data. Streamlined submission process, which is newly, introduced approval process for prescription medicines in Australia. By this process, TGA improvise the transparency of evaluation process and timelines. The implementation of the streamlined submission process is one project within the BPR (Business Process Reform) program. Each month, the BPR update provides information on the progress of PPF (Pre-submission Planning Form) and submissions under the streamlined submission process and other information to assist sponsors with the new requirements. To get a marketing authorization in TGA the generic Sponsors must lodge well-planned, high quality, complete submission dossiers. Sponsors must ensure submissions meet the TGA requirements for format and content

Volume / Issue / Year

4 , 4 , 2014

Starting Page No / Endling Page No

201 - 206