Comparison of Submission Requirements of Generic Drug and Medical Devices In Australia and Canada

Abstract

vii ABSTRACT Drugs and Devices are regulated by Therapeutic Goods Administration (TGA) in Australia and in Canada which is regulated by Health Canada (HC). A generic drug in Australia comes under category 1 and in Canada they have Abbreviated New Drug Submission (ANDS). In Australia and Canada Medical Devices are classified into Risk based classifications & In vitro Diagnostics (IVDs) classification. This thesis represents the submission process of Drug & Medical Devices in Australia and Canada. A hypothetical dossier is prepared using Propofol Injection BP 1% as a reference product. This dossier is prepared according to regional guidelines including the information of regional data, chemistry, manufacturing and control data (CMC).The comparison of registration process for Generic drug and Medical devices is described for Australia and Canada. In this work comparison of CTD Module 1: Administrative and product information is prepared and described for Australia and Canada. Also the Module 2, 3, 4, & 5 is briefly described in this thesis. There is no significant change in Module 2, 3, 4 & 5 in Australia & Canada. In Australia we have to submit Pre-submission planning form (PPF) before submitting the dossier in CTD format and after that they will inspect our facility and we have to submit dossier, while in Canada we have to submit Dossier directly to Health Canada. The overall comparison suggests the registration process of drug products in Australia seems more stringent as compare to Canada.