TAILIEUCHUNG - Access to unapproved therapeutic goods Clinical trials in Australia

The global environment that charac- terises the business world highlights the importance of developing strate- gies that go beyond the geographical boundaries of one country. Wage-rate differentials, expanding foreign mar- kets and improved transportation break down barriers of time and space between countries and force the logistics function to take on a global dimension. Global logistics is the response to the increasing integration of international markets as firms try to remain competitive. The term ‘sup- ply chain management’ has been extensively used to depict the new managerial challenge to compete in the marketplace. The humanitarian world relies on logis- tics for the same basic reasons. It also requires a process for managing the flow of goods, information and finances from the. | Australian Government Department of Health and Ageing Therapeutic Goods Administration Access to unapproved therapeutic goods Clinical trials in Australia Therapeutic Goods Administration About the Therapeutic Goods Administration TGA The TGA is a division of the Australian Government Department of Health and Ageing and is responsible for regulating medicines and medical devices. TGA administers the Therapeutic Goods Act 1989 the Act applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality safety and efficacy performance when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. The TGA relies on the public healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device please see the information on the TGA website. Copyright Commonwealth of Australia 2004 This work is copyright. Apart from any use as permitted under the Copyright Act 1968 no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration Attorney General s Department National Circuit Barton ACT 2600 or posted at http cca Access to unapproved therapeutic goods - clinical trials in Australia October 2004 Page 2 of 104 Therapeutic Goods Administration INDEX About this document 6 Introduction 8 The legal basis for supply of unapproved therapeutic goods 8 Promotion of unapproved therapeutic goods 10 Clinical trials - an overview 10 Classification of clinical trials 11 Clinical trials of medicines 11 Medical device trials 12 Regulation

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