Issues and Concerns for the Registration of Biological Products in Australia
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
ISSUES AND CONCERNS FOR THE REGISTRATION OF BIOLOGICAL PRODUCTS IN AUSTRALIA BRIANL. HILLCOAT,MD,
BSc,
PHD
Drug Safety and Evaluation Branch, Therapeutic Goods Administration, Department of Health and Family Services, Australia
The Australian Guidelines for the Registration of Drugs recommend the contents and format of applications to register biologicals in Australia. This follows European guidelines and the European Union (EU) format is preferred. Registration does not require clinical trials in Australia. The Drug Safety and Evaluation Branch evaluates the application within defined time frames. The Compliance Branch handles Good Manufacturing Practices (GMP).Australia is a member of the APEC working party which is preparing draji guidelines on GMP for the region. Australia markets 17 recombinant products and two monoclonal antibodies. The problems encountered with biologicals are similar in Australia to those of other countries. Special conditions apply to blood products and gene therapy products. Australia has a policy of self-sufficiency in blood products but allows the supply and marketing of products from other countries when the equivalent product cannot be supplied in Australia. The Gene Therapy Committee of the Medical Research Council, as well as the Therapeutic Goods Administration, oversees the use of the gene therapy in humans. The costs of biologicals remains the greatest concern as many are government subsidized. Key Words: Biological products; Biotechnology products; Biotechnology; Registration in Asia Pacific; Australia
INTRODUCTION IN G E W L , REGISTRATION of biologicals in Australia has the same requirements as those for other therapeutic goods and is consistent with those of the European Union. The requirements are set out in the Australian Guidelines for the Registration of Drugs (AGRD) which has appendices on vaccines,
Presented at the DIA 32d Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996, San Diego, California. Reprint address: Dr. B.L. Hillcoat, Director, Drug Safety and Evaluation Branch, TGA, P.O.Box 100, Woden, ACT, Australia 2606.
substances produced by genetic manipulation, monoclonal antibodies, and blood products. Applications in the European Union (EU) format are preferred, but those in the Food and Drug Administration (FDA) format may be accepted. Registration does not require clinical trials to be done in Australia. Most marketed biologicals are imported except for blood products. Quarantine clearance is to be obtained before submitting an application.
PROCESSING OF APPLICATIONS FOR REGISTRATION OF BIOLOGICALS Applications are made to the Therapeutic Goods Administration (TGA), one of the 13
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Brian L. Hillcoat
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divisions of the Department of Health and Family Services (Figure 1). The Dru
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