Issues and Concerns for the Registration of Biological Products in Australia

Abstract

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 draft 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.