Abstract
The Australian approach to regulation of tissue-engineered medical products is described. Common issues of potential transmission of pathogens apply to all therapeutic goods of biological origin, and a common approach has been developed to regulation of both drugs and medical devices. Regulation is based on assessment of risk, with particular attention to minimizing risk of transmission of pathogens in addition to the more conventional premarket evaluation of biological safety. Australia is free of many domestic animal diseases, and there are import restrictions on animal materials to prevent the introduction of exotic diseases. The transmissible spongiform encephalopathies (TSEs) present particular challenges to infection control, and minimizing infectivity is addressed through donor selection and screening criteria in addition to validated processing procedures known to inactivate pathogens. The codes of good manufacturing practice which apply to different types of tissue-engineered medical products are outlined. This approach to regulation of tissue-engineered medical products is set within the broader context of the Australian regulatory system and plans to harmonize Australian legislation with that current in the European Union.
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