Present systems and future needs for risk assessment of veterinary biologicals in Australia: the perspective of the regulator.

The increasing range and complexity of biologicals, and the greater demand for these products, have resulted in a greater volume of trade in animal-based biological material. This has given rise, in turn, to many approaches to the regulation of importation of these materials, as countries seek protection against the introduction of disease. Harmonization of these regulatory approaches would contribute significantly to the availability of veterinary biologicals, to their manufacture and trade, and to disease security. Australia has developed systems for the categorisation and evaluation of biologicals, control by import permits, and specific procedures at point-of-entry and in institutions where these products are used. Computerised records and precedents assist in evaluation and in the issuing of permits. Recognition that some materials must be subject to further control has led to a system of registration of institutions based on levels of biosecurity, and approved use and disposal programmes. Institutions vary from high-security animal health laboratories to human in vitro fertilisation clinics, which use animal-derived media and materials. Such institutions are regulated through quality assurance contracts. Quarantine authorities have linkages with other agencies which have an interest in these products. These linkages reflect the administrative structures of government in Australia, and provide for management of all forms of risk. The author describes these systems and overviews their biological basis.