Nanotherapeutics: New challenges for safety and cost-effectiveness regulation in Australia

• Nanotechnology is a revolutionary field of micromanufacturing involving manipulation, by chemical or physical processes, of individual atoms and molecules. • Pharmaceutical and medical device manufacturers, both in Australia and internationally, have significant investments in nanotechnology research and development. • It is important that safety regulation of nanotherapeutics keep pace with this growing level of industry interest. A recent senate inquiry recommended the establishment of a working party, including representatives of the Therapeutic Goods Administration, to consider whether bulk materials classified as safe should be routinely reassessed for use at the nanoscale level by a permanent, distinct nanotechnology regulator. • Safety regulation of nanotherapeutics may present unique risk assessment challenges, given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic classifications of "medicines" and "medical devices". • Nanotherapeutics is likely to make increasing claims on a particular area of Australian health care regulatory strength: scientific cost-effectiveness assessment of innovation in medical products. • Any review of Australian regulation of nanotechnology should include a critical analysis of both safety issues and cost-effectiveness assessment systems for nanotherapeutics.