Global Regulation of Nanotechnologies and Their Products in Medicine

Abstract

Nanotechnology, an emerging technology, is creating innovative medicinal products for clinical use. The convergence of nanotechnologies with medicine is predicted to transform the health care sector, particularly pharmaceutical development. Jurisdictions, such as the European Union, the United States, Australia, and New Zealand, have witnessed the launch of medical products containing nanomaterials. Many of the nanomedicines on the market, in clinical testing, or under regulatory review, promise to improve existing products and treat diseases more effectively. The purposes of this chapter are to (a) describe nanotechnology, in particular, its clinical applications; (b) analyze the application of medical products regulation in several jurisdictions (the European Union, United States, Australia, and New Zealand); and (c) assess the adequacy of this law for managing the potential risks posed by nanomedicines. There are gaps in the public health/health science evidence about the risks associated with nanomedicines, and there is concern that the novel properties of some nanomedicines will bring unforeseen human and environmental health and safety risks. Analysts project that, by 2014, the market for medical products containing nanomaterials will be US$18 billion per year. Given the predicted market for nanomedicines, and the growing evidence of their potential risks, it is important to have adequate regulation of these products to prevent adverse public health outcomes. Regulators and clinicians will need to consider the risks posed by some nanomedicines against the potential benefits to patients who are prescribed these products.