Toxicological and public good considerations for the regulation of nanomaterial-containing medical products

Abstract

Increasing research interest in the new and unusual properties of nanotechnology-related pharmaceuticals and medical devices has led to international and national reviews of safety regulation. Significant considerations emerging here are the relative paucity of metrological and toxicological data, as well as the absence of adequate funding and standardized approaches for its acquisition. Some areas are better researched, such as the toxicity of carbon nanotubes and use of engineered nanoparicle titanium and zinc oxides as broad-spectrum ultraviolet-blocking agents. Such in vitro studies do reveal concerns – for example, related to oxidative stress and granuloma formation – but their uncertain clinical ramifications may require more integration in preclinical drug discovery of research characterizing structure–toxicity relationships and limiting safety liabilities. Regulatory considerations for medically related nanoproducts should also involve improving cost-effectiveness systems and ensuring that industry involvement in standard-setting does not become a means of reducing competition. It is also important that nanotechnology policy and regulation encourages new models of safe drug discovery and development that are more systematically targeted at the global burden of disease.