Necesidades de Investigation en Nanotecnologia Biomedica para el Desarrollo de las Regulaciones de Control - Biomedical Nanotechnology and Research Needs in Support of Regulation

Abstract

It is expected that the application of biomedical nanotechnology will lead to progress in medical science, particularly in the areas of disease diagnosis, bio-compatible materials and drug delivery systems. In vitro diagnostic techniques employing biosensors and DNA biochips are now available. Advances in biomedical engineering include biomimetic nanostructures for implants and tissue engineering techniques that will allow, potentially, the growth of artificial organs and the regeneration of damaged nerve tissue. Therapeutic systems using nanopowders and nanotubes for drug delivery and anticancer drugs targeted at tumour cells are under development. The convergence of the physical and biological sciences via nanotechnology can be expected to transform medicine and healthcare. There is concern however regarding the risks of adverse ecological and health effects due to nanoparticles dispersed in the environment and in the human body. Public acceptance of nanotechnology is likely to be strongly influenced by the perception of the associated risks. Modifications to the regulatory framework may therefore be required to guarantee the safe implementation of nanotechnology in healthcare applications. The adoption of a precautionary approach is recommended, together with the use of reliable scientific data to determine the true extent of the risks, and some critical research needs are identified.