Nanomedicine Clinical Use, Regulatory and Toxicology Issues in Europe

摘要

Nano medicine is a revolutionizing field that can benefit both diagnosis and treatment and contribute to a better quality of life. Despite the expected huge benefits, the potential risks on human health are significant as well. This thesis aims to defense a perspective that in case of nascent technologies, where the data are still emerging and scientific uncertainty prevails, risk governance should sustain the process of scientific knowledge by developing guidelines, codes of conduct and public information and provide a minimum level of safety acceptable to protect human health. Although Nano medicine is at an early stage of development some cautious measures should be taken that will provide regulatory mechanisms able to respond to the challenges posed by Nano medicine, establish a minimum level of safety but will also allow the further promotion of scientific knowledge. This multidisciplinary approach can contribute in adopting regulatory choices and tools that will help manage the risks, protect human health and promote scientific knowledge.  As the technologies are designed based on a clear understanding of a particular disease, disease specific oriented focus is required for the development of novel pharmaceuticals. In addition, it will be important to establish a case-by-case approach to clinical and regulatory evaluation of each Nano pharmaceutical. High priority should be given to enhancing communication and exchange of information among academia, industry and regulatory agencies encompassing all facets of this multidisciplinary approach.