Nanomedicine – regulatory aspects

Abstract

Nanomedicine is a new revolutionary field that can bring benefits for diagnosis and treatment and contribute significantly to a better quality of life. Although the expected benefits of nanomedicine are huge, the potential risks on human health and environment are considerable as well. The increasing multi-functionality and complexity of coming nanomedical products require a very high safety, quality and effi cacy standards. So in case of nascent technologies, when the data are still emerging and scientifi c uncertainty prevails, risk governance should be in place. Despite the fact that nanomedicine is at a quite early stage of development, regulatory mechanisms should provide the corresponding quality, safety and efficacy of nanomedical products. The process of scientific knowledge should be sustained by developing guidelines and codes of conduct that provides a satisfactory level of safety mean to protect human health. The multidisciplinary approach can help the adopting of guidelines and regulations, intended to manage the risks and protect human health.