作者: Raúl Zamorano Farías
DOI: 10.22201/IIJ.24484873E.2016.147.10647
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摘要: This paper aims to explore the regulatory framework of nanotechnologies (NTs) and nanomedicine, develop a comparative analysis between two regimes: United States European Union. It identifies classifies positions that allow design for NTs. As well, regimes are compared: 1) chemicals, 2) drugs medical devices. The main objective is acknowledge if current regulation efficient, sufficient appropriate In first, three legal frameworks compare: States, Union International Organization Standardization. second regime Medicines Agency Food Drug Administration compared. We conclude on chemical substances still limited case NTs, because there processes not addressed or assumptions do apply addition, in NT, separation chemicals devices can magnify existing loopholes. Similarly, nanomedicine categorization might be inappropriate, since combination products both.