Abstract

VIDAL CORREA, Laura Elena. Comparative Analysis of the Regulation in Nanotechnology in the United States and the European Union. Bol. Mex. Der. Comp. [online]. 2016, vol.49, n.147, pp.277-301. ISSN 2448-4873.

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

Keywords : Nanotecnology; regulation; nanomedicine.