<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0041-8633</journal-id>
<journal-title><![CDATA[Boletín mexicano de derecho comparado]]></journal-title>
<abbrev-journal-title><![CDATA[Bol. Mex. Der. Comp.]]></abbrev-journal-title>
<issn>0041-8633</issn>
<publisher>
<publisher-name><![CDATA[Universidad Nacional Autónoma de México, Instituto de Investigaciones Jurídicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0041-86332016000300277</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Análisis comparativo de la regulación en Nanotecnología en Estados Unidos y la Unión Europea]]></article-title>
<article-title xml:lang="en"><![CDATA[Comparative Analysis of the Regulation in Nanotechnology in the United States and the European Union]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vidal Correa]]></surname>
<given-names><![CDATA[Laura Elena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Autónoma de Zacatecas Unidad en Estudios del Desarrollo ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Mexico</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2016</year>
</pub-date>
<volume>49</volume>
<numero>147</numero>
<fpage>277</fpage>
<lpage>301</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S0041-86332016000300277&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S0041-86332016000300277&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S0041-86332016000300277&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Este trabajo tiene el objetivo de explorar el marco normativo de las nanotecnologías (NTs) y la nanomedicina, y elaborar un análisis comparativo entre dos regímenes normativos: los Estados Unidos y la Unión Europea. En el artículo se identifican y clasifican las posturas que permiten el diseño de un marco regulatorio de las NTs. Además, se comparan dos regímenes normativos: 1) sustancias químicas, y 2) medicamentos y productos sanitarios. El objetivo principal es reconocer si la regulación actual es eficiente, suficiente y apropiada para las NTs. En el primero se contrastan tres marcos jurídicos: los Estados Unidos, la Unión Europea y la Organización Internacional de Normalización. En el segundo régimen se compara la Agencia Europea de Medicinas de la Unión Europea y la Administración de Medicamentos y Alimentos de los Estados Unidos. Se concluye que la regulación actual en materia de sustancias químicas es todavía limitada para el caso de las NTs, debido a que hay procesos que no se abordan o supuestos que no aplican para las NTs. Igualmente, para las NTs, la regulación en sustancias químicas/medicamentos y productos sanitarios puede magnificar los vacíos legales existentes. Asimismo, para el caso de la nanomedicina y las NTs, la categorización en medicamentos y aparatos médicos resulta inapropiada, ya que existen productos de combinación que pueden estar en ambas categorías.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract 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.]]></p></abstract>
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<kwd lng="es"><![CDATA[Nanotecnología]]></kwd>
<kwd lng="es"><![CDATA[regulación]]></kwd>
<kwd lng="es"><![CDATA[nanomedicina]]></kwd>
<kwd lng="en"><![CDATA[Nanotecnology]]></kwd>
<kwd lng="en"><![CDATA[regulation]]></kwd>
<kwd lng="en"><![CDATA[nanomedicine]]></kwd>
</kwd-group>
</article-meta>
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