<?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>1886-5887</journal-id>
<journal-title><![CDATA[Revista de Bioética y Derecho]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. Bioética y Derecho]]></abbrev-journal-title>
<issn>1886-5887</issn>
<publisher>
<publisher-name><![CDATA[Observatori de Bioètica i Dret - Cátedra UNESCO de Bioética]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1886-58872019000100014</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Reflexões bioéticas acerca da inovação em nanomedicamentos]]></article-title>
<article-title xml:lang="en"><![CDATA[Bioethical Reflections on Innovation in Nanomedicines]]></article-title>
<article-title xml:lang="es"><![CDATA[Reflexiones bioéticas acerca de la innovación en Nanomedicamentos]]></article-title>
<article-title xml:lang="ca"><![CDATA[Reflexions bioètiques sobre la innovació en nanomedicaments]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lima-Dora]]></surname>
<given-names><![CDATA[Cristiana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Teixeira-Primo]]></surname>
<given-names><![CDATA[Fabian]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[de-Moraes-Soares-Araújo]]></surname>
<given-names><![CDATA[Gabriela]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidade Federal do Rio Grande Faculdade de Medicina Laboratório de Nanotecnologia]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Brazil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2019</year>
</pub-date>
<numero>45</numero>
<fpage>197</fpage>
<lpage>212</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1886-58872019000100014&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1886-58872019000100014&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1886-58872019000100014&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Resumo A nanotecnologia vem se desenvolvendo de forma exponencial na área farmacêutica, prometendo grandes benefícios, entretanto, pode estar sujeita a riscos intrínsecos relacionados a esta ciência. Neste artigo é realizada uma reflexão acerca dos desafios enfrentados pelos órgãos regulatórios em função da ausência, ou ainda, incipiente legislação, especialmente no Brasil, visto que os documentos disponíveis em relação a regulamentação, não incluem especificações para nanomedicamentos, os quais apresentam alterações na dimensão e constituição, e consequentemente comportamento diferente de medicamentos convencionais. A contingência envolvendo o desenvolvimento de nanomedicamentos e a gestão dos riscos para a vida humana e o meio ambiente fazem com que a bioética seja invocada de forma a analisar quais os impactos decorrem deste processo.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract Nanotechnology has been developing exponentially in the pharmaceutical area, promising great benefits, however, it may be subject to intrinsic risks related to this science. In this article, a reflection is made on the challenges faced by regulatory agencies due to the absence or incipient legislation, especially in Brazil, since the available documents in relation to regulation do not include specifications for nanomedicine, which present changes in the dimension and constitution, and consequently different behavior of conventional drugs. The contingency involving the development of nanomedicine and the management of the risks for human life and the environment, cause bioethics to be invoked in order to analyze the impacts of this process.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen La nanotecnología se está desarrollando de forma exponencial en el área farmacéutica, prometiendo grandes beneficios, sin embargo, puede estar sujeta a riesgos intrínsecos relacionados a esta ciencia. En este artículo se reflexiona sobre los desafíos enfrentados por los órganos regulatorios en función de la ausencia, o aún incipiente legislación, especialmente en Brasil, ya que los documentos disponibles en relación a la reglamentación, no incluyen especificaciones para nanomedicamentos, los cuales presentan alteraciones en la dimensión y la constitución, y consecuentemente un comportamiento diferente de los medicamentos convencionales. La contingencia que involucra el desarrollo de nanomedicamentos y la gestión de los riesgos para la vida humana y el medio ambiente hacen que la bioética sea invocada para analizar qué impactos se derivan de este proceso.]]></p></abstract>
<abstract abstract-type="short" xml:lang="ca"><p><![CDATA[Resum La nanotecnologia s'està desenvolupant de forma exponencial en l'àrea farmacèutica, prometent grans beneficis; no obstant això, pot estar subjecta a riscos intrínsecs relacionats amb aquesta ciència. En aquest article es reflexiona sobre els desafiaments que enfronten els òrgans reguladors en funció de l'absència, o d'una legislació incipient, especialment al Brasil, ja que els documents disponibles en relació a la reglamentació no inclouen especificacions per a nanomedicaments, els quals presenten alteracions en la seva dimensió i constitució, i conseqüentment presenten un comportament diferent al dels medicaments convencionals. La contingència que involucra el desenvolupament de nanomedicaments i la gestió dels riscos per a la vida humana i el medi ambient fan que la bioètica hagi de jugar un paper a fi d'analitzar quins impactes es deriven d'aquest procés.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[bioética]]></kwd>
<kwd lng="pt"><![CDATA[nanotecnologia]]></kwd>
<kwd lng="pt"><![CDATA[legislação de medicamentos]]></kwd>
<kwd lng="pt"><![CDATA[risco]]></kwd>
<kwd lng="pt"><![CDATA[nanomedicamento]]></kwd>
<kwd lng="en"><![CDATA[bioethics]]></kwd>
<kwd lng="en"><![CDATA[nanotechnology]]></kwd>
<kwd lng="en"><![CDATA[drug legislation]]></kwd>
<kwd lng="en"><![CDATA[risk]]></kwd>
<kwd lng="en"><![CDATA[nanomedicine]]></kwd>
<kwd lng="es"><![CDATA[bioética]]></kwd>
<kwd lng="es"><![CDATA[nanotecnología]]></kwd>
<kwd lng="es"><![CDATA[legislación de medicamentos]]></kwd>
<kwd lng="es"><![CDATA[riesgo]]></kwd>
<kwd lng="es"><![CDATA[nanomedicamento]]></kwd>
<kwd lng="ca"><![CDATA[bioètica]]></kwd>
<kwd lng="ca"><![CDATA[nanotecnologia]]></kwd>
<kwd lng="ca"><![CDATA[legislació de medicaments]]></kwd>
<kwd lng="ca"><![CDATA[risc]]></kwd>
<kwd lng="ca"><![CDATA[nanomedicament]]></kwd>
</kwd-group>
</article-meta>
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