<?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>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942023000100003</article-id>
<article-id pub-id-type="doi">10.30827/ars.v64i1.26392</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Procedimiento de autorización de las vacunas contra la COVID-19: Estados Unidos de América, Unión Europea y América Latina]]></article-title>
<article-title xml:lang="en"><![CDATA[Authorization procedure for COVID-19 vaccines: United States of America, European Union and Latin America]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ruiz-Sayritupac de Nué]]></surname>
<given-names><![CDATA[María Esther]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González-Leonor]]></surname>
<given-names><![CDATA[María del Carmen]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Complutense de Madrid Facultad Farmacia Departamento de Farmacia y Tecnología Farmacéutica]]></institution>
<addr-line><![CDATA[Madrid ]]></addr-line>
<country>España</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2023</year>
</pub-date>
<volume>64</volume>
<numero>1</numero>
<fpage>28</fpage>
<lpage>52</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942023000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942023000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942023000100003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción: El reconocimiento de la enfermedad COVID-19 como pandemia, planteó un reto a las Autoridades Reguladoras Nacionales del Medicamento (ARNs). Éstas tuvieron que desarrollar pautas, procedimientos, crear grupos de trabajo y alianzas para maximizar la eficiencia de la evaluación, revisión y autorización de las vacunas. El objetivo del presente trabajo es la exposición de los procedimientos empleados en Estados Unidos, Unión Europea y América Latina para autorizar el uso de las vacunas frente a la COVID-19; y ello con el fin de determinar si la multiplicidad de procedimientos ha dado origen al registro de un elevado número de vacunas.  Método: Se realizó una revisión de la legislación farmacéutica usada para la emisión de autorizaciones de las vacunas para la COVID-19, durante la emergencia sanitaria. La información fue recopilada hasta el 15/10/2022. Las fuentes consultadas fueron sitios web gubernamentales de las ARNs: Estados Unidos, Unión Europea y América Latina.  Resultados: Los Estados Unidos y la Unión Europea usaron actividades consignadas en sus flujos estándares, tales como el pre-Investigational New Drug, y el asesoramiento científico y rolling review, respectivamente. Por su parte, América Latina, hizo uso extensivo del reliance y la autorización de uso de emergencia, con el fin de acceder al mayor número posible de vacunas.  Conclusiones: Los procedimientos usados son diversos, pero todos ellos están orientados a proporcionar de manera rápida un producto de contención a la pandemia. Está diversidad da como resultado la presencia de distintas vacunas en Estados Unidos, Unión Europea y América Latina.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction: The recognition of the COVID-19 disease as a pandemic posed a challenge to the National Drug Regulatory Authorities (NRAs). They had to develop guidelines, procedures, create working groups and partnerships to maximize the efficiency of vaccine evaluation, review and licensure. The aim of this article is to present the procedures used in the United States, European Union and Latin America to license the use of vaccines against COVID-19; in order to determine whether the multiplicity of procedures has led to the registration of a large number of vaccines.  Method: A review of the pharmaceutical legislation used for the issuance of COVID-19 vaccines licenses during the health emergency was carried out. The information was collected up to October 15, 2022. The sources consulted were government websites of the NRAs: United States, European Union, and Latin America.  Results: The United States and the European Union used activities included in their standard flows, such as pre-Investigational New Drug, scientific advice and rolling review, respectively. Latin America, on the other hand, made extensive use of reliance and emergency use authorization in order to access as many vaccines as possible.  Conclusions: The procedures used are diverse, but all of them are oriented to provide a rapid pandemic containment product. This diversity results in the presence of different vaccines in the United States, European Union and Latin America.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[USFDA]]></kwd>
<kwd lng="es"><![CDATA[Unión Europea]]></kwd>
<kwd lng="es"><![CDATA[América Latina]]></kwd>
<kwd lng="es"><![CDATA[infecciones por coronavirus]]></kwd>
<kwd lng="es"><![CDATA[legislación]]></kwd>
<kwd lng="es"><![CDATA[OMS]]></kwd>
<kwd lng="en"><![CDATA[USFDA]]></kwd>
<kwd lng="en"><![CDATA[European Union]]></kwd>
<kwd lng="en"><![CDATA[Latin America]]></kwd>
<kwd lng="en"><![CDATA[coronavirus infections]]></kwd>
<kwd lng="en"><![CDATA[legislation]]></kwd>
<kwd lng="en"><![CDATA[WHO]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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