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      Procedimiento de autorización de las vacunas contra la COVID-19: Estados Unidos de América, Unión Europea y América Latina Translated title: Authorization procedure for COVID-19 vaccines: United States of America, European Union and Latin America

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          Abstract

          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.

          Translated abstract

          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.

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          Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

          ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators’ websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.
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            Archived: WHO Timeline - COVID-19

            (2020)
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              El principio de precaución: implicaciones para la salud pública

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                Author and article information

                Journal
                ars
                Ars Pharmaceutica (Internet)
                Ars Pharm
                Universidad de Granada (Granada, Granada, Spain )
                2340-9894
                March 2023
                : 64
                : 1
                : 28-52
                Affiliations
                [1] Madrid Madrid orgnameUniversidad Complutense de Madrid orgdiv1Facultad Farmacia orgdiv2Departamento de Farmacia y Tecnología Farmacéutica Spain
                Article
                S2340-98942023000100003 S2340-9894(23)06400100003
                10.30827/ars.v64i1.26392
                76a76c83-d608-486e-bd24-59374cfec6b9

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

                History
                : 26 October 2022
                : 24 November 2022
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 59, Pages: 25
                Product

                SciELO Spain

                Categories
                Artículos de Revisión

                OMS,América Latina,Unión Europea,USFDA,WHO,legislation,coronavirus infections,Latin America,European Union,infecciones por coronavirus,legislación

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