{"id":2522,"date":"2023-07-14T20:46:35","date_gmt":"2023-07-14T18:46:35","guid":{"rendered":"https:\/\/leonresearch.com\/?p=2522"},"modified":"2023-07-18T23:16:57","modified_gmt":"2023-07-18T21:16:57","slug":"la-nueva-regulacion-de-los-ensayos-clinicos-en-espana","status":"publish","type":"post","link":"https:\/\/leonresearch.com\/es\/la-nueva-regulacion-de-los-ensayos-clinicos-en-espana\/","title":{"rendered":"La nueva regulaci\u00f3n de los ensayos cl\u00ednicos en Espa\u00f1a"},"content":{"rendered":"\n<p><\/p>\n\n\n<!-- wp:themify-builder\/canvas \/-->\n\n\n<h2 class=\"wp-block-heading\">La nueva regulaci\u00f3n de los ensayos cl\u00ednicos<\/h2>\n\n\n\n<p>Ap\u00fantate esta fecha \u201cMayo de 2016\u201d \u00a1Hac\u00eda tiempo que esper\u00e1bamos esto y por fin ha llegado! Una nueva regulaci\u00f3n de los ensayos cl\u00ednicos para acortar los plazos y aumentar la transparencia y las garant\u00edas de los pacientes.<\/p>\n\n\n\n<p>El pasado diciembre se aprob\u00f3 el Real Decreto 1090\/2015 (que sustituye al Real Decreto 223\/2004) por el que se regulan los ensayos cl\u00ednicos con medicamentos, los comit\u00e9s de \u00e9tica de la investigaci\u00f3n con medicamentos y el Registro Espa\u00f1ol de Estudios Cl\u00ednicos y comenzar\u00e1 a aplicarse en mayo de 2016.<\/p>\n\n\n\n<p>El principal objetivo es adaptar la legislaci\u00f3n espa\u00f1ola para hacer viable la aplicaci\u00f3n actual y futura del Reglamento (UE) n.\u00ba 536\/2014 y desarrollar aquellos aspectos que el reglamento deja a la legislaci\u00f3n nacional.<\/p>\n\n\n\n<p>Surge ante el objetivo de mantener y mejorar la posici\u00f3n competitiva de Espa\u00f1a, ya que actualmente Espa\u00f1a participa en aproximadamente el 18% de los ensayos cl\u00ednicos que se realizan en Europa, la mayor parte son multic\u00e9ntricos y muchos de ellos multinacionales.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"709\" height=\"1024\" src=\"https:\/\/leonresearch.com\/wp-content\/uploads\/2023\/07\/Infografia-Nueva-Regulacion-de-los-Ensayos-Clinicos-709x1024.png\" alt=\"Infograf\u00eda-Nueva-Regulaci\u00f3n-de-los-Ensayos-Cl\u00ednicos\" class=\"wp-image-3002\" srcset=\"https:\/\/leonresearch.com\/wp-content\/uploads\/2023\/07\/Infografia-Nueva-Regulacion-de-los-Ensayos-Clinicos-709x1024.png 709w, https:\/\/leonresearch.com\/wp-content\/uploads\/2023\/07\/Infografia-Nueva-Regulacion-de-los-Ensayos-Clinicos-208x300.png 208w, https:\/\/leonresearch.com\/wp-content\/uploads\/2023\/07\/Infografia-Nueva-Regulacion-de-los-Ensayos-Clinicos.png 720w\" sizes=\"auto, (max-width: 709px) 100vw, 709px\" \/><\/figure>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Estos son los cuatro aspectos fundamentales de los que trata el Real Decreto.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Los plazos de presentaci\u00f3n se acortan<\/strong><\/h3>\n\n\n\n<p>Un ensayo cl\u00ednico con medicamento debe presentarse a los Comit\u00e9s \u00c9ticos y a la AEMPs (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios). Con la nueva regulaci\u00f3n, los tr\u00e1mites se simplifican, ya que s\u00f3lo se tendr\u00e1 que presentar a un Comit\u00e9 de \u00c9tica acreditado y obtener la autorizaci\u00f3n de la AEMPS; donde antes era necesario presentar y recibir la aprobaci\u00f3n de tantos Comit\u00e9s \u00c9ticos como centros participantes en el ensayo.<\/p>\n\n\n\n<p>Adem\u00e1s, el proceso de negociaci\u00f3n de la conformidad para realizar el ensayo en cada uno de los centros, ahora se podr\u00e1 realizar paralelamente mientras se presenta al Comit\u00e9 y a la Agencia, lo que acortar\u00e1 tambi\u00e9n los plazos.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Los pacientes, pieza clave del proceso de investigaci\u00f3n<\/strong><\/h3>\n\n\n\n<p>El Comit\u00e9 \u00c9tico estar\u00e1 formado por un m\u00ednimo de 10 miembros, y ser\u00e1 obligatoria la participaci\u00f3n de por lo menos un miembro ajeno a la investigaci\u00f3n, que representar\u00e1 los intereses de los pacientes. De esta forma se incluyen a los pacientes a participar en decisiones que les afectan directamente.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Aparece el promotor de ensayos cl\u00ednicos no comerciales<\/strong><\/h3>\n\n\n\n<p>El promotor de ensayos sin \u00e1nimo comercial fomentar\u00e1 la investigaci\u00f3n no comercial, que es la que no est\u00e1 financiada por la industria farmac\u00e9utica. El decreto ofrece ciertas ventajas para este tipo de investigaci\u00f3n no comercial como la exenci\u00f3n de tasas y la no necesidad de presentar el seguro del ensayo hasta que no se reciba el dictamen favorable.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Se desarrolla y regula el REec (Registro Espa\u00f1ol de Ensayos Cl\u00ednicos)<\/strong><\/h3>\n\n\n\n<p>El Registro Espa\u00f1ol de Ensayos Cl\u00ednicos surge para aumentar la transparencia y que se puedan consultar los ensayos cl\u00ednicos autorizados en Espa\u00f1a y los centros en los que se realizan. Este decreto lo desarrolla en el art\u00edculo 47 y se puede encontrar en la siguiente direcci\u00f3n:&nbsp;<a href=\"https:\/\/reec.aemps.es\/\">https:\/\/reec.aemps.es<\/a>.<\/p>\n\n\n\n<p>Fuente:<\/p>\n\n\n\n<p><a href=\"http:\/\/www.aemps.gob.es\/informa\/notasPrensa\/docs\/2015\/nota-prensa_04-12-2015-Ensayos-clinicos.pdf\">http:\/\/www.aemps.gob.es\/informa\/notasPrensa\/docs\/2015\/nota-prensa_04-12-2015-Ensayos-clinicos.pdf<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.boe.es\/boe\/dias\/2015\/12\/24\/pdfs\/BOE-A-2015-14082.pdf\">https:\/\/www.boe.es\/boe\/dias\/2015\/12\/24\/pdfs\/BOE-A-2015-14082.pdf<\/a><\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/leonresearch.com\/es\/contacto-leon-research\/\" target=\"_blank\" rel=\"noreferrer noopener\">Contacta con nosotros<\/a><\/div>\n<\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La nueva regulaci\u00f3n de los ensayos cl\u00ednicos Ap\u00fantate esta fecha \u201cMayo de 2016\u201d \u00a1Hac\u00eda tiempo que esper\u00e1bamos esto y por fin ha llegado! Una nueva regulaci\u00f3n de los ensayos cl\u00ednicos para acortar los plazos y aumentar la transparencia y las garant\u00edas de los pacientes. El pasado diciembre se aprob\u00f3 el Real Decreto 1090\/2015 (que sustituye [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":3004,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,1],"tags":[],"class_list":["post-2522","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar","category-uncategorized","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La nueva regulaci\u00f3n de los ensayos cl\u00ednicos en Espa\u00f1a &#8226; Leon Research<\/title>\n<meta name=\"description\" content=\"Estos son los cuatro aspectos fundamentales de los que trata el Real Decreto: plazos, pacientes, promotor no comercial y REec\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/leonresearch.com\/es\/la-nueva-regulacion-de-los-ensayos-clinicos-en-espana\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La nueva regulaci\u00f3n de los ensayos cl\u00ednicos en Espa\u00f1a &#8226; 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