{"id":9662,"date":"2026-03-18T06:23:26","date_gmt":"2026-03-17T22:23:26","guid":{"rendered":"https:\/\/regask.com\/?p=9662"},"modified":"2026-03-18T06:23:26","modified_gmt":"2026-03-17T22:23:26","slug":"el-centro-chino-para-el-control-de-enfermedades-cde-por-sus-siglas-en-ingles-emite-directrices-provisionales-sobre-ensayos-clinicos-para-vacunas-contra-la-gripe","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/china-cde-issues-interim-guidance-on-clinical-trials-for-influenza-vaccines\/","title":{"rendered":"El Centro Chino para la Investigaci\u00f3n y el Desarrollo (CDE, por sus siglas en ingl\u00e9s) emite una gu\u00eda provisional sobre ensayos cl\u00ednicos para\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">En\u00a0<\/span><b><span data-contrast=\"auto\">11 de marzo de 2026<\/span><\/b><span data-contrast=\"auto\">, el\u00a0<\/span><b><span data-contrast=\"auto\">Centro de Evaluaci\u00f3n de Medicamentos (CDE)<\/span><\/b><span data-contrast=\"auto\">\u00a0lanz\u00f3 un\u00a0<\/span><b><span data-contrast=\"auto\">Orientaci\u00f3n provisional sobre ensayos cl\u00ednicos de vacunas contra la gripe<\/span><\/b><span data-contrast=\"auto\">, donde se describen las expectativas regulatorias actualizadas para el desarrollo y la evaluaci\u00f3n cl\u00ednica de vacunas en China.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La gu\u00eda establece\u00a0<\/span><b><span data-contrast=\"auto\">Requisitos t\u00e9cnicos para el dise\u00f1o, la realizaci\u00f3n y la evaluaci\u00f3n de ensayos cl\u00ednicos.<\/span><\/b><span data-contrast=\"auto\">, con el objetivo de apoyar la investigaci\u00f3n cient\u00edfica y la coherencia regulatoria en el desarrollo de vacunas contra la influenza. Se aplica a las organizaciones involucradas en\u00a0<\/span><b><span data-contrast=\"auto\">Investigaci\u00f3n y desarrollo cl\u00ednico, control de calidad y registro regulatorio.<\/span><\/b><span data-contrast=\"auto\">\u00a0de las vacunas contra la gripe y entr\u00f3 en vigor inmediatamente despu\u00e9s de su publicaci\u00f3n.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-1628814434\">\n\n\t<div id=\"col-1356821509\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-2131269068\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2131269068 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1481868215\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1481868215 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La nueva gu\u00eda introduce\u00a0<\/span><b><span data-contrast=\"auto\">normas t\u00e9cnicas que rigen los ensayos cl\u00ednicos de la vacuna contra la gripe<\/span><\/b><span data-contrast=\"auto\">, con requisitos que se aplican a todos los estudios relevantes realizados en China desde\u00a0<\/span><b><span data-contrast=\"auto\">A partir del 11 de marzo de 2026<\/span><\/b><span data-contrast=\"auto\">. Estas normas est\u00e1n dise\u00f1adas para garantizar que el desarrollo y la evaluaci\u00f3n de las vacunas cumplan con las expectativas regulatorias de manera uniforme.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">El documento describe los requisitos para\u00a0<\/span><b><span data-contrast=\"auto\">metodolog\u00eda de ensayos cl\u00ednicos<\/span><\/b><span data-contrast=\"auto\">, proporcionando orientaci\u00f3n sobre c\u00f3mo deben estructurarse los estudios de vacunas contra la gripe para cumplir con los est\u00e1ndares de revisi\u00f3n regulatoria.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Tambi\u00e9n establece expectativas para\u00a0<\/span><b><span data-contrast=\"auto\">procedimientos de control de seguridad<\/span><\/b><span data-contrast=\"auto\">, garantizando que los ensayos de vacunas mantengan una supervisi\u00f3n constante de la seguridad de los participantes durante todo el per\u00edodo del estudio.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Adem\u00e1s, la gu\u00eda aborda\u00a0<\/span><b><span data-contrast=\"auto\">pr\u00e1cticas de recopilaci\u00f3n de datos<\/span><\/b><span data-contrast=\"auto\">, haciendo hincapi\u00e9 en la necesidad de generar datos cl\u00ednicos estructurados y fiables durante los ensayos de vacunas.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Finalmente, especifica\u00a0<\/span><b><span data-contrast=\"auto\">obligaciones de informaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">, aclarando c\u00f3mo deben documentarse y presentarse a las autoridades reguladoras los resultados de los ensayos cl\u00ednicos y la informaci\u00f3n sobre seguridad durante el proceso de desarrollo de la vacuna.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1356821509 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1001757124\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Fecha de entrada en vigor<\/h2>\n\t<div id=\"gap-1125174584\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1125174584 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda provisional se convirti\u00f3 en <strong>Vigente a partir del 11 de marzo de 2026. <\/strong>y se aplica a todos<strong> Ensayos cl\u00ednicos de vacunas contra la gripe, tanto nuevos como en curso, iniciados en China a partir de esta fecha. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1001757124 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1329977170\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-1739804509\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1739804509 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La actualizaci\u00f3n introduce <strong>est\u00e1ndares t\u00e9cnicos claros para los ensayos cl\u00ednicos de vacunas contra la gripe,<\/strong> fortalecer la alineaci\u00f3n regulatoria en todas las actividades de desarrollo de vacunas en China. Al aclarar las expectativas para<strong> Metodolog\u00eda del ensayo, seguimiento de la seguridad e informes,<\/strong> Esta gu\u00eda favorece una evaluaci\u00f3n regulatoria m\u00e1s coherente, al tiempo que ayuda a reducir la incertidumbre para las organizaciones que llevan a cabo la investigaci\u00f3n y el desarrollo de vacunas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1329977170 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-316805586\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-229876581\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-229876581 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n regulatoria es relevante para <strong>Equipos de Asuntos Regulatorios, Investigaci\u00f3n y Desarrollo Cl\u00ednico, Garant\u00eda de Calidad y Seguridad<\/strong> involucrados en el desarrollo de vacunas contra la influenza, incluyendo <strong>Fabricantes e importadores nacionales que buscan autorizaci\u00f3n de comercializaci\u00f3n en China. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-316805586 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1639386413\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1951881705\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1951881705 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones que desarrollan vacunas contra la gripe deber\u00edan\u00a0<\/span><b><span data-contrast=\"auto\">Revisar los protocolos de ensayos cl\u00ednicos existentes y planificados.<\/span><\/b><span data-contrast=\"auto\">\u00a0para garantizar la alineaci\u00f3n con los requisitos actualizados. Se recomienda a los equipos de Asuntos Regulatorios e I+D Cl\u00ednica que eval\u00faen las metodolog\u00edas de los estudios cl\u00ednicos, mientras que\u00a0<\/span><b><span data-contrast=\"auto\">Equipos de garant\u00eda de calidad y seguridad del paciente<\/span><\/b><span data-contrast=\"auto\">\u00a0Se deben evaluar los procedimientos de seguimiento, las pr\u00e1cticas de recopilaci\u00f3n de datos y los procesos de presentaci\u00f3n de informes para garantizar el cumplimiento de las nuevas normas.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Para las empresas que operan en m\u00faltiples mercados, el seguimiento de las expectativas regulatorias en constante evoluci\u00f3n, como las emitidas por la CDE, puede resultar complejo.\u00a0<\/span><b><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de agencia.<\/span><\/b><span data-contrast=\"auto\">\u00a0que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar la IA Agentic avanzada con expertos en el sector,\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0entrega\u00a0<\/span><b><span data-contrast=\"auto\">Informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo<\/span><\/b><span data-contrast=\"auto\">, simplificando los procesos de cumplimiento, mitigando los riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1639386413 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1485871184\">\n\n\t<div id=\"col-1394849409\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1195976291\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1195976291 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW267956491 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW267956491 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfCu\u00e1les son las nuevas directrices del CDE sobre los ensayos cl\u00ednicos de la vacuna contra la gripe?<\/span><\/span><span class=\"EOP SCXW267956491 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1668592875\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1668592875 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27095292 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27095292 BCX0\">Las directrices emitidas por el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27095292 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27095292 BCX0\">Centro de Evaluaci\u00f3n de Medicamentos (CDE)<\/span><\/span><\/strong><span class=\"TextRun SCXW27095292 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27095292 BCX0\">\u00a0el 11 de marzo,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW27095292 BCX0\">2026<\/span><span class=\"NormalTextRun SCXW27095292 BCX0\">\u00a0establece\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27095292 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27095292 BCX0\">Requisitos t\u00e9cnicos para el dise\u00f1o, la realizaci\u00f3n y la evaluaci\u00f3n de ensayos cl\u00ednicos de vacunas contra la gripe en China.<\/span><\/span><span class=\"TextRun SCXW27095292 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27095292 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27095292 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1394849409 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-322370875\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW214959691 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW214959691 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfCu\u00e1ndo entran en vigor las directrices para los ensayos cl\u00ednicos de la vacuna contra la gripe?<\/span><\/span><span class=\"EOP SCXW214959691 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-844144460\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-844144460 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda <strong>Entr\u00f3 en vigor el 11 de marzo de 2026,<\/strong> y se aplica a <strong>Todos los ensayos cl\u00ednicos de vacunas contra la gripe, tanto nuevos como en curso, que se inicien en China a partir de esa fecha. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-322370875 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-241516340\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW3036610 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW3036610 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfQu\u00e9 funciones regulatorias se ven afectadas por la actualizaci\u00f3n?<\/span><\/span><span class=\"EOP SCXW3036610 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1004785496\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1004785496 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La actualizaci\u00f3n afecta principalmente a: <strong>Equipos de Asuntos Regulatorios, Investigaci\u00f3n y Desarrollo Cl\u00ednico, Garant\u00eda de Calidad y Seguridad<\/strong> Responsable del desarrollo de la vacuna contra la gripe, la supervisi\u00f3n de los ensayos cl\u00ednicos y las presentaciones regulatorias.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-241516340 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2089833512\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW14904628 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW14904628 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW14904628 BCX0\" data-ccp-parastyle=\"heading 3\">RegASK<\/span><span class=\"NormalTextRun SCXW14904628 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u00bfC\u00f3mo ayudan las organizaciones a gestionar actualizaciones como esta?<\/span><\/span><span class=\"EOP SCXW14904628 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1484358486\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1484358486 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW233594670 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW233594670 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW233594670 BCX0\">\u00a0ayuda a los equipos regulatorios y de cumplimiento\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW233594670 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW233594670 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW233594670 BCX0\">\u00a0Actualizaciones regulatorias globales, an\u00e1lisis de cambios regulatorios y optimizaci\u00f3n de flujos de trabajo de cumplimiento.<\/span><\/span><\/strong><span class=\"TextRun SCXW233594670 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW233594670 BCX0\">\u00a0en m\u00faltiples\u00a0<\/span><span class=\"NormalTextRun SCXW233594670 BCX0\">jurisdicciones<\/span><span class=\"NormalTextRun SCXW233594670 BCX0\">, lo que permite una adaptaci\u00f3n m\u00e1s r\u00e1pida a los requisitos cambiantes, como las nuevas directrices para ensayos cl\u00ednicos.<\/span><\/span><span class=\"EOP SCXW233594670 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2089833512 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On\u00a0March 11, 2026, the\u00a0Center for Drug Evaluation (CDE)\u00a0released an\u00a0interim guidance on clinical trials for influenza vaccines, outlining updated regulatory expectations for vaccine clinical development and evaluation in China.\u00a0 The guidance\u00a0establishes\u00a0technical requirements for clinical trial design, conduct, and evaluation, aiming to support scientific research and regulatory consistency in influenza vaccine development. 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