{"id":71525,"date":"2025-09-25T00:08:50","date_gmt":"2025-09-25T06:08:50","guid":{"rendered":"https:\/\/politicosaldesnudo.com.mx\/?p=71525"},"modified":"2025-09-24T21:34:16","modified_gmt":"2025-09-25T03:34:16","slug":"presenta-cofepris-16-nuevas-guias-para-fortalecer-ensayos-clinicos-en-mexico","status":"publish","type":"post","link":"https:\/\/politicosaldesnudo.com.mx\/index.php\/2025\/09\/25\/presenta-cofepris-16-nuevas-guias-para-fortalecer-ensayos-clinicos-en-mexico\/","title":{"rendered":"Presenta Cofepris 16 nuevas gu\u00edas para fortalecer ensayos cl\u00ednicos en M\u00e9xico"},"content":{"rendered":"<p class=\"nota-justify\">El Consejo Cient\u00edfico de la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (Cofepris) present\u00f3 16 gu\u00edas de eficacia establecidas por la Conferencia Internacional para la Armonizaci\u00f3n de Requisitos T\u00e9cnicos para el Registro de Productos Farmac\u00e9uticos de Uso Humano (ICH, por sus siglas en ingl\u00e9s), que est\u00e1n orientadas al dise\u00f1o, conducci\u00f3n, seguridad e informes de ensayos cl\u00ednicos para el desarrollo de nuevos medicamentos.<\/p>\n<p class=\"nota-justify\">Las gu\u00edas impulsan la armonizaci\u00f3n internacional de requisitos regulatorios en investigaci\u00f3n cl\u00ednica, bajo el marco de Buenas Pr\u00e1cticas Regulatorias. \u201cSu aplicaci\u00f3n garantiza la validez cient\u00edfica, la seguridad y la calidad de los datos, al tiempo que respeta la dignidad, el bienestar y los derechos de las y los participantes.\u201d, destac\u00f3.<\/p>\n<p class=\"nota-justify\">Durante su participaci\u00f3n, la comisionada federal Armida Z\u00fa\u00f1iga reconoci\u00f3 el trabajo conjunto de los sectores gubernamental, industrial, acad\u00e9mico y gremial. \u201cGracias a la coordinaci\u00f3n efectiva, en tres meses y medio se concret\u00f3 este esfuerzo que fortalece el marco regulatorio nacional en investigaci\u00f3n para la salud\u201d, se\u00f1al\u00f3 la titular de Cofepris.<\/p>\n<p class=\"nota-justify\">Adem\u00e1s, en el contexto del Plan M\u00e9xico, el cual busca posicionar a M\u00e9xico como referente regional en investigaci\u00f3n cl\u00ednica, estas gu\u00edas fomentan la atracci\u00f3n de ensayos cl\u00ednicos, la colaboraci\u00f3n con instituciones o establecimientos de investigaci\u00f3n y el desarrollo de innovaci\u00f3n farmac\u00e9utica, en beneficio de las y los pacientes.<\/p>\n<p class=\"nota-justify\">\u201cM\u00e9xico cuenta hoy con la certeza de tener una autoridad sanitaria competente, que opera bajo criterios homologados a las mejores pr\u00e1cticas internacionales en favor de la salud p\u00fablica\u201d, asever\u00f3.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El Consejo Cient\u00edfico de la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios (Cofepris) present\u00f3 16 gu\u00edas de eficacia establecidas 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