{"id":4054,"date":"2022-12-13T09:00:49","date_gmt":"2022-12-13T01:00:49","guid":{"rendered":"https:\/\/regask.com\/?p=4054"},"modified":"2024-09-27T10:30:28","modified_gmt":"2024-09-27T02:30:28","slug":"enmienda-ctr-sobre-etiquetado-imp","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/ctr-amendment-imp-labeling\/","title":{"rendered":"UE: Modificaci\u00f3n del Reglamento sobre ensayos cl\u00ednicos (CTR)\u2026"},"content":{"rendered":"
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La Comisi\u00f3n Europea (CE)<\/a> revis\u00f3 los requisitos de etiquetado actuales previstos en el Reglamento sobre ensayos cl\u00ednicos (RCC) para medicamentos en investigaci\u00f3n (IMP) en lo que respecta a las fechas de caducidad mediante un Reglamento Delegado. Ahora el reglamento ha sido publicado en el Diario Oficial de la Uni\u00f3n Europea.<\/div>\n
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El CTR entr\u00f3 en vigor el 31 de enero de 2022. Esto ha ido acompa\u00f1ado de una separaci\u00f3n de los requisitos de BPM para los medicamentos en fase de ensayo de los de los medicamentos autorizados. En el caso de los productos que a\u00fan no han sido aprobados, los estudios de estabilidad y vida \u00fatil a menudo no se han completado y, durante la fase de desarrollo, surge nueva informaci\u00f3n sobre la fecha de caducidad del medicamento en fase de ensayo. Esto da lugar a la necesidad de volver a etiquetar posteriormente los medicamentos en fase de ensayo ya entregados y personalizados para el paciente con la nueva fecha de caducidad.<\/div>\n
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La normativa vigente exige el etiquetado tanto del envase interior como del exterior, por lo que cuando se produce un cambio, tambi\u00e9n se deben abrir los envases para actualizar la informaci\u00f3n del envase interior. Las actualizaciones frecuentes de la fecha de caducidad del envase primario de medicamentos no aprobados utilizados en ensayos cl\u00ednicos pueden, en determinados casos, suponer riesgos potenciales para la calidad y la seguridad de estos productos (por ejemplo, por la necesidad de abrir el envase, lo que exige romper los precintos de seguridad y desmontar los conjuntos formados por varias capas o por la exposici\u00f3n prolongada a la luz o a temperaturas m\u00e1s elevadas en el caso de medicamentos sensibles a este respecto).<\/div>\n
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Por tanto, la Comisi\u00f3n Europea considera que, en determinados casos, dada la naturaleza y el alcance del riesgo, resulta adecuado y proporcionado omitir la fecha de caducidad del acondicionamiento primario. Para implementar esta opci\u00f3n en el marco legislativo del CTR, la Comisi\u00f3n Europea public\u00f3 una modificaci\u00f3n del CTR mediante el Reglamento Delegado 2022\/2239.<\/div>\n<\/div>\n
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Contacte con RegASK para saber m\u00e1s sobre los cambios regulatorios en la UE.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\t\tContacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n\n\t\tLeer m\u00e1s<\/span>\n\t<\/a>\n\n

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\n\t\t\t\n\t\t\t\n\n\t\tLea estudios de casos de la industria farmac\u00e9utica y biotecnol\u00f3gica<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n
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La Comisi\u00f3n Europea (CE) revis\u00f3 los requisitos de etiquetado actuales previstos en el Reglamento sobre ensayos cl\u00ednicos (CTR) para medicamentos en investigaci\u00f3n (IMP) en relaci\u00f3n con las fechas de caducidad mediante un Reglamento Delegado. Ahora el reglamento ha sido publicado en el Diario Oficial de la Uni\u00f3n Europea. El CTR se aplica a partir del 31 de enero de 2022. Esto ha sido\u2026<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40],"class_list":["post-4054","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"\nEU Clinical Trials Regulation: IMP Labeling Update | RegASK<\/title>\n<meta name=\"description\" content=\"The EU Clinical Trials Regulation (CTR) has amended current labelling requirements regarding investigational medicinal products (IMP).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/enmienda-ctr-sobre-etiquetado-imp\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Amendment to the Clinical Trials Regulation (CTR) on Investigational Medicinal Products (IMPs) Labelling\" \/>\n<meta property=\"og:description\" content=\"The EU Clinical Trials Regulation (CTR) has amended current labelling requirements regarding investigational medicinal products (IMP).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/enmienda-ctr-sobre-etiquetado-imp\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-12-13T01:00:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-27T02:30:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\" 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