{"id":3340,"date":"2025-08-10T11:39:45","date_gmt":"2025-08-10T11:39:45","guid":{"rendered":"https:\/\/nano-test.de\/?p=3340"},"modified":"2026-02-20T06:29:57","modified_gmt":"2026-02-20T06:29:57","slug":"ema-leitlinien-zur-entwicklung-von-allergenprodukten","status":"publish","type":"post","link":"https:\/\/nano-test.de\/es\/2025\/08\/10\/ema-leitlinien-zur-entwicklung-von-allergenprodukten\/","title":{"rendered":"Directrices de EMA para el desarrollo de productos al\u00e9rgenos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3340\" class=\"elementor elementor-3340\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9640da2 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9640da2\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bac4490 ts-bg-color-over-image\" data-id=\"bac4490\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6656108f elementor-widget elementor-widget-text-editor\" data-id=\"6656108f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #000000;\"><strong>Comienza una nueva era en inmunoterapia y diagn\u00f3stico de alergias<\/strong><\/span><\/h2><p><span style=\"color: #000000;\">Der Leitfaden mit dem Titel \u201eAllergen Products Development for Immunotherapy and Allergy Diagnosis in Moderate to Low Sized Study Populations\u201d (Entwicklung allergenhaltiger Produkte f\u00fcr die Immuntherapie und Allergiediagnostik in Studien mit mittlerer bis geringer Teilnehmerzahl) wurde von der <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\">Europ\u00e4ischen Arzneimittelagentur (EMA)<\/a> ver\u00f6ffentlicht und tritt am 1. Januar 2026 in Kraft. Er wurde speziell f\u00fcr Allergietypen mit einer begrenzten Anzahl von Patienten erstellt. Die Bedeutung, den Umfang und die Details dieses Leitfadens werden wir in unserem Blogbeitrag vorstellen.<\/span><\/p><p><span style=\"color: #000000;\">\u00bfQu\u00e9 innovaciones ofrece esta gu\u00eda, que proporciona a los investigadores y fabricantes marcos regulatorios flexibles para el desarrollo de productos de diagn\u00f3stico e inmunoterapia? Estos son los puntos principales\u2026<\/span><\/p><p><span style=\"color: #000000;\"><b>1. Enfoque flexible para tipos de alergias de pacientes bajos<\/b><\/span><\/p><p><span style=\"color: #000000;\">La dificultad de la investigaci\u00f3n cl\u00ednica en ciertos tipos de alergias es el punto de partida de esta gu\u00eda. La causa principal de la gu\u00eda es la dificultad de encontrar suficientes pacientes para estudios sobre alergias al veneno de insectos raros o ciertas alergias alimentarias.<\/span><\/p><p><span style=\"color: #000000;\">Sin embargo, la EMA admite que puede haber formas alternativas en tales casos.<\/span><\/p><p><span style=\"color: #000000;\">Los productos alerg\u00e9nicos enumerados en las pautas incluyen:<\/span><\/p><ul><li><span style=\"color: #000000;\">Sistema de \u00f3rganos afectados (por ejemplo, v\u00edas respiratorias superiores e inferiores, ojos, piel, afectaci\u00f3n de varios \u00f3rganos (reacci\u00f3n sist\u00e9mica))<\/span><\/li><li><span style=\"color: #000000;\">Fuente de Alagen Alagen (por ejemplo, polen, \u00e1caros, pelo de animal, moho, toxinas de insectos, alimentos, productos qu\u00edmicos),<\/span><\/li><li><span style=\"color: #000000;\">Producto alerg\u00e9nico (por ejemplo, extractos, al\u00e9rgenos purificados, al\u00e9rgenos modificados, al\u00e9rgenos adsorbidos)<\/span><\/li><li><span style=\"color: #000000;\">Independientemente del tipo de aplicaci\u00f3n (por ejemplo, subcut\u00e1neo, sublingual, oral, percut\u00e1neo) Productos al\u00e9rgenos para la inmunoterapia con al\u00e9rgenos para alergias tipo I y para el diagn\u00f3stico de alergias tipo I y tipo IV<\/span><\/li><\/ul><p><\/p><div style=\"width: 847px;\" class=\"wp-video\"><video class=\"wp-video-shortcode\" id=\"video-3340-1\" width=\"847\" height=\"447\" loop autoplay preload=\"metadata\" controls=\"controls\"><source type=\"video\/mp4\" src=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Hukuki-Zemin-ve-Dogru-Danisma-Stratejisi.mp4?_=1\"><\/source><a href=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Hukuki-Zemin-ve-Dogru-Danisma-Stratejisi.mp4\">https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Hukuki-Zemin-ve-Dogru-Danisma-Stratejisi.mp4<\/a><\/video><\/div><p><span style=\"color: #000000;\"><b>2. Base jur\u00eddica y estrategia de consultor\u00eda correcta<\/b><\/span><\/p><p><span style=\"color: #000000;\">Cuando se public\u00f3, la \u00fanica solicitud se consider\u00f3 insuficiente. La evaluaci\u00f3n en conjunto con otras directrices de EMA, CHMP e ICH facilita el logro de los resultados. Es importante que los fabricantes e investigadores se pongan en contacto con los reguladores en una etapa temprana de trabajo para aclarar la estrategia de desarrollo.<\/span><\/p><p><span style=\"color: #000000;\">Las directrices pertinentes son:<\/span><\/p><ul><li><span style=\"color: #000000;\">Directriz para estudios cl\u00ednicos en poblaciones peque\u00f1as - CHMP\/EWP\/83561\/2005<\/span><\/li><li><span style=\"color: #000000;\">Directrices sobre los datos faltantes en la confirmaci\u00f3n de estudios cl\u00ednicos - EMA\/CPMP\/EWP\/1776\/99 Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Directriz para el ajuste de valores basales en estudios cl\u00ednicos - EMA\/CHMP\/295050\/2013<\/span><\/li><li><span style=\"color: #000000;\">Directriz sobre principios estad\u00edsticos para estudios cl\u00ednicos - CPMP\/ICH\/363\/96<\/span><\/li><li><span style=\"color: #000000;\">I E9 (R1) - Ap\u00e9ndice de la gu\u00eda sobre principios estad\u00edsticos para estudios cl\u00ednicos: Estimaciones y an\u00e1lisis de sensibilidad en estudios cl\u00ednicos - EMA\/CHMP\/ICH\/436221\/2017<\/span><\/li><li><span style=\"color: #000000;\">Directrices para la selecci\u00f3n del grupo de control en estudios cl\u00ednicos - CPMP\/ICH\/364\/96 \u2022 Pautas de evaluaci\u00f3n cl\u00ednica - CPMP\/EWP\/1119\/98\/Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Directriz sobre el desarrollo cl\u00ednico de productos de inmunoterapia espec\u00edficos para el tratamiento de enfermedades al\u00e9rgicas - CHMP\/EWP\/18504\/2006<\/span><\/li><li><span style=\"color: #000000;\">Directrices sobre productos de al\u00e9rgenos: Directrices sobre temas de fabricaci\u00f3n y calidad - EMEA\/CHMP\/BWP\/304831\/2007<\/span><\/li><li><span style=\"color: #000000;\">\u2022 Pauta para la validaci\u00f3n de procesos de medicamentos terminados - informaci\u00f3n y datos que se presentar\u00e1n en las solicitudes de aprobaci\u00f3n - EMA\/CHMP\/CVMP\/BWP\/70278\/2012-REV1, Corr.1<\/span><\/li><li><span style=\"color: #000000;\">Recomendaciones sobre enfoques regulatorios comunes para productos alerg\u00e9nicos \u2013 CMDH\/399\/2019<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><b>3. Flexibilidad en estudios de calidad y no cl\u00ednicos<\/b><\/span><\/p><p><span style=\"color: #000000;\">Las categor\u00edas de al\u00e9rgenos contenidas en las directrices son las siguientes.<\/span><\/p><ul><li><span style=\"color: #000000;\">Allergene f\u00fcr diagnostische Zwecke in <a href=\"https:\/\/nano-test.de\/en\/research\/in-vivo-tests\/\">Pruebas in vivo<\/a>: Typ I (Pricktest, Provokationstest, intradermaler\/intrakutaner Test) und Typ IV (epikutaner Patch-Test)<\/span><\/li><li><span style=\"color: #000000;\">Al\u00e9rgeno-munoterapia - AIT (al\u00e9rgenos inhalados, al\u00e9rgenos de veneno de insectos, al\u00e9rgenos de los alimentos).<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Si no se pueden realizar pruebas de laboratorio est\u00e1ndar o estudios no cl\u00ednicos completos en estas categor\u00edas, se pueden aceptar m\u00e9todos alternativos como la investigaci\u00f3n de la literatura y las opiniones de los expertos. Este enfoque pretende ayudar a acelerar el proceso de desarrollo en poblaciones peque\u00f1as.<\/span><\/p><p><span style=\"color: #000000;\"><b>4. Uso de fuentes de datos alternativas<\/b><\/span><\/p><p><span style=\"color: #000000;\">In allergologischen Studien mit geringer Patientenzahl k\u00f6nnen retrospektive Daten, Fallberichte und die Verwendung von Produkten f\u00fcr \u201ebenannte Patienten\u201d als unterst\u00fctzende Daten herangezogen werden. Der Leitfaden betont, dass alternative Metriken wie <b>PR (Positivit\u00e4tsrate)<\/b> y <b>RI (Reaktionsindex)<\/b> bei der Beurteilung der diagnostischen Genauigkeit eine Rolle spielen.<\/span><\/p><p><span style=\"color: #000000;\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft\" src=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/Eine-neue-Ara-in-der-Immuntherapie-und-Allergiediagnose-beginnt-200x300.jpg\" alt=\"\" width=\"200\" height=\"300\">Mit diesem Leitfaden der EMA wird eine neue Regelung f\u00fcr Allergenproduktstudien mit einer geringen Anzahl von Patienten eingef\u00fchrt. Dank flexibler Datenquellen, alternativer klinischer Designs und Anpassungen in den Qualit\u00e4tsprozessen wird die Entwicklung von Diagnose- und Behandlungsoptionen f\u00fcr <b>seltene Allergietypen<\/b> erleichtert.<\/span><\/p><p><span style=\"color: #000000;\">Para obtener informaci\u00f3n detallada, consulte las directrices en: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-allergen-products. -desarrollo-inmunoterapia-alergia-diagn\u00f3stico-moderado-peque\u00f1o-estudio-poblacion_es.pdf<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bb8812e ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bb8812e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div 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Allergiediagnostik in Studien mit mittlerer bis geringer Teilnehmerzahl) wurde von der Europ\u00e4ischen Arzneimittelagentur (EMA) ver\u00f6ffentlicht und tritt am 1. \u2026 <a href=\"https:\/\/nano-test.de\/es\/2025\/08\/10\/ema-leitlinien-zur-entwicklung-von-allergenprodukten\/\" class=\"more-link\" title=\"Continue reading &lt;span class=\" screen-reader-text>EMA Guidelines for the Development of Allergen Products\u00ab&gt;Continue reading <span class=\"screen-reader-text\">Directrices de EMA para el desarrollo de productos al\u00e9rgenos<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3341,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-3340","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - 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