{"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\/it\/2025\/08\/10\/ema-leitlinien-zur-entwicklung-von-allergenprodukten\/","title":{"rendered":"Linee guida EMA per lo sviluppo di prodotti allergenici"},"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>Inizia una nuova era nell'immunoterapia e nella diagnostica allergica<\/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;\">Quali innovazioni ha questa linea guida, che fornisce a ricercatori e produttori quadri regolatori flessibili per lo sviluppo di prodotti diagnostici e immunoterapici? Ecco i punti principali\u2026<\/span><\/p><p><span style=\"color: #000000;\"><b>1. Approccio flessibile per tipi di allergia al paziente basse<\/b><\/span><\/p><p><span style=\"color: #000000;\">La difficolt\u00e0 della ricerca clinica in alcuni tipi di allergie \u00e8 il punto di partenza per questa linea guida. La causa principale delle linee guida \u00e8 la difficolt\u00e0 di trovare un numero sufficiente di pazienti per studi su rare allergie al veleno di insetti o alcune allergie alimentari.<\/span><\/p><p><span style=\"color: #000000;\">Tuttavia, l'EMA ammette che possono esserci modi alternativi in questi casi.<\/span><\/p><p><span style=\"color: #000000;\">I prodotti allergenici elencati nelle linee guida includono:<\/span><\/p><ul><li><span style=\"color: #000000;\">Sistema organico interessato (ad es. tratto respiratorio superiore e inferiore, occhi, pelle, coinvolgimento di diversi organi (reazione sistemica))<\/span><\/li><li><span style=\"color: #000000;\">Fonte di Alagen Alagen (ad es. polline, acari, peli di animali, muffe, tossine di insetti, alimenti, sostanze chimiche),<\/span><\/li><li><span style=\"color: #000000;\">Prodotto allergenico (es. estratti, allergeni purificati, allergeni modificati, allergeni adsorbiti)<\/span><\/li><li><span style=\"color: #000000;\">Indipendentemente dal tipo di applicazione (ad es. allergie sottocutanee, sublinguali, orali, percutanee) per l'immunoterapia allergenica per allergie di tipo I e per la diagnosi di allergie di tipo I e di 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 giuridica e strategia di consulenza corretta<\/b><\/span><\/p><p><span style=\"color: #000000;\">Quando \u00e8 stato pubblicato, l'unica domanda \u00e8 stata considerata insufficiente. La valutazione in combinazione con altre linee guida EMA, CHMP e ICH facilita il raggiungimento dei risultati. \u00c8 importante che i produttori e i ricercatori si mettano in contatto con le autorit\u00e0 di regolamentazione in una fase iniziale del lavoro per chiarire la strategia di sviluppo.<\/span><\/p><p><span style=\"color: #000000;\">Le linee guida pertinenti sono:<\/span><\/p><ul><li><span style=\"color: #000000;\">Linee guida per studi clinici in piccole popolazioni - CHMP\/EWP\/83561\/2005<\/span><\/li><li><span style=\"color: #000000;\">Linee guida sui dati mancanti nella conferma degli studi clinici - EMA\/CPMP\/EWP\/1776\/99 Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Linee guida per l'adeguamento dei valori di base in studi clinici - EMA\/CHMP\/295050\/2013<\/span><\/li><li><span style=\"color: #000000;\">Linee guida sui principi statistici per gli studi clinici - CPMP\/ICH\/363\/96<\/span><\/li><li><span style=\"color: #000000;\">I E9 (R1) - Appendice alle linee guida sui principi statistici per gli studi clinici: stime e analisi di sensibilit\u00e0 in studi clinici - EMA\/CHMP\/CH\/436221\/2017<\/span><\/li><li><span style=\"color: #000000;\">Linee guida per la selezione del gruppo di controllo in studi clinici - CPMP\/ICH\/364\/96 \u2022 Linee guida per la valutazione clinica - CPMP\/EWP\/1119\/98\/Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Linee guida sullo sviluppo clinico di prodotti immunoterapici specifici per il trattamento delle malattie allergiche - CHMP\/EWP\/18504\/2006<\/span><\/li><li><span style=\"color: #000000;\">Linee guida sui prodotti Allergen: Linee guida sui problemi di produzione e qualit\u00e0 - EMEA\/CHMP\/BWP\/304831\/2007<\/span><\/li><li><span style=\"color: #000000;\">\u2022 Linee guida per la convalida del processo per i medicinali finiti - Informazioni e dati da presentare nelle domande di approvazione - EMA\/CHMP\/CVMP\/BWP\/70278\/2012-Rev1, Corr.1<\/span><\/li><li><span style=\"color: #000000;\">Raccomandazioni per approcci normativi comuni per i prodotti allergenici \u2013 CMDH\/399\/2019<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><b>3. Flessibilit\u00e0 negli studi di qualit\u00e0 e non<\/b><\/span><\/p><p><span style=\"color: #000000;\">Le categorie di allergeni contenute nelle linee guida sono le seguenti.<\/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\/\">Test in vivo<\/a>: Typ I (Pricktest, Provokationstest, intradermaler\/intrakutaner Test) und Typ IV (epikutaner Patch-Test)<\/span><\/li><li><span style=\"color: #000000;\">Allergeni-immunoterapia - AIT (allergeni inalati, allergeni velenosi di insetti, allergeni alimentari).<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Se in queste categorie non \u00e8 possibile condurre test di laboratorio standard o studi completi non clinici, possono essere accettati metodi alternativi come la ricerca bibliografica e le opinioni di esperti. Questo approccio ha lo scopo di aiutare ad accelerare il processo di sviluppo in piccole popolazioni.<\/span><\/p><p><span style=\"color: #000000;\"><b>4. Uso di origini dati alternative<\/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> e <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;\">Per informazioni dettagliate, vedere le linee guida su: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-allergen-products . -Sviluppo-immunoterapia-allergia-diagnosi-moderato-basso-di dimensioni-studio-popolazione_en.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\/it\/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\u201c&gt;Continue reading <span class=\"screen-reader-text\">Linee guida EMA per lo sviluppo di prodotti allergenici<\/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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