{"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\/en\/2025\/08\/10\/ema-leitlinien-zur-entwicklung-von-allergenprodukten\/","title":{"rendered":"EMA Guidelines for the Development of Allergen Products"},"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>A new era in immunotherapy and allergy diagnosis begins<\/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;\">What innovations does this guideline bring, offering researchers and manufacturers flexible regulatory frameworks for the development of diagnostics and immunotherapy products? Here are the key points...<\/span><\/p><p><span style=\"color: #000000;\"><b>1. Flexible approach for allergy types with a small number of patients<\/b><\/span><\/p><p><span style=\"color: #000000;\">The difficulty of clinical research in certain allergy types is the starting point for this guideline. The main cause for the guideline is the difficulty in finding enough patients for studies on rare insect venom allergies or certain food allergies.<\/span><\/p><p><span style=\"color: #000000;\">However, the EMA acknowledges that there may be alternative ways in such cases.<\/span><\/p><p><span style=\"color: #000000;\">The allergenic products listed in the guidelines include:<\/span><\/p><ul><li><span style=\"color: #000000;\">Affected organ system (e.g., upper and lower airways, eyes, skin, involvement of multiple organs (systemic reaction)),<\/span><\/li><li><span style=\"color: #000000;\">Allergen source (e.g., pollen, mites, animal hair, mold, insect venoms, food, chemicals),<\/span><\/li><li><span style=\"color: #000000;\">Allergen product (e.g., extracts, purified allergens, modified allergens, adsorbed allergens)<\/span><\/li><li><span style=\"color: #000000;\">regardless of the type of application (e.g., subcutaneous, sublingual, oral, percutaneous) Allergen products for allergen immunotherapy in Type I allergies and for the diagnosis of Type I and Type IV allergies<\/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. Legal basis and correct consulting strategy<\/b><\/span><\/p><p><span style=\"color: #000000;\">When published, the sole application was considered insufficient. The assessment in conjunction with other EMA, CHMP, and ICH guidelines facilitates the achievement of results. For manufacturers and researchers, it is important to contact the regulatory authorities at an early stage of the work to clarify the development strategy.<\/span><\/p><p><span style=\"color: #000000;\">The relevant guidelines are:<\/span><\/p><ul><li><span style=\"color: #000000;\">Guideline for clinical trials in small populations - CHMP\/EWP\/83561\/2005<\/span><\/li><li><span style=\"color: #000000;\">Guideline on missing data in confirmatory clinical trials - EMA\/CPMP\/EWP\/1776\/99 Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Guideline on the adjustment of starting doses in clinical trials \u2013 EMA\/CHMP\/295050\/2013<\/span><\/li><li><span style=\"color: #000000;\">Guideline on Statistical Principles for Clinical Trials \u2013 CPMP\/ICH\/363\/96<\/span><\/li><li><span style=\"color: #000000;\">ICH E9 (R1) \u2013 Addendum to the Guideline on Statistical Principles for Clinical Trials: Estimation and Sensitivity Analyses in Clinical Trials \u2013 EMA\/CHMP\/ICH\/436221\/2017<\/span><\/li><li><span style=\"color: #000000;\">Guidelines for Selection of Control Group in Clinical Studies - CPMP\/Ich\/364\/96 \u2022 Clinical Evaluation Guidelines - CPMP\/EWP\/1119\/98\/Rev. 1<\/span><\/li><li><span style=\"color: #000000;\">Guideline on the clinical development of specific immunotherapy products for the treatment of allergic diseases - CHMP\/EWP\/18504\/2006<\/span><\/li><li><span style=\"color: #000000;\">Guideline on allergen products: Guideline on manufacturing and quality issues - EMEA\/CHMP\/BWP\/304831\/2007<\/span><\/li><li><span style=\"color: #000000;\">\u2022 Guideline on process validation for medicinal products \u2013 information and data to be submitted in marketing authorization applications \u2013 EMA\/CHMP\/CVMP\/BWP\/70278\/2012-Rev1, Corr.1<\/span><\/li><li><span style=\"color: #000000;\">Recommendations for common regulatory approaches for allergenic products \u2013 CMDh\/399\/2019<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><b>3. Flexibility in quality and non-clinical studies<\/b><\/span><\/p><p><span style=\"color: #000000;\">The allergen categories included in the guidelines are as follows.<\/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\/\">In vivo tests<\/a>: Typ I (Pricktest, Provokationstest, intradermaler\/intrakutaner Test) und Typ IV (epikutaner Patch-Test)<\/span><\/li><li><span style=\"color: #000000;\">Allergen-immunotherapy - AIT (inhaled allergens, insect venom allergens, food allergens).<\/span><\/li><\/ul><p><span style=\"color: #000000;\">If standard laboratory tests or comprehensive non-clinical studies cannot be conducted in these categories, alternative methods such as literature research and expert opinions can be accepted. This approach is intended to help accelerate the development process in small populations.<\/span><\/p><p><span style=\"color: #000000;\"><b>4. Use of alternative data sources<\/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> and <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;\">For detailed information, see the guidelines at: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-allergen-products . -development-immunotherapy-allergy-diagnosis-moderate-lowsized-study-population_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 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-4c314d0 ts-bg-color-over-image\" data-id=\"4c314d0\" 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-abfd8b0 elementor-widget elementor-widget-html\" data-id=\"abfd8b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"VideoObject\",\n  \"name\": \"EMA-Leitlinien zur Entwicklung von Allergenprodukten\",\n  \"description\": \"Dieses Video erkl\u00e4rt die regulatorischen Anforderungen und Strategien gem\u00e4\u00df den EMA-Leitlinien zur Entwicklung von Allergenprodukten, einschlie\u00dflich rechtlicher 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geringer Teilnehmerzahl) wurde von der Europ\u00e4ischen Arzneimittelagentur (EMA) ver\u00f6ffentlicht und tritt am 1. \u2026 <a href=\"https:\/\/nano-test.de\/en\/2025\/08\/10\/ema-leitlinien-zur-entwicklung-von-allergenprodukten\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>EMA Guidelines for the Development of Allergen Products\u201c&gt;Continue reading <span class=\"screen-reader-text\">EMA Guidelines for the Development of Allergen Products<\/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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EMA Guidelines 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