In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan-An EAACI position paper

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dc.contributor.authorKlimek, Ludger
dc.contributor.authorHoffmann, Hans J.
dc.contributor.authorKalpaklioglu, Ayse F.
dc.contributor.authorDemoly, Pascal
dc.contributor.authorAgache, Ioana
dc.contributor.authorPopov, Todor A.
dc.contributor.authorMuraro, Antonella
dc.date.accessioned2021-01-14T18:10:25Z
dc.date.available2021-01-14T18:10:25Z
dc.date.issued2020
dc.departmentKKÜ
dc.descriptionBonertz, Andreas/0000-0002-6846-9265; Brough, Helen/0000-0001-7203-0813; Hoffmann, Hans Jurgen/0000-0002-6743-7931; Hoffmann-Sommergruber, Karin/0000-0002-8830-058X; Schmid-Grendelmeier, Peter/0000-0003-3215-3370
dc.description.abstractDiagnostic allergens are defined as medicinal products in the EU. Marketing authorization by national authorities is necessary; however, diagnostic allergens are not homogeneously regulated in different EU member states. Allergen manufacturers argue with increasing costs forcing them to continuously reduce the diagnostic allergen portfolios offered to allergists. In contrast, EAACI and national European Allergy Societies see the need for the availability of a wide range of high-quality diagnostic allergens for in vivo diagnosis of IgE-mediated allergies not only covering predominant but also less frequent allergen sources. In a recent EAACI task force survey, the current practice of allergy diagnosis was shown to rely on skin tests as first option in almost 2/3 of all types of allergic diseases and in 90% regarding respiratory allergies. With the need to ensure the availability of high-quality diagnostic allergens in the EU, an action plan has been set up by EAACI to analyse the current regulatory demands in EU member states and to define possible solutions stated in this document: (a) simplification of authorization for diagnostic allergens; (b) specific regulation of special types of diagnostic allergens; (c) new models beyond the current model of homologous groups; (d) simplification of pharmacovigilance reporting; (e) reduction of regulation fees for diagnostic allergens; (f) reimbursement for diagnostic allergens. Joining forces of allergists, manufacturers and authorities are of high importance to ensure remaining relevant allergens in the EU markets to facilitate a sustainable and comprehensive service for the diagnosis and treatment of allergic diseases.en_US
dc.identifier.citationKlimek, L, Hoffmann, HJ, Kalpaklioglu, AF, et al. In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper. Allergy. 2020; 75: 2161– 2169.en_US
dc.identifier.doi10.1111/all.14329
dc.identifier.endpage2169en_US
dc.identifier.issn0105-4538
dc.identifier.issn1398-9995
dc.identifier.issue9en_US
dc.identifier.pmid32306414
dc.identifier.scopus2-s2.0-85089096167
dc.identifier.scopusqualityQ1
dc.identifier.startpage2161en_US
dc.identifier.urihttps://doi.org/10.1111/all.14329
dc.identifier.urihttps://hdl.handle.net/20.500.12587/12583
dc.identifier.volume75en_US
dc.identifier.wosWOS:000569864500002
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherWILEYen_US
dc.relation.ispartofALLERGY
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectallergen provocation testen_US
dc.subjectEuropean Pharmacopoeiaen_US
dc.subjectmarketing authorizationen_US
dc.subjectregulatory frameworken_US
dc.subjectskin prick testen_US
dc.subjectskin test allergensen_US
dc.titleIn-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan-An EAACI position paperen_US
dc.typeArticle

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