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Klimek, L.* ; Hoffmann, H.J.* ; Kalpaklioglu, A.F.* ; Demoly, P.* ; Agache, I.* ; Popov, T.A.* ; Muraro, A.* ; Schmid-Grendelmeier, P.* ; Bonini, S.* ; Bonertz, A.* ; Mahler, V.* ; Vieths, S.* ; Pfaar, O.* ; Zuberbier, T.* ; Jutel, M.* ; Schmidt-Weber, C.B. ; Hellings, P.W.* ; Dreborg, S.* ; Bonini, M.* ; Brough, H.A.* ; Bouquet, A.* ; Hoffmann-Sommergruber, K.* ; Palomares, O.* ; Ollert, M.* ; Shamji, M.H.* ; Cardona, V.*

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

Allergy 75, 2161-2169 (2020)
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Diagnostic 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.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Allergen Provocation Test ; European Pharmacopoeia ; Marketing Authorization ; Regulatory Framework ; Skin Prick Test ; Skin Test Allergens; Immunotherapy; Legislation; Availability; Provocation; Guidelines; Diseases; Children; Impact
Language english
Publication Year 2020
HGF-reported in Year 2020
ISSN (print) / ISBN 0105-4538
e-ISSN 1398-9995
Journal Allergy
Quellenangaben Volume: 75, Issue: 9, Pages: 2161-2169 Article Number: , Supplement: ,
Publisher Wiley
Publishing Place 111 River St, Hoboken 07030-5774, Nj Usa
Reviewing status Peer reviewed
Institute(s) Institute for Allergy Research (IAF)
POF-Topic(s) 30202 - Environmental Health
Research field(s) Allergy
PSP Element(s) G-505400-001
DOI 10.1111/all.14329
WOS ID WOS:000569864500002
Scopus ID 85089096167
PubMed ID 32306414
Erfassungsdatum 2020-11-12
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