TY - JOUR
T1 - In-vivo diagnostic test allergens in Europe
T2 - A call to action and proposal for recovery plan—An EAACI position paper
AU - Klimek, Ludger
AU - Hoffmann, Hans J.
AU - Kalpaklioglu, Ayse F.
AU - Demoly, Pascal
AU - Agache, Ioana
AU - Popov, Todor A.
AU - Muraro, Antonella
AU - Schmid-Grendelmeier, Peter
AU - Bonini, Sergio
AU - Bonertz, Andreas
AU - Mahler, Vera
AU - Vieths, Stefan
AU - Pfaar, Oliver
AU - Zuberbier, Torsten
AU - Jutel, Marek
AU - Schmidt-Weber, Carsten
AU - Hellings, Peter W.
AU - Dreborg, Sten
AU - Bonini, Matteo
AU - Brough, Helen A.
AU - Bousquet, Jean
AU - Hoffmann-Sommergruber, Karin
AU - Palomares, Oscar
AU - Ollert, Markus
AU - Shamji, Mohamed H.
AU - Cardona, Victoria
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
KW - allergen provocation test
KW - European Pharmacopoeia
KW - marketing authorization
KW - regulatory framework
KW - skin prick test
KW - skin test allergens
UR - http://www.scopus.com/inward/record.url?scp=85089096167&partnerID=8YFLogxK
U2 - 10.1111/all.14329
DO - 10.1111/all.14329
M3 - Article
C2 - 32306414
AN - SCOPUS:85089096167
SN - 0105-4538
VL - 75
SP - 2161
EP - 2169
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
IS - 9
ER -