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

Ludger Klimek*, Hans J. Hoffmann, Ayse F. Kalpaklioglu, Pascal Demoly, Ioana Agache, Todor A. Popov, Antonella Muraro, Peter Schmid-Grendelmeier, Sergio Bonini, Andreas Bonertz, Vera Mahler, Stefan Vieths, Oliver Pfaar, Torsten Zuberbier, Marek Jutel, Carsten Schmidt-Weber, Peter W. Hellings, Sten Dreborg, Matteo Bonini, Helen A. BroughJean Bousquet, Karin Hoffmann-Sommergruber, Oscar Palomares, Markus Ollert, Mohamed H. Shamji, Victoria Cardona

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

23 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)2161-2169
Number of pages9
JournalAllergy: European Journal of Allergy and Clinical Immunology
Issue number9
Publication statusPublished - 1 Sept 2020


  • European Pharmacopoeia
  • allergen provocation test
  • marketing authorization
  • regulatory framework
  • skin prick test
  • skin test allergens


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