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    In-vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan-An EAACI position paper
    (WILEY, 2020) Klimek, Ludger; Hoffmann, Hans J.; Kalpaklioglu, Ayse F.; Demoly, Pascal; Agache, Ioana; Popov, Todor A.; Muraro, Antonella
    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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    The Nose as a Route for Therapy: Part 1. Pharmacotherapy
    (Frontiers Media Sa, 2021) Cingi, Cemal; Muluk, Nuray Bayar; Mitsias, Dimitrios I.; Papadopoulos, Nikolaos G.; Klimek, Ludger; Laulajainen-Hongisto, Anu; Hytonen, Maija
    This article reviews nasal structure and function in the light of intranasal pharmacotherapy. The nose provides an accessible, fast route for local treatment of nose and sinus diseases, with lower doses than are necessary systemically and few adverse effects. It can also be used for other medications as it has sufficient surface area protected from local damage by mucociliary clearance, absence of digestive enzymes, responsive blood flow, and provides a rapid route to the central nervous system.