Klimek Ludger, Hoffmann Hans J, Kalpaklioglu Ayse F, Demoly Pascal, Agache Ioana, Popov Todor A, Muraro Antonella, Schmid-Grendelmeier Peter, Bonini Sergio, Bonertz Andreas, Mahler Vera, Vieths Stefan, Pfaar Oliver, Zuberbier Torsten, Jutel Marek, Schmidt-Weber Carsten, Hellings Peter W, Dreborg Sten, Bonini Matteo, Brough Helen A, Bousquet Jean, Hoffmann-Sommergruber Karin, Palomares Oscar, Ollert Markus, Shamji Mohamed H, Cardona Victoria
Center for Rhinology and Allergology, Wiesbaden, Germany.
Department of Clinical Medicine, Aarhus University, Aarhus C, Denmark.
Allergy. 2020 Sep;75(9):2161-2169. doi: 10.1111/all.14329.
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.
在欧盟，诊断性变应原被定义为药品。需要获得国家当局的上市许可；然而，不同欧盟成员国对诊断性变应原的监管并不统一。变应原制造商称成本不断增加，迫使他们不断减少提供给过敏症专科医生的诊断性变应原产品组合。相比之下，欧洲变态反应和临床免疫学会（EAACI）以及欧洲各国变态反应学会认为，需要提供种类广泛的高质量诊断性变应原，用于IgE介导的过敏症的体内诊断，不仅要涵盖主要的变应原来源，也要包括不太常见的变应原来源。在EAACI最近的一次特别工作组调查中显示，在几乎三分之二的各类过敏性疾病中，以及在90%的呼吸道过敏症诊断中，目前的过敏症诊断做法首选皮肤试验。鉴于需要确保在欧盟提供高质量的诊断性变应原，EAACI制定了一项行动计划，以分析欧盟成员国目前的监管要求，并确定本文件中所述的可能解决方案：（a）简化诊断性变应原的授权程序；（b）对特殊类型的诊断性变应原进行具体监管；（c）超越当前同源组模式的新模式；（d）简化药物警戒报告；（e）降低诊断性变应原的监管费用；（f）诊断性变应原的报销。过敏症专科医生、制造商和当局携手合作对于确保欧盟市场上仍有相关变应原至关重要，以便为过敏性疾病的诊断和治疗提供可持续和全面的服务。
