Ludger Klimek1, Hans Jürgen Hoffmann, Alexa Kugler, Antonella Muraro, Peter W Hellings. 1. aCenter for Rhinology and Allergology, Wiesbaden, Germany bDepartment of Clinical Medicine, Aarhus University, Aarhus C, Denmark cDepartment of Women and Child Health, Padua General University Hospital, Padua, Italy dDepartment of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium eDepartment of Otorhinolaryngology, Academic Medical Centre Amsterdam, The Netherlands fDepartment of Respiratory Disease and Allergy, Aarhus University Hospital, Denmark.
Abstract
PURPOSE OF REVIEW: To discuss the impact of current European Union regulations on the availability of commercially available skin test allergens in European member states. RECENT FINDINGS: European Union legislations now define diagnostic allergens to be medicine requiring market authorization of every individual diagnostic allergen with obligations including clinical trials, application dossiers, a regular update of the dossiers, handling of variation processes and ongoing stability testing of the source material and periodic safety update reporting. The financial expenses of the initiation and maintenance of approvals for diagnostic allergens far exceed their related revenues. Thus, the numbers of authorized test allergens are steadily decreasing. SUMMARY: The current European Union regulations are anticipated to have an immense impact on in-vivo allergy diagnosis in Europe. Available skin test allergens decreased to less than half of what has been before in recent years. EAACI has addressed both the EU and EMA to resolve this situation.
PURPOSE OF REVIEW: To discuss the impact of current European Union regulations on the availability of commercially available skin test allergens in European member states. RECENT FINDINGS: European Union legislations now define diagnostic allergens to be medicine requiring market authorization of every individual diagnostic allergen with obligations including clinical trials, application dossiers, a regular update of the dossiers, handling of variation processes and ongoing stability testing of the source material and periodic safety update reporting. The financial expenses of the initiation and maintenance of approvals for diagnostic allergens far exceed their related revenues. Thus, the numbers of authorized test allergens are steadily decreasing. SUMMARY: The current European Union regulations are anticipated to have an immense impact on in-vivo allergy diagnosis in Europe. Available skin test allergens decreased to less than half of what has been before in recent years. EAACI has addressed both the EU and EMA to resolve this situation.