Impact of changed legislation on skin tests: the present and future. Issue 5 (October 2016)

• Record Type: Journal Article
• Authors: Klimek, Ludger; Hoffmann, Hans Jürgen; Kugler, Alexa; Muraro, Antonella; Hellings, Peter W.
• Is Part Of: Current opinion in allergy and clinical immunology. Volume 16:Issue 5(2016:Oct.)
• Publication Date: 2016-10
• Subjects: diagnostic test allergens -- European Union legislation -- market authorization -- skin prick test; Allergy -- Periodicals; Clinical immunology -- Periodicals; Hypersensitivity; Immunity; Immune System Diseases; Allergy and Immunology; 616.079
• DOI: 10.1097/ACI.0000000000000312
• Languages: English
• ISSNs: 1528-4050

Abstract

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.