Hans Jürgen Hoffmann

Impact of changed legislation on skin tests: the present and future

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleCommunication

  • Ludger Klimek, Ctr Rhinol & Allergol
  • ,
  • Hans Juergen Hoffmann
  • Alexa Kugler, Ctr Rhinol & Allergol
  • ,
  • Antonella Muraro, Padua Gen Univ Hosp, University of Padua, Dept Women & Child Hlth
  • ,
  • Peter W. Hellings, Acad Med Ctr Amsterdam, Dept Otorhinolaryngol

Purpose of reviewTo discuss the impact of current European Union regulations on the availability of commercially available skin test allergens in European member states.Recent findingsEuropean 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.SummaryThe 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.

Original languageEnglish
JournalCurrent Opinion in Allergy and Clinical Immunology
Pages (from-to)465-468
Number of pages4
Publication statusPublished - Oct 2016

    Research areas

  • diagnostic test allergens, European Union legislation, market authorization, skin prick test, DIAGNOSTIC-TEST ALLERGENS, EUROPEAN LEGISLATION

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