To examine the influence of existing European Union rules on the availability of commercially accessible skin test allergens in European member countries was the purpose of this study. Diagnostic allergens are now defined as medicines in European Union legislation, requiring market authorization for each individual diagnostic allergen, with obligations including clinical trials, application dossiers, regular dossier updates, handling of variation processes, ongoing stability testing of the source material, and periodic safety update reporting. The financial costs of initiating and maintaining diagnostic allergen approvals far outweigh the associated income. As a result, the number of permitted test allergens is gradually declining.
The present European Union laws are expected to have a significant influence on allergy diagnosis in Europe. In recent years, the number of skin test allergens available has fallen to less than half of what it was previously. EAACI has contacted both the EU and the EMA in an attempt to settle the problem.