Regulatory aspects of specific immunotherapy in Europe.

ABSTRACT

PURPOSE OF REVIEW The recent developments in the regulation of allergen products and their impact on specific immunotherapy (SIT) in Europe are summarized, and unmet needs are discussed. RECENT FINDINGS: New guidance on the quality, the clinical development, and marketing authorization status of allergen products for SIT has been released. The most important documents are Guidelines from the European Medicines Agency, a revision of the European Pharmacopoeia Monograph on Allergens, regulations, and position papers of scientific societies. SUMMARY: The increased demands on quality, safety, and efficacy will lead to allergen products being better characterized and with enhanced proof of efficacy and safety. In addition, national activities to regulate the existing broad spectrum of named patient allergen products have been started. At the same time these developments represent a challenge to manufacturers to meet all new requirements. Some problems, for example regarding patient-tailored products containing recombinant allergens remain and may require novel regulatory approaches.