Abstract

Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.

Author Details

Authors

• Detlef Bartel
• Andreas Bonertz
• Diana Hartenstein
• Stefan Kaul
• Iris Lauer
• Christina Reeb
• Karen Rösner-Friese
• Katja Sliva
• Julia Zimmer
• Stefan Vieths
• Vera Mahler

Departments

• Paul-Ehrlich-Institut, Langen, Germany

Address

Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51 – 59, 63325 Langen, Germany
Email: [email protected]

Citation