Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Dec 12:7:198-210.
doi: 10.5414/ALX02413E. eCollection 2023.

Allergen-specific immunotherapy and evidence: A European regulatory perspective

Detlef Bartel  1 , Andreas Bonertz  1 , Diana Hartenstein  1 , Stefan Kaul  1 , Iris Lauer  1 , Christina Reeb  1 , Karen Rösner-Friese  1 , Katja Sliva  1 , Julia Zimmer  1 , Stefan Vieths  1 , Vera Mahler  1
Affiliations
Review

Allergen-specific immunotherapy and evidence: A European regulatory perspective

Detlef Bartel et al. Allergol Select. .

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.

Keywords: Directive 2001/83/EC; European Pharmacopoeia; SCIT; SLIT; Therapy Allergen Ordinance (TAO); clinical relevance; cross-product comparability; in-house reference preparation; manufacturing process; marketing authorization.

PubMed Disclaimer

Conflict of interest statement

D. Bartel, A. Bonertz, D. Hartenstein, S. Kaul, I. Lauer, V. Mahler, C. Reeb, K. Rösner-Friese, K. Sliva, and J. Zimmer declare no conflict of interest in relation to this work. S. Vieths declares having no direct or indirect interest in pharmaceutical industry/medicinal products. He reports personal fees for published books Schattauer “Allergologie Handbuch”, Elsevier “Nahrungsmittelallergien und Intoleranzen”, Karger “Food Allergy: Molecular Basis and Clinical Practice”; and as Associate Editor of the Journal of Allergy and Clinical Immunology, all outside the submitted work. Figure 1Important topics and current challenges in allergen-specific immunotherapy from the regulator´s perspective.

Figures

Figure 1
Figure 1. Important topics and current challenges in allergen-specific immunotherapy from the regulator´s perspective.
See this image and copyright information in PMC

References

    1. Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens. OJ L 142, 25.5.1989, p. 14-15.
    1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28.11.2001, p. 67-128.
    1. Arzneimittelgesetz in der Fassung der Bekanntmachung vom 12. Dezember 2005 (BGBl. I S. 3394), das zuletzt durch Artikel 8c des Gesetzes vom 20. Dezember 2022 (BGBl. I S. 2793) geändert worden ist.
    1. Mahler V Kleine-Tebbe J Vieths S Immuntherapien von Allergien: Aktueller Stand. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020; 63: 1341–1356. - PMC - PubMed
    1. Jensen-Jarolim E Bachmann MF Bonini S Jacobsen L Jutel M Klimek L Mahler V Mösges R Moingeon P O Hehir RE Palomares O Pfaar O Renz H Rhyner C Roth-Walter F Rudenko M Savolainen J Schmidt-Weber CB Traidl-Hoffmann C Kündig T State-of-the-art in marketed adjuvants and formulations in Allergen Immunotherapy: A position paper of the European Academy of Allergy and Clinical Immunology (EAACI). Allergy. 2020; 75: 746–760. - PubMed

LinkOut - more resources