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Abstract

Allergologie select, Vol. 7/2023 (198-210)

Allergen-specific immunotherapy and evidence: A European regulatory perspective

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

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

Abstract

Allergologie, Jahrgang 47, 6/2024, S. 329-377

IPES 2023 – 16th International Paul-Ehrlich-Seminar; September 6 – 9, 2023, Langen, Germany

Chair: Stefan Vieths and Vera Mahler, Langen, Germany

Abstract

Allergologie select, Vol. 9/2025 (93-99)

Therapy Allergen Ordinance (TAO): The final stretch

Vera Mahler¹, Diana Hartenstein¹, Iris Lauer¹, Stefan Vieths², Claudia Ruoff³, Julia Zimmer¹, and Susanne Kaul¹

¹Allergology Division, ²President of the Paul-Ehrlich-Institut; Molecular Allergology Research Group, and ³Legal Affairs Section, Safety of Biomedicines and Diagnostics Division, Paul-Ehrlich-Institut, Langen, Germany
The Therapy Allergen Ordinance (TAO) aims to migrate allergen immunotherapy (AIT) products for the treatment of common allergies, which were previously marketed in Germany as named patient products (NPPs), into authorized products provided their quality, efficacy, and safety are adequately shown. The TAO applies to all NPPs containing active ingredients based on the following allergen sources: house dust mites, bee venom, wasp venom, pollen from sweet grasses (excluding maize), birch, alder, or hazel. The last product-specific deadlines granted under the TAO for the submission of clinical data relevant to the marketing authorization process will expire in 2026. The subsequent final assessment of the updated marketing authorization application (MAA) is carried out by the competent authority, the Paul-Ehrlich-Institut. During this period of processing by the competent authority, the products remain marketable until a decision regarding the MAA has been reached. Currently (as of August 08, 2025), 40 AIT products are still marketable under the transitional provisions of the TAO (10 preparations for the treatment of allergies to house dust mites, 10 against tree pollen allergies, 16 against grass pollen allergies, and 4 mixed preparations containing non-homologous allergen groups). For 8 of these products, pharmaceutical companies have initiated the withdrawal of MAA as of October 01, 2025 or January 31, 2026, respectively. Prior to the final assessment of the updated MAAs, the competent authority is unable to make any public statements as to whether the individual applications for the remaining 32 products under the transitional provision will be concluded positively with the granting of the marketing authorization or its rejection. With the rejection of a marketing authorization, the product-specific marketability ends immediately, i.e., there is no additional sell-off period for the TAO products concerned. If a marketing authorization is granted, the marketability of the specific product is perpetuated.Correspondence to:
Prof. Vera Mahler, MD, Abteilung Allergologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany
Email: [email protected]

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