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Updated: May 24, 2026

A Component-resolved Diagnostic Approach for a Study on Grass Pollen Allergens in Chinese Southerners with Allergic Rhinitis and/or Asthma

A Component-resolved Diagnostic Approach for a Study on Grass Pollen Allergens in Chinese Southerners with Allergic Rhinitis and/or Asthma

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[Governmental batch sample testing of allergen products].

D Bartel¹, F Führer, S Vieths

¹Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland. Detlef.bartel@pei.de

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz

|March 1, 2012

Summary

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Allergen Immunotherapy (AIT) in children: a vulnerable population with its own rights and legislation - summary of EMA-initiated multi-stakeholder meeting on Allergen Immunotherapy (AIT) for children, held at Paul-Ehrlich-Institut, Langen, Germany, 16.1.2019.

Clinical and translational allergy·2020

German regulations now require marketing authorization for specific immunotherapy allergen products, including named patient products. The Paul-Ehrlich-Institut (PEI) ensures quality through rigorous batch testing for type I allergies.

Area of Science:

Immunology
Pharmacology
Regulatory Science

Context:

Specific immunotherapy allergen products have been available in Germany since the 1970s.
Recent German Medicinal Products Act revisions (2005) define named patient products as Medicinal Products.
Therapy allergen ordinances now mandate marketing authorization for previously named patient products.

Purpose:

To outline the regulatory evolution of allergen products in Germany.
To describe the quality control processes for allergen products, including named patient products.
To highlight the role of the Paul-Ehrlich-Institut (PEI) in batch release.

Summary:

Allergen products for type I allergy immunotherapy face new regulatory requirements in Germany.
The Paul-Ehrlich-Institut (PEI) conducts experimental quality controls on batch samples.

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Approximately 2,800 allergen product batches are released annually by the PEI, including those for named patient products.

Impact:

Ensures enhanced quality and safety standards for allergen immunotherapy products.
Clarifies the regulatory pathway for both batch-manufactured and named patient allergen products.
Supports the continued availability of essential treatments for type I allergies through stringent oversight.