Assessment of new therapies, scientific advice, marketing authorisation, product testing, preparatory and product-related research and the development of standards – the Allergology division oversees all aspects of medicinal products for specific immunotherapy and in vivo diagnostics. In accordance with the Therapy Allergen Ordinance (Therapeutallergen-Verordnung, TAV), the division’s scientists play a decisive role in guiding therapy allergens for common allergies towards marketing authorisation – with proven quality and clinically tested efficacy.
The department also coordinates centralised and decentralised European marketing authorisation procedures in allergology. Every three years, the division organises the International Paul Ehrlich Seminar (IPES), a think tank for all key players in the field of allergology.
Experts represent the Paul-Ehrlich-Institut (PEI) on committees of the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), the World Health Organization (WHO) and in relevant national working parties. Scientists from this division also participate in the allergens working party within the European Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). This working party promotes a harmonised approach to the authorisation and testing of allergen products throughout Europe.
This section evaluates preclinical data, all reports on clinical trials submitted as part of applications for marketing authorisations and notifications of changes to already authorised medicinal products. It also approves all clinical trials in which the safety and efficacy of the test and therapy allergens in patients must be demonstrated.
This section evaluates the quality of allergen products based on natural allergen sources, as well as biotechnologically or chemically synthesised allergen products. It coordinates the authorisation of test and therapy allergens, monitors over 750 authorised medicines throughout their entire life cycle and processes more than 250 follow-up procedures and change notifications per year.
Federal batch testing of allergens is regulated in Germany in accordance with section 32 of the Medicinal Products Act. Each year, the Allergens Product Testing section evaluates approximately 1,300 batches of authorised test and therapy allergens, as well as sample material in accordance with the Therapy Allergy Ordinance (Therapeutallergen-Verordnung, TAV). The tests carried out in this section are prescribed by sources such as the European Pharmacopoeia (Ph. Eur.). The section is accredited to DIN EN ISO/IEC 17025. Independent federal batch testing guarantees consistent quality and effectiveness of allergen products for patients.
This section assumes an important service function in the context of product testing of biomedicines at the PEI. It improves upon existing testing methods and makes use of innovative techniques for product testing. Qualified, but not accredited methods, such as mass spectrometry, should be provided as a service for product testing as well as for research accompanying the test.
The Proteomics Core Facility enables the identification and quantification of proteins. The composition of pharmaceuticals can be thus determined and contamination and counterfeiting can be detected. This section also performs supporting tasks in the introduction of a new laboratory information management system (LIMS) in the Paul-Ehrlich-Institut and is available as a technical contact for the product testing section.
This section investigates (co)factors of the interaction of allergens and organisms that lead to an allergic disease. Understanding this interaction is the basis for better diagnoses and therapy. The characterisation of individual allergens and epitopes as well as the standardisation of extract-based allergen preparations also creates the conditions for improved product testing and drug evaluation.
Updated: 04.07.2022
