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 (TAO), the division’s scientists play a decisive role in guiding therapy allergens for common allergies towards marketing authorisation – with proven quality and efficacy. 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 PEI in committees of the European Medicines Agency (EMA), the Heads of Medicine Agencies (HMA), the European Directorate for the Quality of Medicines (EDQM), the World Health Organisation (WHO) and in relevant national working parties. A European CMDh working party under the lead of the PEI is creating the foundations for a harmonised approach to the marketing authorisation and assessment of allergen products throughout Europe.
Head of division’s Research Group
The research team investigates (co-)factors within the interaction of allergens and organism that lead to allergic disease. This understanding forms the basis for a better diagnosis and therapy. The proteomics platform makes it possible to identify and quantify proteins such as allergens. This allows for the analysis of the complete composition of allergen products, as well as for the detection of contaminations and counterfeiting.
Batch Control and Allergen Analytics Section
The section examines batches of test and therapy allergens. In 2017/18 2,642 batches were tested, of which 66 were not released by the section. This batch release testing of allergen products is unique in Europe – and guarantees consistent quality and efficacy for patients.
Test and Therapy Allergens Section
The section handles and coordinates the marketing authorisation of test and therapy allergens, oversees 650 authorised medicinal products throughout their lifecycle, and in 2017/18, among other things, handled 363 post-marketing procedures and variation applications.
Clinical Allergology Section
The section assesses and approves all clinical trials where the efficacy and safety of test and therapeutic allergens in patients must be demonstrated. It evaluates the preclinical data and all clinical trial reports submitted as part of applications for marketing authorisations and notifications of changes to medicinal products already authorised.
Recombinant Allergen Therapeutics Section
The section assesses the quality of biotechnologically or chemically synthesized innovative allergen products that are being developed by manufacturers. It examines whether commonly used extracts from natural allergen sources such as pollen can be replaced by manufactured recombinant allergens. The fundamental knowledge of individual allergens also creates the necessary preconditions for improved product testing and evaluation.