Modification of the response to allergens at an early stage and thereby of the natural history of a respiratory allergic disease by preventing disease progression would constitute the key benefit of specific immunotherapy (SIT) in children. However, although allergen products for SIT have been on the market on a named-patient basis for many years, long-term efficacy, the optimal duration of the treatment and the optimal dosage have not been sufficiently elaborated until now. The enactment of the Therapy Allergen Ordinance in Germany mandates that allergen products for SIT of the most prevalent allergies must submit an application for marketing authorization to the German authorities. In line with the European Paediatric Regulation, decisions by the European Medicines Agency on agreed paediatric investigation plans must be included in these applications. These regulatory requirements provide a unique opportunity to fill the gap in knowledge concerning the benefits of SIT for children and to obtain the data needed to support evidence-based authorization of allergen products for immunotherapy. This goal can only be achieved through close cooperation between academia, drug regulators and industry as well as parent/patient organizations. © 2011 John Wiley & Sons A/S.