What we learned from TAO – 10 years of German therapy allergen ordinance

Purpose The Therapy Allergen Ordinance (TAO) came into force in Germany in 2008 in order to ensure proven and tested quality, efficacy and safety of therapy allergens for the treatment of allergies to frequent allergen sources (birch, alder, hazel, sweet grasses (without maize), bee-, yellow jacket-venom). It excludes exemptions from marketing authorizations (MA) for AIT-products containing these allergens. Due to the particular nature of the therapeutic allergens, rather long transitional periods are legally defined to resolve deficient clinical data. The aim was to analyze the status quo of AIT products developed according to TAO.