Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high-quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted. Furthermore, the regulatory agencies from Australia, Canada, Japan, Russia, and Switzerland provided information on the system implemented in their countries for the regulation of allergen products.While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration. K E Y W O R D Sallergen immunotherapy, allergic diseases, allergy, regulation | INTRODUCTIONThe availability of medicinal products to provide a reliable diagnosis of clinical allergy and effective treatment(s) is of critical importance for patients with suspected or proven allergy. Products for allergen immunotherapy (AIT) have been approved by national competent authorities in different regions of the world. However, the regulatory landscape governing the approval of these products is enormously heterogeneous-both within the European Union (EU) and even more so when looking globally-thereby rendering it extremely complicated and challenging to develop a harmonized, international approach to regulating these products.Pharmaceutical companies are increasingly focused on global strategies to develop and market their products. It is therefore very important to understand the current regulatory situation for allergen products from an international perspective, as this will have a direct impact on the availability of these medicinal products to patients throughout the world. Certain regulatory patterns can be observed on a global scale. For example, whereas AIT was previously mainly used and placed on the market on the basis of expert opinions with limited regulatory oversight, the requirements for high-quality clinical data for granting market access have greatly increased during the last 20 years. In the EU, legislation applicable for new and existing products 1,2 has been in force since 1989 demanding that allergen products are registered as medicinal products with corresponding requirements for clinical data. The development of the guid...

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Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. As the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines.

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