Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Abstract

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...

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

“…14 As a result of this, the recent German, Austrian and Swiss guideline has followed a product-specific approach. 11 This approach is more difficult across Europe with differing local regulations 47 and availability of products. 48 The specific recommendations in this guideline need to be seen in this context; only standardized AIT products with evidence of efficacy in the clinical documentation should be prescribed.…”

“…47,132 For others, such as molds, there are problems with the complexity, variability, and stability of the allergens. 133 The lack of standardized extracts may hamper the diagnosis of eligible patients for AIT and may impede the effectiveness of AIT.…”

EAACI guidelines on allergen immunotherapy: Executive statement

“…9,10 This could be improved with the widespread adoption by industry and specialists of the best regulatory framework (Box 2).…”

EAACI guidelines on allergen immunotherapy—Out with the old and in with the new

“…There is a need for a standardized approach between regulatory agencies from different regions of the world. 19 Coordinated actions among regulators, industry, and the scientific environment to find solutions that properly answer the health expectations of the allergic patients are thus needed and should be continuously be updated.…”

“…There is a need for a standardized approach between regulatory agencies from different regions of the world. 19 Coordinated actions among regulators, industry, and the scientific environment to find solutions that properly answer the health expectations of the allergic patients are thus needed and should be continuously be updated.Even the best guideline cannot substitute for the standard of care but can serve as a starting point in the shared decision making with the patient, covering the diagnostic and treatment choices …”