Paul-Ehrlich-Institut, Langen, Germany.
University of Southampton, Southampton, UK.
Allergy. 2018 Jan;73(1):64-76. doi: 10.1111/all.13266. Epub 2017 Aug 30.
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.
变应原免疫治疗（AIT）产品的监管方法和高质量 AIT 产品的供应本质上是相互关联的。虽然过敏原产品在全球许多国家都有供应，但它们的监管却非常多样化。首先，我们描述了适用于欧盟（EU）和美国（US）的 AIT 产品的监管系统。对于欧洲，我们提供了相关程序的不同类型的描述，以及涉及的委员会，并强调了欧盟成员国的国家机构在这个复杂而独特的网络中的基本作用。此外，来自澳大利亚、加拿大、日本、俄罗斯和瑞士的监管机构提供了有关其国家实施的过敏原产品监管系统的信息。虽然 AIT 产品通常被归类为生物药物，但它们通过不同类型的程序供应，最常见的是通过获得营销授权或作为指定患者产品分发。在特殊情况下豁免营销授权，以及从其他国家进口过敏原产品，是各国用来确保所需 AIT 产品供应的额外工具。从这一分析中可以明显看出，AIT 产品存在一些挑战，需要进一步考虑。
