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Allergic diseases are recognized by the World Health Organization (WHO) as a major health problem in the world. At present, allergen products have been widely used in the treatment of various allergic diseases at home and abroad. Allergen therapy is currently the only therapy that can regulate the immune system in patients with allergic rhinitis. However, high quality allergen products are related to the effectiveness of the products. In view of the important clinical value of allergen products, combined with the status quo of listed allergen products and registered allergen products, this paper briefly introduces the registration management classification of allergen products in China and the United States and the technical requirements for the registration of such products in China.

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变态反应性疾病被世界卫生组织（WHO）认为是当前世界性的重大卫生学问题，当前，变应原制品在国内外临床上已被广泛用于各类变应性疾病的治疗。变应原治疗是目前唯一可调节变应性鼻炎（AR）患者免疫系统的对因治疗措施，然而，高质量的变应原制品关系着制品的有效性。鉴于变应原制品在临床上的重要价值，结合已上市变应原制品和已注册申报变应原制品的研发现状，本文简要介绍变应原制品在我国和美国的注册管理分类，以及我国对该类制品的注册技术要求。

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贾燕花，女，主管药师，主要从事生物制品药学技术审评工作。联系电话：(010)80996172，E-mail: jiayh@cde.org.cn。

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贾燕花，女，主管药师，主要从事生物制品药学技术审评工作。联系电话：(010)80996172，E-mail: jiayh@cde.org.cn。

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