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诊断检测和疫苗标准的国际协调:国际兽疫局(OIE)的作用。

International harmonization of standards for diagnostic tests and vaccines: role of the Office International des Epizooties (OIE).

作者信息

Wright P F

机构信息

Canadian Food Inspection Agency, National Centre for Foreign Animal Disease, Winnipeg, Manitoba, Canada.

出版信息

Adv Vet Med. 1999;41:669-79. doi: 10.1016/s0065-3519(99)80052-4.

DOI:10.1016/s0065-3519(99)80052-4
PMID:9890053
Abstract

The OIE is recognized as the world organization for animal health. Serving 145 member countries, the OIE provides current information on disease occurrence, coordinates studies on disease surveillance and control, and harmonizes regulations for trade in animals and animal products. This paper focuses on the role of one the OIE's specialist commissions, the Standards Commission. The Standards Commission works in close collaboration with the Scientific and Technical Department of the OIE's Central Bureau on the international harmonization of standards for diagnostic tests and vaccines. The Manual of Standards for Diagnostic Tests and Vaccines, approved by the International Committee, defines the international standards for diagnostic tests and for the production of biological products as applied to mammals, birds, and bees. The Manual lists and details those tests which are prescribed for international trade and others which are suitable for bilateral trade agreements. The Manual represents one of the key scientific and technical references for harmonization of regulations for trade in animals and animal products. The commission coordinates the activities of a network of some 110 OIE reference laboratories and six collaborating centers. By creating and nurturing this network, international harmonization is promoted through the sharing of knowledge and the establishment of collaborative projects related to methods development and standardization, production and distribution of international reference standards, quality assurance, and assay validation. Through a series of guidelines provided to participants, the commission ensures the quality and focus of these projects. In matters of a scientific and technical nature concerning diagnostic tests and vaccines, the Standards Commission collaborates with other international organizations such as the FAO, WHO, IICA, and PAHO, thus promoting harmonization at the international program level. Underscoring the important role of the OIE at this level, the Sanitary and Phytosanitary Agreement of the World Trade Organization, as included in the Marrakech agreement (1994), specifically recommends the use of standards, guidelines, and recommendations developed under the auspices of the OIE in order to promote harmonization of regulations for trade in animals and animal products.

摘要

世界动物卫生组织(OIE)被公认为全球动物卫生组织。该组织为145个成员国提供服务,提供有关疾病发生的最新信息,协调疾病监测和控制研究,并统一动物及动物产品贸易法规。本文重点关注OIE的一个专业委员会——标准委员会的作用。标准委员会与OIE中央局科学技术部密切合作,致力于诊断检测和疫苗标准的国际协调统一。经国际委员会批准的《诊断检测和疫苗标准手册》规定了适用于哺乳动物、鸟类和蜜蜂的诊断检测及生物制品生产的国际标准。该手册列出并详细说明了国际贸易规定的检测方法以及适用于双边贸易协定的其他检测方法。该手册是统一动物及动物产品贸易法规的关键科学技术参考文件之一。该委员会协调约110个OIE参考实验室和6个合作中心组成的网络的活动。通过创建和培育这个网络,通过知识共享以及开展与方法开发和标准化、国际参考标准的生产和分发、质量保证及检测验证相关的合作项目,促进了国际协调统一。通过向参与者提供一系列指导方针,该委员会确保了这些项目的质量和重点。在诊断检测和疫苗的科学技术问题上,标准委员会与粮农组织、世界卫生组织、美洲农业合作研究所和泛美卫生组织等其他国际组织合作,从而在国际项目层面促进协调统一。世界贸易组织《卫生与植物卫生协定》(包含在1994年《马拉喀什协定》中)特别推荐使用在OIE主持下制定的标准、指南和建议,以促进动物及动物产品贸易法规的协调统一,这突出了OIE在这一层面的重要作用。

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