Espeseth D A
Animal and Plant Health Inspection Service, United States Department of Agriculture, Riverdale, Maryland 20737-1231, USA.
Rev Sci Tech. 1995 Dec;14(4):1143-55. doi: 10.20506/rst.14.4.899.
The authority for regulating veterinary biologicals in the United States of America (USA) is provided in the Virus-Serum-Toxin Act, enacted in 1913 and amended in 1995. The Act authorizes the Secretary of Agriculture to prescribe regulations governing the preparation and marketing of veterinary biologicals shipped into, within or from the USA. The mandate of the United States Veterinary Biologics Program is to ensure that all veterinary biological products under Government jurisdiction in the USA are pure, safe, potent and effective. The Program is based on licensing, inspection and testing. Risk assessment techniques, and effective strategies for risk management and risk communication, are essential tools for regulatory officials charged with the responsibility of developing requirements for licensing veterinary biological products and production facilities. To accommodate scientific advances, heightened consumer awareness and the international harmonization of requirements, regulatory agencies must continually review and update programme requirements. The author discusses programme updates initiated to address future needs of the United States Veterinary Biologics Program.
美国规范兽用生物制品的权力源自1913年颁布并于1995年修订的《病毒-血清-毒素法》。该法案授权农业部长制定有关进入美国、在美国境内或从美国运送的兽用生物制品的制备和销售的法规。美国兽用生物制品计划的任务是确保在美国政府管辖下的所有兽用生物制品纯净、安全、有效且有活性。该计划基于许可、检查和测试。风险评估技术以及有效的风险管理和风险沟通策略，是负责制定兽用生物制品及生产设施许可要求的监管官员的重要工具。为适应科学进步、消费者意识的提高以及要求的国际协调，监管机构必须不断审查和更新计划要求。作者讨论了为满足美国兽用生物制品计划未来需求而启动的计划更新。
