动物卫生条例-美国

动物保健产品的监管, 包括动物饲料, 动物药物, 和杀虫剂, 比如时事热点, 跳蚤和蜱虫的项圈, 以及其他保护动物免受跳蚤和蜱虫等寄生虫侵害的创新产品, varies by type of product involved and whether or not the product is considered a drug or pesticide.

Different federal agencies including the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) and the U.S. Environmental Protection Agency's (环境保护署) Office of Pesticide Programs (OPP) are tasked with regulation of new 动物药物 and pesticide products, 分别, 包括他们的销售和分销. 利记网址 provides regulatory assistance and support for animal health products through our team of animal health regulatory 咨询顾问.

动物饲料监管

两个同伴动物, 比如狗和猫, 还有供人类食用的食用动物, 包括牛, 猪和家禽, 必须用符合联邦安全标准的产品喂养和处理吗. 这确保了他们的健康和福祉,同时也允许安全的人际交往. 的 美国饲料控制官员协会(AAFCO) is an independent organization that provides 指导 to feed control regulators and the industry by developing uniform standards, 法律, 以及动物饲料生产中的强制政策, 标签, 分布, 并在全国销售.
  • 成分 -联邦食品、药品和化妆品法(FD&C法案或FFDCA)要求食用动物食品是安全的, 是否在卫生条件下制备, 是否没有有害物质, 并且被正确地标记. 这些产品包括任何供动物食用的产品, 包括吃饭, 点心和零食, 营养补充剂, nutrient-added水域, 和可食用的咀嚼. FDA履行其对动物饲料的职责, 包括宠物食品, 部分是通过与AAFCO的协议, 由谁管理获批准的动物饲料成分清单. 动物饲料中使用的成分必须由AAFCO列出, 一般认为是安全的(GRAS), 或者是FDA认可的饲料添加剂. 新物质必须经过AAFCO定义过程, 被公认为GRAS, 或在向FDA提交和审查饲料添加剂申请后获得批准.
  • 标签 – Animal feed labels are the primary source of information for consumers about products available for purchase. 每个州都有独特的标签和注册要求. 一旦标签符合所有州的司法管辖区发展, the product must be registered and approved in all states w在这里 the product will be distributed and sold.
  • 吨位报告及年度更新 – Companies must maintain products through licensing and registration renewal and tonnage reporting to ensure uninterrupted sales in states and territories w在这里 they wish to continue marketing their product.

动物药物

FD下&C法, 新的动物药物被定义为用于诊断的物品, 治愈, 缓解, 治疗, or prevention of disease in animals and articles (other than food) intended to affect the structure or any function of the body of animals. 的se products are classified as new 动物药物 and subject to applicable federal regulations. 的 FDA’s CVM is charged with ensuring that animal drug products are both safe and effective through the review of New Animal Drug Applications (NADAs) or Generic New Animal Drug Applications (ANADA). 动物药物产品是为伴侣动物(包括狗)开发的, 猫, 还有马)和能生产食物的动物(包括牛), 猪, 和家禽). FDA的CVM也确保肉类等食品, 牛奶, 鸡蛋对人类来说是安全的. 除了狗等主要物种, 猫, 马, 牛, 家禽, 和猪, CVM还监督为鱼类等小型物种开发的药物产品, 鸟, 和仓鼠.

用于减轻动物病虫害的除害剂产品

的 US 环境保护署 is charged with overseeing the sale and 分布 of pesticide products under the Federal Insecticide, 杀真菌剂, and Rodenticide Act (FIFRA) and issues registrations following review of submitted applications containing data and draft product 标签. 产品化学数据, 毒性, 功效, 伴侣动物安全, and residue chemistry (for food-producing animals) may be submitted to 环境保护署 for review in support of new pesticide applications. 比如新的动物药品, 一种农药产品可以用来治疗或防止动物寄生虫的感染, 比如猫狗身上的跳蚤和蜱虫. 然而, these products differ from new 动物药物 in that they impart their effect on the outside of the animal, 然而,新的动物药物必须被吸收到动物的血液循环中(i.e. 成为系统的),以传递它们的效果。. 跳蚤项圈、蜱项圈等产品, 局部正确的产品, 牲畜蘸和喷药, 以及肥料输送产品, are regulated as pesticide products by 环境保护署’s Office of Pesticide Programs if they impart their effect on the outside of the animal (often through contact with the pest). 现在有一些外用的动物药物,但它们必须被动物吸收才能起作用.

利记在线网址可以帮助

  • 准备并提交农药产品注册和更新
  • Determine the appropriate jurisdiction of a product either as a new animal drug submitted to FDA-CVM, 或提交给美国环保局的农药产品
  • 审查饲料配方是否符合联邦要求
  • 准备并提交A类药品和饲料添加剂申请
  • Prepare and submit New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADA) for generic drugs, 并指导客户通过整个监管流程,最终产品审批
  • 审查方案和起草研究报告
  • Request Investigational New Animal Drug (INAD) files and Generic Investigational New Animal Drug (JINAD) files
  • 代表客户领导CVM提交前的会议和与环境保护署的会议
  • 担任国际公司的美国代理
  • 准备次要用途和次要物种(MUMS)应用程序
  • 准备并提交GRAS通知和自我确认
  • 开发产品标签和声明
  • 提交设立登记
  • 就进出口事宜提供建议
  • 不良事件报告
  • 提交进料吨位报告
  • 为AAFCO新原料的定义提供帮助

需要帮助推出新的动物健康或饲料产品?

为什么利记在线网址

利记网址为企业提供高质量的监管和科学的咨询服务. 利记在线网址的目标是了解客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 利记网址的专家团队注重截止日期,响应及时,并致力于专业. 利记在线网址非常尊重对利记在线网址工作的保密, 较强的项目管理能力, 并积极培养与客户的长期合作关系.

利记在线网址的专业人员

Our team of animal health regulatory 咨询顾问 help clients with all aspects of animal feed, 动物药品、农药制品. Leslie Patton is a senior scientific consultant who has more than a decade of experience in regulatory toxicology. 香农Bryant-Spas specializes in the compliance of products 包括动物饲料 and pet food, at the state level. 弥迦书雷诺兹 specializes in the registration and ongoing compliance of pesticides including animal health products. 蒂姆·多森(Tim Dotson)在美国农药产品注册方面有着丰富的经验.S. 环境保护署 and new animal drug product approvals through the FDA’s Center for Veterinary Medicine (FDA/CVM).

有用的信息

常见问题?

伴侣动物新药申请(NADAs)通常需要3-5年才能完成, 而动物药物的生产申请可能需要5-8年才能完成.

原始提交的质量是最重要的, 与监管机构保持良好的沟通. 当提交的申请质量较差时,可能会出现延误. At 利记网址 we pride ourselves on being able to produce quality applications which help expedite the process for our clients.

也需要遵守联邦法规, 动物饲料产品在国家级注册. 每个州都有自己的产品注册程序, 监督他们的更新, 发展中标签的要求, 并根据销售额收取吨位费. 利记网址 can undertake state registrations, renewals and tonnage reporting on behalf of its clients – 点击这里了解更多内容. 动物药物 are regulated at the federal level and by some states while animal pesticide products are regulated by states and the federal government.

提前确定产品分类是这个过程的关键部分. 在这个例子中, although your cat or dog may enjoy taking its medication – because many oral chewables are flavored and you can offer it to your pet as a ‘treat’ – these products are in fact drugs regulated by FDA. This is because they are systemically absorbed and kill the parasites after they take a blood meal from the animal; they are also administered orally rather than topically.

One label will work for the majority of states; however certain states will need additional information and t在这里fore are likely to require a unique label. 作为动物健康管理顾问, part of developing a regulatory compliance strategy is to help our clients devise the most expedient plan possible with as few label variations as possible.

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