Animal health regulation – USA

动物保健产品的监管, including animal feed, animal drugs, and pesticides, such as topical spot-ons, flea and tick collars, and other innovative products that protect animals against parasites such as fleas and ticks, 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 (EPA) Office of Pesticide Programs (OPP) are tasked with regulation of new animal drugs and pesticide products, respectively, including their sale and distribution. 钱柜平台 provides regulatory assistance and support for animal health products through our team of animal health regulatory consultants.

Animal feed regulation

Both companion animals, such as dogs and cats, 以及供人类食用的食用动物, including cattle, swine and poultry, 必须用符合联邦安全标准的产品喂养和处理. 这确保了他们的健康和福祉,同时也允许安全的人际交往. The 美国饲料控制官员协会 is an independent organization that provides guidance to feed control regulators and the industry by developing uniform standards, laws, 以及动物饲料生产的执行政策, labeling, distribution, and sale across the states.
  • Ingredients 联邦食品、药品和化妆品法(FD&美国FFDCA法案要求食用动物食品是安全的, is prepared in sanitary conditions, is free of harmful substances, and is properly labeled. 这些产品包括任何动物食用的东西, including meals, treats and snacks, nutrient supplements, nutrient-added waters, and edible chews. FDA履行其在动物饲料方面的职责, including pet food, 部分是通过与AAFCO的协议, 哪个机构负责管理经批准的动物饲料成分清单. 在动物饲料中使用的原料必须被AAFCO列出, 被普遍认为是安全的(GRAS), or be FDA approved feed additives. 新物质必须经过AAFCO的定义程序, be recognized as GRAS, 或在FDA提交和审查饲料添加剂申请后被批准.
  • Labeling – 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. 一旦标签符合所有国家司法管辖开发, the product must be registered and approved in all states where the product will be distributed and sold.
  • Tonnage reporting and annual renewal – Companies must maintain products through licensing and registration renewal and tonnage reporting to ensure uninterrupted sales in states and territories where they wish to continue marketing their product.

Animal drugs

Under the FD&C Act, 动物新药定义为用于诊断的物品, cure, mitigation, treatment, or prevention of disease in animals and articles (other than food) intended to affect the structure or any function of the body of animals. These products are classified as new animal drugs and subject to applicable federal regulations. The 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). 动物药品是为两种伴侣动物(包括狗)开发的, cats, 以及马)和生产食物的动物(包括牛), swine, and poultry). FDA的CVM也确保食品产品,如肉类, milk, 人类食用鸡蛋是安全的. 除了主要的物种,比如狗, cats, horses, cattle, poultry, and swine, CVM还监督为鱼类等次要物种开发的药品, birds, and hamsters.

施用于动物以减轻病虫害的除害剂

The US EPA is charged with overseeing the sale and distribution of pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and issues registrations following review of submitted applications containing data and draft product labeling. Data on product chemistry, toxicity, efficacy, companion animal safety, and residue chemistry (for food-producing animals) may be submitted to EPA for review in support of new pesticide applications. Like new animal drug products, 农药产品可用于治疗或预防动物体内的寄生虫感染, 比如猫狗身上的跳蚤和蜱虫. However, these products differ from new animal drugs in that they impart their effect on the outside of the animal, 而新的动物药物必须被动物的循环吸收(i.e. 成为系统性的),以便传递他们的效果。. 跳蚤和蜱项圈等产品, topical spot-on products, livestock dips and sprays, 以及肥料输送产品, are regulated as pesticide products by EPA’s Office of Pesticide Programs if they impart their effect on the outside of the animal (often through contact with the pest). 目前有一些外用的新的动物药物,但它们必须被动物吸收才能发挥作用.

钱柜平台 can help

  • 准备和提交农药产品的注册和更新
  • Determine the appropriate jurisdiction of a product either as a new animal drug submitted to FDA-CVM, 或提交给美国环保署的农药产品
  • 检查饲料配方是否符合联邦要求
  • 准备和提交A类药物和饲料添加剂的申请
  • 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,直至最终产品批准
  • 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预提交会议和与EPA的会议
  • 担任国际公司的美国代理
  • 准备次要用途和次要品种(MUMS)申请书
  • 准备并提交GRAS通知和自我确认
  • Develop product labels and claims
  • Submit establishment registration
  • Advise on import and export issues
  • Report adverse events
  • Submit feed tonnage reporting
  • 为AAFCO提供新成分定义协助

需要帮助推出一个新的动物健康或饲料产品?

Why 钱柜平台

钱柜平台为企业提供高质量的钱柜平台服务. 钱柜手机版的目标是了解钱柜手机版客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 钱柜平台的专家团队以截止日期为中心,响应并致力于专业. 钱柜手机版对工作的保密性有极大的尊重, strong project management skills, 并大力培养与客户的长期合作关系.

Our professionals

Our team of animal health regulatory consultants help clients with all aspects of animal feed, animal drug and pesticide products. Leslie Patton is a senior scientific consultant who has more than a decade of experience in regulatory toxicology. Shannon Bryant-Spas specializes in the compliance of products including animal feed and pet food, at the state level. Micah Reynolds specializes in the registration and ongoing compliance of pesticides including animal health products. Tim Dotson拥有通过美国农业部注册农药产品的丰富经验.S. EPA and new animal drug product approvals through the FDA’s Center for Veterinary Medicine (FDA/CVM).

Useful information

Frequently asked questions?

伴侣动物新动物药物申请(NADAs)通常需要3-5年的时间来完成, 而动物药的生产申请可能需要5-8年的时间才能完成.

原始提交的质量是最重要的, 遵循流程并与监管机构保持良好的沟通. 当提交的申请质量不佳时,可能会出现延误. At 钱柜平台 we pride ourselves on being able to produce quality applications which help expedite the process for our clients.

同时还需要遵守联邦法规, 动物饲料产品在国家一级登记. 每个州都有自己的产品注册程序, overseeing their renewal, developing label requirements, 并按销售额收取吨位费. 钱柜平台 can undertake state registrations, renewals and tonnage reporting on behalf of its clients – read more here. Animal drugs are regulated at the federal level and by some states while animal pesticide products are regulated by states and the federal government.

预先确定产品分类是这个过程的关键部分. In this example, 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 therefore are likely to require a unique label. 作为动物卫生监管顾问, 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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