About FDA

Follow-Up Questions from CVM’s Visit to China – September 2011

1. How long does it take to change the edition of USP? If there are changes to be made to the USP, where can we see the details of the changes? How to download an electronic USP from the Internet?
美国药典换版的周期有多长; 换版时如果内容出现变更; 变更清单在哪里有体现; 以及电子版的《美国药典》如何下载?

Please refer to the following web page for details regarding USP. There is a section of this web page that publishes all USP Pending and Non-U.S. Monographs. There is also a section dedicated to USP education.
http://www.usp.orgdisclaimer icon
有关《美国药典》的相关信息请参考下面的网页。《美国药典》网页上刊登有尚未批准的临时条目以及非美国(药典)的专题。此外,还有关于《美国药典》培训的内容。
http://www.usp.orgdisclaimer icon

2. What are the major laws and regulations that regulate veterinary drugs in America?
美国针对兽药监控管理的主要法典法规是哪些?

Food, Drug, and Cosmetic Act (FD&C): the following link takes you to Chapter V - Subchapter A - Drugs and Devices:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterV DrugsandDevices/default.htm

Code of Federal Regulations (CFR) Parts:

  • 211 – cGMP for finished pharmaceuticals
  • 225 – cGMP Medicated Feeds
  • 226 - cGMP Type A Medicated Articles
  • Parts 510-558 (examples included below):
    • 514 – New Animal Drug Applications (NADAs)
    • 515 – Medicated Feed Mill License
    • 520 - Oral Dosage Form – New Animal Drugs (NADs)
    • 522 – Implantation or Injectable Dosage for NADs
    • 524 – Ophthalmic and Topical Dosage Form
    • 526 – Intramammary Dosage
    • 529 – Certain Other Dosage forms
    • 558 – Type C Medicated Feeds
    • 510 – New Animal Drugs

有《食品,药品,化妆品法》,其中关于药品和器械在第五章第一分章, 请参考下面的链接。
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterV DrugsandDevices/default.htm

另外《联邦法典》的部分章节也可参考, 比如:

  • 211- 成品药GMP
  • 225- 药物饲料GMP
  • 226- A型药物饲料GMP
    第510 – 558部 (包括如下章节)
    • 514 - 新兽药申请
    • 515- 药物饲料厂许可
    • 520 - 口服剂型 – 新兽药
    • 522 – 植入或注射型新兽药
    • 524 - 眼药及外用药剂型
    • 526 - 乳房内剂型
    • 529 - 某些其它剂型
    • 558 - C型药物饲料
    • 510 - 新兽药

An electronic version of the CFR can be found online at:
http://www.access.gpo.gov/nara/cfr/waisidx_11/21cfrv6_11.html
电子版的《联邦法典》可以参考如下链接:
http://www.access.gpo.gov/nara/cfr/waisidx_11/21cfrv6_11.html

Additional information regards laws and regulations can be found at:
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/default.htm
有关法典法规更多的信息可以参考如下链接:
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/default.htm

3. What are the major departments or governmental organizations that are responsible for the management/regulation of veterinary drugs? And, what are their main responsibilities?
美国的哪个国家机构负责兽药的调控和管理, 其主要职责是什么?

The Center for Veterinary Medicine is responsible for veterinary drugs and feeds. For additional Information about this center and its infrastructure, please refer to http://www.fda.gov/AnimalVeterinary/default.htm  
美国FDA的兽药中心负责兽药和饲料的管理。更多信息请参考如下链接:
http://www.fda.gov/AnimalVeterinary/default.htm  

4. What is the registration procedure of veterinary drugs (pharmaceuticals) and animal feed in America?
兽药(化药) 和饲料添加剂在美国的注册程序是什么?

Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, re-packers, and re-labelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. This information helps FDA maintain a catalog of all human and veterinary drugs and biologics in commercial distribution in the United States.
There is a fairly standard set of details which a person must provide, when applying to register a drug. Apart from details of the applicant (name, address, contact details, etc.), detailed information is commonly required in order to compile a dossier on the drug, in particular –

  • name, ingredients, manufacture, pharmacology, toxicology;
  • registration details elsewhere;
  • purpose, route of administration, dosage, side effects, contra-indications;
  • container, packaging and labeling.

《食品、药品、化妆品法》第510部分要求从事生产,制备,传播,合成或处理人用或者兽用药品及人用生物制品生产商,包装商和标签商需注册成立并向FDA提交一个销售产品的清单。该信息帮助FDA制定一个涵盖所有在美国商业流通领域的人用及兽用药品和生物制剂的目录。

当申请注册某种药物的时候,有如下项目需要提供。除了申请者信息(姓名,地址,联系方式等),还需要提供详细的药品信息以便为该药品建立一个档案,特别需要以下内容:

  • 药品名称,成分,生产,药理,毒理;
  • 在其它地方注册的信息;
  • 用途,给药途径,剂量,副作用,禁忌;
  • 容器,包装和标签;

5. What are the requirements that America has on Chinese export enterprises?
美国对中国出口兽药企业的要求有什么?

The same requirements as stipulated for U.S. based manufactures.
与对美国本国企业的要求相同。

6. What is the procedure of changing an already obtained FDA certificate?
FDA证书,如需换证,评审程序是什么?

You would be required to file for another new certificate with the FDA.
更新证书需要向FDA提交新的材料。

7. Please indicate any new veterinary policies made by FDA.
请提示FDA在兽药方面的新政策。

Any changes/updates to veterinary drug polices are published in the Federal Register and a summary is provided on the FDA CVM website at:
http://www.fda.gov/AnimalVeterinary/NewsEvents/default.htm
有关的新政策与动向可参考如下链接。
http://www.fda.gov/AnimalVeterinary/NewsEvents/default.htm

8. To export veterinary products to America, do we have to submit applications to FDA via an agency? What are the requirements for the agencies?
向美国出口兽药,是否需要驻美办事机构或委托代理机构向FDA提出注册申请,对这些机构的相关要求有那些?

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug imported into the United States must identify a United States agent (U.S. agent) for that establishment. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
任何从事进口到美国药品的生产,制备,传播,合成或处理的外国公司必须指定一个在美国境内的代理商。每个外国公司只能指定一个代理商。外国公司也可以指定其美国代理商为其正式的联络代表。外国公司应该提供其美国代理商的名称、地址、电话和传真号码,以及电子邮件。

9. Requirements for the registration data of active pharmaceutical ingredients, are all the data must be in English?
化学原料药注册申请的相关资料,是否全部要求为英文?

All data officially submitted to the FDA for review must be in English. If the information has been translated prior to submission to the FDA, a certificate of accuracy may need to be provided for translation verification purposes.
正式提交给FDA用于评审的资料都必须是英文。若提交给FDA的是经翻译的资料则需要同时提供翻译准确性的证明。

10. Can a factory produce feed additives and feed at the same time?
一个工厂是否可以同时生产添加剂或饲料?

There is no limit to what a firm can manufacture at a specific facility. There can be however differences in the regulations with requirements unique to individual types of ingredients/products.
没有相关的限制,但是对相关产品的规定和要求因产品不同而存在差异。

11. Is there a list of authorized feed additives? How can we get the list?
有没有允许使用的饲料添加剂的目录? 如何获得?

A list of currently authorized feed additives can be found in 21 CFR 172
http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfrv3_05.html  
In addition, a list of food additives that are Generally Recognized As Safe (GRAS) can be found at:
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing
目前允许使用的饲料添加剂可参考《联邦法典》21卷172款。
http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfrv3_05.html  
食品添加剂则可以在如下链接找到:
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing

12. What are the procedures if we want to export feed additives containing amino acid to America?
氨基酸类饲料添加剂出口到美国需要办理什么手续?

The procedure for exporting feed additives to the U.S. is the same for feed additives and feed additives containing amino acids. The ingredients must be feed additives and not be labeled with a claim of action or fall under the definition of a drug per the FD&C Act.
饲料添加剂出口到美国的程序与含氨基酸的饲料添加剂是一样的。其成分必须是饲料添加剂;而且根据《食品,药品,化妆品法》中有关药品的定义,在其产品的标签上没有类似药物作用的内容。

13. What are the procedures of exporting antimicrobials used in animal feed to America?
饲料用抗生素或制剂出口到美国需要什么手续?

Animal feed that contains a drug (as defined in the FD&C) is considered a Medicated Feed. Please refer to 21CFR225 and 21CFR226 for information regarding Type A Medicated Articles and Medicated Feeds. The company would need to be the holder of an approved New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) or the designated supplier of the active pharmaceutical ingredient (API) used in an approved NADA or ANADA.
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
含有药物(在《食品、药品化妆品法案》中规定)的动物饲料被称为药物已混饲料。关于A型饲料预混药物和(已混)药物饲料可参考《联邦法典》第21卷225款和226款。公司需要取得新兽药申请许可或者非专利新兽药申请许可,或者该公司是已批准新兽药或非专利新兽药原料药的指定供应商。
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

14. What are the commonly-seen defects during FDA’s field inspections?
在 FDA的 现场实地检查时,常见的不合格方面有哪些?

This question is very broad and difficult to answer. For additional information regarding this question, you may want to contact someone from the Office of Regulatory Affairs.
Information regarding ORA can be found at:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/default.htm
回答此问题比较复杂,可联系(FDA的)监控事务办公室,相关链接如下:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/default.htm

Page Last Updated: 08/25/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.