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.
2. What are the major laws and regulations that regulate veterinary drugs in America?
Food, Drug, and Cosmetic Act (FD&C): the following link takes you to Chapter V - Subchapter A - Drugs and Devices:
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
- 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:
Additional information regards laws and regulations can be found at:
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?
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
4. What is the registration procedure of veterinary drugs (pharmaceuticals) and animal feed in America?
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.
5. What are the requirements that America has on Chinese export enterprises?
The same requirements as stipulated for U.S. based manufactures.
6. What is the procedure of changing an already obtained FDA certificate?
You would be required to file for another new certificate with the FDA.
7. Please indicate any new veterinary policies made by FDA.
Any changes/updates to veterinary drug polices are published in the Federal Register and a summary is provided on the FDA CVM website at:
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?
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.
9. Requirements for the registration data of active pharmaceutical ingredients, are all the data must be in English?
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.
10. Can a factory produce feed additives and feed at the same time?
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.
11. Is there a list of authorized feed additives? How can we get the list?
A list of currently authorized feed additives can be found in 21 CFR 172
In addition, a list of food additives that are Generally Recognized As Safe (GRAS) can be found at:
12. What are the procedures if we want to export feed additives containing amino acid to America?
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.
13. What are the procedures of exporting antimicrobials used in animal feed to America?
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.
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: