Approval Basis

  • “Regulations on the Administration of Veterinary Drugs” (announced by State Council Order No. 404 of 2004, partially revised by State Council Order No. 653 of 2014, and partially revised by State Council Order No. 666 of 2016).
  • “Regulations on Biosafety Management of Pathogenic Microbiology Laboratories” (State Council Order No. 424, 2004).
  • “Measures for the Management of Research and Development of New Veterinary Drugs” (Ministry of Agriculture Order No. 55, 2005).
  • “Veterinary Drug Registration Measures” (Ministry of Agriculture Order No. 44, 2002).
  • Ministry of Agriculture Announcement No. 442, 449, 2223, 2326, 2335, 2336, 2337, 2368, 2464 and Ministry of Agriculture and Rural Affairs Announcement No. 75.

Application Materials Catalog

  • “Veterinary Drug Registration Application Form” in duplicate (original).
  • Documents proving the applicant’s legal registration, including business license, legal person certificate, etc. (copies).
  • For products of genetically modified biotechnology (except inactivated vaccines and diagnostic products), an agricultural genetically modified organism safety certificate (copy) must be provided.
  • Three consecutive batches of samples and their production inspection records and inspection reports.
  • If it is a biological product, bacteria (virus, insect) species, cells and other relevant materials should also be provided.
  • According to the different categories of new veterinary drugs, other registration information shall be submitted in accordance with the “Veterinary Drug Registration Information Requirements” and other relevant regulations.

Legal Processing Time Limit

      60 working days (if expert review is required, the expert review time shall not exceed 120 working days; if review inspection is required, the review inspection time shall not exceed 120 working days, and if special method inspection is required, the review inspection time shall not exceed 150 working days).

Approval results

      If permission is granted, a “New Veterinary Drug Registration Certificate” will be issued; if permission is not granted, a written decision of disapproval will be made.

Rights and Obligations of Administrative Counterparts

  • Applicants applying for administrative licenses shall truthfully submit relevant materials to the administrative agency and reflect the true situation, and shall be responsible for the authenticity of the substantive content of their application materials.
  • If an administrative license applicant conceals relevant information or provides false materials to apply for an administrative license, the administrative agency will not accept the application or grant the administrative license and will give a warning. If the administrative license application is directly related to public security, personal health, life and property safety, the applicant shall not apply for the administrative license again within one year.
  • From the date of receipt of the notice of rejection or notification of completion (disapproval), the applicant can apply to the Ministry of Agriculture and Rural Affairs for administrative reconsideration within 60 days, or file an administrative lawsuit with Beijing No. 3 Intermediate People’s Court within 6 months.

Q&A About Veterinary Drug Registration

  • A1: Can an individual apply for registration of a new veterinary drug?

Q1: No, the applicant refers to the institution that can bear the corresponding legal responsibility.

  • A2: Can pet drugs be exempted from reporting residue elimination test research data?

Q2: Yes, because pets are non-food animals.

  • A3: Can udder injections used to treat dairy cow mastitis not to submit pharmacokinetic test data?

Q3: Yes. Since it is only used for local treatment of the breast, there is no need to provide pharmacokinetic test data.

  • A4: Where can I check whether an approved new veterinary drug is on the market?

Q4: You can go to the National Veterinary Drug Basic Information Query System to check whether the product has obtained a veterinary drug product approval number. If an approved new veterinary drug has obtained a corresponding product approval number, the product has entered the monitoring period.

  • A5: What does it mean if the registration application form is incompletely filled in?

Q5: According to the requirements, the applicant should fill in the various registration application forms item by item, and the applicant’s legal person signature and official seal, date, etc. should not be missing. Especially if there are multiple applicants, it is impracticable to fill in only part of the applicant information.

  • A6: What does incomplete supporting documents generally mean?

Q6: According to the requirements of Ministry of Agriculture Announcement No. 442, registration applicants should provide four main types of supporting documents. However, there are often situations where there is a lack of clinical trial approval documents, a copy of the GMP certificate of the pilot enterprise, and a copy of the production license.