To further strengthen technical guidance for new veterinary drug research and accelerate the development and market application of veterinary drug products, in accordance with relevant provisions including the Regulations on the Administration of Veterinary Drugs, our Ministry has organized the formulation and revision of 28 technical guidelines for veterinary drug research, including the "Technical Guidelines for Veterinary Drug Safety Pharmacology Studies," which are hereby released for reference and implementation. Announcement No. 1247 of the Ministry of Agriculture and Announcement No. 1596 of the Ministry of Agriculture are simultaneously repealed.

From the date of publication of this announcement, newly formulated, revised, or repealed technical guidelines for veterinary drug research shall be proposed and drafted by the Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs, submitted to the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs for review and approval, and then published on the China Veterinary Drug Information Network and reproduced on the website of the Ministry of Agriculture and Rural Affairs. After a technical guideline for veterinary drug research is newly revised or repealed, the corresponding technical guideline involved in the original announcement shall be automatically repealed.

It is hereby announced.

Attachments:

1. Technical Guidelines for Veterinary Drug Safety Pharmacology Studies

2. Guidelines for Non-Clinical Toxicological Evaluation Tests of Veterinary Drugs

3. Technical Guidelines for Single-Dose Toxicity Studies of Veterinary Drugs

4. Guidelines for 28-Day/90-Day Oral Toxicity Tests of Veterinary Drugs

5. Technical Guidelines for Bacterial Reverse Mutation Tests of Veterinary Drugs

6. Technical Guidelines for Mammalian Bone Marrow Cell Chromosome Aberration Tests of Veterinary Drugs

7. Technical Guidelines for Mammalian Erythrocyte Micronucleus Tests of Veterinary Drugs

8. Technical Guidelines for Mammalian Spermatogonial Cell Chromosome Aberration Tests of Veterinary Drugs

9. Technical Guidelines for In Vitro Mammalian Cell Chromosome Aberration Tests of Veterinary Drugs

10. Technical Guidelines for In Vitro Mammalian Cell Micronucleus Tests of Veterinary Drugs

11. Technical Guidelines for Additional Studies on Genotoxicity Tests of Veterinary Drugs

12. Guidelines for Teratogenicity Tests of Veterinary Drugs

13. Guidelines for Reproductive Toxicity Tests of Veterinary Drugs

14. Guidelines on the Necessity of Carcinogenicity Tests for Veterinary Drugs

15. Guidelines for Environmental Toxicity Assessment of Veterinary Chemical Drugs (Phase I)

16. Technical Guidelines for Repeated-Dose Toxicity Tests of Veterinary Drugs

17. Technical Guidelines for Combined Studies of Chronic Toxicity and Carcinogenicity Tests of Veterinary Drugs

18. Technical Guidelines for Toxicokinetic Studies of Veterinary Drugs

19. Guidelines for Non-Clinical Pharmacokinetic Tests of Veterinary Chemical Drugs

20. Guidelines for Clinical Pharmacokinetic Tests of Veterinary Chemical Drugs

21. Guidelines for Phase II and Phase III Clinical Efficacy Evaluation Tests of Antibacterial Drugs

22. Guidelines for Mouse Sperm Abnormality Tests of Veterinary Drugs

23. Technical Guidelines for Clinical Trials of Veterinary Traditional Chinese Medicines and Natural Drugs

24. Principles for Writing Clinical Trial Reports of Veterinary Traditional Chinese Medicines and Natural Drugs

25. Guidelines for Generic Naming of Veterinary Traditional Chinese Medicines and Natural Drugs

26. Technical Guidelines for Quality Control Studies of Veterinary Traditional Chinese Medicines and Natural Drugs

27. Technical Guidelines for Safety and Efficacy Tests of Dairy Cattle Teat Disinfectants

28. Technical Guidelines for Palatability Tests of Veterinary Oral Preparations

Ministry of Agriculture and Rural Affairs

September 7, 2026

Attachment:
Attachment 1-28.pdf

Notes on This Announcement:

I. Source of Information

This content is reproduced from the official website of the Ministry of Agriculture and Rural Affairs of the People's Republic of China. Original link:
https://www.moa.gov.cn/govpublic/xmsyj/202609/t20260908_6487387.htm

II. Attachment Download

For the complete attachments to this announcement (28 technical guideline PDFs), please visit the official website of the Ministry of Agriculture and Rural Affairs or the China Veterinary Drug Information Network.

III. Disclaimer

This article is provided for industry information reference only. Specific provisions shall be subject to the latest documents officially released by the Ministry of Agriculture and Rural Affairs.