In accordance with the Regulations on the Administration of Veterinary Drugs, our department has organized and completed the preparation of Part Three of the Pharmacopoeia of the People’s Republic of China (Veterinary Drugs) (Seventh Edition) (hereinafter referred to as the Chinese Veterinary Pharmacopoeia (Seventh Edition)). It is hereby issued and shall come into force on 2027 Year 5 Month 1 Day. The relevant matters are hereby announced as follows.
I. The Pharmacopoeia of the People’s Republic of China (Veterinary Drugs) is the statutory technical standard to be followed in veterinary drug research and development, production (import), distribution, use, and supervision and administration.
II. Part Three of the Chinese Veterinary Pharmacopoeia (Seventh Edition) includes veterinary biological products, comprising general notices, individual monographs, and appendices. The individual monographs are general standards: national veterinary drug standards established based on a single antigen and applicable to products of the same type.
III. From the date of implementation, product standards included in Part III of previous editions of the Veterinary Pharmacopoeia of the People’s Republic of China, the Biological Products Volume of the Veterinary Drug Quality Standards (edition of 2017), and the Veterinary Biological Products Regulations of China (edition of 2000), which are not included in Part III of the Veterinary Pharmacopoeia of the People’s Republic of China (seventh edition) and have not been announced as repealed, shall remain in force, but shall comply with the relevant general requirements of Part III of the Veterinary Pharmacopoeia of the People’s Republic of China (seventh edition).
Before the implementation date of Part III of the Veterinary Pharmacopoeia of the People’s Republic of China (seventh edition), manufacturers of the relevant products should promptly conduct comparative studies of the standards to assess whether the veterinary drug registration standards comply with the relevant requirements of Part III of the Veterinary Pharmacopoeia of the People’s Republic of China (seventh edition), and, as necessary, complete the relevant procedures for amending the standards (see attachment).
IV. Relevant veterinary medicinal products manufactured on or after 2027/5/1 shall meet both the requirements of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition) and the veterinary drug registration standards approved by the Ministry of Agriculture and Rural Affairs. Relevant veterinary medicinal products manufactured on or before 2027/4/30 (inclusive) may be tested in accordance with the original veterinary drug quality standards and may be circulated and used during their product validity period.
V. Applications for registration of new veterinary biological products and registration of imported veterinary drugs submitted on or after 2027/5/1 shall meet the requirements of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition).
VI. Applications for veterinary biological product approval numbers submitted from 2027 year 5 month 1 day onward must have their samples tested against veterinary drug registration standards approved by the Ministry of Agriculture and Rural Affairs and meeting the requirements of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition). To renew a veterinary drug product approval number, technical documents meeting the requirements of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition) must be provided. For applications submitted on or before 2027 year 4 month 30 day, inclusive, the applicable standard stated in the veterinary drug inspection report may be either the original veterinary drug registration standard or a newly approved veterinary drug registration standard that meets the relevant requirements of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition) and has been approved by the Ministry of Agriculture and Rural Affairs.
VII. Livestock and veterinary authorities at all levels must actively undertake publicity, communication, and implementation of Volume III of the Chinese Veterinary Pharmacopoeia (Seventh Edition), and collect and provide feedback on related questions and opinions. The Office of the Chinese Veterinary Pharmacopoeia Commission should promptly respond to questions raised by local authorities and provide technical guidance, issue corrections to standards, and perform other related work.
Eight, all veterinary drug companies should conscientiously implement Part Three of the Chinese Veterinary Pharmacopoeia (Seventh Edition) and continuously improve the quality control of veterinary drug products.
This is hereby announced.
Ministry of Agriculture and Rural Affairs
2026 year 10 month 15 day