This Regulation is enacted to strengthen veterinary drug administration, guarantee veterinary drug quality, prevent and control animal diseases, promote the development of breeding industry, and maintain human health. It shall apply to the research, production, operation, import, export, use or supervision of veterinary drugs inside the territory of the People's Republic of China. The Regulation consists of 75 articles divided into 9 Chapters: General provisions (I); Research and development of new veterinary drugs (II); Veterinary drug production (III); Business operation of drugs (V); Use of veterinary drugs (VI); Supervision over veterinary drugs (VII); Legal liabilities (VIII); Supplementary provisions (IX).
The Regulation shall govern the research, production, operation, import, export, use or supervision of veterinary drugs inside the territory of the People's Republic of China.
The state applies a system of administering veterinary drugs by classifying them into prescription veterinary drugs and non-prescription ones. The measures for classifying prescription veterinary drugs and non-prescription ones as well as the specific implementing procedures shall be formulated by the veterinary administration under the State Council. Whoever researches a new veterinary drug shall file an application to the veterinary administration and attach to it the safety appraisal report for the laboratory stage of the new veterinary drug. After the clinical trial is completed, the new veterinary drug researcher shall, when filing an application to the veterinary administration under the State Council for registration of the new veterinary drug, submit a sample of this new veterinary drug and the information as prescribed in Article 9. When researching a new veterinary drug for edible animals, the researcher shall carry out a trial on veterinary drug remnants in accordance with the provisions of the veterinary administration under the State Council, and shall provide such information as the withdrawal period, the maximum limitation of remnants, the methods of testing remnants and the basis thereof, etc.
In order to establish a veterinary drug production enterprise, one shall conform to the national development planning and policies of the veterinary drug industry. A veterinary drug production permit shall indicate the scope of production, producing location, validity period, etc. Veterinary drugs shall meet the national standards for veterinary drugs. Article 22 provides for conditions to be met by entities involved in business operation of veterinary drugs.