Overview of Veterinary Drug Regulations in China

In China, veterinary drugs are regulated by the Ministry of Agriculture and Rural Affairs (MARA) in China. The highest regulation is "Regulations on Administration of Veterinary Drugs (Decree 404 of the State Council)". Any entity engaged in research and development, manufacture, distribution, import and export, use, supervision and administration of veterinary drugs in China must comply with this regulation.

Definition of Veterinary Drugs in China

In China, veterinary drugs are defined as substances (including pharmaceutical feed additives) used to prevent, treat, diagnose animal diseases or purposefully regulate animal physiological functions. They typically include the following product categories:

• Chemical drugs
• Biological products
• Chinese medicines
• Diagnostic reagents
• Disinfectants

Veterinary Drug Registration in China

In China, veterinary drugs require registration with the Chinese Ministry of Agriculture and Rural Affairs (MARA) before they can be produced, imported, sold, or used in China. Detailed registration process and data requirements can be found in the following  regulations:

• Measures for the Registration of Veterinary Drugs (MARA Order 44, 2004)
• Registration Classification and Registration Data Requirements for Veterinary Biological Products. 2004-12-22
• Registration Classification and Registration Data Requirements for Veterinary Chemicals. 2004-12-22
• Imported Veterinary Drug Re-registration Application Materials Requirements. 2004-12-22
• Registration Classification and Registration Application Material Requirements for Veterinary Diagnostic Products. 2004-12-22
• Classification and Application Material Requirements for Veterinary Disinfectants. 2004-12-22
• Classification and Registration Data Requirements for Chinese Traditional Veterinary Medicine and Natural Drugs. 2004-12-22
• Registration Classification of Chemical Drugs and Requirements for the Registration Materials. 2004-12-22
• Registration classification of veterinary diagnostic articles and requirements for the registration materials. 2004-12-22
• Registration classification of biological products for animal use and requirements for the registration materials. 2004-12-22
• Registration classification of Chinese traditional veterinary drugs and natural drugs and the requirements for the registration materials. 2004-12-22
• Classification and Requirements for Registration Information of Veterinary Disinfectant. 2004-12-22
• Requirements for Veterinary Drug Change Registration Items and Application Materials. 2004-12-22