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• Regulations on Administration of Veterinary Drugs

Regulations on Administration of Veterinary Drugs

Original Article by Mr. Gary Zhang

9 April 2004, the State Council of the People’s Republic of China released the Regulations on Administration of Veterinary Drugs .Under this regulation, imported New veterinary drugs shall be registered with Center of Veterinary Drug Evaluation of Ministry of Agriculture (MOA) prior to entering Chinese market, according to Article 5 of the regulation.

Measures for the Registration of Veterinary Drug

• Safety ,efficacy and quality control of veterinary drug must be needed
• MOA is in charge of registration of veterinary drug
• Requirements of data of Veterinary Drug Registration---Announcement 442 of MOA

New Veterinary Drug and Types of Registration

New Veterinary Drug

The veterinary drugs that meet the following two conditions will be considered as new veterinary drugs in China

• Pharmaceutical ingredient and pharmaceutical product which have NOT been sold in China
• Pharmaceutical ingredient and pharmaceutical product which have been sold in some countries except for China

Types of Registration

• Chemical Drugs
• Biological product
• Chinese Veterinary Drugs、Natural Drugs
• Diagnostic reagents
• Disinfectants

Note: It’s better for companies to aware the obligations under the regulations and choose the right type to register.

Application Bodies

Veterinary drugs to be imported to China for the first time,

The representative office established by the importer within the territory of China or the agency within the territory of China

shall apply to MOA for registration, and submit the data and articles

Data and Articles should be submitted

• The document certifying that the veterinary drug regulatory department of the country (region) where the manufacturer is located has approved the production or marketing of such drug;
• The document issued by the veterinary drug regulatory department of the country (region) where the manufacturer is located, certifying that the drug conforms to the Good Manufacturing Practice (GMP) for Veterinary Drugs;
• The method and process of manufacturing, quality standards, analytical method, results of pharmacological and toxicological tests, clinical trial report, stability test report, and other data relevant to the veterinary drug; the data relating to the withdrawal period, maximum residue limits, residue analytical method and their basis for a veterinary drug used for food animals;
• A sample copy of the label and package leaflet of the veterinary drug;
• A sample, reference substance and standard substance of the veterinary drug;
• The environmental impact report and measures for prevention and control of pollution;
• Other data concerning safety of the veterinary drug.

When applying for exporting veterinary biologics to China, the applicant shall, in addition, provide the master seed bacteria (viruses or insects), cell lines and other relevant materials and data.

Reference:

http://english.agri.gov.cn/governmentaffairs/lr/vs/201301/

t20130115_8117.htm

Our services

• Registration of imported veterinary drug in China
• Proposals for the registration (calculations on the duration, cost of the procedure)
• Dossier audits: Data gap analysis and expert services
• Scheme design: How to finish registration economically and quickly?
• Manufacture process study (process and 3 batches of samples need to be provided)
• Preparation of registration dossier
• Submission
• Other service
• Re- registration of imported veterinary drug in China

Contact Us

Mr. Gary Zhang, China Office