In China, the registration of veterinary drugs is overseen by the Ministry of Agriculture and Rural Affairs (MARA). The process involves several steps and can take up to several years to complete. Depending on product type, it takes 1.5-4 years to register a veterinary drug in China.

Pre-registration: Before applying for registration, the applicant should conduct research on the drug's efficacy and safety, as well as prepare the necessary documentation, such as toxicology studies and clinical trial reports.

Application: The applicant can then submit an application for registration to the National Institute for the Control of Veterinary Bioproducts and Pharmaceuticals (NICVBP), which is the agency responsible for reviewing and approving veterinary drug registrations.

Review: NICVBP will review the application, including the technical dossier and data submitted by the applicant, to ensure the drug meets the necessary standards for efficacy, safety, and quality.

Site inspection: If the application is deemed acceptable, NICVBP will conduct an on-site inspection of the manufacturing facility to ensure that the drug is being produced in accordance with Good Manufacturing Practices (GMP) standards.

Approval: If the application is approved, the applicant will receive a veterinary drug registration certificate, which is valid for five years. The drug must also be labeled and packaged in accordance with Chinese regulations.

Because the registration process can be complex and lengthy, applicants are encouraged to seek the assistance of a qualified regulatory consultant to ensure a smooth and successful registration process. TOSUN Pharmaceutical can provide registration agency services for your veterinary drugs exported to China.