China's livestock and animal husbandry market is vast. Concurrently, the ownership of pets is on the rise, leading to an increased demand for pet medications. However, China has specific data requirements and timelines for veterinary drug registration, and registrants must navigate regulatory challenges.
Definition of Veterinary Drugs
In China, veterinary drugs encompass chemicals, therapeutic biological agents, vaccines, diagnostic reagents, as well as disinfectants and topical pesticides for animals.
Registration Requirements for Legal Entities
- To register a veterinary drug in China, the applicant must be the manufacturing company or its affiliated group companies.
- Currently, China has not implemented a marketing authorization holder system for veterinary drugs and does not accept contract manufacturing.
- Foreign companies cannot sell veterinary drugs directly in China; sales must be conducted through Chinese subsidiaries or local agents.
- For imported veterinary drugs, overseas registrants must appoint a local registration agent for submission.
Recognition of Foreign Data
- China requires that veterinary drugs from foreign companies be approved in their country of origin.
- While China is gradually recognizing overseas guidelines and study data, locally submitted dossiers often do not meet Chinese requirements. For instance, imported veterinary drugs typically require target animal verification clinical trials in China.
Considerations for Foreign Companies
- Foreign companies should select promising varieties in China and enter the market swiftly.
- Numerous factors influence market access in China.
Our "Registration of Veterinary Pharmaceuticals in China" course is due to take place on the 21st June 2024.
Book your place to stay fully updated on the implications for your business and to ask questions of expert trainer from knoell, Bi Jun.
Published on Jun 06, 2024 by Angela Spall