The Ministry of Agriculture Further Strengthens Veterinary Drug Registration Management

In order to strengthen the registration management of new veterinary drugs and encourage innovation in the research and development of veterinary biological products, in accordance with China's actual conditions and the provisions of the "Regulations on the Administration of Veterinary Drugs" and the "Measures for the Administration of Research and Development of New Veterinary Drugs", the following adjustments are hereby made to the number of target animals for clinical trials in the research and development of new veterinary biological products as stipulated in Announcement No. 442 of the Ministry of Agriculture.

1. Clinical trials of biological products for prevention and treatment shall be conducted in no fewer than 3 provinces (autonomous regions, municipalities directly under the Central Government). The total number of target animals shall at minimum meet the following: cattle 1000 head; equine animals and deer 300 head (animals); pigs 5000 head, breeding pigs 500 head; sheep 3000 head; small and medium-sized economic animals (foxes, mink, otters, rabbits, dogs, etc.) 1000 head (animals); chickens and ducks 10000 birds, geese and pigeons 2000 birds; pet dogs and cats 200 animals; fish 10000 fish. Where the product applied for is a Class I new veterinary drug, the number of animals in clinical trials shall be doubled.

2. The number of clinical samples tested for veterinary diagnostic products shall be no fewer than 1000 samples, and the number of samples tested for pets such as dogs and cats shall be no fewer than 500 samples.

3. For other categories of animals or sample numbers not specified above, the number shall generally be no fewer than 100 cases. For wild animals and rare animals that are particularly difficult to obtain in clinical practice, the number shall meet statistical requirements.