Ministry of Agriculture strengthens the Administration of Veterinary Drug Registration

In order to strengthen the registration management of new veterinary drugs and encourage the R & D and innovation of veterinary biological products, according to the actual situation of our country and the regulations on the Administration of Veterinary drugs and the measures for the Administration of New Veterinary Drug Development, the following adjustments have been made to the number of clinical trial target animals for the research and development of new veterinary biological products stipulated in the Ministry of Agriculture announcement No. 442.

1. Clinical trials of biological products for prevention and treatment shall be conducted in not less than 3 provinces (autonomous regions and municipalities directly under the Central Government). The total number of target animals should at least be met: 1000 cattle; 300 equine animals and deer; 5000 pigs, 500 breeding pigs; 3000 sheep; 1000 small and medium-sized economic animals (foxes, minks, otters, rabbits, dogs, etc.); 10000 chickens and ducks, 2000 geese and pigeons; 200 pet dogs and cats; 10000 fish. If the applied product is a new kind of veterinary drug, the number of clinical trial animals shall be doubled.

2. The number of clinical samples of veterinary diagnostic products shall not be less than 1000, and the number of pet samples such as dogs and cats shall not be less than 500.

3. The number of other types of animals or samples not specified above should not be less than 100 in general. The number of wild animals and rare animals which are not easy to obtain in clinic should meet the statistical requirements.