Notice of the General Office of the Ministry of Agriculture and Rural Affairs on effectively strengthening the supervision of new veterinary drug research and development activities for the prevention and control of African swine fever

Since the outbreak of African swine fever, the Ministry of Agriculture and Rural Affairs has always actively supported and encouraged qualified scientific research institutions and enterprises to carry out research on veterinary drugs such as African swine fever prevention and control technologies and vaccines. However, some localities and units have recently misconducted in the supervision, management and information disclosure of African swine fever prevention and control drug research and development, which has had a negative impact on the prevention and control of African swine fever. In order to further strengthen the supervision of the research and development activities of new veterinary drugs for the prevention and control of African swine fever, the relevant matters are hereby notified as follows.

1. Improve ideological awareness, adhere to scientific decision-making, democratic decision-making, and administration according to law

African swine fever is the "number one killer" of the world's pig industry, posing a serious threat to my country's pig industry. At present, the prevention and control work of African swine fever and the recovery of live pig production in my country are in a critical period of retreat. Animal husbandry and veterinary authorities in various places should fully understand the importance of African swine fever prevention and control and the recovery of live pig production, and further enhance their overall awareness. Uncompromisingly implement the central government's relevant African swine fever prevention and control measures, focus on concentrating on prevention and control responsibilities, strengthen the implementation of measures, and do everything possible to speed up the recovery of live pig production and ensure stable market supply.

Local animal husbandry and veterinary authorities should carefully learn the lessons learned from the "Jinzhu Polysaccharide Injection" incident by the Department of Agriculture and Rural Affairs of a certain province. , veterinary drug products without an approval number, interfering with the prevention and control of African swine fever. It is necessary to further strengthen study, be familiar with and master relevant laws and regulations, especially the management regulations and rules of the veterinary drug industry, clarify powers and management responsibilities, adhere to administration according to law, perform duties with due diligence, adhere to scientific and democratic decision-making, and avoid hasty and chaotic behavior. The African swine fever prevention and control work has adversely affected.

2. Strengthen the publicity and training of laws and regulations to ensure that the research and development activities of new veterinary drugs for the prevention and treatment of African swine fever are carried out in accordance with laws and regulations

Any unit that develops new veterinary drug products for the prevention and control of African swine fever should strictly abide by the relevant regulations and regulations such as the "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories" and "Regulations on the Management of Veterinary Drugs", and carry out research activities in accordance with laws and regulations. In the research stage of the new veterinary drug laboratory, if it is planned to use the live African swine fever virus to carry out research, the approval of the laboratory activities of highly pathogenic pathogenic microorganisms and the approval of the first class of pathogenic microorganisms for the development of new veterinary drugs shall be submitted to our department in accordance with the regulations before the start of the experiment. Relevant experimental activities can only be carried out after obtaining approval. If the laboratory stage research is completed and the clinical trial is planned to be carried out, if it is a vaccine, the research and development unit shall submit an application to the Ministry for approval of the clinical trial of new veterinary biological products, and the clinical trial can be carried out only after the approval is obtained. The provincial agricultural and rural administrative department submits the filing materials, and the clinical trial can be carried out only after the filing. Clinical trial activities shall comply with the relevant regulations of the Good Clinical Practice for Veterinary Drugs (GCP for Veterinary Drugs). After the clinical trial is completed, the research and development unit shall submit an application for the registration of new veterinary drugs and product approval number to the Ministry in accordance with relevant regulations and procedures. In the case of genetically modified organisms, the research and development unit shall also submit an application for the safety evaluation of genetically modified organisms to the Ministry in accordance with the relevant provisions of the "Regulations on the Safety Management of Agricultural Genetically Modified Organisms".

Local animal husbandry and veterinary authorities should further strengthen the publicity and training of relevant laws and regulations, and carry out legal publicity and training for research and development units of new veterinary drugs for African swine fever prevention and control within their jurisdictions to ensure that they understand relevant laws and regulations, and urge them to carry out research activities in accordance with laws and regulations. It is necessary to strengthen daily supervision and inspection. If it is found that African swine fever virus experimental activities are carried out without corresponding administrative licenses, or clinical trials are carried out without corresponding administrative licenses or without filing, they will be severely investigated and dealt with in accordance with the law, and violations of laws and regulations will be severely cracked down.

3. It is strictly forbidden to publish false information on research results to avoid vicious speculation

Local animal husbandry and veterinary authorities should actively monitor relevant information and public opinion, strengthen the supervision of relevant scientific research units and individuals, and ensure that relevant units and individuals publish research progress and results objectively, impartially, and realistically, and avoid exaggerated propaganda and malicious speculation. We must resolutely prevent the recurrence of false information that can even be questioned by securities exchange agencies, but hastily approved by animal husbandry and veterinary departments. For those who lack scientific basis to exaggerate propaganda and hype, and publish false information to interfere with the overall situation of African swine fever prevention and control, all localities must correct them in a timely manner. In response to the public opinion response, the Ministry will seriously deal with the phenomenon of unresponsive, inaction or random release of information to promote malicious speculation, and will report to the relevant local people's governments and society.

(Source: Ministry of Agriculture and Rural Affairs website, General Office of the Ministry of Agriculture and Rural Affairs, June 24, 2019)