Study On The Legal Issues Of Vaccine Production Supervision

Vaccines are the most effective drugs known to prevent and control infectious diseases.The quality and safety of vaccines is of great strategic importance to public health,public health,social stability and national security.Unlike common medicines used to treat specific people who already have the corresponding conditions,most of the vaccinated vaccines are healthy infants and children.They can prevent the disease by injecting attenuated or anti-virus antigens,and can improve children's immunity.To withstand many once-fatal malignant infectious diseases,the vaccine is directly related to the life and health power of the next generation,and it is responsible for improving the physical quality of the people and ensuring the healthy growth of the people.Therefore,the quality and safety of vaccines are very important to the national economy and the people's livelihood.State organs should establish a regulatory system to ensure citizens' safe and effective vaccines.However,the frequent occurrence of problem vaccine cases in recent years has not only brought great harm to the health of the people,but also exposed the problem that the vaccine supervision in China is not in place.Through the analysis of the 2018 Jilin Changchun longevity vaccine case,it is found that China's vaccine industry has both public welfare and market characteristics.As a market main body,vaccine manufacturers will take unfair or even illegal means to obtain competition under the maximization of interests.Advantage.In this case,in order to reduce costs,the company violated the national drug standards and drug production quality management regulations in the production process,fabricated false production inspection records,and passed the administrative inspection of the regulatory agencies to produce a large number of unqualified vaccines.There were two batches of unqualified vaccines in the case.The first batch of unsatisfactory DTP vaccines entered the circulation market in 2017,and most of them were vaccinated and used.The vaccine recipients will increase the infectious diseases.The risk or other adverse reactions that pose a direct health threat to the public.The second batch of vaccines was detected at the production stage and did not flow into the market.It was an illegal production behavior of the company itself,and did not cause visible health threats and substantial harm to the public.Therefore,the regulation of production links in the vaccine supervision system plays a pivotal role.Only when the production links are in place can the problem of vaccine cases be truly reduced.The problem vaccine case occurs under the combined effect of various factors,including the lack of integrity awareness and basic moral conscience,illegal and illegal operation;insufficient coordination between the central and local drug regulatory authorities;some government leaders and staff members failing to work;but the regulatory authorities Deviation of oversight,on-site inspection of the production process of vaccine companies is not in place,lack of complete traceability system for vaccine quality and safety information,not only the lack of electronic monitoring in the production process,but also the vaccination link has not been included in the traceability system,resulting in major vaccine safety incidents,It is impossible to accurately trace back to the production company to blame.It is impossible to accurately locate and recall the unqualified vaccines already in the market,and it is impossible to follow the specific vaccination targets to take remedial and compensation measures.Therefore,the production management system and the supervision system are perfected to ensure that no unqualified vaccines are produced*Even if there are unscrupulous cases,the unscrupulous vaccines are used to produce unqualified vaccines.The information traceability system is used to locate and track the whereabouts of the vaccines in time to prevent the actual use of the vaccines and cause damage to the health of citizens.The vaccine supervision system should start from the production link,take the improvement of the administrative inspection system and the establishment of the information traceability system as the key means,resolutely guard the public life and health bottom line,and safeguard the security interests of the overwhelming majority of the people.