To improve the long-term mechanism of safe treatment, it is urgent to legislate vaccine alone

[policies and regulations of pharmaceutical Station] vaccine is a kind of automatic immune preparation which is mainly used to prevent and control infectious diseases, which is made of pathogenic microorganisms and their metabolites by artificial detoxification, inactivation or genetic engineering For the supervision of vaccine market, the state has issued a number of policies and regulations In March 2008, the former Ministry of health, the national development and Reform Commission, the Ministry of education and other five ministries jointly issued the implementation plan of expanding the national immunization plan; in December 2011, the national development and Reform Commission and other departments issued the notice on the construction plan of vaccine supply system, requiring to improve the production capacity and quality of class I and class II vaccines, enhance the R & D strength, strengthen the detection and early warning of epidemic situation, etc In April 2016, the State Council issued a decision on Amending the regulations on the administration of vaccine circulation and vaccination, requiring vaccine procurement to be conducted through the provincial public resource trading platform, and establishing a full process vaccine traceability system After the Shandong vaccine incident in 2016, relevant national departments strengthened the supervision of vaccines In February 2017, the general office of the State Council issued the opinions on Further Strengthening the management of vaccine circulation and vaccination In early July 2018, Changchun Changsheng vaccine incident broke out Due to the wide scope and great influence of the event, Chinese leaders attached great importance to the event, which promoted the further improvement of China's vaccine industry legislation On November 11, 2018, the State Administration of Market Supervision issued the vaccine management law of the people's Republic of China (Draft for comments) According to industry experts, the separate legislation of vaccines is mainly based on the three particularities of vaccines As the particularity of drugs Vaccine has a temporary licensing problem For example, a large-scale infectious disease suddenly occurs in a place, and vaccine is urgently needed, but the approval of related vaccine has not been passed in China At this time, it is necessary to speed up the approval of the vaccine, i.e temporary authorization, which is based on public safety and public health considerations Vaccine has this particularity That is, temporary licensing, which is based on public safety and public health considerations Vaccine has this particularity Second, among the strictness, "more strictness" The target of vaccination is healthy people, especially infants, so the social sensitivity of vaccine safety and effectiveness is very high For vaccine related violations, it is necessary to set up a very high degree of punishment Third, the particularity of Chinese vaccine At present, China's vaccine production and vaccination links are managed by two systems separately The full competition of vaccine production links and the administrative monopoly of vaccination links form a contradiction, which leads to the weakness of the basic system of vaccine industry But in foreign countries, these two links are actually one link At present, the supervision of vaccine industry in China is increasingly strict The focus of supervision is to provide the level of vaccine product research and development, strict access to vaccine manufacturing enterprises, guarantee the quantity and quality of vaccine product supply, reduce the circulation of vaccines, expand the scope of vaccine immunization planning, and establish a vaccine traceability system In addition, China has implemented a four-level regulatory system for vaccine market, including provincial, municipal and county-level, and has implemented full life-cycle supervision and management for vaccine production, circulation and storage, quality and safety, and vaccination However, China's vaccine industry is still in a growing stage Most of the enterprises are small in scale, lack of technical reserves, and few annual batches are issued, and most of them are based on traditional processes such as virus reduction, inactivation, cracking, etc., with low technical content However, with the increasingly strict supervision of the vaccine industry by the state, its concentration will be increased In 2019, China will also promote the restructuring and integration of the whole industry.