Official announcement: accelerate the reorganization and integration of vaccine industry in 2019

On February 25, 2019, in order to implement the spirit of the central economic work conference and the national industrial and information work conference, the Ministry of industry and information technology held a National Symposium on the work of consumer goods industry in Chengdu, Sichuan Province, summarizing and exchanging the work summary in 2018, studying and deploying the key tasks in 2019 Wang Jiangping, member of the Party group and vice minister of the Ministry of industry and information technology, presided over the meeting and made a speech It was announced that in 2019, we will do our best to ensure the supply of drugs, promote the restructuring and integration of the vaccine industry, stabilize growth and promote consumption and other major tasks, which will cause a thousand waves This paper analyzes the reorganization and integration of vaccine industry, and puts forward the prospect 1 Brief history of vaccine industry development since the birth of the world's first vaccinia vaccine for smallpox prevention in 1796, the vaccine has a history of more than 200 years, and has become a powerful weapon against various diseases, especially infectious diseases The global vaccine development can be roughly divided into four stages 2 Characteristics of vaccine industry: China is the largest vaccine manufacturer in the world, and one of the few countries in the world that can solve all the planned immunization vaccines by relying on its own ability Domestic vaccines account for more than 95% of the actual vaccination volume in China The safety requirements of vaccines are higher than that of general drugs, and the difficulty of research and development is also very high Only a few enterprises have the strength The national supervision has implemented strict supervision on the vaccine industry, and carried out safety control from the aspects of vaccine development, manufacturing, circulation and after-sales The research and development cycle of vaccine industry is very long, even more than 10 years, and there is greater uncertainty The vaccine industry has the characteristics of high supervision, high concentration and strong research and development According to the announcement of the State Food and drug administration, as of the end of June 2018, there are 45 vaccine manufacturers in China, which can produce 63 kinds of vaccines and prevent 34 kinds of infectious diseases, with an annual production capacity of more than 1 billion doses, accounting for 40% of the global vaccine manufacturers However, the overall scale of the enterprise is relatively small, and the product homogeneity is serious In addition to the six biological product research institutes under the state-owned Zhongsheng group, more than half of the enterprises in China only issue one variety of vaccine each year Although the number of vaccine varieties on the market in China has increased, most of them are traditional vaccines, with low product level, small production scale, weak R & D capacity, single production varieties and irregular production Vaccine companies will be affected by the restructuring and integration of the vaccine industry in 2019 3 To promote the restructuring and layout of vaccine industry, in order to make the development of vaccine industry more standardized, the Ministry of industry and information technology of 2019 is taking the lead in studying and formulating the work plan for promoting the restructuring and integration of vaccine industry, and improving the concentration of vaccine industry, mainly including the following measures: improving market access standards, strictly controlling new vaccine enterprises; At present, there are 45 vaccine enterprises in China In addition to 10 state-owned enterprises, among them, Lanzhou, Wuhan, Changchun, Chengdu, Shanghai and 8 state-owned enterprises, such as Beijing beishengyan and Tiantan biology, are all enterprises of China Biotechnology Co., Ltd and 2 are Liaoning Chengda biology Co., Ltd and medical biology Research of Chinese Academy of Medical Sciences On September 20, 2018, the fourth meeting of the Central Committee for comprehensive deepening reform deliberated and passed the opinions on reforming and improving the vaccine management system, releasing the strong signals that the reform and improvement of the vaccine management system must be based on both symptoms and root causes, taking strong measures, strict market access, and strengthening market supervision Strengthen vaccine quality supervision and gradually guide backward products to exit; opinions on reforming and improving vaccine management system points out that in addition to raising the threshold for new entrants, it also means establishing elimination mechanism for survival of the fittest, standardizing vaccination management, resolutely blocking regulatory loopholes, severely cracking down on violations of laws and regulations, and ensuring the safety of vaccine production and supply Support the association to formulate and issue industry development guidelines to guide the orderly development of the industry; on November 11, 2018, the vaccine management law of the people's Republic of China (Draft for comments) was issued, which attracted widespread attention of the society The vaccine management law of the people's Republic of China (Draft for comments) is a comprehensive integration of the regulatory provisions scattered in multiple laws and regulations, covering all aspects of vaccine development, production, circulation and vaccination, and upgrading the vaccine supervision to the legal level, which also means that the previous situation of decentralized supervision of vaccines in China is coming to an end, and a unified and perfect vaccine supervision is about to be completed The regulatory system is expected to play an important role in cracking down on domestic vaccine market fraud and safeguarding the life safety and social stability of the public Industry insiders call this the most stringent vaccine management law in history They are optimistic that the implementation of vaccine management law policy in the first half of 2019 is obviously a probability event Encourage large-scale enterprises to win the bid for vaccine distribution, and promote the development of advantageous enterprises Encourage large-scale enterprises to win the bid for vaccine distribution, accelerate the development of advantageous enterprises, with the focus on optimizing distribution In 2019, accelerate the construction of retroactive management system for the whole process of vaccines Plan to gradually establish retroactive management system covering the whole process of procurement, supply, storage, logistics and vaccination of all vaccines, which will be conducive to the restructuring and layout of the vaccine industry Reference: [1] www.miit.gov.cn/n1146290/n1146397/c665937/content.html [2] www.zyzhan.com/news/detail/73471.html [3] med.sina.com/article g 2_.html [4] xueqiu.com/2137758205/114206558