vaccine supply system planning notice
SCS 62 [2011]
provinces, autonomous regions and municipalities, the State Council Ministries, agencies directly:
State Council
二 December 22, 2011
vaccine supply system construction plan Development and Reform Commission Ministry of Industry and Information Technology Ministry of Science
Ministry of Agriculture, Ministry of Finance, Ministry of Health, Food and Drug Administration
vaccine is pathogenic micro-organisms and its metabolites, artificially attenuated, inactivated or made use of genetic engineering methods for the prevention and control of infectious diseases, the major auto-immune agents, is an important branch of bio-pharmaceuticals. Vaccination and can block the extinction of the growth and spread of infectious diseases, the incidence and prevalence of infectious diseases prevention and control is the most economical and most effective measures. The term vaccine supply planning system, is the prevention and control of infectious diseases through vaccination, response to public health emergencies involving a complete system, including early warning surveillance and vaccine development, production, distribution, vaccination, reserves, regulatory and other links . Vaccine supply and maintain a sound system for efficient operation and timely development, production and vaccination is the key to effective prevention and control of the epidemic on the protection of people's lives and health, to maintain economic and social stability is important.
2009 influenza h1n1 flu response process, our first production and vaccination, epidemic prevention and control for the full and effective means to provide a key. In recent years the fight against atypical pneumonia prevention and control of highly pathogenic avian influenza, foot and mouth disease outbreak response to children, and Timor , Yushu earthquake disaster prevention, etc. Practice shows that a significant and timely prevention and control of emerging infectious diseases, must be based China, according to Zhao build a complete system of the immune barrier of the target, overall planning capacity building of China's vaccine supply system.
vaccines for infectious diseases prevention and control needs of our country, under the circulation and vaccination regulations based on lessons learned, with the relevant planning requirements, the development of this plan, the planning period of 2011-2015, taking into account the development needs of 2020. The plan to focus on human vaccines, according to a comprehensive prevention and control of the epidemic need to put forward a human zoonotic infectious diseases of veterinary vaccine requirements. Animal vaccines against infectious diseases is not within the scope of this plan.
one's vaccine supply system status
(1) Basic information.
1.'s Vaccine categories and requirements. Vaccination costs paid by Zhao different subjects, vaccines for human use in China is divided into two categories. The first vaccine is that the Government free of charge to citizens, citizens should be subject to government regulations in accordance with Zhao kinds of vaccines, including vaccines and other national immunization program, using the plan developed by the Government and centralized purchasing. The second vaccine is voluntary by the citizens at their own expense and subject to other types of vaccines, mainly rely on market forces of supply and demand.
2.'s Vaccine industry status quo. Management, currently has a health administrative departments at all levels, CDC organizational units of vaccination inoculation, biological products or business plans based on market demand, the government organization of production, the drug regulatory departments to implement quality control, veterinary administrative department responsible for sweeping the mouth Zoonoses and other animal vaccines pattern. Research and development, formed a university-based research institutions and conduct basic research, the business, engineering (technology) center for applied research and engineering, industrial development of the system. Production, China is one of the few self-supply of vaccine one of the countries, with the varieties of vaccine production, the scale has grown to become the largest vaccine producer cones.
3. The effect of vaccination. Vaccine from the country's national immunization program in 1978 Through extensive vaccination, infectious diseases greatly reduced morbidity and mortality in 2008 of Infectious morbidity and mortality rates were 69% lower than in 1985 and 50%, smallpox has been completely eliminated, since 1994, 16 consecutive years was no indigenous polio cases, measles, whooping cough, diphtheria, epidemic encephalitis B, epidemic cerebrospinal meningitis and other disease rates dropped significantly.
In addition, for our country, including highly pathogenic avian influenza, rabies, including nine kinds of zoonoses, extensive animal immunization.
(b) of the main problems.
our existing routine immunization vaccines can basically meet the demand, but as the people's health for life, health and epidemic prevention have become increasingly demanding, coupled with atypical pneumonia, influenza h1n1 influenza and other major and new emerging infectious diseases, vaccine supply system exposed some of the links are obvious problems:
1. low levels of infectious disease monitoring and early warning. Many cases of infectious diseases diagnosed by a doctor based on clinical symptoms, bacteria, viruses, fungi and other pathogens too few diagnostic reagent products, application level is low.
2. R & D is relatively backward. China's basic research is weak vaccine, vaccine quality and effectiveness evaluation support system is imperfect. Lack of innovative and high-end R & D personnel.
3. Large-scale production capacity is weak. Lack of advanced mass production technology.
4. Vaccine management needs to be strengthened. Vaccine supply management involves many departments, the current lack of overall coordination. Vaccine distribution management is relatively weak. Abnormal response to vaccination compensation mechanism has been established.
5. A lack of emergency support. Technical reserves and production capacity of vaccine reserve is insufficient to achieve rapid development and expansion of emergency a lot. Variety of national reserves, too few to cope with large-scale epidemic outbreak and unexpected fluctuations in production means weak. Not yet formed from the surveillance, emergency vaccination to the entire process of dealing with adverse reactions emergency response mechanism.
6. Pricing mechanism needs to be improved. Affected by many factors, the national immunization program vaccine low overall level of government pricing, profit margins smaller, to a certain extent, affected the enterprises to improve product quality and upgrading initiative. The second vaccine product for the market-regulated prices, more circulation, the market price is high.
7. Immunization vaccine still need to improve the actual coverage. Some of the local implementation of the immunization process, there is rural, village-level immunization budget is not implemented, the construction of the cold chain was not complete primary vaccination and the lack of staff and other issues, leading to uneven progress of immunization programs, the actual impact on vaccination coverage improved.
8. Zoonosis is not high overall level of veterinary vaccines. Zoonoses monitoring and early warning capacity is weak. Research and innovation capability is not strong, vaccines variety of small, backward production technology, primary vaccine cold chain storage and transportation systems inadequate. Veterinary vaccine reserves and impact evaluation system has not been vaccinated, adverse reaction monitoring wind Yan assessment carried out less.
(c) the situation and challenges faced.
1. Relatively high incidence of infectious diseases. Compared with developed countries, China's per capita share of low levels of health care resources and uneven regional development, the need to compensate by strengthening the epidemic lack of medical resources. Incidence rate in the control of infectious diseases in China there are still some significant gaps. 2010 World Health Organization data show that China's reported cases of measles cases accounted for 13% of cones, 50% of cases of mumps, rubella cases accounted for 62%, 22% of cases of neonatal tetanus.
2. The increasing demand for disease prevention. In recent years, major international and domestic, emerging infectious diseases continue to emerge, of which 75% are zoonoses. As the economy continues to deepen the degree of all cones, national and regional economic and trade exchanges between the increasing cross-border movement of people is more frequent, faster than the spread of infectious diseases, adverse effects more difficult to control.
3. Vaccine Supply international competition. At present, governments play a more and more attention to the role of the vaccine, developed countries have adopted various measures to encourage and support their development of the vaccine industry enterprises bigger and stronger. Europe's five major multinational vaccine cones market sales accounted for more than 85%, has begun to enter China's market.
Generally speaking, China's vaccine supply system formed in the prevention and control of infectious diseases play an important role, but compared with the actual demand, the overall level of protection there is still a gap between supply capacity is big but not strong . With economic power and comprehensive national strength, China has a necessary and possible for overall planning and construction of the vaccine supply system, integration of resources, increase investment, improve vaccine supply system capacity and product quality to meet the needs of routine and emergency vaccination to protect people's health social stability and economic development.
Second, the guiding ideology, basic principles and development goals
(a) guiding ideology.
fully implement the Party's Seventeenth National Congress, Deng Xiaoping Theory and concept, in order to protect people's health, social stability and national security for the purpose, establish and improve China's national conditions compatible with the vaccine supply system. To improve the whole process of supervision and management of the main line, in order to enhance the overall R & D capabilities as the core, strengthen vaccine supply capacity for effective prevention and control of infectious diseases and public health emergencies should lay a solid foundation.
(b) of the basic principles.
1. Overall layout, system upgrade. Vaccine supply system for the weak links, co-ordinate arrangements for system tasks, rational distribution of key projects, enhance the overall vaccine supply system under normal and abnormal protection capabilities.
2. Self-production, and strengthen innovation. Adhere to national immunization program vaccine, routine and emergency vaccine based on the domestic vaccine production principles to the field of vaccine-related research and innovation capacity building of key technologies as the main way to actively support the development of new vaccines and industrial application of advanced technology, accelerate the species upgrade.
3. Treating the symptoms and distance combination. Strengthening the vaccine development and production of existing infrastructure, focusing on new breakthroughs in vaccine development and mass production technology constraints such as bottlenecks in long-term development, and effectively improve the core competitiveness, efforts to narrow the gap with the international advanced level.
4. Security of supply, effective emergency response. Step to improve part of the vaccine production capacity and quality in terms of equipment capability, improve the current vaccine in kind, such as production capacity and technical reserves, emergency supply of vaccine to respond quickly to establish linkage mechanism.
5. Strengthen the supervision and healthy development. Improve vaccine regulations, strengthen law enforcement efforts to promote the standardization of supervision, increase support for policy and investment, speed up the training, and comprehensively promote the healthy development of the vaccine supply system.
(c) the development goals.
2015, initially built to meet the needs of economic and social development of China's vaccine supply system, through the weak link in the key construction, will achieve the normal security, emergency response capacity has increased significantly. Form a more perfect, including emerging infectious diseases, including surveillance and early warning system, gradually raise the infectious diseases of public health emergencies, and direct reporting network rate; through a comprehensive R & D institutions, R & D technology and application technology platform capacity-building to achieve basic research, applied basic research and industrial development closely together, to narrow the international advanced technology gap; accelerate needed vaccines of new product development and industrialization process, to enhance the part of the active vaccine maximum capacity, to ensure the normal and emergency for the various vaccines Chongzu supply and further improve quality; to the township (town) as a unit of the national immunization programs to achieve and maintain vaccination rates over 90%; perfect vaccine reserve system, the layout of building production capacity reserves, additional reserves of vaccine-kind varieties; improve vaccine quality monitoring and evaluation system inoculation effect; Zoonoses significantly improve the quality of veterinary vaccines, veterinary disease vaccine technology to enhance foreign reserves.
2020's vaccine supply system to further improve and perfect, synchronization with the developed countries cope with emergencies and major outbreaks of strength. Vaccine production technology research and development of basic reach or approach international advanced level, further increase the variety, safety, effectiveness and further improve product quality, variety and size of a reasonable reserve, vaccination services more convenient.
three main tasks
vaccine supply for the existing system of weak links, focus on capacity building, focusing on enhancing research and development, to achieve disease control and vaccine development , production, circulation, vaccination, reserves, regulation of the aspects of development.
(a) to strengthen monitoring and early warning.
integration of existing early warning surveillance resources, expanding infectious diseases and public health emergencies direct reporting network system function, strengthen the system construction and operation and maintenance, medical and health institutions above the county level direct reporting of epidemic rates of up to 100 network %, rural medical and health institutions more than 90%. Improve disease surveillance systems, strengthen respiratory class, class encephalitis, hemorrhagic fever like symptoms such as sudden onset of acute infectious disease surveillance points and build a sound network of sudden onset of acute infectious disease laboratory monitoring, development of rapid diagnostic or detection reagents related to the development unexplained illnesses and emerging infectious diseases of laboratory detection and identification technology. Strengthen epidemiological Pok investigation, emphasis on international cooperation and exchange of information, good epidemic status monitoring and trend analysis, to effectively guide vaccine development, production and use of vaccination.
(b) to enhance research and development.
industrial technology innovation through strategic alliances and other forms of research collaboration to accelerate the production of innovative vaccines Pok R & D system, strengthen laboratory research, new product trial production, industrial development of an effective interface between. Pok Pok and immune enhancing pathogen applied basic research, to speed up vaccine-associated laboratory biosafety capacity building. Integrated use of existing scientific and technological resources, to promote vaccine R & D base, give full play to the role of technology platforms to support, through Tianpingbuqi eliminate weak links, improve vaccine research and development capabilities. Increase the joint research efforts, much-needed breakthrough in key technologies, vaccine research and development engineering efforts to achieve industrialization. Promote the industrialization of research results and accelerate some of the upgrading of the existing varieties of vaccines. Strengthen the important, emerging infectious diseases, vaccine development and evaluation of support system. Strengthen the bacteria and viruses for research and resource sharing.
(c) increase productivity and quality.
support related businesses increase productivity, raise standards, build the production line. The first efforts to solve the vaccine production capacity, production lines and product upgrading a single issue; to guide and encourage second vaccine manufacturers moderate expansion of existing vaccines and new vaccine production capacity; support the vaccine companies to obtain pre-certification and the World Health Organization to enter the international market, effectively maintain respond to outbreaks of influenza and other peak capacity. Strengthening the vaccine development and application of major equipment, and actively promote the introduction and assimilation of key technologies to new breakthroughs in key areas such as large-scale cultivation and purification techniques and equipment bottlenecks. Efforts to increase the advantages of enterprise support, support mergers and acquisitions, to promote large-scale, intensive production.
(d) of Section Pok safe vaccination.
immunization strategy to carry out immunization and infectious disease burden, Division Pok reasonable planning to expand vaccine coverage and species populations. Take specific measures to focus on improving the rural areas in the western and eastern areas of migrant children in national immunization programs in the vaccination rate. Actively vaccine application development policy, increase the knowledge of vaccine-related propaganda to promote the second category of public voluntary vaccination vaccination. Improve the vaccination statistics and abnormal reaction reporting system, and actively carry out vaccination efficacy and safety evaluation, and improve vaccine adverse reaction monitoring system. Establish and improve the compensation mechanism for abnormal reaction to vaccination.
(5) specification storage management.
tissue vaccine production, storage, transport and vaccination units, in cooperation vaccine storage and transportation management study to develop the vaccine storage and transportation practices, specifically related to facilities, equipment requirements and conditions of refrigeration (cold) equipment, vehicle refrigeration equipment, vehicles and other equipment configuration standards. Establish and improve the vaccine cold chain distribution management system, strengthen the cold chain during transportation of standardized management, quality assurance to improve the level of vaccine transport.
(f) improve the reserve system.
strengthen vaccine stockpile management, improve the reserve system, differentiated reserve measures taken to co-ordinate technical reserves, reserve capacity and physical reserves to ensure quick and effective state of emergency supplies. Regularly assess the likelihood of outbreaks of various infectious diseases and immunization requirements, to determine the technical reserve list. By Zhao government, corporate commitment to the principle of reserve mission, organizational capacity reserves and physical reserves. Determine the lowest overall vaccine production capacity is used to maintain the amount of peak demand for flu vaccine reserve of the larger species necessary capacity. Considering changes in the epidemic situation, the wind Yan production disruptions and other factors, the development of physical reserve plan. Strengthening the vaccine Chengchuqiye storage capacity.
(g) enhance emergency support capabilities.
establish emergency vaccine research and development, approval, production, circulation, reserve call, vaccination and other fast-response linkage mechanism. Strengthening the vaccine supply emergency, transporting, supporting capacity building inoculation, developed for high-wind Yan expansion plans for emergency vaccination of infectious diseases, improve vaccine production capacity, the community's emergency inventory requisition and compensation system, a clear in-school students and other key groups Pok emergency vaccination strategies to develop vaccines emergency vaccination plans.
(h) improve the regulatory system.
strengthen vaccine regulatory capacity building, development of vaccine regulatory system construction and development goals, improve infrastructure, innovation and regulatory measures to improve regulatory efficiency. Improve the way the vaccine for regulatory approval. Establish a standardized system of vaccine quality evaluation system, strengthen the quality control standards, improve product quality responsibility system for vaccine production. Strengthen vaccine production, distribution, monitoring the whole process of vaccination, unified planning and construction electronic monitoring system for vaccine production and wholesale enterprises, disease management organizations to implement electronic monitoring, and gradually expand to the vaccination unit. Strict implementation of the vaccine batch release system, increase the daily supervision and inspection and market testing efforts to crack down illegal acts. Strengthening the vaccine production process, especially removal of bacteria virus seed safety supervision.
(i) to enhance international competitiveness.
increase innovation support, encourage research and development of vaccines with independent intellectual property rights of new varieties, new techniques and new technology. Expand international cooperation and exchanges, tracking foreign vaccine development, production technology dynamic. Timely introduction of our much-needed technology, equipment and materials, organizing the digestion and absorption, re-development. In vaccine development, production companies, mergers and acquisitions, closure, bankruptcy process, pay attention and take effective measures to protect key technologies and production capabilities to ensure industrial safety.
(X) to improve prevention and control of zoonoses ability.
strengthen zoonoses animal immunization, improve vaccine quality and supply capacity. The establishment of health care, immigration and quarantine system, veterinary and information resource sharing mechanism, the formation of rapid diagnosis of zoonoses laboratory network, and strengthen disease monitoring and early warning and rapid response capabilities to prevent introduction of foreign diseases. Based on our reality, combined with international status and trends of epidemic diseases well in advance of major zoonoses prevention and control, and laboratory bio-safety and security required technical reserves and the necessary physical reserves.
to accelerate the construction of mission objectives, planning in the overall consideration of the necessity and feasibility of proposed based on five categories of key construction projects. First, the urgent need to foster important new products. Hand, foot and mouth disease vaccine to complete the six kinds of new vaccines and industrialization, accelerate the development of new vaccines and the development of a number of varieties. Second, the construction of key R & D facilities, focusing on new vaccines and other capacity-building, national research centers. Third, the expansion needed capacity and physical reserves. Fourth, the vaccine industry to improve the level of equipment. Fifth, the establishment of vaccine quality control system. Investment in key projects will be about 94 billion yuan.
Fourth, the security measures
(a) strengthening the regulatory and standards system.
promote the improvement of vaccine supply system, relevant laws and regulations, and improve the relevant provisions of the vaccine supply emergency. Division Pok assess and improve the management practices, systems, norms and standards, to improve the overall functioning of the vaccine supply system efficiency.
(b) increase financial support for such policies.
central finance the expansion of national immunization programs of the first class required for the acquisition cost of vaccines and syringes to give support. Funding for local governments to ensure that national immunization programs within the first vaccination work. Further improve and implement for vaccine research and development, production, storage and other enterprise support policies vaccine supply. Improve the vaccine price management, reasonable adjustments to the national immunization program vaccine prices, specifications second vaccine market prices.
(c) to increase research funding.
by major science and technology, national science and technology programs, industry specific and to encourage private investment and other means, to increase vaccine-based Section Pok, experimental research, key technology research and industrialization as well as important research infrastructure, platform capacity building input. Scientific and technological achievements to improve the conversion rate and R & D capital efficiency.
(d) strengthen the training of personnel.
rely on universities and research institutes, according to Zhao great loss of national policy, professional training base for the formation of the vaccine, vaccine R & D required to develop a positive professional technical and management personnel. Promote vaccine R & D efforts to create a favorable environment for the growth of talent, establish and improve the incentive mechanism, and actively introduce the vaccine R & D of high-end talent. Improve disease prevention and control personnel and medical staff job training system to improve primary vaccine management and immunization staff of professional quality. Increase to the public, especially students in the school Pok popularization of health and disease prevention knowledge, knowledge of vaccination efforts.
(e) to strengthen the coordination of vaccine supply system.
vaccine supply system construction plan of specific tasks and projects implemented by the relevant departments under the normal duties by the division of responsibilities and carry it out; major epidemic deployed by the State Council to implement the emergency co-ordinating multi-power common response and timely solutions to common, affecting the overall situation of the major problems. Improve the government departments, research institutions, production reserves of normal contact between enterprises and the state of emergency mechanism for rapid mobilization mechanisms, and improve vaccine supply emergency support and coordination.
(This piece has excision)
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