State Food and Drug Administration: publicize and implement the vaccine administration law of the people's Republic of China

Drug administration of all provinces, autonomous regions and municipalities directly under the central government, drug administration of Xinjiang production and Construction Corps, all departments, bureaus and units directly under the Bureau: The vaccine management law of the people's Republic of China (hereinafter referred to as the vaccine management law) was deliberated and adopted at the 11th meeting of the Standing Committee of the 13th National People's Congress on June 29, 2019, and shall come into force on December 1, 2019 In order to do a good job in the publicity and implementation of the vaccine management law, the relevant matters are hereby notified as follows: first, fully understand the significance of the publicity and implementation of the vaccine management law vaccine is related to people's health, public health safety and national security, and is a national strategic and public welfare product The CPC Central Committee and the State Council attached great importance to the supervision of vaccines General Secretary Xi Jinping and Premier Li Keqiang made important instructions on several occasions, calling for speeding up the long-term mechanism of vaccine and drug supervision and improving laws, regulations and rules The formulation of "vaccine management law" is an important measure to implement the decision-making and deployment of the CPC Central Committee and the State Council on strengthening vaccine supervision The "vaccine management law" adheres to the people-centered idea, solidifies the new measures of vaccine supervision deployed by the central government in the form of laws, integrates the scattered vaccine management norms, and makes systematic provisions on vaccine development, production, circulation, vaccination and supervision management, so as to promote reform through legislation, strengthen supervision through legislation, and protect rights and interests through legislation "Vaccine management law" is the first comprehensive vaccine management law in the world, which fully reflects the great attention of the CPC Central Committee to vaccines It is of great significance to promote the innovation of vaccine industry and the healthy development of the industry, to ensure the safety, effectiveness and accessibility of vaccines, to rebuild the people's confidence in vaccine safety, and to protect and promote public health All units should fully understand the importance and necessity of publicizing and implementing the vaccine management law from the perspective of implementing the spirit of the important instructions and instructions of the Party Central Committee and the State Council on strengthening vaccine management, firmly safeguarding the fundamental interests of the masses, and further enhance their sense of responsibility and mission in accordance with the requirements of "scientific legislation, strict law enforcement, fair justice and law-abiding by the whole people" We should pay close attention to the publicity and implementation of the vaccine management law, actively carry out the study, publicity and training of the vaccine management law, formulate and improve the relevant supporting systems, practically strengthen the construction of vaccine regulatory capacity, and actively prepare for the implementation of the law We should conscientiously perform our regulatory duties, strengthen law enforcement inspection, crack down on illegal acts, and actively safeguard public health Two, deeply understand the essence and basic contents of the vaccine management law Guided by the spirit of the nineteen and nineteen sessions of the Third Plenary Session of the nineteen Central Committee, conscientiously implement the general secretary Xi Jinping's important directive spirit of vaccine supervision work, clarify the work objectives, strengthen learning publicity and training, and thoroughly understand and accurately grasp the essence and basic content of the vaccine management law Drug supervision and administration departments at all levels should closely focus on learning the legal provisions and spirit, strive to create a good atmosphere for the implementation of the law, highlight the pertinence and effectiveness, carry out in-depth learning, publicity and training, and strengthen the awareness of the main body of the enterprise, the responsibility of the supervision Department, the rights of the masses and social supervision （1） Make a practical learning and training plan It is necessary to take the study, publicity and implementation of the vaccine management law as a specific measure to carry out the theme education activity of "never forget the original intention and keep the mission in mind", as an important work of the current drug supervision, formulate a study and training plan, clarify the study tasks and specific requirements, implement the division of responsibilities and supervision and assessment, and achieve a plan, a goal, an implementation and an assessment We should pay special attention to the study of leading cadres The main comrades in charge should set an example and take the lead in the study It is necessary to strengthen the learning and training of front-line law enforcement personnel by holding training courses, seminars, special lectures, online training and sending them to the grass-roots level under the law, in close combination with the actual situation of supervision, so as to further improve the legal administrative level and ability of vaccine regulators It is necessary to guide and urge the vaccine marketing license holders, distribution and vaccination units in their respective administrative regions to carefully study and understand the vaccine management law, comprehensively implement the main responsibilities, and form a comprehensive, multi-level and dead space free learning and publicity pattern （2） Grasp the key points of study Firmly grasp the basic principles of "safety first, risk management, whole process control, scientific supervision and social co governance", carefully study the most strict vaccine management system, carefully study the specific requirements of vaccine quality management in the whole life cycle and specific measures to encourage innovation, development and guarantee accessibility, carefully study the specific responsibilities of governments at all levels and relevant departments, and seriously study vaccine safety The specific provisions of social co governance should be carefully studied and the specific contents of severely punishing and severely punishing illegal acts should be carefully studied （3） Innovative learning and publicity methods We will integrate the study, publicity and implementation of the vaccine management law into the scope of public welfare publicity, the important content of the universal law, the National Children's vaccination day, the national month of safe drug use and other brand activities, and carry out in-depth the legal publicity and education theme activities of the vaccine management law, such as "going to organs, villages, communities, schools, enterprises and units", and take a variety of measures To carry out various forms of learning and publicity activities We need to strengthen the construction of learning and publicity resources, and build a database of vaccine management law and vaccine safety knowledge popular science resources and experts relying on the Internet Make full use of newspapers, radio, movies, TV, Internet, mobile phones and other media, set up special columns, organize experts, and thoroughly interpret the content of the vaccine management law We will take the shooting of vaccine popularization, popular science micro videos and micro films as an important part of the 16th National Law based animation micro video works collection and exhibition activity, expand the publicity influence, and strive to create a good atmosphere for learning and promoting the vaccine management law 3、 Strengthen the construction of supporting system and regulatory capacity, and make preparations for the implementation of the vaccine management law To publicize and implement the "vaccine management law" is an important responsibility of drug supervision and administration departments at all levels, as well as an inevitable requirement for the construction of a modern management system of drug safety We should focus on the construction of supporting systems and regulatory capacity, and actively make preparations for the implementation of the "vaccine management law" The vaccine management law will be implemented on December 1, 2019, which stipulates that the country should establish a number of systems At present, the State Drug Administration is organizing efforts to work out the whole process electronic traceability system for vaccines, implement strict access system for vaccine production, vaccine batch issuance system, vaccine liability compulsory insurance system and uniform release of vaccine safety information, and accelerate the formulation and revision of relevant regulations, normative documents and technical guidelines, and in accordance with the team of professional inspectors The overall deployment of the construction, strengthening the capacity-building of the supervision team, and improving the work system of flight inspection, causal inspection, and post inspection Local drug supervision and administration departments at all levels should implement the deployment requirements of the central government that "local Party committees and governments at all levels must resolutely shoulder the political responsibility for drug safety, especially vaccine safety, and take overall responsibility for vaccine drug safety within their jurisdiction", actively report to local Party committees and governments, strengthen vaccine supervision capacity and infrastructure construction under the unified leadership of Party committees and governments, and work with relevant departments Coordinate and coordinate with each other to promote and improve the supporting policies for the implementation of the vaccine management law Local drug supervision and administration departments at all levels shall, in accordance with the deployment arrangements, accelerate the preparation for the evaluation of the national vaccine regulatory system, complete the self-evaluation on schedule, and formulate a detailed work plan for the existing shortcomings and shortcomings We should take the evaluation as an opportunity to further establish and improve the quality management system and effectively improve the regulatory capacity and level 4、 We will effectively strengthen the supervision and law enforcement of vaccine drugs, and actively safeguard the health rights and interests of the people (1) we will deepen the reform of the drug review and approval system Encourage vaccine drug innovation and product accessibility We will encourage the research and development of multi linked and multi valent vaccines, innovative vaccines and vaccines needed for the prevention and treatment of major diseases, optimize the review and approval process, and give priority to the review and approval of varieties that meet the requirements Drug supervision and administration departments should intervene in advance to guide enterprises in terms of laws, policies and technical requirements We will strengthen the supervision of the development process of enterprises, strengthen the management of vaccine clinical trial institutions, and seriously investigate and punish the illegal acts of applying for carrying out vaccine clinical trials or applying for vaccine registration to provide false data, data and samples （2） We will strengthen supervision and inspection and crack down on illegal activities in the field of vaccines and drugs We should firmly establish the problem orientation, adhere to the risk concept, make overall use of inspection, inspection, monitoring, complaint reporting and other means to identify risks, and prevent vaccine quality risks from the source We should ensure the high frequency and full coverage of the inspection of vaccine manufacturers, and strictly check and punish illegal production activities in accordance with the law At the same time of enterprise administrative punishment, we should also punish the relevant responsible person, and pursue the responsibility to the individual It is necessary to take integrity punishment measures jointly with relevant departments, and prohibit the illegal from entering the industry According to the requirements of the vaccine management law, we should strengthen the supervision of vaccine quality in storage, transportation, distribution and vaccination, focus on the supervision and inspection of cold chain control and flow tracing, investigate and deal with illegal behaviors according to law; urge the listing license holders to carry out the monitoring of suspected abnormal vaccination reactions, formulate and implement the post listing risk management plan, and carry out Post marketing research and evaluation of vaccines （3） Strengthen the construction of vaccine supervision team Through training, recruitment, resource integration and other ways, select a group of inspectors with excellent style and excellent business, and continue to strengthen business training and practice, and constantly improve the overall quality and business level of the supervision team 5、 Strengthen the organization and leadership, ensure the implementation of the vaccine management law, and the drug regulatory departments at all levels should put the publicity and implementation of the vaccine management law on the current important work agenda, strengthen the leadership, clear the task, implement the responsibility, make a thorough deployment, formulate the work implementation plan, and establish the corresponding personnel and financial funding input guarantee mechanism It is necessary to take the publicity and implementation of the vaccine management law as an important part of the supervision, inspection and evaluation of the drug safety work and the law popularization work of departments and localities, establish and improve the evaluation, supervision and inspection mechanism, regularly supervise and inspect the publicity and implementation, and ensure the implementation of the work The State Drug Administration will take the publicity and implementation of the vaccine administration law as an important part of this year's drug inspection All localities shall timely summarize and publicize the good experience and practice in the work of implementing the vaccine management law, as well as the problems and suggestions reflected The relevant information shall be submitted to the Department of policies and regulations of the State Drug Administration in a timely manner SFDA July 25, 2019