Notice of the State Food and Drug Administration on Propaganda and Implementation of the Law of the People's Republic of China on Vaccine Management

The Drug Administration of the provinces, autonomous regions, and municipalities directly under the Central Government, the Drug Administration of the Xinjiang Production and Construction Corps, the bureaus and bureaus of the bureaus, and the units directly under it:
The "Law Management Law of the People's Republic of China" (hereinafter referred to as the "Vaccine Management Law") was reviewed and approved by the 11th meeting of the Standing Committee of the 13th National People's Congress on June 29, 2019, from December 1, 2019. Implemented. In order to do a good job in the promotion and implementation of the Vaccine Management Law, the relevant matters are hereby notified as follows:
First, fully understand the importance of propaganda and implementation of the "Vaccine Management Law"
The vaccine is related to the health of the people, the public health security and national security. It is a national strategic and public welfare product. The Party Central Committee and the State Council have attached great importance to vaccine supervision. General Secretary Xi Jinping and Premier Li Keqiang have repeatedly issued important instructions to speed up the improvement of the long-term mechanism for the regulation of vaccine drugs and improve laws, regulations and institutional rules. The formulation of the Vaccine Management Law is an important measure to implement the decision-making arrangements of the Party Central Committee and the State Council on strengthening vaccine supervision. The Vaccine Management Law adheres to the people-centered thinking, solidifies the new measures for vaccine supervision deployed by the central government in a legal form, integrates and integrates scattered vaccine management regulations, and makes a system for vaccine development, production, circulation, vaccination and supervision and management. Sexual provisions, to promote reform through legislation, to strengthen supervision by legislation, to protect rights and interests by legislation. The Vaccine Management Law is the world's first comprehensive vaccine management law, which fully reflects the Party Central Committee's high priority for vaccines, promotes vaccine industry innovation and the healthy development of the industry, and ensures the safety, effectiveness, and accessibility of vaccines, and reshapes the people. Vaccine safety confidence is important for protecting and promoting public health.
All units must fully implement the spirit of the important instructions of the Party Central Committee and the State Council on strengthening vaccine management, and resolutely understand the importance and necessity of propagating and implementing the Vaccine Management Law in accordance with the principle of resolutely safeguarding the most fundamental interests of the broad masses of the people. The requirements of scientific legislation, strict law enforcement, fair justice, and law-abiding for the whole people further enhance the sense of responsibility and mission, pay close attention to the promotion and implementation of the Vaccine Management Law, and actively carry out the study, publicity and training of the Vaccine Management Law. We will promptly formulate and improve relevant supporting systems, effectively strengthen the capacity of vaccine supervision, and actively prepare for the implementation of the law. It is necessary to earnestly perform its supervisory duties, strengthen law enforcement inspections, crack down on illegal activities, and actively protect public health.
Second, profoundly understand the spirit and basic content of the Vaccine Management Law
Guided by the spirit of the 19th National Congress of the Communist Party of China and the spirit of the 2nd and 3rd Plenary Session of the 19th Central Committee, we conscientiously implemented the spirit of the important instructions of the general secretary of the internship on the supervision of vaccines, clarified the work objectives, strengthened the study and publicity training, and thoroughly understood and accurately grasped the vaccine management. The spirit and basic content of the Law. Drug supervision and administration departments at all levels should focus on learning and understanding the legal provisions, learning the legal spirit, and strive to create a work goal of implementing the law in a good atmosphere, highlighting the pertinence and effectiveness, deepening the study, propaganda and training, and strengthening the corporate subject consciousness. , the sense of responsibility of the regulatory authorities, the awareness of the rights of the people and the awareness of social supervision.
(1) Formulate a practical learning and training program. It is necessary to study and publicize the implementation of the Vaccine Management Law as a specific measure to implement the educational activities of “not forgetting the original heart and keeping in mind the mission”. As an important task of current drug supervision, formulate a learning and training plan to clarify the learning tasks and specific requirements. Implement the division of responsibilities and supervision and assessment, and achieve planning, goals, implementation, and assessment. It is necessary to focus on the study of leading cadres, and the main responsible comrades should lead by example and take the lead in learning. It is necessary to strengthen the supervision and training of front-line law enforcement personnel by holding training courses, seminars, special lectures, online training and grassroots training, and further improve the legal administration level and ability of vaccine supervisors. It is necessary to guide and supervise the holders of vaccine marketing licenses, circulation distribution and vaccination units in their administrative areas to conscientiously study and understand the "Vaccine Management Law", fully implement the main responsibility, and form a comprehensive, multi-level, no-dead study and propaganda pattern.
(2) Grasping the key points of learning. Firmly grasp the basic principles of “safety first, risk management, whole process control, scientific supervision, and social co-governance”, conscientiously study the most stringent vaccine management system, carefully study the specific requirements of vaccine life cycle quality management and encourage innovation and development. We will ensure specific measures for accessibility, earnestly study the specific responsibilities of governments at all levels and relevant departments, conscientiously study the specific provisions on social security of vaccine safety, and conscientiously study the specific content of severely punishing violations.
(3) Innovative learning and propaganda methods. Incorporate the study and propaganda and implementation of the "Vaccine Management Law" into the scope of public welfare propaganda, and include it as an important part of the popular law of the whole country. It will be combined with the National Child Vaccination Day and the National Safe Drug Month and other brand activities to carry out the "Vaccine Management Law". Into the countryside, into the community, into the school, into the enterprise, into the unit of the "rule of law propaganda and education theme activities, to adopt a variety of lively, lively, the masses like to see the form and means to carry out various forms of learning and publicity activities. It is necessary to strengthen the construction of learning and publicity resources, relying on the Internet to build the "Vaccine Management Law" and the science and technology library of vaccine safety knowledge and expert libraries. Make full use of various media such as newspapers, radio, film, television, internet, mobile phones, etc., set up special columns, organize experts, and deeply interpret the contents of the Vaccine Management Law. The filming of vaccines, popular science videos and micro-movies will be taken as an important part of the 16th National Rule of Law animation micro-video works collection campaign, to expand the influence of publicity, and strive to create a good atmosphere for learning and promoting the Vaccine Management Law.
Third, strengthen the supporting system and supervision capacity building, and do a good job in the preparation of the implementation of the Vaccine Management Law
Propagating and implementing the Vaccine Management Law is an important responsibility of the drug supervision and administration departments at all levels, and is also an inevitable requirement for the construction of a modern drug safety management system. It is important to focus on supporting systems and regulatory capacity building, and actively implement the Vaccine Management Law. Preparation for the work.
The Vaccine Management Act will be implemented on December 1, 2019, stipulating that the state should establish a number of systems. At present, the State Drug Administration is organizing its efforts to speed up the development of a full-line electronic traceability system for vaccines, a strict access system for vaccine production, a vaccine batch issuance system, a compulsory vaccine liability insurance system, and a unified publication of vaccine safety information. Regulations and normative documents, technical guidelines and revisions, and in accordance with the overall deployment of professional inspector team building, strengthen the capacity building of the supervision team, improve the flight inspection, cause inspection, station inspection and other work systems.
Local drug supervision and administration departments at all levels must implement the central government's requirements for the deployment of local party committees and governments at all levels must resolutely set off the political responsibility for drug safety, especially vaccine safety, and bear the overall responsibility for the safety of vaccine drugs within their jurisdictions. The government reported that under the unified leadership of the party committee and the government, the vaccine supervision capability and infrastructure will be strengthened, and relevant departments will coordinate and coordinate to promote the implementation of 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 of the evaluation of the national supervision system for vaccines, complete self-assessment on schedule, and formulate detailed work plans for the shortcomings and shortcomings. It is necessary to take the assessment as an opportunity to further establish and improve the quality management system and effectively improve the supervision capability and level.
Fourth, effectively strengthen the supervision and enforcement of vaccine drugs, and actively protect the health rights and interests of the people
(1) Deeply promote the reform of the drug review and approval system. Encourage vaccine drug innovation and product accessibility. Encourage the research and development of multi-linked multi-valent vaccines and innovative vaccines and vaccines needed to prevent and treat major diseases, optimize the review and approval process, and give priority review and approval to the varieties that meet the requirements. The drug supervision and administration department must intervene in advance and provide guidance to enterprises in terms of laws, regulations, and technical requirements. Strengthen the supervision of the enterprise development process, strengthen the management of vaccine clinical trial institutions, and seriously investigate and punish illegal activities for applying for vaccine clinical trials or applying for vaccine registration to provide false data, materials and samples.
(2) Strengthen supervision and inspection and severely crack down on illegal activities in the field of vaccines and drugs. It is necessary to firmly establish the problem orientation, adhere to the risk concept, and use the means of inspection, inspection, monitoring, complaints and reports to check risks and prevent vaccine quality risks from the source. It is necessary to do a high-frequency and full coverage of the inspection of vaccine manufacturers, and strictly investigate and punish violations of laws and regulations. At the same time as the administrative punishment of the enterprise, it is necessary to punish the relevant responsible person and pursue the pursuit of the sentence to the individual. It is necessary to jointly take discretionary and disciplinary measures with the relevant departments and impose an industry ban on those who violate the law. In accordance with the requirements of the Vaccine Management Law, it is necessary to strengthen the supervision of vaccine quality in storage, transportation, distribution and vaccination according to its responsibilities, focus on the supervision and inspection of cold chain control and flow traceability, and investigate and deal with violations of laws and regulations according to law; The person conducts suspected vaccination abnormal response monitoring as required, develops and implements a post-marketing risk management plan, and conducts post-marketing research and evaluation.
(3) Strengthening the construction of the vaccine supervision team. Through training, recruitment, resource integration and other means to select a group of excellent and well-inspected inspectors, and continue to strengthen business training and practical drills, and constantly improve the overall quality and business level of the supervision team.
V. Strengthen organizational leadership and ensure the implementation of the Vaccine Management Law
Drug supervision and administration departments at all levels should include the promotion and implementation of the Vaccine Management Law on the current important agenda of work, strengthen the leadership of the vaccine supervision, clarify tasks, implement responsibilities, carefully deploy, formulate work implementation plans, and establish corresponding personnel and Financial funding investment guarantee mechanism. It is necessary to publicize and implement the work of the Vaccine Management Law as an important part of the departmental and local drug safety work and the supervision, inspection and evaluation of law-enforcement work, establish and improve the evaluation, supervision and inspection mechanism, regularly supervise the inspection and publicity, and ensure the work falls. To be practical. The State Drug Administration will take the promotion and implementation of the Vaccine Management Law as an important inspection content during this year's drug inspection and inspection.
All localities should promptly summarize and disseminate the good experiences and practices in the work of the Vaccine Management Law, as well as the problems and suggestions reflected. Please report to the Policy and Regulation Department of the State Drug Administration in a timely manner.