Adopted by the Standing Committee of the National People's Congress, the full text of the vaccine management law of the people's Republic of China

On the afternoon of June 29, the 11th session of the Standing Committee of the 13th National People's Congress held a closing meeting, at which 170 votes were for and 1 abstention was given, and the vaccine management law was adopted There are 11 chapters and 100 articles in vaccine management law, which clearly stipulate vaccine development and registration, vaccine production and batch issuance, vaccine circulation, vaccination, abnormal reaction monitoring and handling, post market management of vaccines, safeguard measures, supervision and management, and legal responsibilities It is the first special law on vaccine management in China since December 1, 2019 After the closing meeting, the general office of the Standing Committee of the National People's Congress held a press conference, attended by Jiao Hong, director of the State Drug Administration, Yuan Lin, director of the drug regulatory department of the State Drug Administration, Yuan Jie, director of the administrative law office of the legal work committee of the Standing Committee of the National People's Congress, and Cui Gang, deputy inspector of the disease prevention and Control Bureau of the National Health Commission What's the difference between vaccines and other drugs? According to Jiao Hong, director of the State Food and drug administration, there are three differences between vaccines and other drugs, which is also one of the starting points for the formulation of vaccine management law First, the vaccine involves public security and national security, Jiao said Therefore, the vaccine law clearly stipulates that the vaccine is a national strategic and public welfare product Second, vaccine is a very effective public health means to prevent and control infectious diseases It is a preventive product for healthy people, especially a large part of the healthy people are infants, which is a very prominent feature Third, vaccine product is a biological product In the production process of biological products, it has complexity This complexity means that vaccine production must be safe, effective and controllable, and there must be more requirements In order to make vaccines safe, effective and accessible, the Party Central Committee and the State Council attach great importance to the special legislation The purpose of legislation is to ensure the safety of vaccines, to ensure effective and safe access, and to ensure public health According to Jiao Hong, the most strict regulator of vaccine management law, vaccine management law is a special law based on the general principles of drug management law and aiming at the characteristics of vaccines This Law clearly proposes that the vaccine should be subject to the most strict supervision, and puts forward special systems and regulations for the whole process of vaccine development, production, circulation and vaccination First, the most strict development management emphasizes the requirements of biosafety control and management of bacterial strains and cell lines in the development process Special management regulations are also made for vaccine clinical trials, which require careful selection of subjects Vaccine clinical trials should be organized and implemented by medical institutions at or above the third level or disease control institutions at or above the provincial level Secondly, strict management of production access should be carried out To engage in vaccine production activities, in addition to meeting the general requirements of the drug administration law, it should also conform to the development planning and industrial policies of the industry, have appropriate scale and capacity reserve, and have systems and facilities to ensure biological safety The legal representative and main person in charge of the production enterprise shall have good credit record, and the personnel in other key positions shall also have corresponding professional background and experience Third, strict process control The vaccine production process is required to meet the approved process and quality control standards continuously Audit and test the whole process of vaccine production and vaccine quality according to regulations After the product is put on the market, it is also necessary to formulate and implement risk management plan, actively carry out post market research, and continuously optimize production process and quality control standards Changes that may affect the safety and effectiveness of vaccines should be fully verified It is also necessary to implement the management of batch issuance for vaccines, and each batch of products should be reviewed and inspected by the batch issuing agency before being put on the market Fourth, strict control of circulation and distribution The vaccine shall be directly supplied to the CDC by the marketing license holder according to the purchase contract The CDC shall supply the vaccine to the vaccination unit according to the regulations The distribution of vaccine shall also follow the management specifications for vaccine storage and transportation The whole process shall meet the specified temperature, cold chain storage and other relevant requirements, and the temperature can be monitored and recorded in real time to ensure the quality of the vaccine Fifthly, severe punishment should be carried out In the vaccine management law, for those who produce and sell fake vaccines, apply for vaccine registration and provide false data, as well as those who violate the relevant quality management standards and other illegal acts, the punishment is far higher than that of ordinary drugs, and it is clear that the punishment should be strictly imposed on the person, the legal representative, main person in charge, directly responsible executives and key positions of the illegal unit and other responsible persons Severe qualification punishment, property punishment and free punishment shall be given For the responsibility of violating the law, the vaccine management law clearly stipulates that "criminal responsibility shall be investigated in accordance with the law." In terms of fines, if the vaccines produced or sold are fake drugs, a fine of not less than 15 times but not more than 50 times the value of the vaccines shall be imposed; if the vaccines produced or sold are inferior drugs, a fine of not less than 10 times but not more than 30 times the value of the vaccines shall be imposed If the value of the goods is less than 500000 yuan, it shall be calculated as 500000 yuan If a vaccine produced or sold is a fake medicine or a vaccine produced or sold is a substandard medicine and the circumstances are serious, the legal representative, the person in charge, etc shall be fined not less than one time but not more than ten times the income of the place, be prohibited from engaging in drug production and marketing activities for life, and be detained by the public security organ for not less than five days but not more than 15 days How to implement the management in the specific management, Yuan Lin, director of the drug regulatory department of the State Drug Administration, introduced: on the first hand, we need to fully implement the responsibilities of all parties The first is to strengthen the implementation of the main responsibility of enterprises The holders of vaccine marketing license are required to be responsible for the quality management of the whole life cycle of the vaccine and the safety, effectiveness and quality controllability of the vaccine Second, implement the territorial responsibilities of local governments at all levels In the vaccine management law, the people's governments of provinces, autonomous regions and municipalities directly under the central government, as well as the local people's governments at or above the county level, have put forward clear division of labor and related requirements Third, implement the responsibilities of all departments According to the vaccine administration law, the drug regulatory department under the State Council is responsible for the supervision and administration of vaccines nationwide, and the health and health department under the State Council is responsible for the supervision and administration of vaccination nationwide The second aspect focuses on strengthening the supervision measures in all aspects One is to implement an electronic vaccine traceability system, which can be traced and verified throughout the whole process The second is to require the vaccine marketing license holders, that is to say, the production enterprises should establish a complete set of production quality management system, use the information and electronic means to record the production and inspection data, and bear its main responsibility, and be responsible for the continuous compliance of the whole production process with the relevant requirements and specifications Third, in the aspect of batch issuance, in order to ensure the quality and safety of all vaccines before they are put on the market, the data should be reviewed batch by batch, including the data of production and inspection At the same time, the sampling inspection should be done before they are put on the market, not the simple inspection, but the data, the whole process of production and inspection, and the records should be reviewed Once quality risks and problems are found in the implementation process of batch issuance, effective measures shall be taken immediately In terms of vaccination, Cui Gang, deputy inspector of the disease prevention and Control Bureau of the national health and Health Commission, introduced that first, the setup of vaccination units has set up necessary conditions, including institutional qualification, hardware conditions and personnel access conditions, all of which have strict requirements Second, the management of vaccines, how to ensure the quality and safety of vaccines in the process of circulation and use, and how to protect the effectiveness of vaccines in the process of transportation and storage, should be carried out in strict accordance with relevant specifications Third, how to operate normally in the process of implementation This is also the highlight of this law During the implementation of vaccination, we summarize the work experience accumulated over many years and improve the process For example, we often say "three checks and seven pairs", that is, how to understand the relevant situation of the recipients during the implementation process, whether they can be vaccinated or not, and the medical staff need to check, such as the effective period of the vaccine, the dose of the vaccine, and the way to vaccinate, which is arm beating , or other parts, standardized by law How to establish a whole process electronic traceability system for vaccines? Yuan Lin introduced that the vaccine management law clearly proposed that the drug regulatory department under the State Council, together with the health department under the State Council, should formulate a unified vaccine traceability standard and corresponding specifications Establish a national vaccine information traceability collaborative platform, integrate vaccine production, circulation, vaccination related information, and finally realize the whole process of vaccine electronic traceability In 2019, the State Drug Administration studied and formulated the guiding opinions on the construction of drug information traceability system, which clearly pointed out that "one thing, one code, and the same code" should be followed, which pointed out the direction for the construction of vaccine traceability system The guiding opinions on the construction of drug information traceability system also specifically stipulates that the national standards and specifications should be established, which is the responsibility of the national regulatory authorities, and that vaccine enterprises should build their own systems and integrate data The main responsible person for the construction of the traceability system is to establish the whole process electronic traceability system for vaccines The national drug regulatory department and the health department establish a collaborative platform to form a complete drug traceability data chain Article 56 of the law on the administration of compensated vaccines stipulates the "compensation system for abnormal reactions in vaccination" Make it clear that the death, serious disability, organ and tissue damage and other damages of the seed recipient occurred during or after the implementation of vaccination belong to the abnormal reaction of vaccination or cannot be excluded, and compensation shall be given The scope of compensation shall be subject to catalog management and dynamically adjusted according to the actual situation At the same time, it is stipulated that the financial department of the people's Government of the province, autonomous region and municipality directly under the central government shall arrange the compensation expenses for vaccination; the compensation expenses for vaccination of non immunization vaccines shall be borne by the relevant vaccine listing license holders The State encourages compensation for the recipients of abnormal vaccination reactions through various forms such as commercial insurance Chapter I General principles of the catalogue of vaccine administration law of the people's Republic of China Chapter II vaccine development and registration Chapter III vaccine production and batch issuance Chapter IV vaccine circulation Chapter V vaccination Chapter VI abnormal reaction monitoring and handling Chapter VII post marketing management Chapter VIII safeguard measures Chapter IX Supervision and management This law is formulated for the purpose of strengthening vaccine management, ensuring vaccine quality and supply, standardizing vaccination, promoting the development of vaccine industry, safeguarding public health and safeguarding public health and safety Article 2 this Law shall be applicable to the research, production, circulation and supervision of vaccination within the territory of the people's Republic of China Where there are no provisions in this law, the drug administration law of the people's Republic of China, the law of the people's Republic of China on the prevention and control of infectious diseases and other laws and administrative regulations shall apply