Vaccine safety will be subject to strict supervision. By the end of March next year, an information-based traceability system will be established nationwide

[pharmaceutical network industry trends 】On December 12, the comprehensive Department of the State Food and Drug Administration and the national health and Health Commission jointly issued the notice on the construction of vaccine information traceability system (hereinafter referred to as the notice) It is required that by March 31, 2020, vaccine information traceability system should be established in all parts of the country to realize the traceability of all vaccines on the market and ensure the traceability and verifiability of vaccine small packaging units
According to the notice, Beijing, Tianjin, Inner Mongolia, Shanghai, Jiangsu, Hainan and Chongqing will take the lead in the pilot project, take the lead in completing the construction of vaccine information traceability system, and complete the connection with the collaborative platform by December 31, 2019 By January 31, 2020, the whole process of vaccine production, circulation and vaccination traceability information will be provided to the collaborative platform according to the regulations, reaching the goal of To vaccine traceability requirements At the same time, other regions with conditions shall be encouraged to participate in the pilot, and regions not participating in the pilot shall accelerate the construction of traceability system in accordance with the requirements of this circular In addition, the notice also stressed that the construction of vaccine information traceability system is included in the annual drug safety and health assessment project For those who fail to establish the vaccine information traceability system as required, and the vaccine information traceability system fails to operate effectively, they shall be seriously dealt with in accordance with the vaccine management law and other relevant laws and regulations It is reported that at present, Jiangsu Province has first completed the "vaccine whole process traceability system", realizing the whole process traceability of the transportation, storage, cold chain temperature control, vaccination and other links in the process from entering Jiangsu Province to vaccination to children's body In fact, vaccines are related to people's life and health, public health and safety, and the future quality of life of the country and the nation In recent years, the state has also been trying to strengthen the strict control of all drugs, including vaccines Since 2006, the former State Food and drug administration has started to implement the electronic supervision of drugs, and adopted the "drug electronic supervision code" to supervise the status of drugs in the production and circulation process, but this method was stopped in 2016 due to data security and other issues By 2018, the guiding opinions on the construction of drug information traceability system issued by the State Food and Drug Administration described the "drug information traceability system" as an organic whole that all participants in drug traceability work track and trace all links of drug production, circulation and use through information-based means Recently, the construction of vaccine information traceability system is a subdivision and upgrade of drug traceability system In order to achieve the traceability of all drugs, including vaccines, related technical work has been carried out for a long time In March next year, the State Food and Drug Administration will launch the first unified vaccine traceability and collaborative service platform in China All 46 domestic vaccine manufacturers' product flow information and vaccination information of disease control departments will be logged on the platform "According to the regulatory needs, collect and collect industry-specific data, rationalize the channels of data resource aggregation, open up the information islands of data departments of the State Administration and directly affiliated units, realize the timely data exchange between the national and provincial data departments, and establish the three business application platforms of drugs, medical devices and cosmetics that are collaborative and effective," said the head of relevant national departments In the future, after the vaccine information traceability system has been established all over the country, the information technology will be better used to ensure the quality of vaccine development and production In order to help vaccine production to be more safe and reliable, realize the scale and intensification of vaccine production, the pharmaceutical enterprises should continuously strengthen the supervision of production process and pharmaceutical equipment, put an end to quality problems, and strive to ensure that the data of vaccine and other drugs in the production process and inspection process are true, complete, reliable and traceable!