Recently, the General Department of the State Administration of Drug Administration and the General Office of the National Health and Health Commission jointly issued the "Notice on the Construction of a Vaccine Information Traceability System" (hereinafter referred to as the "Notice"), calling for the active promotion of the establishment of coverage vaccine production, distribution and prevention The information-based traceability system of the entire vaccination process can realize the traceability of the entire vaccine process, so that the source can be traced, the traceability can be traced, and the responsibilities can be investigated. The level and efficiency of vaccine supervision are improved, and the vaccine quality and safety are effectively guaranteed.
According to reports, Beijing, Tianjin, Inner Mongolia, Shanghai, Jiangsu, Hainan, and Chongqing will be piloted first to complete the construction of vaccine information traceability system, and complete the connection with the collaborative platform before December 31, 2019, before January 31, 2020 Provide the collaborative platform with traceability information for the entire process of vaccine production, distribution and vaccination in the province (region, city) in accordance with regulations, and meet the vaccine traceability requirements. The "Notice" requires that before March 31, 2020, vaccine information traceability systems should be established throughout the country to achieve traceability of all marketed vaccines and ensure that the smallest packaging unit of the vaccine is traceable and verifiable.
Regarding the construction of vaccine information traceability system, the "Notice" put forward clear requirements: to establish uniform traceability standards and norms. At present, all five standards required for the construction of vaccine information traceability system have been released and implemented; a collaborative vaccine traceability service platform and a supervision system have been established. The State Drug Administration and the provincial drug regulatory agencies have established national and provincial vaccine informatization retrospective supervision systems, collecting data according to regulatory needs, monitoring vaccine flow, and giving full play to retrospective information in daily supervision, risk prevention and control, product recalls, and emergency response. Role in regulatory work such as treatment; establishment of provincial immunization planning information system. This system verifies the information of vaccine purchase and storage in the province, truthfully records the traceability information of the province's vaccine circulation, inventory, and vaccination according to law, and provides the traceability information to the collaborative platform according to standards; establishes a vaccine information traceability system. The holder of the marketing authorization bears the main responsibility for the construction of the vaccine information traceability system, and establishes a vaccine information traceability system based on the principle of "one object, one code, and the same code for tracking", and is linked with the collaborative platform. It is necessary to code the produced vaccines, provide traceability data on the production and circulation of packaging units at all levels of the vaccine, and to query the traceability information of the vaccine. The marketing authorization holder can build the vaccine information traceability system by itself or through a third-party technical institution; social parties provide technical services. Information technology enterprises, industry organizations and other units can serve as third-party technical institutions to provide professional services for vaccine information traceability. Relevant code-issuing organizations should have clear coding rules, and assist holders of drug marketing authorization to record their basic information, coding rules, drug identification and other related information with the collaborative platform to ensure the uniqueness and accuracy of drug traceability codes. (Reporter Yang Mengfan)
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