7 pilot to take the lead in accessing the vaccine traceability collaborative platform

December 12, the General Department of the State Drug Administration and the General Office of the State Health and Health Commission jointly issued the Notice on the Construction of the Vaccine Information Trace System (hereinafter referred to as the Notice), giving a clear timetable for the promotion of the vaccine traceability system.Beijing, Tianjin, Inner Mongolia, Shanghai, Jiangsu, Hainan, Chongqing piloted the first to complete the vaccine information traceability system construction, and by December 31, 2019 to complete the interface with the collaborative platform, by January 31, 2020 to provide the collaborative platform in accordance with the provisions of the province (region, city) vaccine production, circulation and vaccination process traceability information, to meet the vaccine traceability requirements. Other conditional areas are encouraged to participate in the pilot.Areas that have not participated in the pilot shall accelerate the construction of the traceability system in accordance with the above-mentioned notification requirements. By March 31, 2020, a vaccine information traceability system should be built throughout the country to realize the traceability of all vaccines on the market, and ensure that the minimum packaging unit of vaccines can be traceable and verifiable.

a thing one yard, the same code with the"Notice" clearly, the listing license holders bear the main responsibility for the construction of vaccine information traceability system, in accordance with the "one thing, one yard, one code with the pursuit" principle of the establishment of vaccine information traceability system, and with the collaborative platform to connect;Listed licensees can build their own vaccine information traceability systems through third-party technical institutions. The vaccine information traceability system should meet the relevant standards and norms and meet the needs of the public inquiry.The licensed holder of the imported vaccine may entrust the imported vaccine agent to perform the above-mentioned responsibilities.The vaccine distribution unit shall, in accordance with the relevant requirements of vaccine storage and transportation management, provide the relevant retrospective data to the entrusting party in accordance with the contract at the same time as completing the vaccine distribution business.

five companion files have been publishedThe supervision of drug wisdom is the due meaning of carrying out the spirit of the Fourth Plenary Session of the 19th CENTRAL Committee of the Communist Party of China and promoting the modernization of the national governance system and governance ability, which is not only a major theoretical proposition, but also a practical proposition of reform and development.The Vaccine Management Law requires the State Drug Administration, together with the National Health And Health Commission, to develop uniform vaccine traceability standards and norms. At present, the standards required for the construction of the vaccine information traceability system have all been issued and implemented, including the Guidance for the Construction of the Drug Information Trace System, the Requirements for drug traceability code coding, the Basic Technical Requirements for the Drug Trace System, the Basic Data Set for Vaccine Traceability, and the Basic Technical Requirements for Vaccine Traceability Data Exchange.Among them, "Drug Trace System Construction Guide" "Drug Trace Code Code Requirements" "Drug Trace System Basic Technical Requirements" are 3 basic common standards, "Vaccine TraceAbility Basic Data Set" "Vaccine Trace Data Exchange Basic Technical Requirements" 2 standards for vaccine traceability participants put forward traceability information collection, storage, transmission and exchange of specific technical requirements.

three major platforms to build aIn addition, "Pharmaceutical Economics" reporter in the previous few days, "drug traceability platform ecological construction and application seminar" also learned that vaccine manufacturers first need to work together on the platform for traceability code filing, after the record passed, production enterprises into the production process, the vaccine code, the establishment of large, medium and small packaging and the vaccine sales, the vaccine traceability data generated at this stage is uploaded by the manufacturer to the vaccine traceability system, the vaccine traceability system can be self-built by the production enterprise or rented a third-party system, and then transited through the collaborative platform to the provincial disease control system for vaccine sales.Take a class of vaccines, for example, the provincial disease control department after receiving the vaccine, and their own system of vaccine traceability information can be compared, scanned into the database. Vaccine follow-up in the city disease control, district and county disease control and vaccination point circulation information and vaccine use information, unified convergence to the provincial disease control platform, by the provincial disease control platform uploaded to the collaborative platform, through the collaborative platform back to the traceability system. Throughout the data exchange process, all data flows through the collaborative platform, but the collaborative platform retains only document data to meet regulatory needs, and the traceability system retains code-level data for full traceability of the smallest packaging unit.In the interview, the reporter also learned that the State Drug Administration is not only about to launch a vaccine traceability system, is being established in sync with the three major business application platforms of drugs, medical devices, cosmetics. The online implementation of this series of platforms will enable online processing, timely upload of information, timely disposal of problems, recording the entire process of retention.
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the official website of the State Drug Administration)