Original title: State Food and Drug Administration: China will establish a vaccine traceability system to clarify the path
China's vaccine traceability system was implemented on December 1 this year
At the end of June, the 11th meeting of the Standing Committee of the 13th National People's Congress voted and adopted the vaccine management law of the people's Republic of China, and the newly promulgated vaccine management law will go into effect on December 1. At a seminar on the interpretation and implementation of the vaccine management law held recently, how to establish China's vaccine whole process electronic traceability system according to the legal requirements has become the focus of attention.
In fact, as early as 2008, China began to explore the construction of drug information traceability system, but it 'gave up halfway' due to various reasons. The promulgation and implementation of the vaccine management law will accelerate the construction of China's drug electronic traceability system. As a special drug, vaccine will take the first step, and its information traceability system is' ready to come out '.
Vaccine was one of the first batch of pilot drug varieties in China's drug electronic supervision. A relevant expert in the pharmaceutical field said that at present, domestic vaccine manufacturers are using the previous drug electronic supervision code to assign codes to products, but the traceability systems used are different, which also leads to the failure of interconnection of various systems and the formation of a complete vaccine information chain.
"The future vaccine electronic traceability can coexist with multiple codes, but it must not coexist with random codes. The formulation of unified standards and specifications is an important prerequisite." Zhang Yuan, deputy director of the planning and Standards Department of the information center of the State Drug Administration, introduced that in accordance with the requirements of the vaccine management law, the national drug regulatory department has organized and formulated unified standards and specifications related to vaccine traceability in conjunction with the competent health department. The basic data set for vaccine traceability and the basic technical requirements for vaccine traceability data exchange have been completed for public comment, and the expert review has been completed; The two technical documents to be officially released regulate the content and format of vaccine traceability data that should be stored, as well as the format and transmission mode of data exchange documents.
Zhang Yuan said that on the basis of clarifying technical standards and specifications, the construction of vaccine information traceability system will be fully carried out from four levels: vaccine traceability system, provincial disease control agency information system, vaccine traceability collaborative service platform and vaccine traceability supervision system.
According to the requirements of the vaccine administration law, the vaccine marketing license holder shall bear the main responsibility for building a traceability system. " The marketing license holder can build it by himself or adopt the vaccine traceability system provided by a third-party technical institution. " Zhang Yuan said that the vaccine traceability system should meet the general requirements including the whole process traceability data, docking the vaccine traceability collaborative service platform, and having a variety of traceability information collection methods. In terms of specific functional requirements, the vaccine traceability system should be able to maintain the basic information of vaccine marketing license holders, manufacturers and vaccine products, record the packaging specifications, drug identification codes and their corresponding vaccine names and preparation specifications to the collaboration platform, and maintain the whole chain vaccine traceability information.
Experts said that disease prevention and control institutions and vaccination units should truthfully record vaccine circulation and vaccination according to law, and provide traceability information to the national vaccine electronic traceability collaborative platform according to regulations. Combined with the actual situation of information construction of disease control system in China, the information system of provincial disease control institutions will realize this function.
"In the vaccine information traceability system, the information system of provincial disease control institutions shall realize the functions of verifying upstream traceability data, uploading upstream and downstream flow direction and use data." Zhang Yuan introduced that the information system of provincial disease control institutions should request relevant traceability information from upstream enterprises in the vaccine procurement link and feed back and check information to them in the acceptance link; And provide relevant traceability information to downstream institutions, collect the flow direction and use data of downstream institutions, timely update the corresponding status identification of vaccine, and upload the flow direction and use information of vaccine to the collaboration platform.
National and provincial drug regulatory authorities will organize the construction of vaccine traceability collaborative service platform and vaccine traceability supervision system. " The traceability collaborative service platform is the bridge and hub of the vaccine information traceability system, which can connect the traceability information of the whole process of vaccine production, circulation and use. " Zhang Yuan introduced that the main functions of the collaboration platform include distributing basic data of vaccine enterprises and products, providing coding rule filing and management services, providing address resolution services of different traceability systems, etc. After the completion of the vaccine traceability supervision system, it will be mainly used to query production, inventory and flow direction, and provide recall warning, risk warning and other functions.
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Both the United States and the European Union have established a relatively perfect system of laws and regulations, requiring enterprises to implement the traceability subject responsibility through legislation, and realize the serialization of drugs with information technology.
The United States promulgated the drug supply chain security act in 2013, which requires enterprises in the drug supply chain to implement the "one thing, one code" serialization management of prescription drugs step by step, and the drug information is recorded and verified electronically at the time of transaction. The whole process traceability mode is adopted, the enterprise assumes the main responsibility, and independently selects the service provider of commercial information platform in line with laws and regulations to realize drug serialization management.
In 2011, the EU passed the EU anti counterfeiting drug directive, which clearly requires the establishment of a unique identification of "verifiable authenticity" for each box of drugs circulating in the EU, which is used to track drugs in the whole supply chain, prevent counterfeit drugs from entering the legal supply chain and protect the safety of patients. The EU has established a unified serial data exchange system for prescription drugs, allowed multiple coding schemes to be parallel, and entrusted a third party to establish a unified data exchange platform.