The 14th five year plan for the construction of network security and informatization in drug supervision was issued and put forward these objectives
2022-05-16
Optimize and upgrade the national and provincial drug administration cloud platforms, promote the digital management of drugs in the whole life cycle, and improve the intelligent supervision ability of "two products and one device"... The State Drug Administration recently issued the "14th five year plan" for the construction of drug supervision network security and information technology (hereinafter referred to as the "plan"), which is about the construction objectives, key tasks and Safeguard measures have been clarified. The plan points out that looking forward to the 14th five year plan and the long-term goal of 2035, China should realize the great leap forward development from a large pharmaceutical country to a powerful pharmaceutical country, which puts forward higher requirements for the efficiency of drug review and approval and the ability of drug safety risk management. At present, there are still many deficiencies in the informatization construction of drug supervision. The integration and innovation ability of information technology and supervision business needs to be enhanced, the ability of data-driven and knowledge service needs to be improved, the overall construction and operation management of information resources needs to be optimized, and the network and information security need to be further strengthened. The plan puts forward the construction goals of more perfect support of "big platform", more intelligent driving of "big data" and more comprehensive application of "big system". The plan specifies that at the end of the 14th Five Year Plan period, we will build a perfect technical framework for intelligent drug supervision with the goal of supporting drug safety and high-quality development: implement the reform requirements of "release, management and service", optimize the business environment, and realize the "one network" of all government services; Promote the digital management of the whole life cycle of drugs, improve the variety archives, establish safety and credit archives, and improve the level of accurate supervision based on big data; In addition, improve the drug information traceability system to realize the traceability of key drug varieties; Promote the linkage application of the unique identification of medical devices in the fields of medical treatment, medical insurance and medicine; Strengthen the information application integration and mobile construction of cosmetics supervision business; Promote the digital and intelligent transformation and upgrading of the pharmaceutical industry; Build a social co governance system for drug supervision, enhance public participation in drug safety, and make the people more satisfied and assured of drug quality and safety. The plan puts forward five key tasks: upgrading the intelligent supervision ability of "two products and one equipment", improving the integrated service ability of government affairs, promoting the integration and driving of supervision data, building a solid digital base for intelligent supervision of drugs, and consolidating the comprehensive guarantee ability of network security. At the same time, in the form of columns, the plan puts forward the construction of drug supervision capacity, medical device supervision capacity, cosmetics supervision capacity, information traceability system, the improvement of the national adverse drug reaction monitoring system, the construction of information support capacity for the management of specialized supervision teams, the mobile capacity of supervision business system, the improvement project of government service capacity, the construction of national integrated drug intelligent supervision platform 16 key tasks are to improve the construction of national and provincial data centers, further improve the "two products and one device" variety files, create drug safety credit files, build and improve the standard and specification system, upgrade the drug administration cloud resource pool, improve the network security trust system, and improve the security management operation and maintenance center. Among them, in terms of drug regulatory capacity-building, the plan proposes to take the quality supervision of vaccine production process as the breakthrough, and explore the digital management of vaccine production quality, quality risk early warning and emergency disposal mechanism through the research on the data of key links of vaccine production based on the electronization of production and inspection data of vaccine production enterprises, so as to improve the efficiency of drug regulation and risk management ability. In terms of capacity-building of medical device supervision, the plan proposes to strengthen the application of digital supervision of medical devices, fully implement the electronic management of medical device review and approval of the National Bureau, and build a medical device review and approval system covering acceptance, registration, continuation, change and approval. In terms of cosmetics regulatory capacity-building, the plan proposes to continuously build and improve business systems and functions such as registration and filing of cosmetics and new cosmetics raw materials, sampling inspection of cosmetics quality and safety, registration and filing inspection, adverse reaction monitoring, on-site verification, flight inspection and standard preparation and revision management, realize integration, sharing and business collaboration based on the unified application support system, and improve the mobile service and regulatory service capacity of cosmetics. Promote the electronic issuance of cosmetics registration certificates. In terms of the construction of information traceability system, the plan proposes that the National Bureau of health will continue to strengthen the operation and management of the vaccine traceability collaborative service platform and the national vaccine traceability supervision system, and on this basis, promote the construction of drug information traceability system, establish and improve the drug traceability system, expand the construction of drug traceability collaborative service platform and traceability supervision system, and gradually realize the supervision of narcotic drugs, psychotropic drugs, blood products The State shall organize the centralized procurement of key varieties such as selected varieties for traceability supervision. In terms of building drug safety credit files, the plan proposes to speed up the construction of drug safety credit files for drug marketing license holders (manufacturing enterprises) in accordance with the unified national planning and deployment and in combination with the actual situation of the drug industry, and collect information including drug production licenses, daily supervision and inspection results, investigation and punishment of illegal acts, random inspection of drug quality, records of bad behaviors The information related to drug safety risks and credit, such as complaints and reports, shall be announced to the public in accordance with the law and regulations and updated in a timely manner. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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