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The State Food and Drug Administration officially issued the "14th Five-Year Plan" (hereinafter referred to as the "Plan") for the construction of drug regulatory network security and informatization, which clearly proposes to upgrade the "two products and one machine" smart supervision capabilities and improve the integration of government servic.
5 key tasks, including promoting the integration and driving of regulatory data, consolidating the digital base for intelligent drug supervision, and consolidating the comprehensive security capability of network securi.
The construction of drug regulatory informatization is an important part of the national government informatization construction, and an important means to improve the level of drug safety governance and regulatory efficien.
Since the 18th National Congress of the Communist Party of China, China's drug regulatory informatization system has been gradually improved, and the role of informatization in promoting the improvement of regulatory capabilities has continued to play a positive role in the efficient development of regulatory wo.
In order to further implement the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" and the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" and other important documents, promote the construction of drug regulatory informatization, and accelerate the modernization of supervision with informatizati.
process, the State Food and Drug Administration formulated this pl.
The "Plan" adheres to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly and fully implements the spirit of the 19th National Congress of the Communist Party of China, takes the "four strictest" as the fundamental adherence, adheres to the people-centered approach, and promotes the drug regulatory system and supervision Capability modernization is the goal, and informatization leads the modernization of supervisi.
The "Plan" implements the drug supervision concepts of risk governance, responsibility governance, whole-process governance, and smart governance, and proposes the basic principles of systematic thinking, overall coordination, business leadership, data-driven, technology empowerment, integrated innovation, intensive construction, and safety and controllabili.
It aims to further clarify the technical framework and construction tasks of smart drug supervision in the new era, propose a development strategy and construction plan for promoting smart drug supervision, and use cloud computing, big data, "Internet +" and other information technologies to build and optimize the development environment for smart drug supervision , promote the integrated development of information technology and business, continuously promote the innovation and upgrading of drug supervision business, and help the scientific, legal, international and modern drug supervisi.
The "Plan" clearly puts forward the construction goals of China's smart drug supervision during the "14th Five-Year Plan" period: to build a perfect technical framework for smart drug supervision; "One-stop service"; promote the digital management of the whole life cycle of drugs, improve the variety files, establish safety credit files, and improve the level of precise supervision based on big data; improve the drug information traceability system to realize the traceability of key drug varieties; promote the unique identification of medical devices in Linkage applications in the fields of medical care, medical insurance, and pharmaceuticals; 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 and increase public participation in drug safety, Make the people more satisfied and reassured about the quality and safety of medicin.
Through the network security and information construction of drug supervision, the "big platform" will be more fully supported, the "big data" drive will be more intelligent, and the "big system" application will be more comprehensi.
The "Plan" clarifies: implement the drug supervision concepts of risk governance, responsibility governance, whole-process governance, and intelligent governance, adhere to systematic thinking, make full use of the results of regulatory scientific research, innovate regulatory methods and methods, improve regulatory systems and mechanisms, and promote the integration of information technology and business developme.
, let all links of the supervision chain cooperate with each other, the allocation of supervision resources is more reasonable, the response to supervision needs is more rapid, the supervision service is more high-quality and efficient, the supervision system is more accurate and intelligent, the people's sense of acquisition of drug safety is enhanced, and the high-quality development of the drug industry is promot.
Help realize scientific, legal, international and modern drug supervisi.
The "Planning" also proposes 16 specific engineering projects in the form of task colum.
It is reported that the setting of key tasks and task columns adheres to the needs of drug supervision business as the guide, leads the development of smart supervision with informatization, and empowers the innovation and development of supervision business through informatization "new infrastructure", and improves the ability of drug supervision and government servic.
, to ensure the efficient development of drug regulatory business, and to promote the modernization of the drug regulatory system and regulatory capabiliti.
The "Plan" requires that organizational leadership and policy support should be strengthened, the work guarantee system should be improved, the management of informatization projects should be strengthened, and performance evaluation should be implement.
Drug regulatory departments at all levels should strengthen the organization and leadership of drug regulatory informatization work, give full play to the leading role of the network information management department, establish and improve drug regulatory informatization management mechanisms, and jointly promote the work of smart drug supervisi.
5 key tasks, including promoting the integration and driving of regulatory data, consolidating the digital base for intelligent drug supervision, and consolidating the comprehensive security capability of network securi.
The construction of drug regulatory informatization is an important part of the national government informatization construction, and an important means to improve the level of drug safety governance and regulatory efficien.
Since the 18th National Congress of the Communist Party of China, China's drug regulatory informatization system has been gradually improved, and the role of informatization in promoting the improvement of regulatory capabilities has continued to play a positive role in the efficient development of regulatory wo.
In order to further implement the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" and the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" and other important documents, promote the construction of drug regulatory informatization, and accelerate the modernization of supervision with informatizati.
process, the State Food and Drug Administration formulated this pl.
The "Plan" adheres to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly and fully implements the spirit of the 19th National Congress of the Communist Party of China, takes the "four strictest" as the fundamental adherence, adheres to the people-centered approach, and promotes the drug regulatory system and supervision Capability modernization is the goal, and informatization leads the modernization of supervisi.
The "Plan" implements the drug supervision concepts of risk governance, responsibility governance, whole-process governance, and smart governance, and proposes the basic principles of systematic thinking, overall coordination, business leadership, data-driven, technology empowerment, integrated innovation, intensive construction, and safety and controllabili.
It aims to further clarify the technical framework and construction tasks of smart drug supervision in the new era, propose a development strategy and construction plan for promoting smart drug supervision, and use cloud computing, big data, "Internet +" and other information technologies to build and optimize the development environment for smart drug supervision , promote the integrated development of information technology and business, continuously promote the innovation and upgrading of drug supervision business, and help the scientific, legal, international and modern drug supervisi.
The "Plan" clearly puts forward the construction goals of China's smart drug supervision during the "14th Five-Year Plan" period: to build a perfect technical framework for smart drug supervision; "One-stop service"; promote the digital management of the whole life cycle of drugs, improve the variety files, establish safety credit files, and improve the level of precise supervision based on big data; improve the drug information traceability system to realize the traceability of key drug varieties; promote the unique identification of medical devices in Linkage applications in the fields of medical care, medical insurance, and pharmaceuticals; 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 and increase public participation in drug safety, Make the people more satisfied and reassured about the quality and safety of medicin.
Through the network security and information construction of drug supervision, the "big platform" will be more fully supported, the "big data" drive will be more intelligent, and the "big system" application will be more comprehensi.
The "Plan" clarifies: implement the drug supervision concepts of risk governance, responsibility governance, whole-process governance, and intelligent governance, adhere to systematic thinking, make full use of the results of regulatory scientific research, innovate regulatory methods and methods, improve regulatory systems and mechanisms, and promote the integration of information technology and business developme.
, let all links of the supervision chain cooperate with each other, the allocation of supervision resources is more reasonable, the response to supervision needs is more rapid, the supervision service is more high-quality and efficient, the supervision system is more accurate and intelligent, the people's sense of acquisition of drug safety is enhanced, and the high-quality development of the drug industry is promot.
Help realize scientific, legal, international and modern drug supervisi.
The "Planning" also proposes 16 specific engineering projects in the form of task colum.
It is reported that the setting of key tasks and task columns adheres to the needs of drug supervision business as the guide, leads the development of smart supervision with informatization, and empowers the innovation and development of supervision business through informatization "new infrastructure", and improves the ability of drug supervision and government servic.
, to ensure the efficient development of drug regulatory business, and to promote the modernization of the drug regulatory system and regulatory capabiliti.
The "Plan" requires that organizational leadership and policy support should be strengthened, the work guarantee system should be improved, the management of informatization projects should be strengthened, and performance evaluation should be implement.
Drug regulatory departments at all levels should strengthen the organization and leadership of drug regulatory informatization work, give full play to the leading role of the network information management department, establish and improve drug regulatory informatization management mechanisms, and jointly promote the work of smart drug supervisi.
