Illustration of network security and informatization construction of drug supervision "14th Five-Year Plan"

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.

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.

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" 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 entire 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 integration and mobile construction of informatization applications for 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.

The "Plan" clarifies: implement the drug supervision concepts of risk governance, responsibility governance, whole-process governance, and smart 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.

The "Planning" also proposes 16 specific engineering projects in the form of task colum.

The "Planning" 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 appraisal should be implement.