"14th Five-Year Plan" for Drug Regulatory Network Security and Informatization Construction

On May 11, the State Food and Drug Administration issued the "14th Five-Year Plan for Drug Regulatory Network Security and Informatization Constructio.
The plan mentioned that the construction of drug supervision informatization is an important part of the national government affairs informatization construction, and an important means to improve the level of drug safety governance and supervision 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 promote the information construction of drug supervision and accelerate the process of modernization of supervision with information The "14th Five-Year Plan" and other documents to promote the national government informatization plan, formulate this pl.
The original text is as follows:Current Situation and Situation (1) Construction Effectiveness During the "13th Five-Year Plan" period, drug regulatory authorities at all levels earnestly implemented the spirit of the 19th National Congress of the Communist Party of China, and adhered to the "four strictest" requirements of General Secretary Xi Jinping and insisted on putting the people fir.
Center, adhere to the new development concept, deepen the reform of "decentralization, management and service", and strengthen the layout of smart supervisi.
In particular, since the release of the Action Plan of the State Drug Administration on Accelerating the Promotion of Smart Drug Supervision, drug regulatory authorities at all levels have actively promoted various construction work in accordance with the overall design blueprint for smart drug supervision, and the construction of an information-based infrastructure to support the environment has been basically complet.
Breakthrough progress has been made in the construction of two-level data centers and various regulatory business sectors, the drug regulatory informatization system has been basically established, and the drug regulatory efficiency has been steadily improved, laying a solid foundation for further opening up a new situation of drug regulatory informatization during the "14th Five-Year Plan" peri.

Establish a unified standard and standard system The State Drug Administration (hereinafter referred to as the "National Bureau") adheres to the business needs-oriented, and publishes the overall framework of the drug regulatory information standard system, covering 7 sub-systems and 25 secondary categories , and issued more than 20 informatization standards such as drug traceability and unique identification of medical devices, effectively guiding the informatization construction work in related fiel.
Improve the specialization and synergy of government services, actively integrate the application system, sort out the catalogue of government services, promote the establishment and improvement of applications such as electronic certificates, initially establish the "Internet + government services" system framework for drug supervision, and launch the national bureau government service platfo.
Simultaneously build a national drug smart supervision platform, provide the public and supervisors with a unified entry for online handling and supervision work, and improve the overall capacity of the national bureau for government servic.
Strengthen data resource sharing and big data applicati.
Fully implement the national big data strategic plan, strengthen the management and application of drug regulatory data, build a drug regulatory data sharing platform, and effectively gather national drug regulatory data resources to achieve national bureau and provincial cooperati.
data interconnection between offic.
Explore and improve data applications such as drug variety files and medical device unique identifiers to provide strong data support for regulatory busine.
Promote the overall deployment and upgrade of infrastructure and cloud-based transformation The National Bureau has completed the first phase of the construction of the drug regulatory cloud, forming a "one cloud with multiple pools" structure, realizing flexible scheduling and unified management of cloud resources, and completing security reinforcement and migration of multiple business syste.

clo.

Most provincial bureaus have built provincial-level drug administration clouds through self-built or leased methods according to business nee.

Improve network security protection and information security construction The National Bureau actively builds a security management and operation platform, and builds and improves the security trust system through various technical means, and builds a unified service management model for large operation and maintenance and large securi.

The provincial bureaus actively carried out the construction of network security and other supporting facilities, and the security guarantee capability was significantly improv.

(2) Development situation During the "13th Five-Year Plan" period, China's drug safety supervision system and mechanism have been gradually optimized, the reform of the review and approval system has been continuously deepened, the regulatory standard system has been continuously improved, and the innovation capability and service level have been continuously enhanc.

Completed the formulation and revision of a series of laws and regulations and rules and regulations centered on the "Two Laws and Two Regulations" ("Drug Administration Law", "Vaccine Administration Law", "Medical Device Supervision and Administration Regulations", "Cosmetics Supervision and Administration Regulations.

The "four beams and eight pillars" of the drug regulatory system in the new e.

Smart supervision and supervision science have developed rapidly, and their technical support capabilities have been continuously enhanc.

The establishment of a new regulatory system, the implementation of new regulatory laws and regulations, and the release and implementation of important documents such as the "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" have put forward higher requirements for informatization, and information is urgently need.

The deep integration of technology and regulatory business supports the efficient development of regulatory wo.

With the rapid development of biomedical technology and information technology, new technologies such as genetic technology, nanotechnology, 3D printing, big data, artificial intelligence, industrial Internet, and blockchain have brought major changes to the pharmaceutical industry, and also brought significant changes to the pharmaceutical indust.

Production and circulation have had a profound impa.

In the face of new technologies, new formats, new risks and new challenges, drug regulatory authorities urgently need to make full use of information technology and use information chains to link industrial chains, benefit chains, risk chains, and responsibility chains to improve the predictability and targeting of supervisi.

, timeliness, to achieve drug life cycle risk manageme.

Looking forward to the "14th Five-Year Plan" and the long-term goals of 2035, China will realize the leap-forward development from a big pharmaceutical country to a strong pharmaceutical country, which puts forward higher requirements for drug review and approval efficiency and drug safety risk management capabiliti.

At present, there are still many deficiencies in the construction of drug regulatory informatizati.

The integration and innovation capabilities of information technology and regulatory business need to be enhanced, the data-driven and knowledge service capabilities need to be improved, the overall construction of information resources and operation management need to be optimized, and network and information security guarantees still need to be improv.

need to be further strengthen.

Entering the "14th Five-Year Plan" period, the construction of drug supervision informatization should closely focus on the key work of drug supervision, adhere to problem orientation and goal orientation, further promote the in-depth integration of technological innovation and application with the improvement of drug supervision capabilities, enhance comprehensive supervision efficiency, and improve government service capabiliti.

, making information technology a key support for promoting the modernization of the drug regulatory system and regulatory capabiliti.

General requirements (1) Guiding ideology Adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly and comprehensively implement the spirit of the 19th National Congress of the Communist Party of China, take the "four strictest" as the fundamental adherence, adhere to the people-centered, Promote the modernization of the drug regulatory system and regulatory capacity as the goal, and lead the modernization of regulation with informatizati.

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.

Links cooperate with each other, the allocation of regulatory resources is more reasonable, the response to regulatory needs is faster, the regulatory services are more high-quality and efficient, the regulatory system is more accurate and intelligent, the people's sense of acquisition of drug safety is enhanced, the high-quality development of the drug industry is promoted, and the scientific drug supervision is realiz.

, the rule of law, internationalization and modernizati.

(2) Basic principles Systematic thinking, overall planning and coordinati.

Accurately grasp the development direction and work priorities of drug supervision in the new era, use systematic thinking to make a comprehensive layout, focus on key pain points, blocking points, and difficulties, highlight pertinence and operability, and follow the blueprint of smart supervision planning to strengthen cross-regional, cross-border Efficient coordination and linkage across levels and departments to coordinate the promotion of informatization constructi.

Business-led, data-driv.

Adhere to the regulatory business as the center, take the regulatory needs as the guide, correctly grasp the relationship between regulatory services and technical support, drive the reform and upgrade of smart regulation with digital transformation, break the information silos, strengthen data sharing and openness, and build a new model of digital regulation for the full life cycle of drugs , to improve the supervision and management capabilities of the regulatory authorities and the level of government servic.

Technology empowerment, integration and innovati.

Give full play to the role of information technology in interim and ex post supervision, and through business innovation, management innovation, and system innovation, promote the integration and innovation of supervision subjects, elements of supervision and information technology, reduce supervision costs, improve supervision efficiency, and expand the breadth of drug supervision and depth, and promote the modernization of the drug regulatory system and regulatory capaci.

Intensive construction, safe and controllab.

Reasonably coordinate various information construction resources, accelerate the construction of a unified infrastructure cloud platform and support platform, improve the unified operation and maintenance guarantee system, and avoid scattered investment and repeated constructi.

Adhere to the equal emphasis on network security and innovation and development, establish and improve the security protection system of key information infrastructure, and make every effort to ensure network and information securi.

(3) Construction goals At the end of the "14th Five-Year Plan" period, with the goal of supporting drug safety and high-quality development, build a complete technical framework for smart drug supervision; implement the reform requirements of "decentralization, regulation and service", optimize the business environment, and realize all government servic.

"One-stop handling" of matters; 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 uniqueness of medical devices The linkage application of logos in the fields of medical treatment, medical insurance and medicine; strengthen the integration and mobile construction of information application 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 to make the people more satisfied and assured of the quality and safety of medicin.

The "big platform" support is more comple.

Upgrade the e-government internal and external networks, optimize and upgrade the national and provincial drug administration cloud platforms, expand cloud resources, enhance cloud computing power, and comprehensively improve the comprehensive service capabilities of cloud platforms; realize the intensive construction and management of information-based basic resources, improve Informatization security protection capability and operation, maintenance and management efficiency; optimize and improve the two-level application structure of the national bureau and provincial bureau, and realize the integration of national and provincial smart supervision platforms; improve and perfect the informatization standard system, network security system and application support syst.

Gradually realize the integrated and coordinated "big platform" for intelligent drug supervision with the information standard system as the guide, the network security system as the guarantee, and the application support system as the li.

"Big Data" drives more intelligen.

Improve the integrated construction of national and provincial data centers; promote the digital management of the full life cycle of drugs, improve variety files, build credit files, and achieve full coverage of listed drug varieties, drug marketing license holders, and drug production enterprises; improve drug production Supervise big data analysis applications and service capabilities, improve data resource catalogs, enrich data resources, and provide data exchange and sharing services for cross-level, cross-regional, and cross-departmental business collaboration; establish business-led and data-driven early warning models for drug safety risk management , to improve the accuracy and effectiveness of supervisi.

Deepen the sharing and opening of regulatory data resources, improve data collection, sharing and financing, risk research and judgment, and decision-making support capabilities, and promote regulatory and industrial digital upgrad.

The "big system" application is more comprehensi.

Comprehensively promote the electronic management of multiple business fields such as administrative approval, supervision and inspection, retrospective supervision, inspection and testing, government services, emergency management, risk analysis and credit management, strengthen the investigation of potential drug safety hazards, and improve the "two products and one machine" smart supervision To improve the service level for supervisors and the general public; combine the characteristics of the “two products and one machine” supervision business to promote the construction of a standardized, digital, and networked smart supervision platform for the entire supervision process, and build a unified standard, overall linkage, and deep integrati.

National integrated supervision "big syste.

Key tasks (1) Upgrade the smart supervision capability of "two products and one machine" Guided by business needs, the national and provincial drug regulatory authorities will jointly build a coordinated and efficient integrated drug regulatory business application system in accordance with their powers and ste.

The national bureau is based on the power business of the national bureau and the cross-provincial collaborative business, and the provincial bureaus optimize the regulatory application structure based on the power at the same level, and gradually form a national and provincial regulatory business application platform with flexible mechanism, business coordination, and data sharing to achieve cross-level supervisi.

Business collaboration and linkage between syste.

Strengthen the construction of drug supervision capabilities, build a modular drug business application system, build a smart supervision platform covering key business areas such as approval and filing, daily supervision, strengthen drug supervision business collaboration, and promote drug registration and production supervision data sharing and application, Continuously improve post-market supervisi.

Actively explore the integrated application of information technology and drug supervision, and use new supervision methods such as digitalization, perception, and mobile to improve the efficiency of drug supervisi.

Task Column 1 Drug Supervision Capability Building Deeply integrate drug approval and filing and information collection businesses, continuously improve the construction of drug business application systems, and realize the integration of drug approval filing, production licenses, annual reports, production supervision inspections, and collection of administrative punishment informati.

One-stop" filling, supervision and inqui.

Carry out the functional transformation of the drug approval and filing module, realize the online electronic declaration of drug registration and other approval matters and the electronic certification of approval documents, and promote the collection and application of electronic licens.

Continue to promote the construction and improvement of the inspection and testing business system and the aggregation and utilization of inspection and testing da.

Taking the quality supervision of the vaccine production process as a breakthrough, on the basis of the electronic production and inspection data of vaccine production enterprises, through the research on the data of key links of vaccine production, explore the digital management of vaccine production quality, quality risk early warning and emergency response mechanism, improve the Drug regulatory work efficiency and risk management capabiliti.

Strengthening the construction of medical device supervision capacity In accordance with the basic principles of risk management, whole-process control, scientific supervision, and social co-governance, promote the electronic management of the whole process of medical device review and approval by the State Administration, strengthen the digital construction of post-market supervision, and increase the supervision of medical devic.

Data sharing and application, and gradually build a medical device supervision information system of "full chain digital supervision + all-round intelligent applicatio.

Task Column 2 Medical Device Supervision Capacity Building Strengthen the application of digital supervision of medical devices, fully implement the electronic management of medical device review and approval by the State Administration, and build a medical device review and approval system that covers acceptance, registration, renewal, change, and approv.

Strengthen the construction of medical device supervision and inspection, inspection and testing, adverse event monitoring, online transaction monitoring and other systems, promote electronic and intelligent post-market supervision, and support intelligent and precise supervision of medical devic.

Improve the medical device unique identification database management information system, continue to promote data reporting and sharing, and promote the linkage application of medical device unique identification in the fields of medical care, medical insurance, and medici.

Promote the issuance, management and application of electronic certificates for medical device registration certificat.

Carry out research and application of medical device regulatory risk analysis models, and improve the ability to intelligently identify and warn of medical device safety ris.

Exploring the application demonstration of intelligent supervision of medical devices throughout the life cycle based on the unique identification of medical devic.

Strengthen the construction of cosmetics supervision capacity Strengthen the platform, intensive and service-oriented construction of cosmetics supervision information system, build a cosmetics application support system with unified user management, unified basic information resource management, and unified business collaborative management, gradually integrate the system, and strengthen cosmetics registration Business collaboration and data sharing for filing and post-listing supervisi.

Provincial bureaus strengthen the construction of business systems and databases such as cosmetics production licenses, daily supervision, and credit fil.

Task Column 3 Cosmetics Supervision Capacity Building Continue to build and improve the registration and filing of cosmetics and new cosmetic raw materials, cosmetic quality and safety sampling inspection, registration and filing inspection, adverse reaction monitoring, on-site inspection, unannounced inspection and standard formulation and revision management and other business systems and functions, based on unified The application support system realizes integration, sharing and business collaboration, and improves the mobile service and supervision service capabilities of cosmeti.

Promote the issuance of electronic licenses for cosmetic registration certificat.

Strengthen the aggregation, sharing and application of cosmetics supervision data, carry out research and construction in the fields of cosmetics enterprise quantitative classification, variety files, risk analysis and early warning, network monitoring, e.

, to improve the digital and intelligent level of cosmetics supervisi.

Carry out information-based traceability capacity building Strengthen the construction of the information-based traceability system, the national bureau has established and improved the drug traceability collaborative service platform and the drug information-based traceability supervision system; the provincial bureaus will build their province's drug information-based traceability supervision system according to regulatory nee.

Play the role of traceability data in supervision work and provide data support for supervision decision-maki.

All provincial bureaus should implement their territorial supervision responsibilities, promote the construction of provincial drug information traceability supervision system, guide and urge marketing license holders to carry out traceability system construction, and explore the construction of information traceability system for medical devices, Chinese medicine pieces, e.

Task Box 4 Construction of an information-based traceability system The National Bureau continues to strengthen the operation and management of the vaccine traceability collaborative service platform and the national vaccine traceability supervision system, and on this basis, promotes the construction of a drug information-based traceability system, establishes and improves the drug traceability system, and expands the construction of drug traceabili.

Collaborate with the service platform and the traceability supervision system to gradually realize the traceability supervision of key varieties such as narcotic drugs, psychotropic drugs, blood products, and the varieties selected for centralized procurement by national organizatio.

Through the drug traceability collaborative service platform, the traceability information of drug production, circulation, use and other links can be integrated to realize the interconnection of traceability informati.

Further improve the drug information traceability supervision system, carry out automatic collection and analysis of traceability data, provide data support for regulatory decision-making, and give full play to the role of traceability big data in daily supervision, risk prevention and control, product recall, emergency response, e.

Supervision precision level and full governance capabili.

Strengthen the construction of risk management capabilities Carry out comprehensive risk management for "two products and one machine", use information technology to optimize the risk governance structure, strengthen the risk management capabilities and the whole process control capabilities of drug regulatory authorities, and gradually realize the process from result governance to process governance, The transition from coping governance to preventive governance and from passive governance to active governan.

Build a unified and complete "two products and one device" adverse reaction (event) monitoring information system, improve the ability of adverse reaction monitoring and evaluation at all levels, build a national integrated pharmacovigilance system, medical device adverse event monitoring system and cosmetic adverse reaction monitoring system, Form a cross-regional and cross-departmental risk early warning and coordinated disposal mechani.

Task Box 5 Improve the national adverse drug reaction monitoring system Relying on the "Drug Administration Cloud" to strengthen the basic support environment, transform and implement the electronic transmission data standard for individual safety reports of the International Association for the Harmonization of Drug Registration for Human Use, and establish online reports, gateway transmissions, e.

Reporting channels, explore the application of technologies and methods such as big data and artificial intelligence, realize data sharing and feedback, risk early warning and identification and other functions, promote the construction of the national cosmetic adverse reaction monitoring information system, and improve the report collection, information retrieval, and statistics of the monitoring information syst.

Analysis and other functions to establish a convenient reporting, easy-to-use and compatible national adverse drug reaction monitoring syst.

Improve the management of professional supervision team management informatization support capacity to give full play to the supporting role of information technology in the management of professional supervision team, realize intelligent management and convenient services, and further strengthen the construction and development of supervision professional talent team and licensed pharmacist te.

manageme.

Build a unified national inspector information management platform to achieve unified management of national inspectors; upgrade the licensed pharmacist registration management system, continuously improve the efficiency of administrative approval, and build a full-process management service system for licensed pharmacis.

Promote the sharing and application of data on the supervised professional talent team and the licensed pharmacist team, improve the management level of the professional talent team, and give full play to the social service role of the supervised professional talents and licensed pharmacis.

Task Column 6 Supervision Professional Team Management Informatization Support Capability Building The National Bureau builds a unified national inspector information management platform, connects with the provincial bureau systems through data interfaces, summarizes data resources such as the information database of all varieties of inspectors in each provincial bureau, and provides information to personn.

Unified management and application of information to achieve unified dispatch and collaborative sharing of inspectors across the count.

Further upgrade the licensed pharmacist registration management system, build a full-process and full-chain management service system for licensed pharmacists, strengthen the sharing and application of licensed pharmacist management data, and give full play to the role of licensed pharmacists in drug management, prescription review, and rational drug use guidan.

Develop the electronic file management function of licensed pharmacists, and fully realize the "one-stop service" and "cross-province handling" of related business.

Promote the mobile construction of application systems Make full use of the advantages of the mobile Internet, carry out the mobile transformation of the supervision business system as needed, and innovate the development of mobile applications in the field of supervision business and public servic.

Provide a variety of convenient service channels for enterprises and the publ.

Task Column 7 Mobility capacity building of regulatory business system With the help of mobile Internet technology, through APP, public account and small programs, e.

, promote the innovation of regulatory business and regulatory service methods, and realize the realization of national, provincial, municipal and county drug regulatory authorities at all leve.

Synergistic development in the supervision of business mobile interconnecti.

Continue to promote the construction of key mobile applications such as "China Drug Supervision" and "Cosmetics Supervision"; encourage drug regulatory authorities at all levels to innovate service content according to actual application scenarios, improve service breadth, and gradually build a comprehensive and multi-dimensional mobile Internet service for drug supervisi.

patte.

Improve the innovation ability of technology business integration and actively explore the application potential of new technologies such as big data, artificial intelligence, blockchain, Internet of Things, and privacy computing in various scenarios such as review and approval, regulatory inspection, law enforcement evidence collection, and full-chain traceabili.

In order to meet the new needs of innovative supervision such as full life cycle supervision, digital supervision, mobile supervision, online and offline supervision, and full-time dynamic supervisi.

Strengthen the "network management network", strengthen the supervision of new industries, new formats and new models of production and operation of "two products and one machine" represented by the platform economy, and explore a comprehensive system integrating investigation, evidence collection, handover, feedback, credit, and publici.

Process network supervision and management, effectively analyze and identify illegal behaviors and potential risks, and improve the pertinence, timeliness and effectiveness of supervision wo.

Taking the innovative application of information technology as the starting point, promote data integration and improve data services, promote the formation of joint forces between regulatory authorities and pharmaceutical companies in the field of informatization, promote the digital transformation and upgrading of the pharmaceutical industry, and urge pharmaceutical companies to implement the main body of quality management in the entire life cycle of drugs responsibility, and comprehensively promote the simultaneous improvement of regulatory capacity and industrial developme.

(2) Improve the service capability of integrated government affairs Further strengthen the construction of government affairs services, deepen the depth and breadth of "decentralization and management services", build an integrated government affairs service platform for drug supervision, realize the online closed-loop handling of all government affairs service matters, and improve the standardization of government affairs services , network lev.

Strengthen the construction of government website service capacity Further strengthen the comprehensive service capacity of the government website of the National Bureau, establish and improve the development and construction, operation and maintenance management and scientific service mechanism of the government website, and further promote the convenience service of the government websi.

Actively adapt to the development and changes of the Internet, and effectively promote the establishment of a website that is convenient and beneficial to the people; scientific classification and visual interpretation of the released information; Provide personalized, convenient and intelligent servic.

Gradually build the government website into a more comprehensive platform for public disclosure of government affairs, a more authoritative platform for policy release interpretation and public opinion guidance, and a more timely response to concerns and convenient service platfo.

Strengthen the construction of government service platform and promote the standardized management of government service matte.

In accordance with the principle of "no service leakage, full coverage of standards", based on the list of responsibilities for drug supervision, implement standardized list management of government service matters, standardize departmental work procedures and discretionary standards, and promote the realization of handling guidelines, application materials, and processing time limi.

It is unified with the standards of the approval process, and provides guidance for enterprises and the public to handle affai.

Help optimize the business process of matters, streamline handling materials, and shorten the handling time limit to achieve stronger supervision, simpler handling, and better servi.

Strengthen the capacity building of government service platfor.

Under the overall planning of the National Bureau, an integrated online government service system for the public shall be built and improved, and the development of online services in the direction of intelligence, precision, initiative and refinement shall be promot.

The vertical management system planned and constructed by the National Bureau, in accordance with the requirements and mechanisms of system docking specifications, realizes mutual trust and mutual recognition of identity, business collaboration and data exchange with local government service platfor.

For business systems with no special requirements, each provincial bureau relies on the provincial government service platform to carry out overall planning and construction of the business application system at the same lev.

Task Column 8 Government Service Capability Improvement Project Upgrade the technical framework of the government service platform of the State Administration, establish an integrated basic service support environment with complete functions, and strengthen the building of the comprehensive application support capacity for the integration of government servic.

Optimize and expand the construction of online service halls, strengthen the depth and breadth of business system integration, and improve the service capabilities of "viewing, checking, handling, asking, and evaluatin.

Explore an integrated intelligent customer service system to achieve personalized service for government affai.

Actively promote the extension of the government service platform to the mobile terminal, and make full use of the characteristics of the mobile terminal to promote the integration of business models and the innovation of application scenari.

Promote the refined and standardized management of service matters, and realize the issuance and shared application of "two products and one machine" electronic licens.

Promote simplified administration and convenience for the people, and explore the development of intelligent services such as "automatic service" and "unmanned servic.

Promote the construction of an integrated intelligent supervision platform On the basis of the existing national drug intelligent supervision platform construction, further optimize and upgrade, support cross-provincial business collaboration and resource sharing, and strengthen overall planning and integrati.

Carry out the construction of a national integrated drug intelligent supervision platform, build an integrated comprehensive online supervision platform at all levels with the national "Internet + supervision" system as the main hub, and promote the integration of supervision matters, data support, and business collaborati.

, to achieve "network communication", "data communication" and "business communication", better support digital supervision, credit supervision, key supervision and other work, and promote the innovation of supervision metho.

Task Column 9 Construction of a National Integrated Drug Smart Supervision Platform The State Administration guides and regulates the construction of a national integrated drug smart supervision platfo.

Based on the functional framework of the established smart supervision platform, upgrade and improve the unified portal for smart supervision and the unified certification center, build a unified comprehensive portal for supervisors, establish an integrated office portal for the relevant regulatory business systems of the national bureau, and gradually build a national drug regulatory business collaboration cent.

Organize provincial bureaus to promote the construction and transformation of provincial-level smart supervision platforms, data centers and business systems, realize the connection between business systems at all levels and the smart supervision platform at the same level, and then realize the integration and docking of the provincial-level smart supervision platform and the national smart supervision platfo.

Strengthen data sharing and business collaboration services, and build a two-level smart supervision platform collaboration syst.

(3) Promote the integration and driving of regulatory data Promote the digital management of the whole life cycle, and explore a new type of "data-driven" supervisi.

Promote the aggregation, sharing, governance and application of "two products and one device" regulatory data, strengthen the analysis and mining of big data for the supervision of drugs, medical devices and cosmetics, and improve the management capability and application level of regulatory data resourc.

Promoting the aggregation and sharing of data resources Focusing on the overall goal of building an integrated management system for national drug regulatory data resources, improve the overall layout of national and provincial data centers, establish and improve an authoritative and efficient sharing and coordination mechanism for drug regulatory data, and comprehensively improve national and provincial data cente.

The level of data aggregation and sharing in two-tier data cente.

Improve the data service capabilities of national and provincial drug regulatory data centers, focusing on the role of "public entrance" for data services, "public channels" for data exchange, and "data brains" for comprehensive analys.

Further expand the scope of data sharing and data services of national and provincial data centers, and coordinate and promote the co-construction and sharing of social data with public service agencies, related enterprises, and third-party platfor.

Task Column 10 Improve the construction of national and provincial data centers Build an integrated management system for national drug regulatory data resources, and improve the construction of national and provincial data cente.

Strengthen the construction of the national bureau data center, focus on data aggregation and integration, data exchange and sharing, and data fusion and application, build a national drug regulatory data resource pool with comprehensive data aggregation and extensive application services, and provide comprehensive, professional and Authoritative data servi.

Strengthen the construction of provincial data centers, realize the aggregation and integration of drug regulatory data resources within the administrative region, strengthen data quality management, meet the requirements of data governance, data exchange, data sharing, business collaboration, e.

, and create a provincial drug regulatory data resource po.

The provincial regulatory authorities provide accurate and convenient data servic.

Strengthen the hierarchical management of data resource catalo.

The National Bureau of Drug Regulatory Data Resource Catalog is refined and sorted out by the National Bureau Data Center according to the drug regulatory business, and is designed and compiled in combination with the actual database resources of the National Bureau Data Center; the provincial bureau data resource catalog is compiled by the responsible department of the provincial bureau and submitted to the national bure.

Bureau Data Center Summa.

Improve the integration and governance of data resources Make full use of big data concepts, technologies and resources, strengthen overall design, and innovate supervision metho.

National and provincial drug supervision departments respectively promote the "two products and one machine" variety files and drug safety credit files according to their powe.

Construction, comprehensively summarize drug supervision data, industry data and Internet data, e.

, establish a panoramic image of enterprises through data integration and association, grasp the situation of market players in a timely manner, classify and classify according to safety risks, and scientifically allocate supervision resourc.

Task Column 11 Further improve the “two products and one machine” variety files Drug variety files are unified by the National Bureau, and each relevant unit collects various data information from the drug variety files according to their duties, so that the electronic result data involved in the drug variety files should be collect.

Finally, the full coverage of the listed drug varieties will be realiz.

The collection scope of drug variety files includes: drug registration application acceptance, safety-related reports during clinical trials, certification documents for review, verification, inspection, and approval, and related appendices for approval (drug production process, quality standards, instructions and labels), As well as the approval, filing, reporting, adverse reaction monitoring and other information of post-marketing changes of dru.

Referring to the construction mode of drug variety archives, promote the construction of medical device and cosmetic varieties archives in accordance with the law, strengthen the "one product, one file" management of product varieties, and realize the full life cycle management of produc.

The national bureau and the provincial bureaus will work together to build a national drug safety credit file management system, and coordinate the promotion of the national and provincial level linkages for the construction of drug safety credit files for marketing license holders (manufacturing enterprise.

Task Column 12 Create a drug safety credit file According to the unified national planning and deployment, combined with the actual situation of the pharmaceutical industry, accelerate the construction of drug marketing authorization holders (manufacturing enterprises) drug safety credit files, and collect information including drug production licenses, daily supervision and inspection results , investigation and punishment of illegal acts, drug quality random inspections, bad behavior records, complaints and reports and other related drug safety risks and credit-related information, which are announced to the public in accordance with laws and regulations and updated in a timely mann.

Through the analysis of drug safety credit files, it can effectively identify the supervision objects that fail to pass the inspection, have defects in the inspection, fail to implement the main responsibility for traceability and have bad credit records, increase the frequency of supervision and inspection in a targeted manner, and effectively support the supervision and inspection of the supervision department joint punishme.

Referring to the construction mode of drug variety files for drug marketing license holders (manufacturing enterprises), according to the division of responsibilities, promote the construction of drug safety credit files for drug distribution enterprises, drug non-clinical safety evaluation research institutions, drug clinical trial institutions and medical institutio.

, promote the construction of safety credit files for medical devices and cosmetics, strengthen the management of "one enterprise and one file", and realize the whole process and whole link management from the laboratory to the end us.

Improve the application level of data resources Research and explore key common technologies and applications based on regulatory big data, and deeply mine the application value of data through data analysis, so that regulatory decisions can be based on data and evidence, and digital technology means to improve the precision of supervision lev.

In accordance with the reform requirements of “delegating power, delegating power, delegating power and improving services” in the field of drug supervision, improve data sharing, exchange, analysis and application capabilities, strengthen the development and utilization of government regulatory data, industry data, enterprise data and third-party platform data, and further realize “data travels more and more, the masses Run less erran.

" Establish a business-led and data-driven drug safety risk management model, strengthen the construction of drug regulatory big data application risk analysis and network monitoring and early warning systems, use the big data platform to comprehensively analyze drug safety risk factors, and enhance the perception, prediction, and monitoring of risk facto.

Preventive capacity, accelerate the improvement of drug regulatory risk response capaci.

Use regulatory data to support innovative, public welfare and value-added social use, create data open service windows, continue to optimize the business environment, enhance the guiding role of regulatory authorities on the market and industry, and promote digital upgrading of regulation and industri.

(4) Building a solid digital base for smart drug supervision Starting from the actual needs of drug supervision work, on the basis of the existing informatization construction achievements, through "new infrastructure" to empower the innovation and development of supervision business, optimize and improve the drug supervision informatization standard system, Promote the in-depth application of cloud technology, improve the support and service capabilities of the drug supervision cloud platform, realize the comprehensive cloud deployment of business systems, build a "Internet of Things, Data Connection, and Zhilian" digital base for smart drug supervision, and promote the digital transformation and upgrading of drug supervisi.

Improve the information standard system The National Bureau strengthens the overall planning of the regulatory information standards for drugs, medical devices, and cosmetics, and encourages provincial drug regulatory authorities, industry associations, enterprises, and scientific research institutions to participate in the formulation and revision of standar.

Combined with the needs of drug regulatory business and the development trend of advanced information technology, the framework of the drug regulatory informatization standard system shall be enriched and improved, and the preparation of informatization standards in terms of data resources, application support and informatization management shall be promot.

Actively participate in international exchanges and cooperation on drug regulatory informatization standar.

Strengthen the publicity, implementation and application of drug regulatory informatization standards, and promote information sharing, business collaboration and big data application among regulatory departments at all levels and industri.

Task Column 13 Build and improve the standard and standard system to comprehensively sort out the business of "two products and one device", in accordance with the requirements of "two laws and two regulations", combined with the actual needs of drug supervision, and according to the principle of emergency first, carry out information on key areas of supervision of drugs, medical devices, and cosmetics The formulation and revision of chemical standards and specifications mainly include information standards and specifications for electronic licenses, drug traceability, variety files, credit files, and administrative licensi.

Strengthen the publicity and implementation of informatization standards, promote international exchanges and cooperation on drug regulatory informatization standards, and study the benchmarking work of drug regulatory informatization standards and international standar.

Plan ahead in terms of informatization standards to help the National Bureau join the Drug Inspection Cooperation Program (PIC/.

Upgrade the infrastructure service capabilities of the drug supervision cloud On the basis of the existing cloud platform, further carry out the construction of a drug supervision cloud resource pool based on Xinchuang products, and build a "one cloud and multiple pools" drug supervision cloud platfo.

Upgrade and expand the basic computing resources of the drug administration cloud, optimize and transform network equipment and security equipment, promote IPv6 transformation, improve the service capabilities of the drug administration cloud infrastructure, and continue to promote application migration and adaptation deployme.

Explore the construction of a disaster recovery backup system for the drug administration cloud platform, improve the operation and management capabilities of the drug administration cloud platform, build a resource operation management platform, and realize the visibility, measurability, management, and control of resource operation manageme.

The provincial bureaus are actively promoting the construction of the provincial drug regulatory cloud resource pool, accelerating the construction of a national and provincial regulatory cloud system, and supporting the integration of drug regulatory business and services across the count.

Task Column 14 Upgrade the Cloud Resource Pool for Drug Administration Accelerate the construction of the cloud resource pool of the National Bureau based on Xinchuang products, expand and improve the cloud platform of the National Bureau of Drug Administration, realize the continuous integration, delivery and deployment of the cloud platform, and realize the intensive infrastructure of various business systems Share and improve resource efficien.

Carry out in-depth and continuous application migration and adaptation work, and gradually migrate the established business application system to the drug administration cloud resource pool according to security needs, so as to realize the integrated upgrade of application system and business data disaster recovery backup and infrastructu.

Build a multi-pool backup system for the drug supervision cloud platform, and research and explore system reliability guarantee schemes such as disaster recovery backup and load balancing based on advanced technology for the core business system of drug supervisi.

Enhance the support service capabilities of the drug administration cloud platform Relying on the existing drug administration cloud platform infrastructure, expand and build a unified cloud-based application support platform, build a unified application support environment for various business systems, and promote the cloud platform from IaaS service mode to PaaS service The expansion and upgrade of the model realizes the overall improvement of cloud service capabilities and support capabilities, and supports business collaboration and data sharing across fields, applications, and syste.

Introduce technologies and concepts such as cloud native, micro-service, service grid, and data middle-end into the drug administration cloud platform to improve the flexibility and maintainability of the cloud platform, and effectively support the agile development, intensive deployment and integrated management of business application syste.

(5) Consolidate the comprehensive security capability of network security, improve the network security management system, establish a network security responsibility system, implement the main responsibility of network security management, upgrade the security measures such as information system security construction, security assessment, disaster recovery and backup, and improve the e-government intranet and network securi.

External network management, form a network security prevention, monitoring, notification, response and disposal mechanism that cooperates with all parties, and build a comprehensive and multi-level security protection system covering physical, network, data, and syste.

Strengthen the ability to guarantee services such as online video conferencing and video teleconferenci.

Strengthen network security assurance management Improve the network security assurance system, improve the network security management system, and carry out information system security level protection filing and information security level protection assessment, key information infrastructure security protection, password application security assessment and other wo.

According to the "Cyber ​​Security Law", "Cryptography Law" and other regulations, implement the "Regulations on the Security Protection of Critical Information Infrastructure", implement the responsibility system for network security work, and further improve the overall security syst.

Task Column 15 Improve the network security trust system Based on the actual construction of the drug administration cloud platform service and the cryptographic requirements of business applications, further build and improve the network security trust syst.

According to the characteristics of cryptographic applications in each business system, gradually improve the national bureau's cryptographic resource service capabilities, meet the requirements of relevant laws and regulations and management regulations, and realize active security protection of systems and da.

Build a unified authentication service system, improve the basic level of cryptographic services, expand the types of cryptographic services, improve the availability of cryptographic services, and strengthen unified management of cryptographic services from service forms, deployment methods, access interfaces to operation and maintenance management, e.

Advanced technology, complete solutions, efficient and available password security protection capabiliti.

Promote the construction of data security assurance In accordance with the requirements of the "Data Security Law" and other regulations, carry out the top-level design and overall management of data security, clarify the main body of data security responsibility, improve the data security management working mechanism, and improve data storage security and transmission security through technical means , access security and use security to ensure the confidentiality, integrity and availability of da.

Establish a unified, efficient, and collaborative data security risk reporting, research, judgment, and disposal syst.

Upgrade the safety management operation and maintenance platform to further strengthen the safety management operation and maintenance of system resources, data resources and hardware resources, and further integrate operation and maintenance resources according to the unified service management model of big security and big operation and maintenance, and upgrade and improve the national bureau The security management operation and maintenance center improves the intelligence, standardization and professionalism of operation and maintenance work, and establishes an integrated security operation and maintenance system from the three dimensions of key infrastructure security, business system security, and data resource security to ensure the security management of information syste.

Confidentiality, integrity, availability, controllability, non-repudiati.

Task Column 16 Improve the safety management operation and maintenance center Improve the safety management operation and maintenance center of the National Bureau, use big data analysis technology to aggregate, process, and analyze the operation and maintenance monitoring data, and realize the analysis of business operation situation, safety operation situation and system operation state monitori.

Build a drug regulatory big data security assurance platform, adopt data protection technologies such as anti-leakage, anti-theft, anonymization, e.

, to improve data security risk perception and early warning and disposal capabilities; Functions such as data flow monitoring and data flow traceability ensure the security of big data in drug supervisi.

Fo.

Safeguard measures (1) Strengthen organizational leadership and policy suppo.

Drug regulatory departments at all levels should strengthen organizational leadership of drug regulatory informatization work, give full play to the leading role of the Internet information management department, establish and improve drug regulatory informatization management mechanisms, and clarify drug regulatory informati.

Supervise the personnel and responsibilities of the informatization business management department and the technical support department, establish a multi-departmental coordination mechanism oriented by business needs and supported by professional technology, and jointly promote the intelligent supervision of dru.

All provincial bureaus should actively carry out research and formulation of policies and measures, and formulate rules and regulations that conform to the characteristics of local supervision in terms of infrastructure construction and use, business function design, data resource management, network security assurance, and innovative application implementation, and promote informatization construction and upgradi.

, to promote the accelerated formation of a national game of chess situation for smart drug supervisi.

(2) Improve the work security system Drug regulatory departments at all levels should attach great importance to the construction of the information construction security system, and establish and improve the institutional system and operation mechanism compatible with the drug regulatory informatization wo.

Improve the human resources guarantee system, optimize the way of talent growth, and improve the talent evaluation and incentive mechani.

Include network security and informatization education and training work in the key direction of personnel training, and comprehensively improve the comprehensive quality and ability of informatization of the majority of cadr.

Actively strive for local governments to invest in informatization construction, increase funding support for drug supervision informatization, and take multiple measures to promote the steady development of drug smart supervisi.

(3) Strengthen information-based project management Drug regulatory departments at all levels should strengthen information-based project management, improve the project management mechanism, and establish project supervision and inspection procedur.

Build a full life cycle management system for informatization projects, clarify the management rules for each stage of project initiation, construction, acceptance, operation and maintenance, and project termination, implement the top-level design of smart drug supervision, implement the construction concept of informatization resources integration and sharing, and ensure the safety of informatization projects stable operati.

(IV) Implementing performance appraisal and evaluation Continuously improve the performance appraisal and appraisal mechanism for information construction, formulate appraisal and appraisal indicators, and incorporate appraisal and appraisal results into the drug regulatory performance appraisal and appraisal syst.

Drug regulatory departments at all levels should, in light of their own work conditions, use the supervision role of assessment and evaluation to improve work modes and work results; strengthen the supervision, inspection and guidance of information construction work, and regard the results of assessment and evaluation as an important part of tracking the progress of work and promoting the implementation of the wo.

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