The State Drug Administration has further strengthened the system and capacity-building of adverse drug reaction monitoring and evaluation.

Guide: At present, there are still short boards in the monitoring and evaluation of adverse drug reactions in China, the number of grass-roots monitoring and evaluation institutions has decreased, the number of professional personnel is insufficient, the monitoring information system lags behind, and the monitoring and evaluation ability needs to be improved urgently.
the Drug Administration of the provinces, autonomous regions and municipalities directly under the Central Government, the Drug Supervision Administration of the Xinjiang Production and Construction Corps: In recent years, the work of adverse drug reactions, adverse events of medical devices, adverse reactions in cosmetics, drug abuse monitoring and evaluation (collectively referred to as the monitoring and evaluation of adverse drug reactions) has achieved remarkable results, the system norms have been continuously improved, the monitoring and evaluation system has been gradually established, the number and quality of reports have been steadily improved, the means of risk control have been more mature, and international cooperation has been strengthened. At the same time,
it must be seen that the current monitoring and evaluation of adverse drug reactions in China still has short board, the number of grass-roots monitoring and evaluation institutions has decreased, the number of professional personnel is insufficient, the monitoring information system lags behind, the monitoring and evaluation capacity needs to be improved urgently, the financial guarantee is difficult to meet the demand, has affected the improvement of drug safety level and public health rights and interests to a certain extent.
in order to fully implement the central government's requirements for strengthening drug safety work in the new era, the following comments are put forward on further strengthening the system of monitoring and evaluating drug adverse reactions and capacity-building: First, the main objective is to always put the people's health rights and interests first, adhere to scientific, rule of law, internationalization, modern development direction and professional, professional, professional construction requirements, continue to strengthen the construction of drug adverse reaction monitoring and evaluation system, continuously improve the monitoring and evaluation capacity, and comprehensively promote the safety of the public with drug use.
by 2025, we will strive to achieve the following main objectives: (i) a more sound system for the monitoring and evaluation of adverse drug reactions.
scientifically formulate the development plan of the technical system for the monitoring and evaluation of adverse drug reactions, and establish and improve the technical system for the monitoring and evaluation of adverse drug reactions with clear responsibilities, clear division of labor, complete system and coordinated and efficient drug adverse reactions.
(2) The system of monitoring and evaluation of adverse drug reactions is more perfect.
to speed up the revision of laws and regulations related to supporting documents, the formation of a systematic and perfect drug adverse reaction monitoring and evaluation rules and guidelines.
(3) The personnel of drug adverse reaction monitoring and evaluation have been strengthened in an all-round way.
drug adverse reaction monitoring institutions at all levels should be equipped with a sufficient number of professional and technical personnel with the ability to monitor and evaluate, and train a politically firm, skilled and excellent style of drug monitoring and evaluation team.
(4) The drug adverse reaction monitoring information system has been comprehensively upgraded.
enrich the reporting channels, improve data quality, strengthen data management and analysis, incorporate drug adverse reaction monitoring information into the variety file, strengthen information sharing and utilization, and support the identification and control of product risk signals.
(5) The method of monitoring and evaluating adverse drug reactions is innovative.
to promote the construction of drug adverse reaction monitoring posts (bases), integrate professional resources of social advantages, innovate the model of monitoring and evaluation, and continue to promote the research and application of new methods of drug safety monitoring and evaluation.
(vi) International cooperation in the monitoring and evaluation of adverse drug reactions has been continuously deepened.
promote in-depth cooperation with uppsala monitoring centres in data sharing, personnel exchanges and methodological research, timely translation and implementation of ICH-related guidelines, and active participation in the activities of relevant international organizations in the production and revision of international common rules and technical guidelines for the monitoring and evaluation of pharmaceuticals, medical devices, cosmetics.
. Main Tasks The Drug Supervision and Administration Departments at all levels should speed up the construction of a "one-in-one, two-wing" working pattern in which drug adverse reaction monitoring institutions, holders and medical institutions fulfill their relevant responsibilities in accordance with the law.
focusononononononon on the following tasks around strengthening the drug adverse reaction monitoring and evaluation system and capacity-building objectives.
(1) Further strengthen the construction of drug adverse reaction monitoring and evaluation institutions.
adapt to the requirements of drug supervision, scientifically formulate the development plan of the technical system for the monitoring and evaluation of adverse drug reactions.
focus on strengthening overall planning and systematic upgrading, and comprehensively strengthen the construction of a national drug adverse reaction monitoring center.
the National Drug Adverse Reaction Monitoring Center shall cooperate with the top-level design and overall planning for the development of drug adverse reaction monitoring and evaluation, organize and carry out the national technical work on the monitoring and post-market safety evaluation of adverse drug reactions, organize the formulation of technical standards and norms for the monitoring and evaluation of adverse drug reactions, and strengthen the operational guidance of technical institutions for the monitoring and evaluation of adverse drug reactions at all levels.
focusonononononon on improving functions and strengthening supporting, and vigorously promote the construction of provincial and municipal drug adverse drug reaction monitoring and evaluation institutions.
provincial drug adverse reaction monitoring and evaluation institutions shall cooperate with the planning and design of the monitoring and evaluation of adverse drug reactions in their administrative areas, undertake the technical work of drug adverse reaction monitoring and post-market safety evaluation within the scope of their duties, and conduct operational guidance to the technical institutions for the monitoring and evaluation of adverse drug reactions at the municipal and county levels.
the municipal drug adverse reaction monitoring and evaluation technical institutions in the district to undertake the monitoring and evaluation of adverse drug reactions in the region.
to expand coverage, solid foundation as the focus, and steadily promote the county-level monitoring and evaluation of technical institutions.
the technical institutions for the monitoring and evaluation of adverse drug reactions at the county level shall undertake the collection, verification, reporting, publicity and training of reports of the jurisdictions within the scope of their responsibilities.
(2) to speed up the improvement of the system of monitoring and evaluation of adverse drug reactions.
implement the requirements of the Drug Administration Law, the Vaccine Administration Law, the Regulations on the Supervision and Administration of Medical Devices, and the Regulations on the Supervision and Administration of Cosmetics, and formulate relevant supporting systems and guiding principles.
to speed up the revision of the Measures for the Administration of Adverse Drug Reaction Stakes, study and formulate requirements related to drug alert quality management norms, drug abuse reporting and monitoring management, and study and formulate guidelines for the preparation of the annual report on drug alert for drug licensing holders, and guidelines for the preparation of drug alert entrustment agreements.
explore and study the medical device alert system.
to speed up the development of cosmetic adverse reaction monitoring and management methods and supporting technical specifications.
provincial drug supervision and administration departments to speed up the implementation of relevant laws and regulations, the formation of a systematic and complete system of drug adverse reaction monitoring and evaluation system, basically completed in line with China's actual supervision of drug vigilance system.
(iii) focus on the construction of monitoring and evaluation of personnel.
drug adverse reaction monitoring institutions at all levels shall be equipped with a sufficient number of medical, pharmaceutical, epidemiological and health statistics-related professional and technical personnel with monitoring and evaluation capabilities according to operational needs.
strengthen the training and guidance of drug adverse reaction monitoring and evaluation personnel, improve the ability of information collection, risk identification and comprehensive analysis and evaluation, and train a group of high-level business and strong technical ability of monitoring and evaluation personnel.
establish the database of experts in the monitoring, analysis and evaluation of adverse drug reactions and risk assessment, and give full play to the role of experts in decision-making advice and technical guidance in the monitoring and evaluation of adverse drug reactions.
improve the mechanism of monitoring and evaluating the promotion of technical posts, reasonably set the proportion of posts at all levels and the corresponding compensation distribution mechanism, to ensure that professional personnel attract, stay, use well, monitoring and evaluation capacity continues to improve.
(iv) to build an efficient national drug adverse reaction monitoring information system.
speed up the construction of the "13th Five-Year Plan" for drug safety and the construction of the national drug adverse reaction monitoring system (Phase II).
relying on the "National Drug Regulatory Cloud" to strengthen the basic support environment, transform the implementation of the International Human Drug Registration Technology Coordination Committee (ICH) E2B (R3) data standards, establish online reporting, gateway transmission and other reporting channels, explore the application of big data, artificial intelligence and other technologies and methods, to achieve data sharing and feedback, risk early warning and identification, holder assessment and evaluation intelligence and other functions.
to incorporate the monitoring information of adverse drug reactions into the variety file, and realize the docking of the drug adverse reaction monitoring information with the national drug regulatory data sharing platform.
promote the construction of a national system for monitoring and monitoring adverse reactions in cosmetics in accordance with the Regulations on The Supervision and Administration of CosmeticS and the Measures for the Monitoring and Management of Adverse Reactions in Cosmetics.
explore new channels for patients to report adverse reactions directly, and build a national drug adverse reaction monitoring information system that is easy to report and easy to use.
(v) to study and explore new methods for drug safety monitoring and evaluation after market.
, leading the way in implementing the regulatory scientific action plan, continues to promote the research and application of new standards and new methods for the evaluation of new tools for drug safety monitoring and evaluation after the market.
continue to promote the construction of adverse drug adverse medical device adverse event monitoring posts, cosmetic adverse reaction monitoring and evaluation base, give full play to the high-level technical support units of professional and technical advantages and demonstration role, carry out research on related topics, undertake special tasks, etc. , build a medical big data-based active monitoring and evaluation system, improve the identification and evaluation of drug safety risks Joint universities, medical unions, regional medical centers, etc., to pilot the construction of drug alert research bases, to explore the use of real-world data, research post-market safety monitoring and evaluation of new methods, innovative products, high-risk products in the clinical use of the risk, the use of multi-source data to provide technical support for supervision.
(vi) to guide and urge the holder to carry out the main responsibility for drug safety.
drug listing license holders (including medical device registrers, filers and cosmetics registrants, filer) shall fulfill their product safety main responsibilities in accordance with the law, strengthen the life cycle management of pharmaceutical and medical device cosmetics, establish and improve the monitoring and evaluation system, carry out post-market adverse reaction monitoring, actively collect, follow up analysis and timely report ingested suspected adverse reaction information, and take timely risk control measures against pharmaceutical cosmetics that have identified risks.
provincial drug supervision and administration departments shall take effective measures to guide and urge the holders to implement the requirements for direct reporting of adverse reactions, increase the inspection of the monitoring and evaluation of the holders and their agents, and strengthen the responsibility of the holder's safety subject.
strengthen the organic interface between monitoring and evaluation and registration review, and incorporate adverse reaction monitoring into the important review elements of product re-registration (continuation registration).
technical institutions for the monitoring of adverse drug reactions shall strengthen the technical guidance to the holders.
(7) adhere to and consolidate the working mechanism for reporting adverse drug reactions in medical institutions.
the drug supervision and administration department under the State Council strengthens communication and coordination with the competent department of health and health under the State Council, adheres to and consolidates the system of reporting adverse drug reactions in medical institutions, strengthens data sharing, and forms a virtuous circle of adverse reaction reports originating from clinical and service clinical.
the provincial and below drug supervision and administration departments should strengthen cooperation with the health departments at the same level, establish a mechanism for the evaluation of adverse drug reaction reports in medical institutions and a regular notification system, so as to achieve full coverage of reportmonitoring and monitoring of medical institutions at the second level and above.
technical institutions for the monitoring of adverse drug reactions at all levels shall strengthen training guidance, improve the ability of medical personnel to recognize adverse drug reactions and report awareness, and promote the complete and accurate standards of information filling in.
continue to promote the establishment of a system of reporting and monitoring of adverse drug reactions in medical institutions, fulfill reporting responsibilities in accordance with the law, and strengthen the use of monitoring data analysis.
(VIII) continue to raise public awareness of adverse reactions.
strengthen cooperation with medical colleges, trade associations, medical institutions, etc., and strive to make the knowledge of adverse drug reactions as an important part of professional basic courses and medical personnel re-education and vocational and technical level assessment, so as to achieve full coverage of the training of doctors, nurses, pharmacists and technicians in the training of safe drug use.
use the news media, network platforms and other media to promote the knowledge of adverse drug reactions, relying on safe drug use month, medical device publicity week, cosmetics safety science publicity week, international anti-drug day and other platforms, to carry out drug adverse reaction knowledge into hospitals, into the community, into the campus and other forms of publicity activities to enhance public awareness.
(9) continue to deepen international exchanges and cooperation.
deepen sing-on-up with the World Health Organization (WHO), the national drug regulatory agency, and the Uppsala Monitoring Centre (UMC) in the field of drug vigilance.
to promote the National Drug Adverse Reaction Monitoring Center to apply to become the WHO International Drug Monitoring Project Cooperation Center.
promote in-depth cooperation with the Uppsala Monitoring Centre in data sharing, personnel exchanges and methodological research.
actively promote the implementation of ich drug alert-related guidelines, participate in ICH, the International Forum of Medical Device Regulators (IMDRF), the International Society of Drug Vigilance (ISOP), the International Committee of Medical Science organizations (CIOMS), the International Pharmaceutical Engineering Association (ISPE) and other drug alert, medical device adverse event monitoring related areas of international general rules and technical guidelines revision, for the international drug alert development of China's wisdom and strength.
. Organizational safeguards (i) strengthen organizational leadership.
drug supervision and administration departments at all levels should deeply understand the importance of further strengthening the drug adverse reaction monitoring and evaluation system and capacity-building, from the effective realization of drug safety risk control and the protection and promotion of public health, seriously study and plan the monitoring and evaluation of adverse drug reactions, improve the monitoring and evaluation system, strengthen the system and capacity-building, effectively strengthen organizational leadership and overall coordination, to ensure that the monitoring and evaluation of adverse drug reactions are comprehensively strengthened.
(ii) strengthen financial security.
drug supervision and administration departments at all levels should increase the investment in the monitoring and evaluation of adverse drug reactions, fully guarantee the construction of the drug adverse reaction monitoring and evaluation system and carry out report collection, investigation and verification, analysis and evaluation, emergency disposal and other work requirements and equipment requirements, improve the efficiency of the use of funds, and create good conditions for the solid promotion of monitoring and evaluation work.
(iii) strengthen the implementation of responsibilities.
provincial drug supervision and administration departments should closely integrate the actual situation in the region, clarify regulatory responsibilities and work objectives, establish and improve the inspection and evaluation mechanism, and strive to promote the implementation of the objectives and tasks.
the State Drug Administration will include the monitoring and evaluation system and capacity-building in the annual assessment of local governments, and organize special supervision and inspection in due course to ensure that the objectives and tasks are put in place.
the State Drug Administration on July 28, 2020.