Issued by the State Council: establish a team of professional drug inspectors, which will be basically completed by the end of 2020

On July 18, the general office of the State Council issued the opinions on the establishment of a professional team of drug inspectors (hereinafter referred to as the "opinions"), calling for the establishment of a professional team of drug inspectors, and further improving the drug regulatory system and mechanism The opinion points out that we should take Xi Jinping's new socialist ideology with China's characteristics as the guide and follow the decision making arrangements of the Central Committee and the State Council on strengthening drug safety supervision, follow the scientific regulation rules, deepen the reform of the drug regulatory system and mechanism, adhere to the strict prevention of the source, strict process control and strict risk control, and strengthen drug safety supervision and inspection, so as to ensure the health of the people And medical equipment safety According to the opinion, professional and professional drug inspectors (including medical devices and cosmetics) refer to the personnel identified by the drug regulatory authorities who legally confirm the compliance and risk assessment of the places and activities where the management counterpart is engaged in drug research and development, production and other activities, and are important support forces for strengthening drug supervision and ensuring drug safety We should adhere to the direction of professionalization and the requirements of professionalism and technicality By the end of 2020, the drug regulatory department under the State Council and the provincial drug regulatory department will basically complete the system construction of professional drug inspectors On this basis, it will take another three to five years to build a professional professional drug inspector team system that basically meets the requirements of drug supervision, and further improve the inspector team with full-time inspector as the main body, part-time inspector as the supplement, excellent political quality, excellent business, clean and efficient The opinions put forward five policy measures First, improve the drug inspection system and mechanism We will build a professional team of drug inspectors at the national and provincial levels, strengthen the construction of inspection institutions, clarify the division of inspection powers, implement inspection requirements, and improve the coordination mechanism of inspection work Second, implement the configuration of inspectors Reasonably determine the scale of the team, standardize the establishment and management of inspectors, innovate the management mechanism of inspectors, and enrich the team of inspectors through multiple channels Third, strengthen the management of inspectors Professional and professional drug inspectors shall be managed in different levels and categories, with strict post access and working conditions established, and scientific and reasonable assessment and evaluation and rank rise and fall mechanisms established Fourth, constantly improve the quality of inspectors Strengthen the professional training of inspectors, encourage inspectors to improve their ability level, and innovate the training mode of high-quality inspectors Fifth, establish incentive and restraint mechanism Broaden the space for inspectors' career development, improve the policies for inspectors to participate in the evaluation of corresponding professional titles, establish the guarantee mechanism for inspectors' salary and treatment, and strengthen discipline restraint and supervision Original attached comments: People's governments of all provinces, autonomous regions and municipalities directly under the central government, ministries and commissions under the State Council, and organizations directly under the State Council: Professional and professional drug (including medical devices and cosmetics) inspectors refer to the personnel identified by the drug regulatory authorities who, in accordance with the law, conduct compliance confirmation and risk study and judgment on the places and activities where the management counterpart is engaged in drug research and development, production, etc., which is an important support for strengthening drug supervision and ensuring drug safety In order to implement the decision-making and deployment of the Party Central Committee and the State Council, establish a professional team of drug inspectors, and further improve the drug regulatory system and mechanism, the following opinions are hereby put forward with the consent of the State Council 1、 General requirements (1) guiding ideology Guided by Xi Jinping's socialist ideology with China's characteristics in the new era, we should comprehensively implement the spirit of the nineteen and third Plenary Session of the nineteen and second plenary session of the party, and follow the decision making arrangements of the Central Committee and the State Council on strengthening drug safety supervision, follow the scientific supervision rules, deepen the reform of drug supervision system and mechanism, and adhere to strict prevention at the source, strict process control and strict risk control, so as to enhance drug safety Supervision and inspection shall be carried out to ensure the physical health of the people and the safety of medical equipment （2） Main objectives Adhere to the direction of professionalization and professional and technical requirements By the end of 2020, the drug regulatory authorities under the State Council and provincial drug regulatory authorities will basically complete the construction of professional professional drug inspector team system On this basis, in another three to five years, we will build a professional professional drug inspector team system that basically meets the requirements of drug supervision, further improve the professional professional drug inspector team with full-time inspector as the main body and part-time inspector as the supplement, excellent political quality, exquisite business, clean and efficient, and form a team with clear rights and responsibilities, smooth cooperation and coverage Build a comprehensive drug supervision and inspection system 2、 Improve the system and mechanism of drug inspection (3) build a professional team of drug inspectors at the national and provincial levels The drug regulatory department under the State Council and the provincial drug regulatory department shall establish the national and provincial professional drug inspector teams respectively, and provide full-time inspectors meeting the inspection requirements to provide technical support for drug regulatory administrative law enforcement On this basis, the drug regulatory authorities under the State Council and provincial drug regulatory authorities should focus on strengthening the construction of high-risk drug inspectors such as vaccines （4） Strengthen the construction of inspection institutions Further strengthen the construction of drug audit and inspection institutions and national vaccine inspection institutions of the drug regulatory department under the State Council, and take charge of the daily management of the national professional drug inspectors We will improve the establishment of inspection institutions of provincial drug regulatory authorities, and take charge of the daily management of provincial professional drug inspectors According to the needs of regulatory work, the drug regulatory authority under the State Council strengthened drug inspection efforts in key areas such as drug industry concentration and high-risk drug production concentration, and implemented key inspection and precise inspection According to the needs of supervision, the provincial drug regulatory authorities should strengthen the work of drug inspection in the areas where drug production is concentrated Where conditions permit, inspection branches can be set up in different regions to carry out nearby inspection and normalized inspection （5） Clear division of inspection authority The drug regulatory department under the State Council is mainly responsible for the on-site inspection of the R & D process of drugs, medical devices and cosmetics for special purposes, as well as the compliance inspection of the implementation of the non clinical research quality management specifications, clinical trial quality management specifications and clinical trial quality management specifications of medical devices; overseas on-site inspection of drugs, medical devices and cosmetics as well as the important production links A big cause check The provincial drug regulatory authorities mainly undertake the on-site inspection of the production process of drugs, medical devices and cosmetics, as well as the compliance inspection of the implementation of relevant production quality management specifications; undertake the on-site inspection of the drug wholesale enterprises, retail chain headquarters and the third-party platform for Internet sales; guide the municipal and county-level market regulatory authorities to carry out the operation and use of drugs, medical devices and cosmetics On site inspection of links and compliance inspection of the implementation of relevant operation quality management specifications According to the affiliation of the functional departments, drug inspection items are clearly defined as the central or local financial affairs, and the financial departments at the same level shall bear the expenditure responsibility Further strengthen the inspection of high-risk drugs such as vaccines The drug regulatory authority under the State Council strengthened the flight inspection and overseas inspection in the development and production of high-risk drugs such as vaccines, irregularly carried out patrol inspection and strengthened random inspection The provincial drug regulatory authorities are directly responsible for the post inspection and daily inspection of the production process of high-risk drugs such as vaccines, implement more centralized and strict on-site inspection, information publicity, adverse reactions monitoring report and other systems, and implement strict territorial supervision （6） Implement inspection requirements The drug regulatory department under the State Council and the provincial drug regulatory department shall formulate and improve the rules and procedures for drug inspection, and strengthen the inspection work We should further strengthen the risk management of quality and safety in the whole process of drugs, and carry out the "double random and open" supervision in special inspections and flight inspections, and speed up the intelligent supervision of drugs based on cloud computing, big data and Internet plus, so as to improve the efficiency of supervision and inspection We will accelerate the improvement of the internal whistleblower system The team of drug inspectors shall implement the requirements for on-site inspection of drug registration, on-site inspection of vaccine drugs, territorial inspection and overseas inspection, actively cooperate with drug supervision, inspection and handling of cases, implement the requirements for due inspection, and provide technical support for scientific supervision and legal investigation and handling of drug violations （7） Improve the coordination mechanism of inspection work The drug regulatory authority under the State Council shall establish a unified national inspector database and inspector information platform to realize the information sharing and inspection coordination and linkage between national and provincial inspectors Establish and improve the unified deployment and use mechanism of inspectors, and coordinate the deployment of inspectors to carry out inspection according to work needs According to the needs of the work, the higher drug regulatory department can mobilize the lower drug regulatory department to carry out the inspection; if the lower drug regulatory department encounters complex and difficult problems in the work, it can apply to the higher drug regulatory department to send inspectors for on-site guidance 3、 Implement the allocation of inspectors (VIII) reasonably determine the team size According to the power of supervision, the scale of pharmaceutical industry and inspection tasks, the organization establishment department, the financial department, together with the pharmaceutical regulatory department, scientifically and reasonably determine the scale of professional professional pharmaceutical inspectors Based on the overall consideration of the existing pharmaceutical regulatory personnel and establishment at all levels, further strengthen the staffing of national and provincial full-time pharmaceutical inspectors, and reasonably guarantee the work needs Yes In areas where there are high-risk drug manufacturers such as vaccines, there should also be a corresponding number of drug inspectors with inspection skills and practical experience of high-risk drugs such as vaccines （9） Standardize the preparation and management of inspectors The public welfare nature of drug inspection shall be fully considered, and the staffing of drug inspection institutions shall be considered as a whole according to the needs of inspection Strictly implement the requirements of preparation management, take various forms to guarantee the preparation requirements of inspectors, and attract and stabilize inspection backbones and high-level inspectors Innovate the management mechanism of inspectors, implement the combination of the establishment of inspectors and the purchase of inspection services by the government, optimize the structure of the establishment of inspectors, and ensure the stability of inspectors （10） We will enrich the professional and professional team of drug inspectors through various channels The drug regulatory department shall, in strict accordance with the corresponding qualification conditions, enrich the team of professional and professional drug inspectors in a planned and step-by-step manner The team of inspectors can be continuously enriched by directly transferring qualified supervisors within the supervision department, training and assessment of relevant professionals, and open recruitment to the public We should innovate the way of talent selection, implement the action plan for expanding the team of high-level inspectors, and vigorously train and recruit drug inspectors with high-risk drug inspection skills and practical experience, such as vaccines In combination with the reform of the local market supervision system, the inspection (supervision) personnel originally engaged in drug production and wholesale supervision in cities and counties are encouraged to be transferred to enrich the provincial professional professional drug inspector team, establish an inspector team system with the provincial drug supervision department as the main body and the participation of personnel with corresponding drug inspection qualifications in the market supervision departments at all levels, and implement the administrative region The requirement of full coverage of supervision on drug production in the region The personnel with the qualification of drug research and development, production and other inspections managed by the market supervision departments at all levels can be included in the national and provincial part-time inspectors for deployment and use At the same time, qualified personnel are employed as part-time inspectors from relevant scientific research institutions, inspection and testing institutions and colleges and universities to provide important supplement for the full-time inspectors 4、 Strengthen the management of inspectors (XI)