Attention! "Major new drug creation technology major special implementation management rules" issued!

Recently, the national health and Health Commission issued the notice on printing and distributing the management rules for the implementation of major science and technology projects of the national health and Health Commission The circular pointed out that in order to carry out the decision-making and deployment of the Party Central Committee and the State Council, implement the outline of the national medium and long term scientific and technological development plan (2006-2020), ensure the smooth implementation of the two major scientific and technological projects (hereinafter referred to as the two projects) for the development of major new drugs, the prevention and control of major infectious diseases such as AIDS and viral hepatitis, and make the management more scientific, standardized, precise, efficient and transparent Ming, in accordance with the notice of the Ministry of science and technology development and Reform Commission and the Ministry of Finance on printing and distributing the regulations on the administration of major national science and technology projects (people's mouth) and other relevant requirements of national science and technology plans, the national health and Health Commission, together with the logistics support department of the Central Military Commission, as the leading organization departments of the two projects, jointly studied and formulated the detailed rules for the administration of major new drug creation projects and the rules for the implementation of major science and technology projects and the HIV / AIDS program Detailed rules for the implementation and management of major special projects for the prevention and control of major infectious diseases such as sexual hepatitis The full text of detailed rules for the implementation of major special projects of major new drug creation technology is as follows: detailed rules for the implementation of major special projects of major new drug creation technology chapter I General rules Article 1 In order to implement the decision-making and deployment of the Party Central Committee and the State Council, implement the outline of the national medium and long term plan for science and technology development (2006-2020), ensure the smooth implementation of the task of the major science and technology special project for new drug creation (hereinafter referred to as the new drug special project), and make the management more scientific, standardized, precise, efficient, open and transparent, according to the national science and technology development and Reform Commission of the Ministry of science and technology Circular of the Ministry of Finance on the issuance of measures for the administration of national science and technology major special (minkou) funds (caikejiao [2017] No 74), Circular of the Ministry of science and technology on the issuance of regulations for the administration of national science and technology major special (minkou) files (guokefa [2017] No 145), Circular of the Ministry of science and technology on the issuance of national science and technology major special (minkou) files (guokefa [201 7] No 348), notice of the development and Reform Commission of the Ministry of science and technology of the people's Republic of China on the issuance of the measures for the administration of acceptance of major national science and technology projects (GKFG [2018] No 37) and the relevant requirements of the national science and technology plan management reform, combined with the actual situation of new drug projects, the detailed rules are formulated Second article The new drug project aims to meet the growing health needs of the people, promote the development of medical health industry, give full play to the new national system under the market economy, inherit and develop traditional medicine, make the national new drug technology innovation ability reach the international advanced level through original innovation, integrated innovation and introduction, digestion and re innovation, and accelerate the research and development of new drugs in China from imitation oriented to international advanced level With independent innovation as the main transformation, the new drug industry has changed from a big country to a powerful country Third article The new drug is aimed at 10 major diseases (malignant tumor, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, diabetes, mental diseases, autoimmune diseases, drug-resistant pathogens infection, tuberculosis, viral infectious diseases and other common and frequently occurring diseases) that seriously endanger the health of the people of our country It attaches importance to the use of drugs for children and rare diseases and focuses on the research and development of new drugs And major scientific and technological problems in the process of industrialization, breaking through a batch of core key technologies restricting the creation of new drugs, producing a batch of innovative achievements with great clinical value and urgently needed chemical drugs, traditional Chinese medicine and biotechnology drugs, and basically forming a national drug innovation system with characteristics Article 4 basic principles for the organization and implementation of new drugs （1） Innovation driven, demand oriented Adhere to the innovation driven development strategy with scientific and technological innovation as the core, face the construction of a healthy China and a world power in science and technology, focus on people's health needs and the development of the pharmaceutical industry, adhere to independent innovation with Chinese characteristics, and realize the leapfrog development of new drug creation （2） Government led, market led Give full play to the leading role of the government's strategic planning, and increase the support to the original innovation and other market failure areas We will strengthen the dominant position of enterprises in technological innovation in the market, and give full play to their important roles in the determination of special objectives and tasks, the allocation of innovation input and resources, the industrialization of innovation achievements and market expansion （3） Talent first, mass innovation and development Adhere to talent as the first innovation resource, form a national new drug innovation talent system with scale, quality, structure and vitality, promote the transformation of innovation mode from "small crowd, single point, closed" to "public, multi-point, open" mode, and fully mobilize the vitality of the majority of innovation subjects We will strengthen the introduction and training of high-level talents and give full play to the role of high-level talents in task organization and implementation (four) highlight the key points and coordinate as a whole Strengthen the top-level design, highlight the strategic focus, focus on the main direction of attack, identify core scientific issues, achieve key breakthroughs, and ensure the realization of key tasks Establish a scientific and standardized management mechanism, coordinate and integrate superior scientific and technological resources, give full play to the role of all departments and local governments, strengthen military civilian integration, and form a collaborative innovation system mechanism of deep integration of "government, industry, learning, research and use" （5） Optimize the environment and strengthen supervision Continuously improve the policy environment conducive to independent innovation, talent focus and achievement transformation, promote the organic combination of projects, talents, bases and industries; improve the performance evaluation management system of "survival of the fittest, dynamic adjustment, rolling support, open sharing", strengthen supervision and evaluation; establish an organizational management system with clear division of labor and clear responsibilities, optimize management services, and simplify supervision Process, improve the efficiency of special management of new drugs, and ensure the progress and quality of research and development Article 5 under the inter ministerial joint meeting system of national science and technology plan (special projects, funds, etc.), the Ministry of science and technology, together with the national development and Reform Commission and the Ministry of Finance (hereinafter referred to as the three departments), shall be responsible for the comprehensive coordination and overall promotion of new drug special projects The national health and Health Commission and the logistics support department of the Central Military Commission, as the leading organizations, are responsible for the specific organization and implementation of new drug projects, and strengthen macro management, strategic planning and policy support The general expert group (hereinafter referred to as the general group) carries out technical consultation on major decisions of new drug projects and checks the technical route The Research Center for medical and health science and technology development of the national health and Family Planning Commission (hereinafter referred to as the science and Technology Development Center) is the professional organization of project management, responsible for the specific management of new drug special topics Through the unified national science and technology management information system to accept the project applications put forward by various units, organize project review, project approval, process management and final acceptance, and be responsible for the realization of task objectives Article 6 the main functions and responsibilities of the State Health Committee （1） Establish a new drug special implementation management office (hereinafter referred to as the special office) jointly with relevant departments and units to be responsible for the daily work of new drug special organization and implementation （2） Set up a special overall group for new drugs （3） To be responsible for organizing the formulation of detailed rules for the implementation and management of new drug projects, as well as rules and regulations for fund management, confidentiality management and file management （4） To be responsible for organizing the formulation of the stage implementation plan, annual guidance, review and report the annual implementation plan and annual report of the new drug project （5） To be responsible for the approval and acceptance of new drug projects （6） In accordance with the annual supervision and inspection plan for new drug special projects of the three departments, and in conjunction with professional institutions, conduct supervision and inspection on the implementation of specific topics and responsibility inversion, and guide and urge the implementation of new drug special projects （7） To be responsible for strengthening the guidance and supervision over the team building, condition guarantee and other macro businesses of the science and technology development center （8） To coordinate and implement relevant supporting conditions and supporting policies for the implementation of new drug projects, and promote the transformation and industrialization of achievements （9） To organize and implement the connection between new drug projects and other national science and technology plans (special projects, funds, etc.), national major projects, industrial plans, and other scientific and technological resources （10） Review and approve the adjustment of the relevant contents of the new drug special implementation plan, stage implementation plan and annual plan, and make the adjustment after consulting with the opinions of the three departments on major issues related to the new drug special objectives, technical routes, budget estimates, progress, organization and implementation methods （11） Organize the preparation and submission of annual implementation report and summary report of new drug special projects; apply to the three departments for special acceptance of new drugs according to the completion of tasks （12） To be responsible for the management, supervision and inspection of the special confidentiality work of new drugs Article 7 the main responsibilities of the logistics support department of the Central Military Commission （1） To carry out the organization and implementation of the new drug project jointly with the national health and Health Commission （2） To be responsible for the specific project approval of special military drug projects for new drugs and formulate corresponding rules and regulations Article 8 main responsibilities of the general team （1） To be responsible for carrying out research on development strategy, policy environment and management system in related fields of Health Science and technology, and providing advice （2） To be responsible for the research and consultation of new drug creation technology prediction, technology foresight, technology trend and direction Put forward consultation opinions on key directions, technical routes and R & D Progress of new drugs （3） Together with the special office and the science and technology development center, we will give advice on the project approval review Suggestions on the special development plan, stage implementation plan, annual guidance and annual plan of new drugs are put forward Suggestions are put forward for the design of new drug special integration scheme, the connection and coordination of research topics, and the promotion of integrated application of new drug special achievements （4） Participate in the supervision, inspection, evaluation and acceptance of new drug special topics （5） In principle, the members of the general team shall not undertake the special task of new drugs Article 9 the main responsibilities of the science and Technology Development Center (professional institution) （1） Be responsible for formulating corresponding management rules and regulations according to different stages of new drug special subject management （2） Participate in the formulation of the implementation plan and annual guidelines for the special stage of new drugs （3） According to the special guidelines for new drugs, organize the acceptance of project application, select the project undertaking unit, put forward project proposal, issue project proposal notice, sign task contract with the project undertaking unit (including budget statement, the same below), propose annual plan proposal to the special office, implement the fund allocation work, and report the relevant situation of fund allocation to the special office （4） Implement the annual supervision and inspection plan for new drugs, organize the supervision and inspection of the implementation of the project and the transformation of achievements, and submit a report to the special office （5） Organize the acceptance of new drug special projects, and cooperate with the national health and Health Commission in the overall acceptance of new drug special projects （6） Adjust the task or budget of the project according to the needs, and inform the project undertaking unit of the adjustment opinions in time （7） Propose adjustment suggestions for special implementation plan, stage implementation plan and annual plan of new drugs as required; (VIII) submit and report the progress of project implementation, summarize, compile and report the annual implementation, stage implementation and summary materials （9） To be responsible for the management, supervision and inspection of the archives and confidentiality work of the project （10） Research and put forward suggestions on special organization and management of new drugs, supporting policies, etc （11） Establish a credit management mechanism for special research on new drugs （12） To carry out dynamic tracking and prospective research in the field of new drug creation, science and technology and management, so as to provide reference for the scientific decision-making of the National Health Committee （13） Complete other specific management related work of new drug special project arranged by the three departments and the national health and Health Commission