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Guiding Opinions of the General Office of the State Council on Promoting the Healthy Development of the Pharmaceutical Industry

Author: ComeFrom: Date:2016/11/29 16:00:27 Hits:2275
The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions under the State Council,
         Pharmaceutical industry is to support the development of medical and health services and health services is an important foundation, is a strong growth, relevance and driving the Chaoyang industry, in the people's livelihood, steady growth has played an active role. Vigorously developing the pharmaceutical industry is of great significance for deepening the reform of the medical and health system, promoting the healthy construction of China and fostering new impetus to economic development. Since reform and opening up, China's pharmaceutical industry has made great progress, rapid growth of industrial scale, supply capacity significantly increased, but still face independent innovation capability is not strong, irrational industrial structure, market order is not standardized and so on. At present, the global pharmaceutical technology development by leaps and bounds, the pharmaceutical industry profound adjustment and change, the people's health needs continue to grow, all of the pharmaceutical industry transformation and upgrading of the urgent requirements. In order to promote the core competitiveness of China's pharmaceutical industry and promote the sustained and healthy development of the pharmaceutical industry, the State Council agrees to present the following comments.
           First, the general requirements
         (A) the guiding ideology.
          Fully implement the Party's 18th and 18th three, four, five in the spirit of the plenary session, in accordance with the Party Central Committee and State Council decision-making arrangements, firmly establish and effectively implement the innovation, coordination, green, open and shared development concept, The new round of industrial reform, by optimizing the application environment, strengthen the elements of support, adjust the industrial structure, strict industry supervision, and deepen the opening and cooperation, stimulate pharmaceutical industry innovation vitality, reduce the cost of pharmaceutical products from R & D to market, accelerate medical product approval, Production, circulation, the use of areas of institutional mechanisms to promote the pharmaceutical industry intelligent, service-oriented, ecological and achieve high-speed industrial development and transformation in the high-end, and continuously meet the people's multi-level and diverse health needs.
         (B) the basic principles.
          Adhere to market-led, government guidance. Strengthen the dominant position of the enterprise market, the market in the allocation of resources play a decisive role and better play the role of government. To implement the relevant health care reform policies, improve the industrial policy and regulatory system, standardize market order, focus on industrial upgrading and promote the application of mutual promotion and create a level playing field.
          Adhere to innovation-driven, open cooperation. Improve the innovation environment, promote the integration of political and industrial research with the depth, strengthen medical technology innovation capacity-building, promote technology, products and business model innovation. Accelerate the management of pharmaceutical products, quality, standards, registration system and international standards, make full use of international resource elements, strengthen the global industrial layout and international cooperation.
          Adhere to industrial agglomeration, green development. To promote chemical raw materials to the environment carrying capacity, production conditions supporting a good gathering of the park. Guide the Chinese medicine, ethnic drug companies planting (breeding), processing integration. The implementation of enterprise recycling production, industrial recycling portfolio, the park recycling-style transformation, and promote the green transformation of the pharmaceutical industry to upgrade and green and safe development.
          Adhere to enhance the quality, protection of supply. Strengthen the quality of the main responsibility of enterprises, improve the quality standards and testing system to ensure safe and effective products. We will strengthen the production and supply of essential drugs, build up the information network for medicine distribution, and establish a fast-track for the examination and approval of market-deficient drugs and innovative drugs and market access so as to improve the supply security capacity.
         (C) the main objectives.

          By 2020, the innovation capacity of the pharmaceutical industry will be significantly improved, the supply security capacity will be significantly enhanced, more than 90% of major patent expiry drugs to achieve generic imitation of the market, the shortage of clinical supply shortages effectively alleviate the situation; industry green development, safe and efficient, quality management level improved significantly ; The industrial structure further optimized, the system and mechanism improved gradually, the market environment improved significantly; the scale of the pharmaceutical industry further expanded, the main business income annual growth rate higher than 10%, industrial added value growth continues to rank among the forefront of the industry.

Second, the main task
          (D) to strengthen technological innovation, improve core competitiveness.
           Promote innovation capacity. We will intensify the reform of science and technology system and improve the collaborative innovation system of medicine used in the research of political science, industry and academy. We will strengthen the construction of innovative capacity of the original drug, the first imitation medicine, the traditional Chinese medicine, the new preparation and the high-end medical equipment, optimize the allocation of scientific and technological resources, and create a rational scientific and technological innovation base. The use of databases, computer screening, the Internet and other information technology, construction of pharmaceutical product technology research and development, industrialization, safety evaluation, clinical evaluation and other public service platform. And actively develop public space, and vigorously promote the public innovation and entrepreneurship, cultivate a number of characteristics of technology, high-end talent innovative small and medium enterprises, to promote R & D outsourcing to the whole process of innovation and change, improve the ability of new product development.
            Promote the industrialization of major drugs. Continue to promote the creation of new drugs, speed up the development of chiral synthesis, enzyme catalysis, crystallization control and other chemical preparation technology to promote large-scale cell culture and purification, antibody conjugation, serum-free medium culture and other biotechnology research and development and engineering, Long-acting, slow release, targeting and other new formulations of technical level. To the needs of clinical drug-oriented, in the tumor, cardiovascular and cerebrovascular diseases, diabetes, neurodegenerative diseases, psychiatric diseases, high immune diseases, major infectious diseases, rare diseases and other areas, focusing on the development of targeted, , The role of the new mechanism of treatment of drugs, focusing on imitation of the market potential, the clinical need of foreign patents expired drugs. And accelerate the development and industrialization of new types of antibodies, proteins and peptides. Improve the vaccine supply system, and actively create hand-foot-mouth disease vaccine, new polio vaccine, cervical cancer vaccine and other urgent needs of new varieties and adjuvants. According to the needs of children's medication, the development of children's physiological characteristics of new varieties, dosage forms and specifications. To carry out clinical essential, the amount of small, the market supply of essential drugs designated production, to strengthen its capacity building and normalization of reserves to meet the basic needs of the masses of medicine.
            Accelerate the transformation and upgrading of medical equipment. Focus on the development of digital detectors, superconducting magnets, high-capacity X-ray tube and other key components, precise positioning and navigation surgery, data acquisition and processing and analysis, biological three-dimensional (3D) printing technology. The development of nuclear medicine imaging equipment PET-CT and PET-MRI, superconducting magnetic resonance imaging system (MRI), multi-row spiral CT, color ultrasound diagnosis, image guided radiation therapy, proton / heavy ion tumor therapy, medical robots, Telemedicine and other high-performance diagnostic equipment. Promote the automatic biochemical analyzer, chemiluminescence immunoassay analyzer, high-throughput gene sequencer, five categories of blood cell analyzer and other in vitro diagnostic equipment and reagents industrialization. The development of heart valves, pacemakers, full degradation of vascular stents, artificial joints and spine, cochlear implant and other high-end intervention products, and rehabilitation equipment in the high-end products. And actively explore the medical device based on the theory of Chinese medicine research and development.
            Promote the modernization of Chinese medicine. To carry out the research on the technical standards of traditional Chinese medicine, national medicine and clinical application, to strengthen the development of technical standards for cultivating Chinese herbal medicines, to establish the standard system of authentic Chinese herbal medicines, and to strengthen the protection of geographical indications in the field of Chinese medicine. To carry out the breeding of traditional Chinese medicine and modern cultivation (breeding), production technology promotion, in the appropriate area to build standardized cultivation (breeding), large-scale integrated processing base. Accelerate the establishment of dynamic monitoring system of Chinese herbal medicine resources, wild resources to carry out the use of Chinese herbal medicine ecological environment impact assessment. Strengthen the production of Chinese herbal medicine, Chinese medicine, circulation and use of retrospective system construction, improve the quality of Chinese medicine products and safety standards. Development of modern Chinese medicine extraction and purification technology, developed in line with the characteristics of traditional Chinese medicine mucosal drug delivery and other preparation technology, promotion of quality control, automation and on-line monitoring technology in the production of traditional Chinese medicine application. In the field of treatment of traditional Chinese medicine advantages, to promote the development and application of the classic secondary development, the development of a number of effective, safe, effective ingredients clear, clear mechanism of action of traditional Chinese medicine products. Strengthen the national medicine theory research, promote the Tibetan medicine, Victoria medicine, Mongolian medicine, Dai medicine and other national drug system development, improve the level of preparation of national medicine and medical institutions, to create a resource characteristics and efficacy of new varieties.
           (E) to speed up the quality of upgrading, and promote green and safe development.
            Strict production quality management. The full implementation and strict implementation of the new version of pharmaceutical production quality management practices (GMP), improve the whole life cycle and the whole industry chain quality management system, the implementation of full, the whole process, all-round quality management, improve drug safety traceability system. Strict temperature control, cleanliness and other production environment standards, strengthen management standards, work standards and other documents management, the establishment of quality risk prevention and control, supplier audits, continuous stability inspection, quality attorney and other quality management system. Strengthen the quality and safety of pharmaceutical companies responsible for the first consciousness, the implementation of the quality of the main responsibility. Strengthen quality and safety training, strict environmental, occupational health and safety (EHS) management, improve staff quality. Standardize the production and management behavior, focus on re-certification of light implementation, heavy hardware, software and other issues to strengthen the quality of essential drug supervision, supervision and pharmaceutical production enterprises to enhance the overall quality management level.
            Improve quality control technology. The establishment of scientific and effective quality standards and control methods to promote the use of advanced quality control technology, improve product design, optimize the process line, improve the whole process from raw materials to finished product quality control system, effectively improve the quality of drugs. Speed ​​up the chemical impurities, solubility, solvent residues and drug crystal technology development and application of control, improve product purity and stability. Enhance biological activity, equivalence, utilization and other biological properties of research, enhance fermentation and cell culture and other biological process variability control, focus on improving the safety of vaccines and other biological products, effectiveness. Increase the traditional Chinese medicine and other traditional Chinese medicine products, material basis for research efforts to improve the quality of the stability of the solvent, reduce the incidence of adverse reactions.
            Improve the quality standard system. We will improve the national drug standard system with the "Pharmacopoeia of the People's Republic of China" as the core, implement the action plan for improving the standards of drugs and medical devices, and promote the development of basic medicines, high-risk medicines, pharmaceutical excipients, packaging materials and basic, universal and high-risk medical care. Equipment quality standards to upgrade and improve the traditional Chinese medicine, medicine and herbal medicine production and technical standards and quality control standards to improve the scientific standards, rationality and maneuverability, and strengthen the authority of the standard and seriousness. Further improve the drug quality evaluation system, the establishment of drug impurities database, quality evaluation methods and testing platform. To improve the quality of generic drugs, to improve the methods and technical specifications of generic drug conformance evaluation, to carry out third-party testing and evaluation, and to improve the quality of generic drugs. Focusing on the quality of essential drugs and efficacy evaluation of consistency, improve the quality of essential drugs. To carry out risk assessment of harmful residues of Chinese medicine to strengthen the safety evaluation of traditional Chinese medicine injections, maintenance of Chinese medicine product quality and safety. Accelerate the improvement of metrology, standards, inspection and testing, certification and other public technical service platform, to encourage the construction of third-party quality and reliability evaluation platform to promote enterprises to increase investment and enhance product reliability.
            The implementation of green transformation and upgrading. The use of modern biotechnology to improve the traditional production process, and vigorously promote genetic engineering, biocatalysis and other biological alternative technology, and actively using bio-fermentation method of production of pharmaceutical active substances. Development of biotransformation, efficient extraction and purification, high yield and low consumption of bacteria and other clean production technology, to strengthen the fermentation of bulk raw material pollution prevention and control. Accelerate the application of non-toxic and harmless raw materials, strengthen the management of new chemical substances in R & D outsourcing enterprises, and promote the source of environmental pollution control. Construction of green factories and recycling economy park, to promote mutual supply of raw materials, sharing of resources, strengthening the by-product recycling, waste harmless treatment and comprehensive management of pollutants. Strict management of resource utilization, the implementation of energy system optimization project, to promote energy-saving water and land and equipment, eliminate backward process equipment, to strengthen high-value medical supplies recycling management, improve energy efficiency and cleaner production levels. Strengthen environmental risk control, investigation and management of environmental safety hazards, to prevent the occurrence of unexpected environmental events.
           (F) to optimize the industrial structure, enhance the intensive development level.
            Adjust the industrial organization structure. Strengthen the adjustment of enterprises' organizational structure, promote cross-sectoral and cross-sectoral mergers and reorganizations, support pharmaceutical and chemical, medical equipment and equipment, Chinese herbal medicines and proprietary Chinese medicines, pharmaceutical raw materials and preparations, production and circulation enterprises strong combination, Integration of enterprise groups, the real solution to small, scattered, chaos problems. Promote the production of essential drugs to the advantages of concentration, enhance the level of intensive production, protection of product quality and stable supply. To industry leading enterprises, joint products and technology similar to the innovative enterprises, research institutes and other units, to inject funds, technology shares and other forms of cooperation, the formation of industrial alliances or consortium. To play a key enterprise capital, technology and other advantages, strengthen the effective integration of production factors and business process reengineering, and strengthen new product development, marketing and brand building; play small and medium enterprises close to the market, flexible mechanisms, the development of technical precision, high quality medicine Package materials, and other ancillary products, the formation of large and medium-sized enterprises division of labor, mutual benefit and win-win industrial organization structure.
             Promote regional coordinated development. Give full play to the advantages of regional elements of resources, build a new pattern of coordinated development of the eastern, central and western regions. The use of the eastern coastal areas of capital, technology, personnel and other advantages, the construction of international advanced research and development centers and headquarters base, the development of high value-added, low consumption of biological drugs, pharmaceutical preparations and medical equipment to guide the lack of comparative advantage of the product out of order . The central region to carry out the advantages of East and West, according to the carrying capacity of resources and environment, and actively undertake the eastern region of industrial transfer, relying on the central city to carry out research and development and industrialization of high-end pharmaceutical products, local conditions, the development of medical supplies and other labor-intensive medical device products. The use of western and northeastern areas of medicinal resources and geographical advantages along the border, construction of traditional Chinese medicine, national medicine production bases and peripheral countries for the export of specialty pharmaceutical products base.
            Guide the development of industrial agglomeration. Promote the pharmaceutical industry scale, intensive, park, and create a number of management norms, environment-friendly, prominent features, high degree of industrial clusters of industrial clusters. (GAP) to carry out large-scale, standardized cultivation (breeding), in the Chinese herbal medicine resources to build large-scale production and processing base of traditional Chinese medicine, in the ethnic minority areas in the construction of the characteristics of the area of ​​?? the development of Chinese herbal medicine production and management National drug production base. With the adjustment of chemical raw material distribution and industrial transfer, relying on the environment carrying capacity, complete supporting facilities, the supply of raw materials and convenient chemical medicine park, building a high level of chemical raw material production base in coastal and border areas in line with international standards of export preparations Processing base. In the central city with talents and technological superiority, the construction of high-end R & D and industrialization bases of medical devices will be made through the radiation effects of industries such as electronics, information and equipment. Guide the conditional areas, the overall use of local medical, traditional Chinese medicine, ecotourism and other advantages of resources, play the role of the tourism market, development and construction of a number of sets of pension, medical, rehabilitation and tourism as one of the medical health tourism demonstration base to further improve social old- , Medical, rehabilitation, integrated tourism service system.

(Seven) the development of modern logistics, construction of medical integrity system.
             The establishment of modern marketing model. Improve the enterprise logistics information system, make full use of provincial drug centralized procurement platform information resources, build the national drug information platform, to the public price of drugs, dosage, quality, circulation and other information, accept the supervision of the masses, the establishment of information sharing and feedback tracing mechanism. The establishment of modern medicine circulation system to promote the construction of large enterprises throughout the urban and rural drug distribution network, give full play to postal enterprises, express delivery network advantage, improve grass-roots and remote areas of drug supply security capabilities. Promote the small and medium-sized circulation enterprises specialization, characteristics of development, so fine to do specifically to meet the multi-level market demand. According to the requirements of the new version of GSP, the retail enterprises should be promoted to carry out chain management, unified purchase and distribution, quality management, service regulation, information management and brand identity. The chain stores should be standardized and scaled. To promote the establishment of medical equipment communication protocol, fault feedback, testing and maintenance aspects of the open-source system, to encourage the development of third-party professional maintenance and after-sales service team.
              Strengthen the credit system. Improve the integrity of medical management mechanism and system to improve the market integrity of the environment. The Company will integrate the existing credit information resources and establish the credit record files of pharmaceutical R & D, production and circulation enterprises, and integrate them into the unified national credit information sharing and exchange platform. The information shall be disclosed in the "Credit China" website and the enterprise credit information publicity system in accordance with the relevant regulations. The development of information collection, evaluation, disclosure and other systems, the establishment of corporate credit "blacklist." The use of media, market access and other means to increase the joint punishment of corporate bad faith efforts to improve the cost of dishonesty. Speed ​​up the construction of enterprise credit and commodity quality insurance system, explore the implementation of product quality and safety mandatory commercial insurance, strengthen enterprise self-restraint. Guide enterprises to establish credit management system, the development of evaluation system, take the initiative to carry out commitments and trustworthy, consciously accept the social supervision.
            (8) close convergence of medical reform, and create a favorable market environment.
             Improve the medical service system. Accelerate the reform of public hospital compensation system, establish a scientific and reasonable system of rewards and punishments, combined with the separation of medicine, eliminating the addition of drugs such as the implementation of policies to strengthen the treatment of behavior management to prevent excessive treatment of non-standard behavior and control of medical expenses. Medical institutions should be in accordance with the generic name of the drug prescription, and take the initiative to provide patients with prescriptions to protect the patient's purchase of drugs to choose the right to promote the ownership of various types of medical institutions to share equipment to promote mutual recognition of medical institutions to check the results to reduce duplication of inspection, burden. Improve the social environment for the development of medical institutions in the market access, social insurance, key specialty construction, job evaluation, academic status, grade evaluation of all medical institutions equal treatment to accelerate the formation of diversified medical services pattern, Option. Promote doctors to practice more, to enhance primary health care service capacity, speed up the implementation of classification treatment.
              Improve the price, health insurance policy. The implementation of medical, health insurance, pharmaceutical linkage reform, give full play to the role of market mechanism, the actual transaction price of drugs mainly formed by the market competition. Strengthen the price, health insurance, bidding and other policy convergence, scientific development of health insurance payment standards, strengthen the comprehensive supervision of medical expenses and price behavior, improve drug price monitoring system, promote price information disclosure. Actively and steadily push forward the price reform of medical services, the establishment of changes in cost and income structure based on the dynamic price adjustment mechanism, and gradually rationalize the relationship between medical services parity, and effectively reflect the value of medical and technical personnel services. According to the principle of "total control, structural adjustment, rising and falling, and gradually put in place", the price of medical service should be adjusted rationally, and the adjusted expenses should be included in the scope of medical insurance payment to realize the burdens of the masses. Actively promote the reform of Medicare payment methods, strengthen the health insurance fund budget, the implementation of disease, according to a variety of payment methods, such as a combination of payment methods. According to the ability of medical insurance funds, in time to meet the conditions, the price is reasonable, with independent intellectual property rights of drugs, medical equipment and medical treatment projects in accordance with the prescribed procedures into Medicare payment range. Improve the serious illness insurance policy, carry out the work of medical treatment of major diseases, vigorously develop commercial health insurance, to meet the diversification of social health insurance and pharmaceutical products.
         (9) Deepen the cooperation with foreign countries and expand the international development space.
          Optimize the export structure. Accelerate the development of international emerging pharmaceutical market, adjust the export structure. We will give full play to the international competitive advantages of chemical APIs and promote the export of deep processed products such as vitamins, penicillins, erythromycin and cephalosporins. We will vigorously implement the international strategy of preparations, speed up the preparation of first imitates, recombinant protein drugs, antibody drugs and vaccines. Export, improve the bulk drug, combination of export capacity, to cultivate well-known brands of Chinese medicine. Establish and improve the overseas sales and service system, and promote the export of PET-CT, X-ray machine, electrocardiogram machine, B-class medical equipment, and gradually increase the export value-added. Strengthen the international exchange of Chinese medicine, improve the international community awareness, enhance the international standard of Chinese medicine to develop the right to speak, to promote natural medicine, Chinese medicine and other products exports.
           Promote international registration certification. Introduce and cultivate international pharmaceutical registration personnel who are familiar with overseas laws, regulations and market environment, and improve the international registration capacity. System to carry out international market product registration, to promote the patent protection has been made of the original international research and clinical drug research and registration, to speed up the brand generic drug international registration certification. And actively carry out with the medical device-related measurement of international comparison. In accordance with international standards, improve the process route, quality testing and analysis methods, improve the environment, occupational health and safety (EHS) management system, the establishment and implementation of raw materials and accessories for the record management system. Speed ​​up the production of quality management practices (GMP) and other international quality system certification, and promote enterprise construction in line with international quality standards of the production line and improve the international level of production and management to speed up the process of testing and certification of the international. Encourage enterprises to apply for foreign patents, the formation of an effective overseas patent layout.
            Accelerate the pace of international cooperation. Implement the strategy of "all the way along the way", focus on the global allocation of resources, speed up the "going out" pace. The establishment of overseas research and development centers, production bases, sales networks and service systems, access to new products, key technologies, production licenses and sales channels, to accelerate the integration into the international market. Market, creating a number of internationally influential well-known brands. Encourage enterprises to actively participate in international public health cooperation, and continuously expand and consolidate the international market. Improve the investment environment, strengthen the construction of supporting system, increase the "introduction to" efforts to encourage enterprises under special customs supervision to undertake bio-pharmaceutical outsourcing business. To promote multinational companies to build high-level pharmaceutical R & D centers, production centers, procurement centers in China, to accelerate industrial cooperation from processing and manufacturing links to R & D design, marketing, brand cultivation and other high value-added links to extend the level of international cooperation.

(X) to nurture new industry, to promote the development of industrial intelligence.
            Construction of intelligent demonstration plant. Promote the intelligent production process of medicine, carry out the demonstration of intelligent factory and digital workshop construction. Speed ​​up human-computer interaction, industrial robots and other technical equipment in the pharmaceutical production process applications, to promote the manufacturing process simulation optimization, real-time feedback and adaptive state control information. The paper builds a new production model of consumer demand dynamic perception, crowdsourcing design and personalized customization of medical products by applying the technologies of large data, cloud computing, Internet and material manufacturing. Speed ​​up the digitalization and intelligentization of medical devices and focus on the development of wearable and portable mobile medical and auxiliary equipment products, and promote the application of new technologies such as biological three-dimensional (3D) printing technology and data chips. Promote the intelligent upgrading of pharmaceutical production equipment, speed up industrial control systems, intelligent sensing components such as core technology and equipment R & D and industrialization, support the pharmaceutical industry, intelligent factory building.
            To carry out intelligent medical services. Quality medical resources to play a leading role to encourage social forces to participate in the integration of online and offline resources, regulate the medical Internet of things and health care applications (APP) management. Actively carry out the Internet online health consultation, appointment clinics, waiting reminders, price paid, medical reports and other convenient services. Strengthen the integration of regional medical and health service resources, encourage medical service institutions to establish medical information platform, and actively carry out Internet health care information services. Guide medical institutions to use information technology, intelligent technology and equipment, for the grassroots, remote and underdeveloped areas, carry out remote pathological diagnosis, image diagnosis, expert consultation, monitoring guidance, surgical guidance and other telemedicine services.
            Third, strengthen policy support and organization and implementation
           (11) to strengthen financial and financial support. Innovation and financial funds to support the use of incentives to guide, capital injection, application of demonstration subsidies to support the application demonstration and public service platform construction has a strong public service nature of the project; use and guide industry investment, venture capital funds to support Innovative product research and development, industrial construction and other aspects of a for-profit, competitive projects to support innovation and development capabilities of key enterprises and industry alliances, the integration of upstream and downstream industry chain resources. Explore medical device manufacturers and financial leasing companies, finance leasing companies, for all types of ownership of medical institutions to provide large-scale medical equipment purchase services. Research and development of domestic shortages, to be breakthroughs in the list of key pharmaceutical products, the chemical structure of the directory clear, in line with the tax classification rules to meet the regulatory requirements of raw materials, research and implementation of the lower provisional tax rate, the development of the use of units in medicine Product innovation, value-added services and demonstration applications and other aspects of the incentive mechanism. Support eligible innovative pharmaceutical manufacturers listed financing, issuance of bonds, mergers and acquisitions, restructuring.
            (12) to support innovative product promotion. Research and development of innovative and excellent drugs, medical equipment product catalog. Increase the publicity of innovative products, and enhance the clinicians and the masses of people with independent intellectual property rights of pharmaceutical products recognition. Through the first (sets) of major technical equipment insurance compensation pilot work to support qualified high-end medical equipment application promotion, continue to promote the implementation of innovative medical device product application demonstration project (including "ten million project"), in some provinces To carry out large-scale medical equipment configuration pilot. And further increase the promotion of innovative medical device products, at different levels of medical institutions to carry out pilot demonstration applications. Encourage pharmaceutical companies and large hospitals to build innovative drugs, medical equipment demonstration base, training center, the formation of demonstration applications - clinical evaluation - technological innovation - radiation promotion of a virtuous circle.
            (XIII) improve the government procurement mechanism. In accordance with the principles of open and transparent, fair competition, improve the bidding and purchasing mechanism, and gradually into the public procurement of medicines and chemical products trading platform. The implementation of classification of procurement, scientific setting review factors to promote drugs, high-value medical supplies procurement coding standardization to ensure that the price is reasonable to protect the supply, quality and safety. Regulate the order of competition, breaking the market segmentation of pharmaceutical products, local protection. To further improve the double envelope evaluation method, the bid price was significantly lower, there may be quality and supply of drugs, must be comprehensive assessment, to avoid vicious competition. And comprehensively promote the information disclosure, the establishment of the high price of drugs and dynamic adjustment of the verification mechanism to ensure that all aspects of drug procurement in the sun to run. According to regional health planning, develop and improve medical equipment at all levels of medical equipment standards, strict control of financial funds to purchase unreasonable standards, high-end equipment. Strict implementation of the "People's Republic of China Government Procurement Law" provides that domestic drugs and medical equipment to meet the requirements of government procurement projects in principle, the procurement of domestic products to be gradually increase the level of public medical institutions made equipment configuration.
             (XIV) Deepening the examination and approval and reform. The establishment of more scientific and efficient drug medical device review and approval system. Strengthen the construction of the review team and recruit experts and scholars with experience in international review and approval. Strengthen the government procurement review services, strengthen the technical review collaboration capacity building, improve the review and approval capacity and efficiency. Public acceptance, approval of relevant information, increase the transparency of review and approval. Strict control of the market oversupply, low-level duplication, production process backward product approval, to accelerate the clinical urgently needed innovative drugs, medical device product review, guide the applicant to orderly research and development, scientific reporting. Accelerate the development of new diagnostic and therapeutic techniques of clinical application of technical specifications. In the case of genetic testing products that have been identified as innovative medical devices, priority should be given to the examination and approval of innovative medical devices and procedures to accelerate the entry of innovative medical services into the health care system and the promotion of new technologies for clinical use. Accelerate the drug licensing system to pilot the pilot to promote drug research and development and production of specialized division of labor, accelerate the transformation of scientific research. Encourage the development of drug research and development, production, and gradually relax the restrictions on the transfer of drugs, and guide enterprises mergers and reorganization, reduce homogenization of competition and review of waste of resources.
            (15) Accelerate the construction of qualified personnel. Depth implementation of the talent development strategy, focusing on drug innovation, the core of hardware and software development of medical devices, Chinese medicine heritage, the international registration of pharmaceutical products and other needs, improve talent introduction, training, incentive mechanism, to make the best use of talent. surroundings. Continue to implement the "thousands of people plan" and other projects to attract intellectual, to attract overseas product innovation, international registration and other aspects of high-level talent and team innovation and entrepreneurship in China. Encourage pharmaceutical enterprises to set up post-doctoral research station. To improve the quality of drug management and enterprise competitiveness as the core, and actively carry out various forms of pharmaceutical enterprise management training, training a group of leading pharmaceutical entrepreneurs. Strengthen vocational education and skills training, the construction of medical application technology education and training base, to create a skilled team of skilled personnel. Improve the evaluation of medical institutions and post positions related to the approach. Support enterprises and institutions of higher learning, medical institutions, medical equipment engineers and other practical training of technical personnel. Encourage the establishment of entrepreneurial innovation centers and other personnel training platform to enhance collaborative innovation. Strengthen the building of the pharmaceutical team to enhance the service capacity of practicing pharmacists, and promote safe and rational use of drugs. Establish a sound technology, skills and other factors involved in the income distribution mechanism to encourage the adoption of technology shares and other forms, to fully mobilize the enthusiasm and creativity of talent.
            (16) to strengthen coordination of industry supervision. Improve the regulatory authorities, industry associations, pharmaceutical companies communication mechanism, improve the horizontal to the edge, vertical in the end of the regulatory network, the formation of a total social governance governance pattern. Support industry associations and other social groups to carry out industrial operation monitoring and analysis, industrial development strategy research and industry information release. Strengthen the management of drugs and medical devices in the process of use, strengthen the monitoring of adverse drug reactions, the implementation of enterprise products after listing the main responsibility for monitoring adverse reactions. Improve the safety evaluation of drugs after the listing mechanism, the establishment of drug delisting system. Establish and improve a comprehensive evaluation system for clinical drug use with the focus on basic drugs, improve the early warning mechanism for drug shortage, dynamically grasp the production situation of key enterprises, and improve the supply support capacity and level. We should strengthen the construction of laws and regulations for the supervision of pharmaceuticals and medical devices, intensify flight inspection, and promptly investigate and deal with illegal enterprises according to law. Strict security, environmental protection, and resolutely shut down according to the law does not meet the requirements of pharmaceutical companies. To the chemical and pharmaceutical enterprises to carry out response risk analysis, the formal design, equipment, reliable and automatic control system to enhance the level of intrinsically safe. For other pharmaceutical enterprises that use hazardous chemicals, it is necessary to establish a sound management system for hazardous chemicals, strengthen staff training and improve risk management and control capabilities. Strengthen the protection of medical intellectual property rights, speed up the construction of intellectual property rights social credit system, increase the crackdown on infringement, establish a punitive compensation system, reduce the cost of enterprise rights. Rectify and standardize the pharmaceutical market, crack down on the production and operation of counterfeit and shoddy pharmaceutical products, the implementation of commercial bribery, secretly manipulating prices and other illegal activities.
              All localities and departments should fully understand the importance of promoting the healthy development of the pharmaceutical industry, strengthen organization and leadership, improve the working mechanism, the formation of work together. All regions should formulate concrete implementation plans in light of actual situations, and organize and implement them meticulously so as to ensure that all tasks are carried out. Departments in accordance with the division of responsibilities to develop complementary policies to create a good environment. National Development and Reform Commission to strengthen co-ordination, a clear timetable for the implementation of various policy measures, together with relevant departments to strengthen policy guidance and supervision and inspection, and promote sustained and healthy development of the pharmaceutical industry.
Office of the State Council 
March 4, 2016

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