General office of the state council on promoting the healthy development of the pharmaceutical industry guidance

Time: 2016-03-15

Source: Chinese government net

Countries do hair [2016] 11

The provinces, autonomous regions and municipalities directly under the central government, ministries under the state council, directly affiliated institutions:

The pharmaceutical industry is the support the development of medical and health undertakings and the important basis of health services, will guide the whole construction machinery is strong growth, relevance and sunrise industry, in livelihood, steady growth has played an active role. To develop the medicine industry, for deepening the reform of medical health system, promote the health of China construction, is of great significance to foster economic development momentum. Since the reform and opening, our country medicine industry achieved rapid development, the rapid growth of industrial scale, will markedly enhance its capability of supply, but still faces the independent innovation ability is not strong, irrational industrial structure, the problems such as nonstandard market order. At present, the global pharmaceutical technology development by leaps and bounds, the pharmaceutical industry a profound adjustment change, people's health demand continues to grow, to transformation and upgrading of the pharmaceutical industry put forward the urgent request. In order to promote our country medicine industry core competitiveness, and promote the sustained and healthy development of the pharmaceutical industry, agreed to by the state council, we put forward the following opinions.

First, general requirements

(a) the guiding ideology. Fully implement the party's eighteen big eighteen class 3, 4, and fifth plenary session of the spirit, in accordance with the party central committee and the state council decision deployment, firmly establish and earnestly implement the innovation, the coordination, the development of green, open, sharing ideas, take the initiative to meet a new round of industrial transformation, by optimizing the application environment, strengthening elements support, adjusting the industrial structure, strict industry supervision, deepen the opening up and cooperation, the medicine industry innovation vigor, the reduction of pharmaceutical products from r&d to listed all the links of cost, speed up for examination and approval of pharmaceutical products, production, circulation, use system reform, to promote the pharmaceutical industry intelligence, value-chain, ecology, implement industry high-speed development and to the high-end transformation, continuously meet the health needs of the people's multi-level and diversification.

(2) the basic principles.

Adhere to the market leading, government guidance. Strengthened enterprise market main body status, make the market plays a decisive role in the allocation of resources and better give play to the role of the government. Cooperate with related reform policy implementation, perfect the industrial policy and regulatory system, standardize the market order, and pay attention to industrial upgrade and application promote each other, to create a fair competition environment.

Insist on innovation drive, opening up and cooperation. Improve the innovation environment, and promote political study in depth fusion, to strengthen the construction of medical technology innovation ability and promote innovative technologies, products and business models. To speed up the pharmaceutical products management, quality, standard and registration system in line with international standards, make full use of international resources, strengthen the industry layout and international cooperation around the world.

Adhere to the industrial concentration and green development. Promote chemical pharmaceuticals to the environmental carrying capacity is strong, good zone reflect production supporting conditions. Guide the traditional Chinese medicine and national medicine enterprises grow (breeding), processing integration. Of enterprise circular production, industrial circulating combination, garden circulation, promote the development of medicine industry upgrade and green green security.

Adhere to improve the quality and ensure supply. To strengthen the enterprise quality of main body responsibility, improve the quality standard and inspection system, ensure that the product is safe and effective. To strengthen the construction of basic drugs production, supply capacity and improve the pharmaceutical circulation information network, establish a market shortage of drugs and innovative drug approval for examination and approval and market access channel quickly, improve the ability of supply security.

(3) the main goal. By 2020, the medicine industry innovation ability obviously improved, markedly enhance its capability of supply security, implement generic listing more than 90% of the major drug patents expire, tight supply situation effectively relieve the shortage of clinical drugs; Industry green, safe and efficient development and quality management level improved significantly; To further optimize the industrial organization structure, system, mechanism gradually perfect market conditions improved significantly; The further growth of the pharmaceutical industry's main business income growth rate above 10%, industrial added value growth among the industry forefront.

Second, the main task

(4) to strengthen technological innovation, and improve the core competitive ability.

Promote the innovation ability. Increase the intensity of science and technology system reform, perfecting the administration of production, use medicine, collaborative innovation system. Strengthen the original drugs, medicine and new preparations of Chinese medicine,, high-end medical equipment, such as innovation ability construction, the optimize allocation of resources of science and technology, building layout is reasonable, scientific and efficient scientific and technological innovation base. Screening using database and computer, the Internet, such as information technology, the construction of pharmaceutical products technology research and development, industrialization, safety assessment, clinical evaluation and other public service platform. Actively develop the space, vigorously promote the innovation in the public business, foster a batch of has characteristics of technology, talents of innovative small and medium-sized enterprises, to promote research and development outsourcing enterprises to the whole process of innovation, improve medicine and new product development ability.

Promote the industrialization of major drug. Continue to promote the drug discovery and accelerate the development of chiral synthesis, enzyme catalysis, chemical medicine preparation technology, such as crystallization control promote large-scale cell culture and purification, antibody coupling, a medium without serum protein, such as biotechnology research and development and engineering, promote long-term, sustained and targeted new preparation technology. Guided by the demands of clinical medicine, in cancer, cardiovascular disease, diabetes, neurodegenerative diseases, mental illness, high-risk sexual immune diseases, major infectious diseases, is a rare disease, and other fields, key development has targeted, high selectivity, the new mechanism of drug treatment, key generic market potential, foreign patent medicines for urgent clinical needs. Accelerate new antibodies, proteins and peptides, biological medicine research and development and industrialization. Perfect vaccine supply system, positive initiative, foot and mouth disease vaccine, new polio vaccine, cervical cancer vaccine and other much-needed variety and novel adjuvants. Demand for children's drugs, new products conform to the children's physical characteristics, types and specifications. Clinical required, small dosage of fixed-point production, market supply of basic drugs, strengthen its production capacity and normalized reserves, meet the demand of the basic drugs.

To speed up the transformation and upgrading of medical equipment. Focus on developing the digital detector, superconducting magnet, high heat capacity of X-ray tube and other key components, the operation precision positioning and navigation, data acquisition, processing and analysis, three-dimensional (3 d) printing technology. Nuclear medical imaging equipment developed PET, CT and PET, MRI, superconducting magnetic resonance imaging (MRI) system, multiple row helical CT and color ultrasound diagnosis, image guided radiotherapy, proton/heavy-ion cancer therapy, surgical robot, health monitoring, remote medical treatment and other high-performance medical equipment. Promote full automatic biochemical analyzer, chemical luminescence immunity analyzer, high-throughput gene sequencing machine, five categories in vitro diagnostic equipment and facilities, such as blood cell analyzer reagent industrialization. Development of heart valve, heart pacemakers, full degradable stent, artificial joints and spine, cochlear implants, such as high-end rooted in products, as well as the rehabilitation equipment in high-end products. Active exploration based on the theory of traditional Chinese medicine research and development of medical equipment.

Promote the modernization of traditional Chinese medicine. In traditional Chinese medicine, folk medicine and clinical application of technical standards, strengthening Chinese herbal medicine planting (breeding) cultivating technology standards, Chinese drugs of TCM, standard system, strengthen the protection of geographical indications in the field of Chinese medicine products. To carry out the well-bred breeding and modern Chinese herbal medicine planting, breeding), production technology, construction standardization planting in suitable region (breeding), the integration of large-scale processing base. We will accelerate the establishment of a Chinese herbal medicine resources dynamic monitoring system, the development of wild medicinal herbs resource utilization of the ecological environment impact assessment. Strengthen the traditional Chinese medicine, Chinese traditional medicine production, circulation and use the traceability system construction, improve the product quality and safety level. The extraction and purification technology, the development of modern Chinese medicine research and development accord with the characteristics of traditional Chinese medicine (TCM) such as mucosal drug delivery formulation technology, promotion of quality control, automation and online monitoring technology in the application of traditional Chinese medicine production. The advantages of traditional Chinese medicine therapy, and promote classic square secondary development and application, developed a batch of curative effect, high safety, clear, clear mechanism of effective components of traditional Chinese medicine products. Strengthen the national medicine theory research, and promote Tibetan medicine, medicine, Mongolian and dai medicine such as national medicine system development, improve the level of national pharmaceutical preparations of medical institutions, to create with resources characteristics and new varieties of curative effect advantage.

(5) to speed up the quality upgrading, promote the development of green security.

Strict production quality management. Fully implement and strictly implement the new pharmaceutical production quality management practices (GMP), and the whole industry chain in whole life cycle of perfect quality management system, implementation of full, whole process and comprehensive quality management, improve the drug safety traceability system. Strict production environment, such as temperature, cleanliness standards, strengthen the management standard, working standard, such as file management, establish quality risk prevention and control, supplier audit and continuous stability test, quality authorized person of the quality management system. Enhance the consciousness of the pharmaceutical enterprise quality and safety of the first, to carry out the principal responsibility for the quality. Strengthen the quality and safety training, strict environmental, occupational health and safety (EHS) management, improve the quality of employees. Regulating the behavior of the production and operation, and address the light weight certification implementation, hardware and software problems, strengthen the regulation of essential medicines quality, urge the pharmaceutical production enterprise comprehensive quality management level of ascension.

Improve quality control technique. Establish scientific and effective quality control standards and methods, application of advanced quality control technology, improve product design, optimization of process route, from raw materials to finished products to improve the whole process of quality control system, effectively improving the quality of medicines. To speed up the chemical medicine impurities, solubility property, solvent residue and drug control technology development and application, such as crystal shape to improve product purity and stability. Strengthen biological activity, equivalence, exploitation degree, such as biological medicine performance research, to enhance the biological processes, such as the fermentation and cell cultures variability control ability, strive to improve the safety and effectiveness of vaccines and other biological products. More Chinese medicine, traditional medicine products material such as national medicine basic research, improve the quality of cosolvent stability, reduce the incidence of adverse reactions.

Perfect the quality standard system. Sound to the "pharmacopoeia of the People's Republic of China" as the core of the national drug standards system, the implementation of drugs, medical devices standards improve action plan, promote the basic drugs, high-risk medicines, medicinal materials, packaging materials and basic, versatility and high risk medical instrument quality standard upgrade, improve the traditional Chinese medicine, folk medicine medicinal and pharmaceutical production specification and quality control standard, improve the standard of scientific nature, rationality and maneuverability, improved standards authority and seriousness. We will further improve the drug quality evaluation system, establish the database of impurities, the quality evaluation methods and testing platform. Improve the generic consistency evaluation method, technical specifications, to carry out the third party testing, evaluation, improve the quality of generic drugs. Focus on basic drug quality and curative effect evaluation consistency, comprehensively improve the quality of basic drugs. In Chinese traditional medicine residues in risk assessment, strengthen the safety evaluation of traditional Chinese medicine injections, maintain product quality and safety of Chinese medicine. To improve measurement, standards, testing, certification and accreditation, such as public technical service platform, encourage the construction of the third party quality reliability evaluation platform, promote enterprise increasing investment, improve product reliability.

Implementation of green upgrade. Use modern biological technology to improve the traditional production technology, vigorously promote biological substitute technology such as gene engineering, biocatalysis, active medicinal active material was produced by fermentation method. Development of bioconversion, efficient extraction and purification, strains of high yield and low consumption, application of clean production technology, strengthening prevention and control of fermentation type of bulk drug substances pollution. To speed up the popularization and application of non-toxic harmless raw materials, to strengthen the management of r&d outsourcing enterprise new chemical substance, promote environmental pollution source. Building a green plant and the circular economy park, promote the raw material for each other, sharing resources, strengthen the by-product recycling, waste disposal and pollution comprehensive treatment. Strict management of resource use, energy system optimization project implementation, promote energy conservation and water saving technology and equipment in rhythmic, backward process equipment, in order to strengthen the management of high value medical consumables recycling, improve the utilization efficiency of energy resources and clean production level. To strengthen environmental risk control, the governance environment safety, prevent emergency environmental accidents.

(6) to optimize the industrial structure, enhance the level of intensive development.

Adjust the structure of industrial organization. Increase the intensity of enterprise organization structure adjustment, promote cross-industry, interdisciplinary merger and reorganization, support medical and chemical industry, medical devices and equipment, medicines and proprietary Chinese medicine, drug substances and drug products, combination of production and circulation enterprises, thus forming the integration of upstream and downstream enterprise group, really solve the problem of small, scattered and disorderly. Basic drug production superior enterprises to the central, enhance the level of intensive production, ensure product quality and stable supply. Is given priority to with industry leading enterprises, joint of similar products and technology innovation-oriented enterprises, scientific research institutes and other units, to take money, technology investment, and other forms of cooperation, establish industrial union or association. Play to the advantages of the backbone enterprise capital, technology, strengthen the production factors effective integration and business process reengineering, strengthen new product development, marketing and brand building; Play to small and medium-sized enterprise characteristic such as close to the market, flexible mechanism, the development of technology, high quality of pharmaceutical intermediates, auxiliary materials, packaging and other supporting products, form a medium enterprise division of labor cooperation, mutual benefit and win-win industrial organization structure.

Promote balanced development among regions. Give full play to the regional factor resources advantage, to build the east new pattern of coordinated development in the Midwest. Using the eastern coastal areas capital, technology and talent advantages, the construction of the international advanced research and development center and headquarters base, developing high added value, low resource consumption of biological drugs, medical devices and pharmaceutical preparations, guiding the roll-out lack of comparative advantage products. Play a central area linking the west location advantages, according to the resources and environment carrying capacity, actively undertake industrial transfer in the east, relying on the central city to develop high-end medical products research and development and industrialization, adjust measures to local conditions to develop medical consumables such as labor intensive medical equipment products. Use of medicinal material resources and border areas in the western, northeast location advantages, establish production bases of traditional Chinese medicine, folk medicine and characteristics of pharmaceutical products export base for neighboring countries.

On the development of industrial agglomeration. To promote the pharmaceutical industry scale, intensive, park, creating a batch of standardized management, environment friendly, outstanding characteristics, the industrial connection high industrial concentration area. Lead advantage enterprises grow in the appropriate medicine area, according to Chinese herbal medicine production quality management standard (GAP) to carry out large-scale, standardized cultivation (breeding), in traditional Chinese medicine source construction of large Chinese medicine production and processing base, the construction of the national minority community of the characteristics of ethnic medicine production base. In combination with chemical pharmaceuticals layout adjustment and industry transfer, relying on the environmental carrying capacity is strong, complete supporting facilities, raw materials supply convenient industrial park, construction of a high level of chemical pharmaceuticals production base, in the coastal and border area construction preparation of international standard export processing base. In central cities with talent and technology advantages, use of electronic, information, and the radiation effect of equipment industry, the construction of high-end medical equipment research and development and industrialization base. Guide the conditional region, overall use of local medical care, Chinese medicine, the advantages of the ecological tourism resources, give play to the role of the tourism market, development and construction of a batch of pension, medical, rehabilitation and tourism as one of the medical health tourism demonstration base, further improve the social pension, medical, rehabilitation, tourism services integrated system.

(7) the development of modern logistics, build medical credit system.

Modern marketing model is established. Improve enterprise logistics information system, make full use of the provincial drug centralized purchasing information resources platform, to build national drug information platform, to the public drug information such as price, amount, quality, distribution, accepts the populace to supervise, establishing information sharing and feedback tracking mechanism. Modern medicine circulation system, promote the construction of large enterprises in urban and rural distribution network of drug circulation, give full play to the postal enterprises, express delivery companies deliver network advantage, improve the ability of drug supply in remote areas at the grass-roots level and security. Promote the development of small and medium circulation enterprises specialization, characterization, doing fine designed, meet the multi-level market demand. According to the new drug management quality management standard (GSP) requirements, the advantage of retail enterprises to carry out chain operation, unified purchase and distribution, quality management, service specification, information management and brand identity, improve the level of chain pharmacies standardization, scale management. Promote the establishment of medical equipment of the communication protocol, inspection maintenance, fault feedback of open source system, encourage the development of the third party professional maintenance and after-sales service team.

To strengthen the construction of credit system. Improve the medicine, the good faith management mechanism and system, improve market credit environment. Integration of the existing credit information resources, the establishment of pharmaceutical research and development, production and circulation enterprises credit records, into the national unified exchange of credit information sharing platform, and in a timely manner in accordance with the relevant regulations in the "credit" China public website, enterprise credit information publicity system. For information collection, evaluation and disclosure system, establish credibility enterprises "blacklist". Technics of media publicity, market access, increase the faithless enterprise joint punishment strength, raise the cost of broken promises. Accelerate the construction of enterprise credit and quality insurance system, to explore the implementation of product quality and safety compulsory insurance business, strengthening enterprise self-discipline. Guide enterprises to establish the good faith management system, establish evaluation system, and actively carry out honest promise, accept social supervision.

(8) to connect the health, create a good market environment.

Improve the medical service system. We will accelerate reform of the public hospital compensation mechanism, establish a scientific and reasonable evaluation system of rewards and punishments, combined with medicine separately, cancel the drug addition, policy implementation, in order to strengthen the management of medical behavior, prevent excessive treatment of irregularities, such as controlling medical expense. Medical institutions shall, in accordance with the generic prescription drugs, and take the initiative to provide patients with prescription, ensuring patients drug options; Promote Shared ownership of medical institutions equipment, promote results mutual recognition between medical institutions, reduce duplication of inspection, reduce the patients' medical burden. Improve the development environment of medical institutions run by social forces, in market access, social insurance, key specialty construction, title evaluation, academic status, grade evaluation of all medical institutions treated, speed up the formation of diversified medical service pattern, increase the option. Push the doctor more practice, improving the capacity of grassroots medical institutions service, accelerate the implementation of hierarchical diagnosis and treatment.

Perfect price, health care policy. Implementation of medical treatment, health care, medical reform of linkage, fully give play to the role of market mechanism, drug actual transaction prices are mainly formed by the market competition. Strengthen prices, health care, bidding and purchasing policy such as cohesion, science for medical insurance payment standard, strengthen the comprehensive medical costs and price behavior regulation, improve the drug price monitoring system, promote public information. Actively yet prudently proceed with medical service price reform, established on the basis of cost and income structure change of price dynamic adjustment mechanism, making medical service price comparison relations gradually, which embody the medical staff of technical labor value. According to the "total amount control, structural adjustment, mixed, gradually in place," the principle of reasonable adjustment of medical service prices, adjusted to produce fees according to regulations in medical insurance to pay limits, realizing the burden of the masses. Payment actively promote health care reform, strengthen the medical insurance fund budget, implement according to disease, according to wait for a variety of methods of combining the composite method of payment. According to the medical insurance fund bear ability, will conform to the conditions in time, the price is reasonable, with independent intellectual property rights of drugs, medical devices and diagnostic program according to the prescribed procedures included in medical insurance to pay limits. Major workplace sound serious security policy, and how to carry out comprehensive disease medical relief work, vigorously develop commercial health insurance, meet the demand of social diversified health care and medical products.

(9) to deepen international cooperation, expand the international development space.

Products export structure optimization. To speed up the development of international emerging pharmaceutical market, adjust the export structure. Advantage of chemical pharmaceuticals international competition, promote vitamin, penicillin, erythromycin, cephalosporins varieties of advantages, such as deep processing products exports, vigorously implement the internationalization strategy, speed up the first copy, recombinant protein drugs, antibody drugs, vaccines and other preparation products export, improve the ability of combination drug substances and drug products export, cultivate Chinese medicine famous brand. Establish and perfect sales and service system, promote PET - CT, X-ray, electrocardiogram machine, B chao deng medical equipment export, gradually increase export of added value. To strengthen cultural exchanges with other countries of traditional Chinese medicine, raising awareness, the international community to enhance Chinese medicine international standards say, facilitate the export of natural medicines, proprietary Chinese medicine, and other products.

Promote the international registration of certification. Introduce and cultivate familiar with foreign laws and regulations and market environment of international registered medical personnel, improve the ability of international registration. Product registration system for international market, promote has obtained patent protection for the domestic original international clinical research and drug registration, to speed up the international brand of generic drugs registration certification. Actively carry out medical apparatus and instruments related measurement international comparison. According to international standards, perfect technology, quality testing and analysis methods, improve the environment, occupational health and safety (EHS) management system, establish and implement the raw materials and auxiliary materials for the record management system. Accelerate drug production quality management practices (GMP) production of international quality system certification, promote the construction of enterprise in line with international quality standard production line, improve the level of internationalization of production and operation management, accelerate the process of internationalization of certification testing. Encourage enterprises to apply for patents abroad, form effective overseas patent layout.

To speed up the pace of international cooperation. All the way around the implementation of the "" strategy, focus on the global resources, speed up the pace of" going out ". Use a variety of forms of cooperation, to promote medical advantage enterprises carry out overseas mergers and acquisitions and equity investment, venture investment, set up overseas research and development center, production base and sales network and service system, to obtain the permission of new products, key technology, production and sales channels, accelerate into the international market and create a batch of well-known brand with international influence. Encourage enterprises to actively participate in international cooperation in the field of public health, continue to expand and consolidate the international market. Improve the investment environment, strengthen the construction of supporting system, increase the strength of "introducing", encourage enterprises within the areas under special customs supervision to undertake biomedical outsourcing business. Promote the construction of multinational companies in China, a high level of pharmaceutical research and development center, production center, purchase center, speed up industrial cooperation from the processing and manufacturing link to r&d, design, marketing, brand cultivation, high value-added links, improve the level of international cooperation.

(10) to foster new formats, promoting the development of industry intelligence.

Building intelligent demonstration plant. Promote the pharmaceutical production process intelligent and carry out intelligent plant and the model of the digital workshop construction. To speed up the man-machine intelligent interaction, industrial robot technology and equipment in the pharmaceutical production process, the application of push manufacturing process simulation optimization, the state information real-time feedback and adaptive control. Application of big data, cloud computing, Internet, increase material manufacturing technology, such as construction of pharmaceutical products consumption demand dynamic perceived, the package design, customization, a new mode of production. To speed up the digital and intelligent medical devices and focus on developing wearable, portable mobile medical treatment and auxiliary equipment, such as product, drive the three-dimensional (3 d) new technologies, such as printing, data chip in the application of the plant in the product. To promote medical intelligent production equipment upgrade, speed up the industrial control system, intelligent perception components such as the core technology and equipment research and development and industrialization, support the intelligent factory construction of pharmaceutical industry.

To carry out intelligent medical services. High quality medical resources should play the role of lead, encourage social forces to participate in, the integration of online resources, standardize medical networking and health management of medical application (APP). Actively carry out online health consultation, diagnosis and treatment, waiting to remind, accurately capture to expend, booking convenient services such as medical report query. To strengthen regional health service resources integration, medical service institutions are encouraged to set up the medical and health information service platform, actively carry out Internet medical and health information service. Guide the use of information, intelligent technology and equipment, medical institutions, remote and undeveloped areas at the grass-roots level, to carry out the remote pathological diagnosis, image diagnosis and expert consultation, care guide, guide operation such as remote medical service.

Three, strengthen policy support and organize their implementation

(11) to strengthen financial support. Innovative financial fund support, the use of rewards guidance, capital injection, to demonstrate the application assistance, support to demonstrate the application and construction of public service platform with strong public service nature of the project; Apply and guide the industry investment, risk investment funds, support innovation product research and development, industrialization of for-profit, competitive projects, the backbone of the ability to support the development of creative industry and enterprise alliance, the integration of industrial chain upstream and downstream resources. To explore the medical device manufacturing enterprise and financial leasing companies, financial leasing companies, for all kinds of ownership installment purchase of large medical equipment medical institutions to provide services. Study and formulate domestic shortage, to break through the API key product catalog, the directory structure clear, conform to the tariff classification rules and meet the regulatory requirements of API, study the implementation of lower temporary tariff rate, improve the development, use the unit in the pharmaceutical product innovation, value-added services and application demonstration of incentive mechanism. Support qualified innovative pharmaceutical production enterprises listed financing, issuing bonds and m&a, restructuring.

(12) support innovation product promotion. Research to develop innovation and excellent drugs, medical devices product catalog. More innovative products publicity, enhance clinical doctors and the masses of medical products with independent intellectual property rights agreement. Through the first (set), major technical equipment insurance compensation pilot work support eligible high-end medical equipment application promotion, continue to promote the implementation of innovative medical devices application demonstration project (including "10 million project", etc.), in some provinces and municipalities to carry out the trial of large medical equipment. To further increase the intensity of innovative medical devices product promotion, at different levels of medical institutions to carry out the pilot demonstration application. To encourage innovation in cooperation with pharmaceutical companies large hospital construction of drugs and medical appliance application demonstration base, training center, form the demonstration application radiation, clinical evaluation, technology innovation, promotion of a virtuous cycle.

(13) and improve the mechanism of government procurement. According to the principle of transparency, fair competition, improve the mechanism of the bidding procurement, pharmaceutical products bidding procurement will be incorporated into public resources trading platform. Classified purchasing, science set up the evaluation factors, promote medicine, high value medical consumables purchase coding standardization, ensure the reasonable price, ensuring the supply, quality and safety. We should standardize the order of competition, break the pharmaceutical products market segmentation and local protection. Further perfect the double envelope evaluation method of bidding price significantly lower quality and supply, there may be a risk of drugs, must make a comprehensive assessment, and avoid vicious competition. Comprehensively promote information disclosure, establish verification of drug prices artificially high and dynamic adjustment mechanism, to ensure that every link of drug purchase to run in the sun. According to the regional health planning, formulate medical institutions at all levels of medical apparatus and instruments equipped with standard, strict control of fiscal fund procurement unreasonable grade, high-grade equipment. Strictly implement the "government procurement law of the People's Republic of China" regulation, Chinese medicines and medical equipment to meet the requirements of the government procurement project in principle must purchase domestic products, gradually raise the level of public medical institutions domestic equipment configuration.

We will deepen reform of the review of the examination and approval (14). To establish a more scientific and efficient system for examination and approval of drug review of medical equipment. To strengthen the construction of the review team, recruitment for examination and approval of the international review of experience of experts and scholars. Increase the intensity of government purchase review service, strengthening the construction of technical evaluation cooperation ability, improve the ability and efficiency for examination and approval of review. Public acceptance, examination and approval of relevant information, increasing transparency for examination and approval of review. Strictly control the market supply, low level repeated, backward production technology, product approvals, accelerate the innovation of clinical need drugs, medical apparatus and instruments product review, guiding the research and development, the science applicants declare. Accelerate development of new clinical application of diagnosis technology specification. For the identified as genetic testing product innovation of medical equipments, etc., in accordance with the innovative medical device approval process priority review, accelerate the innovation of medical service project into the medical system, promote the new technology in clinical use. To speed up the drug marketing authorisation holder system pilot, promote drug research and development and production of specialized division of labor, speed up the transformation of scientific research achievements. Encouraged to carry out the pharmaceutical research and development, production, by gradually ease restrictions on drug approval document transfer, guide the advantage enterprise merger and reorganization, reduce the homogeneity competition and review resources waste.

(15) to speed up the construction of talent team. Further implement the strategy of priority to the development of talent, focus on drug innovation core software and hardware development and inheritance of traditional Chinese medicine, medical equipment, pharmaceutical products, such as international registration requirements, improve the talent introduction, training, incentive mechanism, build and use good environment. We will continue to implement the "one thousand plan" project, exchanging and attract overseas product innovation, the international registration of high-level personnel and team innovation entrepreneurship in China. Encourage pharmaceutical enterprises to set up a post-doctoral scientific research workstation. In order to improve the drug quality management level and enterprise competitiveness as the core, actively carry out various kinds of pharmaceutical enterprise management personnel training, cultivating a batch of LingJunXing pharmaceutical entrepreneur. Strengthening the vocational education and skills training, medical applications technical education and training base, build the skills of skilled personnel. To perfect the relevant title evaluation and post setting to medical institutions. Support business cooperation with universities and medical institutions training practical medical equipment engineers and other technical personnel. Encouraged to set up the business innovation center personnel training platform, such as strengthening the collaborative innovation. To strengthen the construction of pharmacy team, promote licensed pharmacists service ability, promoting safety and rational drug use. Establish and improve the technology, skills, elements such as participating in income distribution mechanism, encourage through the form of technology investment, fully arouse the enthusiasm of talent and creativity.

Strengthen the supervision of industry collaboration (16). Perfecting the supervision department, industry association, pharmaceutical enterprise communication mechanism, perfect in longitudinal and transverse to the edge of the end of regulation network, form the regulatory pattern of the whole society work. Support industry associations and other social groups in industry operation monitoring analysis, industry development strategy research and industry information. Strengthen the use of drugs and medical devices in the process of management, strengthen the adverse drug reaction monitoring, implement enterprise product post-marketing adverse reaction monitoring main responsibility. Improve the working mechanism of drug post-marketing safety evaluation, and establish the delisting system. To establish and perfect, with emphasis on the basic drugs, the synthetic evaluation system of clinical medicine, improve the drug shortage of early warning mechanism, dynamic master key enterprise production situation, improve supply security ability and level. To strengthen the construction of drugs and medical devices supervision laws and regulations system, increase the intensity of flight check, violation of laws and regulations and enterprises in a timely manner. Strict safety and environmental regulations, firmly shut down in accordance with the law is not in conformity with the requirements of pharmaceutical enterprises. Response to chemical pharmaceutical enterprises to carry out risk analysis, formal design, equipment and reliable automatic control system, improve essential safety level. The use of other dangerous chemicals, pharmaceutical companies, to establish and perfect the system of dangerous chemicals management, strengthen staff training, improve the ability of risk control. Strengthen the protection of intellectual property rights, accelerate the construction of intellectual property rights of social credit system, intensify the blow for infringement, build system of punitive damages, decrease the cost of enterprise rights protection. And standardize medical market, production and operation to crack down on counterfeit pharmaceutical products, the implementation of commercial bribery, secretly price-fixing violation behavior, etc.

All localities and departments concerned should fully understand the importance of promote the healthy development of the pharmaceutical industry, strengthen organizational leadership, improve the working mechanism, form the joint effort. Each region should formulate specific implementation plan, combined with the actual implementation, to ensure implement various tasks. All departments concerned should, according to the division of responsibility to promptly formulate supporting policies, create a good environment. National development and reform commission to strengthen overall coordination, clear policies and measures to carry out the specific schedule, together with the relevant departments to strengthen policy guidance and supervise, promote the sustained and healthy development of the pharmaceutical industry.

The state council general office

On March 4, 2016