Weigh! Six departments of the state jointly issued the guidelines for the development planning of the pharmaceutical industry

Source: Ministry of industry and information technology November 7, 2016 The Ministry of industry and information technology, the national development and Reform Commission, the Ministry of science and technology, the Ministry of Commerce, the national health and Family Planning Commission and the State Food and Drug Administration jointly issued the guidelines for the development planning of the pharmaceutical industry, aiming to implement the outline of the 13th five year plan for the economic and social development of the people's Republic of China and made in China 2025 》To guide the pharmaceutical industry to accelerate the transformation from large to strong Eight main goals are proposed in the planning guide By 2020, the scale benefit will increase steadily, the innovation ability will be significantly enhanced, the product quality will be improved in an all-round way, the supply guarantee system will be more perfect, the pace of internationalization will be significantly accelerated, and the overall quality of the pharmaceutical industry will be greatly improved Eight key tasks are proposed in the planning guide, such as enhancing industrial innovation ability, improving quality and safety level, improving supply guarantee ability, promoting green transformation and upgrading, promoting deep integration of industrialization and industrialization, optimizing industrial organization structure, improving international development level, expanding new fields and developing new formats, etc The planning guide also proposes to promote the development of key areas, including biological medicine, chemical medicine, traditional Chinese medicine, medical devices, pharmaceutical excipients and packaging systems, pharmaceutical equipment and other fields Pharmaceutical industry is an important industry related to the national economy and people's livelihood, a key area of made in China 2025 and strategic emerging industries, and an important guarantee to promote the construction of a healthy China The 13th Five Year Plan period is the decisive period for building a moderately prosperous society in an all-round way, and also the critical period for the overall leap of China's pharmaceutical industry In order to speed up the transformation of the pharmaceutical industry from large to strong, this guide has been prepared in accordance with the outline of the 13th five year plan for national economic and social development of the people's Republic of China and made in China 2025 1、 Review of the 12th Five Year Plan (1) rapid growth of scale efficiency During the 12th Five Year Plan period, the added value of pharmaceutical industry above designated size increased by 13.4% annually, and its proportion in the added value of national industry increased from 2.3% to 3.0% In 2015, enterprises above Designated Size achieved a main business income of 2688.5 billion yuan and a total profit of 276.8 billion yuan During the 12th Five Year Plan period, the average annual growth rate was 17.4% and 14.5% respectively, ranking first in all industries At the same time of rapid growth of scale benefit, the product variety is increasingly rich, and the output is greatly increased, which has played a positive role in ensuring supply, stabilizing growth, adjusting structure, etc （2） The innovation ability has improved significantly In 2015, R & D investment of Enterprises above designated size was about 45 billion yuan, quadrupling compared with 2010 Under the promotion of major science and technology projects of "major new drug creation", a batch of high-quality innovative achievements have emerged During the 12th Five Year Plan period, 210 innovative drugs have been approved for clinical research, and 15 class 1 innovative drugs, such as exetinib, apatinib, sidabamide and conbercept, have been approved for production A number of new chemical generic drugs have been launched, the quality control and safety technology level of traditional Chinese medicine have been improved, and a number of large-scale medical equipment such as PET-CT and 128 row CT, as well as high-end implant intervention products such as brain pacemaker and cochlear implant have been approved for listing Represented by Tu youyou's Nobel Prize, China's pharmaceutical innovation has been further recognized internationally （3） Quality management has been continuously strengthened The national action plan for the improvement of drug and medical device standards continued to be promoted, the Chinese Pharmacopoeia (2015 version) was issued and implemented, and the drug standards were further in line with the international standards The quality management standards of all links in the whole industrial chain have been continuously improved, and the drug production quality management standards (revised in 2010) (GMP) have been fully implemented The production quality management of a number of advantageous enterprises is in line with the international advanced level, and more than 600 API varieties and more than 60 preparation enterprises have reached the international advanced level GMP requirements （4） Technical equipment has been greatly upgraded During the 12th Five Year Plan period, the investment in fixed assets of the whole industry has exceeded 2 trillion yuan, with a substantial increase compared with the 11th Five Year Plan period The growth rate ranks in the forefront of all industries in the industry, which has promoted the overall leap in the level of technical equipment in the pharmaceutical industry The level of automation and intelligence in the production process has been significantly improved, advanced technologies such as biocatalysis, chiral synthesis, controlled release and drug delivery have been industrialized, the level of quality control in the whole process of traditional Chinese medicine has been improved, and the large-scale and efficient cultivation of biological drugs is close to the international advanced level （5） The reorganization and integration were promoted rapidly The number and scale of enterprise merger and reorganization increased, and the amount of merger and acquisition transactions during the 12th Five Year Plan period reached more than 150 billion yuan Large enterprises have further grown and become stronger 16 enterprises with main business income of more than 10 billion yuan have reached, and a number of innovative small and medium-sized enterprises have developed rapidly With the deep integration of industry and finance, 89 enterprises have been listed on the domestic and foreign stock markets, and more than 200 enterprises have been listed on the new third board A large number of venture capital and equity investment funds have invested in the field of medicine, which has promoted the integration of industry resources and the enhancement of the core competitiveness of enterprises （6） The pace of internationalization has accelerated Exports grew steadily, reaching US $56.4 billion in 2015 The export structure has been improved, the proportion of preparations and medical equipment has increased, and the sales of preparations to developed countries have made breakthroughs The R & D of drugs has been accelerated to be in line with the international standards Hundreds of generic drugs have been registered and approved by European and American countries, and more than 50 new drugs have carried out international clinical research Overseas investment has developed from the establishment of R & D centers to the establishment of production bases, with more than 10 overseas M & A projects exceeding US $100 million However, there are still some problems in the development of the pharmaceutical industry, which are mainly manifested in the following aspects: the original innovation ability is not strong, the basic research and transformation research ability is weak, and the high-quality innovation achievements are few; the task of product quality upgrading is urgent, and the quality standards and quality levels in the fields of chemical generic medicine, Chinese herbal medicine and Chinese patent medicine, medical equipment, auxiliary materials and packaging materials need to be improved urgently; the short board and low level of drug supply guarantee exist Price medicine, children medicine and rare disease medicine are still in short supply; cleaner production and "three wastes" The governance level is low, the sustainable development capacity of chemical APIs is insufficient; the industry concentration is low, the enterprises are many, small and scattered, the product homogeneity and repeated construction are prominent; the international competitiveness is weak, the added value of export products is low; there are irregular behaviors in R & D, marketing and other links, which affect the healthy competition and development of the industry 2、 "13th five year plan" development situation (1) steady growth of market demand From a global perspective, the growth rate of the pharmaceutical market in developed economies has picked up, the demand of emerging pharmaceutical markets is strong, and the proportion of biotechnological drugs and chemical generic drugs in the pharmaceutical structure has increased, bringing new opportunities for China's pharmaceutical exports At home, the national economy has maintained a medium to high growth rate, the disposable income of residents has increased and the consumption structure has been upgraded, the construction of a healthy China has been steadily promoted, the health insurance system has been further improved, the aging population and the implementation of the comprehensive two child policy will continue to promote the rapid growth of the pharmaceutical market （2） Technological progress is accelerating Precision medicine and translational medicine provide a new direction for new drug development and disease diagnosis and treatment Innovative drugs based on new targets, new mechanisms and breakthrough technologies continue to emerge, and the pace of transformation of new technologies such as tumor immunotherapy and cell therapy accelerates Medical devices are developing towards intelligence, network and portability New materials are widely used Internet and health big data are closely combined with medical products and medical services New impetus has been injected into industrial upgrading and development （3） Industrial policy is more favorable In "made in China 2025", biomedicine and high-performance medical devices are regarded as key development areas, and the state continues to take strategic emerging industries such as biomedicine as pillar industries of national economy to accelerate the cultivation of "major new drug creation" The continued implementation of major science and technology projects will provide strong policy support for the improvement of innovation ability, quality brand, intelligent manufacturing and green development level of the pharmaceutical industry （4） Industry supervision continued to strengthen The reform of drug and medical device review and approval system has been fully implemented, the drug registration has been adjusted, the registration standard has been improved, the review and approval speed has been accelerated, the pilot of drug listing license holder system, the promotion of quality and efficacy consistency evaluation of generic drugs, and the whole process of quality supervision has been strengthened, which will promote technological innovation, survival of the fittest and product quality improvement The implementation of the newly revised environmental protection law, the improvement of environmental protection standards, and the strengthening of supervision and inspection put forward higher requirements for the green development of the pharmaceutical industry （5） The policy of medical reform has been continuously improved The reform of the medical and health system has been deepened in an all-round way, the reform of public hospitals and the hierarchical diagnosis and treatment system have been accelerated, and the market-oriented mechanism for the formation of drug prices has been gradually established The policy of drug classified purchase, which is mainly based on system, direct network, price negotiation and fixed-point production, has been fully implemented, the payment standard of medical insurance has been gradually established, and the measures of medical insurance cost control and comprehensive cost control of medical institutions have been implemented, which will have a profound impact on the development trend and competition pattern of the pharmaceutical industry In general, the pharmaceutical industry in the 13th Five Year Plan period is facing better development opportunities However, we should also see that the developed countries are forming new competitive advantages relying on technological change and technological breakthrough, and other emerging market countries have won the first chance in the international competition of generic drugs; the power to support the rapid growth of China's pharmaceutical industry in the early stage is weakening, various constraints are constantly strengthened, structural contradictions are further highlighted, and it is urgent to speed up the transformation of growth momentum from the old to the new The sustainable and healthy development of the industry still faces many difficulties and challenges 3、 Guiding ideology, basic principles and development objectives (1) guiding ideology We will thoroughly implement the spirit of the 18th National Congress of the Communist Party of China and the third, fourth and fifth plenary sessions of the 18th Central Committee of the Communist Party of China, firmly establish the concept of innovation, coordination, green, open and shared development, comprehensively implement the strategic plan of building a manufacturing power and a healthy China, give full play to the decisive role of the market in allocating resources and better play to the role of the government, and focus on meeting the growing health needs of the people We will vigorously promote supply side structural reform, accelerate technological innovation, deepen opening-up and cooperation, ensure quality and safety, increase effective supply, increase varieties, improve quality and create brands, realize medium and high-speed development of the pharmaceutical industry and move forward to the medium and high-end, support the further reform of the pharmaceutical and health system, and better serve the people's livelihood, stabilize growth and adjust structure （2） Basic principles Adhere to innovation driven We will strengthen the building of innovation capacity, improve the collaborative innovation system, and promote innovation and upgrading We will accelerate the in-depth integration of the pharmaceutical industry and the new generation of information technology, guide and support enterprises to expand new areas and develop new formats Quality first Take quality and safety as the lifeline of the development of the pharmaceutical industry, strengthen the quality responsibility of the enterprise, improve the quality standard system, strictly supervise the quality and safety, and promote the quality improvement of key fields such as chemical generic drugs We will ensure supply Around the needs of disease prevention and control, we need to develop clinical urgently needed products, strengthen the construction of basic drug supply capacity, improve the drug distribution network, improve the pharmaceutical reserve system, and improve the supply guarantee capacity Adhere to the aggregation agreement We will strengthen regional coordination and regional linkage, develop specialized and circular pharmaceutical parks, guide enterprises to restructure and integrate, build an advanced manufacturing system featuring division of labor, cooperation, green, low-carbon, intelligent and efficient, and improve product concentration and production intensification Adhere to open cooperation Seize the country and one belt, one road, and build a great opportunity.