On November 7, the Ministry of Industry and Information Technology, together with the Health and Family Planning Commission and CFDA, issued the "Guidelines for the Development Planning of the Pharmaceutical Industry". The guidelines propose to vigorously develop the six major areas of biological medicine, new varieties of chemical medicine, high-quality Chinese medicine, high-performance medical equipment, new excipient packaging materials and pharmaceutical equipment.
The article mentioned that my country's pharmaceutical market demand is strong, and the proportion of biotechnology drugs and chemical generic drugs in the drug structure has increased. During the 13th Five-Year Plan period, the transformation of technologies such as tumor immunotherapy and cell therapy will be accelerated. Comprehensively strengthen the level of industry supervision, promote technological innovation, and improve product quality.
While promoting the development of innovative technologies, the country will also promote the development of producer services and service-oriented manufacturing industries. Vigorously develop new productive service industries such as contract production, contract research and development, medical e-commerce, biotechnology services, and third-party maintenance of medical equipment, to promote further specialization of division of labor, increase efficiency and reduce costs.
This is after the Central Committee of the Communist Party of China and the State Council issued the "Healthy China 2030" Planning Outline, and the Health and Family Planning Commission, CFDA and other departments issued the "Guiding Opinions on Comprehensively Promoting Health and Health Technology Innovation", another promotion of my country's health and health An important document for better and faster development of the industry. It is a key area of Made in China 2025 and strategic emerging industries, and an important guarantee for promoting the construction of a healthy China.
The full text of the "Pharmaceutical Industry Development Planning Guide" is as follows:
Pharmaceutical Industry Development Planning Guide
The pharmaceutical industry is an important industry related to the national economy and people's livelihood. It is a key area of Made in China 2025 and strategic emerging industries, and an important guarantee for promoting the construction of a healthy China. The "Thirteenth Five-Year Plan" period is a decisive stage for building a well-off society in an all-round way, and it is also a critical period for the overall rise of my country's pharmaceutical industry. In order to accelerate the transformation of the pharmaceutical industry from large to strong, this guide is compiled in accordance with the "Outline of the 13th Five-Year Plan for the National Economic and Social Development of the People's Republic of China" and "Made in China 2025".
1. "Twelfth Five-Year" development review
(1) Rapid growth of economies of scale.
During the "Twelfth Five-Year Plan" period, the added value of the pharmaceutical industry above designated size increased by 13.4% annually, and its share in the national industrial added value increased from 2.3% to 3.0%. In 2015, enterprises above designated size realized revenue from main operations of RMB 2,688.5 billion and realized total profit of RMB 276.8 billion. During the "Twelfth Five-Year Plan" period, the average annual growth rate was 17.4% and 14.5% respectively, consistently ranking the forefront of various industries. With the rapid growth of economies of scale, the variety of products has become increasingly abundant, and the output has increased substantially, playing an active role in ensuring supply, stabilizing growth, and adjusting structure.
(2) The innovation capability has been significantly improved.
In 2015, enterprises above designated size invested about 45 billion yuan in R&D, quadrupling from 2010. Driven by the “Major New Drug Development” major science and technology project, a number of high-quality innovations have emerged. During the “Twelfth Five-Year Plan” period, 210 innovative drugs were approved for clinical research. Icotinib, apatinib, and Sidaben 15 Class 1 innovative drugs such as amine and Conbercept have been approved for production, more than 110 new chemical generic drugs have been launched, the quality control and safety technology of traditional Chinese medicine have been improved, a batch of large-scale medical equipment such as PET-CT, 128-row CT, etc. High-end implanted interventional products such as brain pacemakers and cochlear implants have been approved for the market. As represented by Tu Youyou's Nobel Prize, my country's pharmaceutical innovation has been further recognized internationally.
(3) Continuously strengthening quality management.
The National Pharmaceutical and Medical Device Standards Improvement Action Plan continued to advance. The Chinese Pharmacopoeia (2015 Edition) was released and implemented, and the pharmaceutical standards were further in line with international standards. The quality management practices of all links in the entire industry chain have been continuously improved, and the "Good Manufacturing Practices for Drugs (Revised in 2010)" (drug GMP) has been fully implemented. The production quality management of a group of superior enterprises is in line with the international advanced level, and more than 600 raw material drug varieties and more than 60 preparation companies have reached the international advanced level GMP requirements.
(4) Substantial upgrade of technical equipment.
During the "Twelfth Five-Year Plan" period, the entire industry completed a fixed asset investment of more than 2 trillion yuan, a substantial increase in scale compared to the "Eleventh Five-Year Plan", and the growth rate ranked first among all industries, which 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, and modified-release drug delivery have been industrialized. The quality control level of the whole process of Chinese medicine has been improved, and the large-scale and efficient cultivation of biological drugs has approached the international advanced level.
(5) Reorganization and integration are advancing rapidly.
The number of enterprise mergers and reorganizations has increased and the scale has expanded. During the "Twelfth Five-Year Plan" period, the transaction volume of mergers and acquisitions reached more than 150 billion yuan. Large-scale enterprises have further expanded and become stronger. There are 16 enterprises whose main industrial business income exceeds 10 billion yuan, and a number of innovative small and medium-sized enterprises have developed rapidly. Industry and finance are deeply integrated, 89 companies are listed on domestic and foreign securities markets, and more than 200 companies are listed on the New Third Board. Venture capital and equity investment funds invest heavily in the pharmaceutical field, which has promoted the integration of industry resources and the enhancement of corporate core competitiveness.
(6) The pace of internationalization has accelerated.
Exports have grown steadily, with exports reaching 56.4 billion U.S. dollars in 2015. The export structure has improved, the proportion of preparations and medical equipment exports has increased, and the sales of preparations for the markets of developed countries have achieved breakthroughs. The research and development of medicines has accelerated in line with international standards. A total of hundreds of generic drugs have obtained registration approvals in 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: weak original innovation capabilities, weak basic research and translational research capabilities, and few high-quality innovation results; urgent task of upgrading product quality, chemical generic drugs, Chinese medicinal materials and Chinese patent medicines, medical The quality standards and quality levels of equipment, auxiliary materials and packaging materials need to be improved urgently; there are shortcomings in the supply of medicines, and shortages of low-priced medicines, children’s medicines, and rare disease medicines still occur; clean production and "three wastes" treatment levels are low, and chemical Insufficient ability for sustainable development of APIs; low industry concentration, multiple, small, and scattered companies, prominent product homogeneity and repeated construction; weak international competitiveness and low added value of export products; irregular behavior in R&D and marketing. Affect the healthy competition and healthy development of the industry.
2. Development situation during the 13th Five-Year Plan
(1) Stable growth in market demand.
From a global perspective, the growth rate of the pharmaceutical market in developed economies has rebounded, the demand in emerging pharmaceutical markets is strong, and the proportion of biotechnology drugs and chemical generic drugs in the drug structure has increased, bringing new opportunities for my country's pharmaceutical exports. From a domestic perspective, the national economy has maintained medium-to-high-speed growth, residents' disposable income has increased and consumption structure has been upgraded, the construction of a healthy China has been steadily advanced, the medical insurance system has been further improved, the aging of the population and the implementation of the comprehensive two-child policy will continue to promote the pharmaceutical market faster increase.
(2) Technological progress continues to accelerate.
Precision medicine and translational medicine provide new directions for new drug development and disease diagnosis and treatment. Innovative drugs based on new targets, new mechanisms and breakthrough technologies continue to appear, and the pace of transformation of new technologies such as tumor immunotherapy and cell therapy is accelerating. Medical equipment is developing towards intelligence, networking, and portability. New materials are widely used. The Internet, health big data, medical products and medical services are closely integrated, and industrial upgrading and development have injected new impetus.
(3) Industrial policies are more favorable.
"Made in China 2025" takes biomedicine and high-performance medical devices as the key development areas. The country continues to accelerate the cultivation of strategic emerging industries such as biomedicine as pillar industries of the national economy, and continues to implement scientific and technological plans such as the "Major New Drug Creation" science and technology project. It will provide strong policy support for the pharmaceutical industry's innovation capability, quality brand, intelligent manufacturing and green development.
(4) Industry supervision continued to be strengthened.
The reform of the review and approval system for drugs and medical devices has been fully implemented, the classification of drug registration has been adjusted, the registration standards have been improved, the review and approval speed has been accelerated, the trial of the drug marketing authorization holder system, the evaluation of the quality and efficacy of generic drugs has been promoted, and the quality supervision of the whole process has been strengthened , 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) Continuous improvement of medical reform policies.
The reform of the medical and health system has been comprehensively deepened, the reform of public hospitals and the hierarchical diagnosis and treatment system have been accelerated, and the market-led drug price formation mechanism has been gradually established. The "double envelope" system, direct network, price negotiation, and designated production are mainly used for drug classification procurement policies Full implementation, the gradual establishment of medical insurance payment standards, and the implementation of medical insurance fee control and comprehensive fee control measures for medical institutions will have a profound impact on the development trend and competitive landscape of the pharmaceutical industry.
In general, the pharmaceutical industry is facing good development opportunities during the 13th Five-Year Plan period. However, it must also be noted that developed countries are forming new competitive advantages relying on technological changes and technological breakthroughs, and other emerging market countries have won the first opportunity in the international competition of generic drugs; the driving force supporting the rapid growth of my country's pharmaceutical industry is weakening. Constraints continue to be strengthened, structural contradictions have become more prominent, and there is an urgent need to accelerate the transformation of growth momentum from the old to the new. The sustained and healthy development of the pharmaceutical industry still faces many difficulties and challenges.
3. Guiding ideology, basic principles and development goals
(1) Guiding ideology.
Thoroughly implement the spirit of the 18th National Congress of the Communist Party of China and the 3rd, 4th, and 5th Plenary Sessions of the 18th Central Committee, firmly establish the concept of innovation, coordination, green, open, and shared development, fully implement the strategic deployment of building a manufacturing power and a healthy China, and give full play to the market The decisive role of allocating resources and better play the role of the government to meet the growing health needs of the people as the center, vigorously promote supply-side structural reforms, accelerate technological innovation, deepen open cooperation, ensure quality and safety, increase effective supply, and increase Variety, quality improvement, and brand creation, realize the mid-to-high-speed development of the pharmaceutical industry and advance to mid-to-high end, support the continuous deepening of the reform of the medical and health system, and better serve the people's livelihood, stable growth, and structural adjustment.
(2) Basic principles.
Insist on innovation-driven. Strengthen the construction of innovation capabilities, improve the collaborative innovation system, and promote innovation and upgrading. Accelerate the deep integration of the pharmaceutical industry and the new generation of information technology, guide and support enterprises to expand into new fields and develop new business formats.
Insist on quality first. Regarding quality and safety as the lifeline of the development of the pharmaceutical industry, strengthening the main responsibility of enterprise quality, improving the quality standard system, strict quality and safety supervision, and promoting quality improvement in key areas such as chemical generic drugs.
Insist on guaranteeing supply. Focusing on the needs of disease prevention and control, develop urgently needed clinical products, strengthen the construction of essential drug supply capabilities, improve the drug distribution network, improve the drug storage system, and improve the supply security capabilities.
Insist on gathering together. Strengthen regional synergy and regional linkage, develop specialized and circular pharmaceutical parks, guide enterprises to reorganize and integrate, build an advanced manufacturing system with division of labor, green, low-carbon, smart and efficient, and improve product concentration and production intensification.
Persist in open cooperation. Seize the major opportunities for the country to promote the “Belt and Road” construction, make full use of international resource elements, strengthen cooperation in technology, talent, production capacity, and capital, and promote pharmaceutical companies to "go global" and improve international competitiveness.
(3) Main goals.
By 2020, economies of scale will grow steadily, innovation capabilities will be significantly enhanced, product quality will be improved across the board, the supply guarantee system will be more complete, the pace of internationalization will be significantly accelerated, and the overall quality of the pharmaceutical industry will be greatly improved.
-Industry scale. Main business income maintained a medium-to-high-speed growth, with an average annual growth rate of more than 10%, and its share in the industrial economy increased significantly.
-Technological innovation. Enterprise R&D investment continues to increase. By 2020, the R&D investment intensity of enterprises above designated size in the industry will reach over 2%. The quality of innovation has improved significantly, the proportion of new drug registration in drug registration has increased, a number of high-quality innovations have been industrialized, and a breakthrough has been made in the international registration of new drugs.
--product quality. The quality standards of medicines and medical devices have been improved, quality management practices in all aspects have been effectively implemented, and product quality and safety guarantees have been strengthened. Basically complete the quality and efficacy consistency evaluation of the generic oral solid preparations of essential drugs. More than 100 preparation companies have passed the international advanced level GMP certification.
--ECO development. Compared with 2015, in 2020, the energy consumption per unit of industrial added value of enterprises above designated size will drop by 18%, the carbon dioxide emissions per unit of industrial added value will drop by 22%, the water consumption per unit of industrial added value will drop by 23%, and the emissions of volatile organic compounds (VOCs) A drop of more than 10%, the green production level of chemical raw materials has been significantly improved.
——Intelligent manufacturing. By 2020, the level of automation and informatization of the pharmaceutical production process will be significantly improved, the key process of large enterprises will be basically automated, the utilization rate of the manufacturing execution system (MES) will reach more than 30%, and a batch of intelligent manufacturing demonstration workshops will be built.
——Supply guarantee. The national basic medicines and commonly used low-cost medicines have been strengthened to ensure the supply of drugs, the shortage of clinical medicines has been significantly improved, the clinically urgently needed patent expired drugs have basically achieved imitation and listing, the national medical reserve system has been further improved, and emergency research and development and emergency response to public health emergencies Production capacity has been significantly enhanced.
-Organizational structure. Industry restructuring and integration is accelerating, and concentration continues to increase. By 2020, the proportion of the top 100 companies' main business income will increase by 10%, and the leading role of large enterprises in the development of the industry will be further strengthened.
--globalization. Pharmaceutical exports have grown steadily, and the export delivery value will account for 10% of sales revenue. The export structure has been significantly improved, and the export proportion of preparations and medical equipment has increased. The scale of overseas investment has expanded, international technical cooperation has deepened, and international development capabilities have been greatly improved.
4. Main tasks
(1) Enhance industrial innovation capabilities.
Improve the collaborative innovation system of government, industry, university, research and use. Give full play to the guiding and promoting role of the government to create a policy environment that encourages innovation. Strengthen the dominant position of enterprises in technological innovation, give full play to the role of key enterprises in integrating scientific and technological resources, and support the development of small R&D enterprises that master key technologies. Promote enterprises to strengthen technical cooperation with universities, scientific research institutes and medical institutions, establish investment, profit, and risk sharing mechanisms that meet the characteristics of new drug research and development, and accelerate the industrialization of research and development results. Mobilize the enthusiasm of medical institutions in medical innovation, improve the level of clinical research on new drugs, and promote the transformation and application of scientific and technological achievements.
Promote innovation and upgrade. Guide enterprises to improve the quality of innovation, cultivate major products, meet important needs, solve key issues, and improve the level of industrialization technology. Promote the transfer of chemical drug research and development from imitation to independent innovation. To carry out research on key varieties of compound prescriptions, effective parts and active ingredients of traditional Chinese medicine for dominant diseases of Chinese medicine, and develop modern Chinese medicines with stable and controllable quality and outstanding clinical advantages. Improve the level of research and development and preparation of biotechnology drugs such as antibody drugs and tumor immunotherapy drugs, and accelerate the localization of biosimilar drugs and combined vaccines urgently needed in clinical practice. Strengthen the development of core technologies and key components of medical devices, and improve integrated innovation capabilities and manufacturing levels. Break through common key technologies and promote the industrialization of major innovations and clinically urgently needed products.
Strengthen research and development support. Support the construction of a pre-clinical drug efficacy evaluation platform, standardize the construction and management of the drug and medical device clinical trial base (GCP base), optimize the layout of the national scientific and technological innovation base, coordinate the construction of the national clinical research center, improve the quality of clinical research, and meet the development of new products To meet the needs of post-market quality evaluation of drugs and medical devices, promote the transformation and application of scientific and technological achievements. Support the construction of small business service platforms such as entrepreneurial incubation and open laboratories, and support the development of small R&D enterprises. Strengthen the construction of public data and resource platforms for pharmaceutical research and development, and improve the level of open sharing and professional service capabilities. Give full play to the role of financial innovation in promoting technological innovation, guide social capital to set up venture capital funds and equity investment funds in the pharmaceutical field, and support the implementation of early R&D projects and the growth of innovative enterprises.
Box 1 Innovation Ability Improvement Project
1. Construction of an innovation center for the pharmaceutical manufacturing industry. Build a pharmaceutical and medical device manufacturing innovation center, integrate government and social input, scientific research institutes and corporate R&D strength, medical institution clinical research resources, corporate industrialization capabilities and other resources, and carry out cooperation around common key technical issues for industrial development to achieve 10-15 key technological breakthroughs to improve the innovation capability of the entire industry chain and promote innovation-driven development.
2. Construction of service platform for innovation and entrepreneurship of small and micro enterprises. Support the construction of entrepreneurial incubators, open laboratories, scientific and technological achievements transformation centers and other innovation and entrepreneurship service platforms, and support the innovation activities of small and micro enterprises.
3. Pharmaceutical industry venture capital plan. Guide social capital to set up more than 50 pharmaceutical industry venture capital funds, with a total scale of more than 10 billion yuan, to provide investment and financing support for pharmaceutical technology innovation projects.
4. Pharmaceutical research and development data and public resource platform construction. Support the construction and integration of disease clinical information databases, biological sample libraries, and compounds
