The 14th Five-Year Plan for the development of pharmaceutical industry



I. Background of the preparation of the Plan

The pharmaceutical industry includes chemical pharmaceutical preparations, raw materials, Chinese herbal medicines, proprietary Chinese medicines, biological drugs, auxiliary materials, pharmaceutical equipment, medical equipment, health materials, etc. It is a strategic industry related to the national economy and people's livelihood, economic development and national security, and is an important foundation for the construction of a healthy China.

Since the "13th Five-Year Plan", under the strong leadership of the Party Central Committee and The State Council, under the joint efforts of all parties, China's pharmaceutical industry has made outstanding achievements, the development foundation is more solid, the development momentum is more strong, the overall development level has jumped to a new level, the industrial innovation has made new breakthroughs, the supply security level has been continuously enhanced, and the pace of internationalization has been continuously accelerated. It has made outstanding contributions to the prevention and control of the novel coronavirus epidemic. However, the problems restricting the development of the industry are still prominent, the original innovation capacity of the frontier field is still insufficient, the industrial ecology of coordinated development has not yet formed, the supply risk of small varieties of drugs is still there, the quality control level of generic drugs, traditional Chinese medicine, auxiliary materials and other fields needs to be improved, and the international competitive advantage of high value-added products is not strong.

During the "14th Five-Year Plan" period, the internal and external environment for the development of the pharmaceutical industry faced complex and profound changes. The construction of a healthy China was promoted in an all-round way, and the health service changed from focusing on treatment of diseases to focusing on people's health. A new development pattern with domestic circulation as the main body and international and domestic double circulation promoting each other has been formed, and the domestic pharmaceutical market has entered a stage of high-quality development. A new round of technological change and cross-border integration is accelerating, big data and artificial intelligence are deeply integrated into all aspects of the development of the pharmaceutical industry, and transformative new drug creation technologies, innovative therapies, and new drugs continue to emerge. The new development stage puts forward higher requirements for the pharmaceutical industry, and the pharmaceutical industry needs to accelerate the quality change, efficiency change, and power change to provide strong support for the construction of a new development pattern.

In the face of the new situation and new requirements, in order to promote the transformation of China's pharmaceutical industry to innovation-driven, and accelerate the realization of high-quality development, according to the 14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of the 2035 Vision Goals, the Ministry of Industry and Information Technology and nine other departments jointly prepared the Plan.

Ii. Main features of the Plan

1. Coverage was further expanded. Compared with the "Guidelines for the Development of the Pharmaceutical Industry" during the "13th Five-Year Plan" period, the preparation department of the "Plan" added the Department of Emergency Management, the State Medical Insurance Bureau, and the State Administration of Traditional Chinese Medicine, and further enriched the relevant tasks.

2. Focusing on key development tasks On the basis of the national "14th Five-Year Plan" and other important documents, the "Plan" focuses on the high-quality development of the industry, adheres to the problem-oriented, the industrial innovation, industrial chain, supply security, manufacturing capacity, international competition and other key tasks into a separate article, put forward the key tasks to promote the development of the pharmaceutical industry during the "14th Five-Year Plan", and enhance the guidance of the "Plan".

3. Pursuing balanced development and security Since the outbreak of COVID-19, relevant departments have undertaken a number of key tasks in epidemic prevention and control. On the basis of a comprehensive summary of relevant work experience, the "Plan" in-depth study of key work such as medical material security, proposed key tasks such as enhancing supply security capabilities, and compiled columns such as vaccine and shortage of drugs supply security projects.

(4) The outlook to 2035 has been added. According to the current situation of China's pharmaceutical industry innovation ability and the rapid improvement of industrial scale, the Plan carefully analyzes the future development trend, puts forward the long-term goal of China's pharmaceutical industry in 2035, and looks forward to industrial innovation and meeting the needs of the masses.

Third, the overall requirements of the Plan

 Overall development and security, comprehensively improve the modernization of the pharmaceutical industry chain, achieve stable and controllable supply chains, accelerate the transformation of innovation-driven development, cultivate new growth drivers, promote high-end, intelligent and green industries, build new advantages in international competition, improve the pharmaceutical supply security system, and better meet the diversified and multi-level health needs of the people.

In accordance with the basic principles of life first, innovation-led, systematic promotion, open cooperation, the development goals for the next five years and the vision goals for 15 years. By 2025, the main economic indicators will achieve medium-to-high growth, innovation achievements in frontier areas will be prominent, innovation momentum will be enhanced, the modernization level of the industrial chain will be significantly improved, the supply security system for pharmaceutical equipment will be further improved, and the level of internationalization will be comprehensively improved. By 2035, the strength of the pharmaceutical industry will achieve an overall jump; An innovation-driven development pattern has been fully formed, the industrial structure has been upgraded, and products with more variety and better quality have been produced to meet the health needs of the people at a higher level, providing a solid guarantee for building a healthy China in all respects.

The Plan sets out six specific goals.

First, economies of scale are growing steadily. On the basis of a comprehensive analysis of the "13th Five-Year Plan" period of the pharmaceutical industry scale economy indicators, comprehensive consideration of domestic and foreign technological development, policy changes and other factors, the "Plan" proposed that the "14th Five-Year Plan" period of the pharmaceutical industry operating income, total profits of the average annual growth rate of more than 8%, added value accounted for the proportion of all industries increased to about 5%, the concentration of leading enterprises in the industry further improved.

Second, innovation-driven transformation has achieved remarkable results. During the "13th Five-Year Plan" period, a large number of traditional pharmaceutical enterprises accelerated innovation and transformation, innovative entrepreneurial enterprises increased significantly, and the number of new drugs entering the clinical stage and R&D investment increased significantly. During the "14th Five-Year Plan" period, a large number of pharmaceutical innovation results will complete clinical research and listing, and the pharmaceutical industry will continue to increase innovation investment and accelerate innovation-driven transformation. The "Plan" proposed that during the "14th Five-Year Plan" period, the average annual growth of R&D investment in the industry was more than 10%; By 2025, the proportion of new sales of innovative products in the increase of operating income of the whole industry will further increase.

Third, the industrial chain and supply chain are stable and controllable. The advantages of large-scale systematic pharmaceutical manufacturing have been further consolidated, a number of industrialization key common technologies have made breakthroughs, and positive results have been achieved in key areas to make up for weaknesses, and a number of key enterprises with industrial ecological leading ability have been cultivated in the subdivision field.

Fourth, the ability to ensure supply continued to increase. The supply of medicines, vaccines, protective materials and diagnosis and treatment equipment for the prevention and control of major diseases is adequate, and the medical reserve system has been improved. The supply of essential drugs, small varieties of drugs, and drugs prone to shortage was stable, and the ability to ensure a number of urgently needed medicines for children and drugs for rare diseases was improved.

Fifth, the manufacturing level system is improved. The quality management of the whole life cycle of drugs and medical devices has been strengthened, and the number of generic drugs that have passed the conformance evaluation has further increased; The level of green, digital and intelligent development of enterprises has been significantly improved, the level of safety technology and management has been effectively improved, and the ability to control production safety risks has been significantly enhanced.

Sixth, international development has been accelerated in an all-round way. Pharmaceutical exports maintained growth; Chinese patent medicine "going out" breakthrough; Cultivate a number of world-renowned brands; A number of large pharmaceutical enterprises with global R&D and production layout and a high proportion of international sales have been formed.

Iv. Key tasks of the Plan

"Planning" around the development goals, put forward five key tasks to be implemented during the "14th Five-Year Plan" period, and combined with the trend of technological development, in the form of columns, put forward the pharmaceutical innovation product industrialization project, pharmaceutical industrialization technology research project, vaccine and shortage of drugs supply security project, product quality upgrade project, the pharmaceutical industry green low-carbon project and other five projects.

(1) Accelerating product innovation and technological breakthroughs in industrialization

First, strengthen the research of key core technologies, vigorously promote the research and development of innovative products, and improve the level of industrialization technology. The second is to promote the industrialization and application of innovative drugs and high-end medical devices, accelerate the industrialization process of new products, and promote the promotion and application of innovative products. The third is to improve the pharmaceutical innovation support system, strengthen industry-university-research medical technology collaboration, improve professional R & D service capabilities, and create a good environment to encourage innovation.

2. Improving the stability and competitiveness of the industrial chain

First, make up for the shortcomings of the industrial chain, carry out research on key technology products, in-depth carry out the "one-stop" application demonstration of key products and processes, and improve government procurement, first (set), and first batch of second policies. The second is to enhance the advantages of the industrial chain, encourage enterprises to continue to strengthen the advantages of systematic manufacturing, consolidate the advantages of API manufacturing, create an integrated advantage of "API + preparation", and encourage the development of biological drug industrialization technology. The third is to cultivate high-quality market players in different fields, implement the cultivation project of pharmaceutical pilot enterprises, and support the development of specialized and special "small giant" enterprises. The fourth is to optimize the regional layout of the industrial chain, focusing on supporting about 10 cities to develop into the main engine of new industrial momentum, and focusing on supporting about 7 ethnic areas to develop the ethnic medicine industry.

3. Enhancing the ability to ensure supply

First, build a solid foundation for emergency support, strengthen the construction of the medical reserve system, strengthen the technical layout of emergency products, and enhance the mobilization capacity for emergency production. The second is to improve the level of normal security, enhance the ability to ensure the supply of drugs prone to shortage, and strengthen the development and introduction of clinically urgent varieties. Third, improve the vaccine supply system, increase the capacity of vaccine emergency research and development and production, and strengthen vaccine supply guarantee.

(4) Promote the upgrading of pharmaceutical manufacturing capacity systems

First, continue to improve the level of quality and safety, improve the quality of products in key areas, strengthen the main responsibility for enterprise quality, and improve the quality supervision system. The second is to promote industrial digital transformation, empower pharmaceutical research and development with a new generation of information technology, promote the deep integration of information technology and production and operation, and actively develop new models and new business formats. Third, promote the green and low-carbon development of the whole industrial chain, build a green industrial system, improve the level of green manufacturing, and implement carbon emission reduction actions in the pharmaceutical industry. Fourth, improve the ability to control security risks, focus on preventing production safety risks, and improve the essential safety, personnel skills and quality, and safety informatization level.

5. Creating new advantages in international competition

The first is to attract global pharmaceutical innovation elements to gather in China, attract global innovative drugs and medical devices to take the lead in registering in China, and improve the internationalization level of clinical research. The second is to promote domestic pharmaceutical enterprises to enter the international market at a higher level, support enterprises to carry out simultaneous registration of innovative drugs at home and abroad, and encourage vaccine manufacturers to carry out international certification. The third is to consolidate the foundation of international medical cooperation, promote the integration of domestic and foreign regulations, mutual recognition of standards and mutual trust in quality, give play to the global leading role of TCM standards, and build a public service platform for international medical cooperation.

5. Safeguard measures of the Plan

In order to strengthen implementation, the Plan proposes four safeguard measures.

First, we need to strengthen policy coordination and plan implementation. Relevant state departments have established coordination mechanisms around the implementation of the plan, formed policy synergy, and promoted the implementation of the planning objectives and tasks and the high-quality development of the pharmaceutical industry. Relevant local departments shall formulate implementation plans and local supporting policies. Industry associations play the role of Bridges and links, and cooperate with government departments to monitor and evaluate the implementation of the plan.

Second, we will increase the level of fiscal and financial support. We will implement support policies such as additional deductions for research and development costs and simple VAT collection on drugs for cancer and rare diseases. Guide financial institutions to innovate financial products, optimize supply chain financial services, support eligible enterprises to issue corporate credit bonds, and guide early investment to support scientific and technological innovation in the pharmaceutical industry. Encourage social capital to develop specialized medical venture capital funds and equity investment funds.

Third, we will standardize the order of market competition. Correct the improper trend in the field of pharmaceutical purchase and marketing, strictly regulate the registration management of pharmaceutical representatives and conduct norms, and crack down on illegal activities in related fields. We will strengthen law enforcement against unfair competition, and resolutely investigate and punish acts of unfair competition such as commercial bribery in the pharmaceutical sector. We will strengthen anti-monopoly law enforcement in the field of drugs in short supply and raw materials, and formulate and implement anti-monopoly guidelines in the field of raw materials. Remove local protection and market segmentation, and cancel unreasonable requirements for drug market access.

Fourth, we will strengthen the construction of human resources. Focus on training the industry shortage of drug discovery, clinical trial design, biological drug manufacturing and other professional talents and interdisciplinary talents. Through encouraging school-enterprise cooperation in running schools, commissioning training, building practical training bases, and connecting the growth channels of skilled workers, a number of "great craftsmen" in the pharmaceutical field are cultivated. Local governments and enterprises will be encouraged to introduce more high-level talents from overseas.