According to the website of the Ministry of industry and information technology, nine departments including the Ministry of industry and information technology and the development and Reform Commission recently jointly issued the “14th five year plan” for the development of pharmaceutical industry (hereinafter referred to as the “plan”).
The plan proposes six specific objectives:
First, the economies of scale grew steadily. Based on a comprehensive analysis of the scale efficiency indicators of the pharmaceutical industry during the 13th Five Year Plan period and taking into account the technological development and policy changes at home and abroad, the plan proposes that the average annual growth rate of the operating revenue and total profit of the pharmaceutical industry during the 14th Five Year Plan period will remain above 8%, the proportion of added value in all industries will increase to about 5%, and the concentration of industry leading enterprises will further increase.
Second, innovation driven transformation has achieved remarkable results. During the 13th Five Year Plan period, a large number of traditional pharmaceutical enterprises accelerated their innovation and transformation, significantly increased innovative and entrepreneurial enterprises, and significantly increased the number of new drugs entering the clinical stage and R & D investment. During the 14th Five Year Plan period, a large number of pharmaceutical innovation achievements will complete clinical research and apply for listing. The pharmaceutical industry will also continue to increase innovation investment and accelerate innovation driven transformation. The plan proposes that the R & D investment of the whole industry will increase by more than 10% annually during the 14th Five Year Plan period; By 2025, the proportion of new sales of innovative products in the increment of operating revenue of the whole industry will further increase.
Third, the industrial chain and supply chain are stable and controllable. The advantages of large-scale and systematization of pharmaceutical manufacturing have been further consolidated. Breakthroughs have been made in a number of key common technologies for industrialization, and positive results have been achieved in making up for weaknesses in key fields. A number of key enterprises with leading and driving ability of industrial ecology in subdivided fields have been cultivated.
Fourth, the supply guarantee capacity has been continuously strengthened. The supply of drugs, vaccines, protective materials and diagnosis and treatment equipment for major diseases is sufficient, and the medical reserve system has been improved; The supply of essential drugs, minor drugs and drugs that are easy to be in short supply is stable, and the guarantee ability of a number of clinically urgently needed drugs for children and rare diseases is enhanced.
Fifth, the manufacturing level is systematically improved. The whole life cycle quality management of drugs and medical devices has been strengthened, and the number of generic drugs passing the consistency evaluation has further increased; The development level of green, digital and intelligent enterprises has been significantly improved, the safety technology and management level have been effectively improved, and the ability of production safety risk management and control has been significantly enhanced.
Sixth, international development has been accelerated in an all-round way. The export volume of medicine kept growing; Breakthrough in “going out” of Chinese patent medicine; Cultivate a number of world-famous brands; A number of large pharmaceutical enterprises with global layout of R & D and production and high proportion of international sales have been formed.
Focusing on the development objectives, the plan puts forward five key tasks to be implemented during the 14th Five Year Plan Period:
(I) accelerating product innovation and technological breakthroughs in industrialization
First, strengthen key core technology research, vigorously promote innovative product research and development, and improve the level of industrialization technology. Second, 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. Third, improve the pharmaceutical innovation support system, strengthen the technical cooperation between industry, University, research and medicine, improve the professional R & D service ability, and create a good environment for encouraging innovation.
(II) enhance the stability and competitiveness of the industrial chain
First, make up for the shortcomings of the industrial chain, tackle key technical products, deeply carry out “one-stop” application demonstration of key products and processes, and improve government procurement, first set, first batch and other policies. The second is to enhance the advantages of the industrial chain, encourage enterprises to continuously strengthen the advantages of systematic manufacturing, consolidate the advantages of API manufacturing, create the integration advantages of “API + Preparation”, and encourage the industrial technology development of biological drugs. Third, cultivate high-quality market players in different fields, implement the cultivation project of pharmaceutical pilot enterprises, and support the development of specialized and new “little giant” enterprises. Fourth, optimize the regional layout of the industrial chain, focus on supporting the development of about 10 cities as the main engine of new industrial momentum, and focus on supporting the development of national medicine industry in about 7 ethnic minority areas.
(III) enhance supply guarantee capacity
First, build a solid foundation for emergency support, strengthen the construction of medical reserve system, strengthen the technical layout of emergency products, and improve the mobilization capacity of emergency production. Second, improve the normal guarantee level, enhance the supply guarantee capacity of drugs prone to shortage, and strengthen the development and introduction of varieties urgently needed in clinic. Third, improve the vaccine supply system, improve the vaccine emergency R & D and production capacity, and strengthen the guarantee of vaccine supply.
(IV) promote the upgrading of pharmaceutical manufacturing capacity system
First, continuously improve the quality and safety level, improve the product quality in key areas, strengthen the main responsibility of enterprise quality, and improve the quality supervision system. Second, promote the digital transformation of the industry, enable 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 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 of safety risk management and control, focus on preventing production safety risks, and improve the level of intrinsic safety, personnel skill quality and safety informatization.
(V) creating new international competitive advantages
First, 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. Second, promote China Meheco Group Co.Ltd(600056) enterprises to enter the international market at a higher level, support enterprises to carry out synchronous registration of innovative drugs outside China, and encourage vaccine manufacturers to carry out international certification. Third, consolidate the foundation of international pharmaceutical cooperation, promote the integration of Chinese and foreign laws and regulations, mutual recognition of standards and mutual trust in quality, give play to the global leading role of traditional Chinese medicine standards, and build a public service platform for international pharmaceutical cooperation.
