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

(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.