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Ministry of Industry and Information Technology of National Development and Reform Commission: Promote high-quality development of API industry

Source: www.qierge.net Author: Qi Erge Time: 14:32, November 10, 2021 Views: 54225

Ministry of Industry and Information Technology of National Development and Reform Commission: Promote high-quality development of API industry

To all provinces, autonomous regions, municipalities directly under the Central Government and cities specifically designated in the state plan, the Development and Reform Commission of Xinjiang Production and Construction Corps, and the competent departments of industry and informatization:

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Chemical APIs are the basic raw materials and effective ingredients of drugs, and are an important part of the pharmaceutical industry. Since the 18th National Congress of the Communist Party of China (CPC), China's API industry has achieved rapid development, with continuous improvement of production technology, steady improvement of quality level, and continuous expansion of industrial scale. It has become the world's largest producer and exporter of API. However, there are also problems such as unreasonable industrial structure, imperfect industrial layout, and low level of green production. This implementation plan is formulated to accelerate the high-quality development of the API industry in the new situation and promote the core competitiveness of the pharmaceutical industry.

1、 General requirements

（1） Guiding ideology.

Adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the Second, Third, Fourth and Fifth Plenary Sessions of the 19th Central Committee, base on the new development stage, fully, accurately and comprehensively implement the new development concept, adhere to innovation driven, strengthen the system concept, complement the shortcomings of technology and equipment, and accelerate the green and low-carbon transformation, We will promote the optimization and adjustment of the distribution, foster new advantages in international competition, build a new development pattern of the API industry, and consolidate the foundation of pharmaceutical supply security.

（2） Basic principles.

Adhere to innovation and leadership. Optimize the environment for industrial innovation and development, strengthen the dominant position of enterprises in innovation, promote comprehensive innovation, including process innovation and mode innovation, closely follow the urgent needs of the development of the API industry, foster an innovation system that combines production, education and research, and links upstream and downstream, and improve the level of autonomy and controllability of the supply chain of the API industry chain.

Adhere to green and low-carbon. Comply with the new situation and requirements of API development, strictly enforce energy efficiency and environmental protection standards, promote green and low-carbon technology and equipment, encourage new projects to be advanced in benchmarking, promote technological transformation and upgrading of existing projects, and explore the formation of a green production mode with high production efficiency, low resource consumption, small environmental impact, and low carbon emission intensity.

Adhere to scientific layout. Taking environmental protection, safety production, industrial supporting and other factors into consideration, we should guide API enterprises to gather in regions with better comprehensive conditions and compliance parks, strengthen the optimization and adjustment among regions, promote the coordinated layout of the industrial chain, promote the concentration of API production entities and regional agglomeration, and enhance the comprehensive competitiveness of the industry in the layout adjustment.

Adhere to open development. Promote the API industry to carry out all-round and in-depth open cooperation, participate in the global resource allocation and international pharmaceutical industry division at a higher level, consolidate the scale, cost and technical advantages of the API industry, cultivate well-known brands, improve quality and efficiency, and build an industrial development pattern oriented to domestic and international double circulation.

（3） Development goals.

By 2025, we will develop a number of high value-added and high growth varieties, break through a number of green and low-carbon technical equipment, cultivate a number of internationally competitive leading enterprises, and create a number of globally influential industrial clusters and production bases. The innovative development and advanced manufacturing level of the API industry have been significantly improved, the green and low-carbon development capability has been significantly improved, and the toughness of the supply system has been significantly enhanced, providing strong support for the development of the pharmaceutical industry and forging a characteristic long plate for international competition and cooperation.

2、 Main tasks

（1） Promote the innovation and upgrading of production technology.

Comply with the trend of API technology innovation, accelerate the development and application of advanced technologies such as synthetic biotechnology, continuous flow micro reaction, continuous crystallization and crystal form control, and use modern technology to transform traditional production processes. Promote key enterprises to carry out digital and intelligent transformation and upgrading, and improve production efficiency and quality control level. Support the development of a number of public service platforms with strong externalities around the key common technologies of API production.

（2） Promote green and low-carbon industrial transformation.

We will strengthen the layout of forward-looking research and develop green and low-carbon production technologies for APIs. We will promote green transformation of bulk APIs, and continue to reduce energy consumption and emissions per unit product. Strengthen the resource utilization of by-products in API production process, promote the treatment and transformation of volatile organic compounds (VOCs), and improve the comprehensive treatment level of solid waste, high salt wastewater and organic waste liquid. Promote the promotion and application of advanced energy-saving equipment, accelerate the transformation and upgrading of high energy consumption process modules such as refrigeration and fermentation, and realize the cascade utilization of energy.

（3） Promote the optimization and adjustment of industrial structure.

Closely follow the trend of changes in the structure of clinical medication, vigorously develop characteristic APIs and innovative APIs, and increase the proportion of new products and high value-added products. Promote the large-scale and intensive development of API production, encourage competitive enterprises to become bigger and stronger, and enhance industrial concentration. Guide the development of new business forms such as specialized contract R&D and production services in the field of API. Strictly implement the Guiding Catalogue of Industrial Restructuring and other policies, strictly implement the standards of environmental protection, energy consumption and safety, and accelerate the elimination of backward products, technologies and equipment.

（4） Promote the development of industrial concentration and agglomeration.

Comply with the changes in the external environment of industrial development, implement the requirements of regional ecological environment zoning management and control plan, ecological environment access list, etc., promote new API projects to enter suitable areas and chemical (pharmaceutical) parks established in compliance, and guide existing API enterprises to optimize and adjust the layout among regions. Comprehensively considering factors such as raw materials, market and technology, we will build world-class industrial clusters and production bases in areas with good development foundation, prominent regional advantages and abundant element resources. Further improve the public infrastructure support capacity of the park, and promote the transformation of "three wastes" disposal from decentralized treatment of enterprises to specialized centralized disposal of the park.

（5） Promote breakthroughs in major equipment research.

Facing the cutting-edge technology field of API production, we should guide backbone enterprises to deploy the innovation chain together with the upstream and downstream of the industrial chain and scientific research institutes, accelerate the development of high-end production equipment such as nucleic acid reactors and special consumables such as high-end membrane materials, break through the bottleneck constraints of industrial development, and improve the level of supporting the industrial chain itself. Strengthen the sharing of advanced technologies in petrochemical, chemical, pharmaceutical and other industries, and improve the level of industrial integration and innovation.

（6） Promote the division of labor and cooperation in related industries.

Give full play to the advantages of China's industrial system and scale, promote pharmaceutical intermediates, APIs and preparations enterprises to strengthen business collaboration, and improve the stability of the supply chain. Promote cross field resource sharing and cooperation, strengthen the financial cooperation between enterprises such as bioengineering, fine chemicals, hazardous waste disposal, pharmaceutical equipment and API enterprises, and improve the modernization level of the industrial chain. Encourage the integrated development of API preparations and guide API enterprises to develop preparations relying on superior varieties.

（7） Promote the construction of industrial standard system.

We will strengthen the guidance of standards and improve the level of green and high-end industrial development. Improve the evaluation index system of API cleaner production, and guide enterprises to carry out green manufacturing pilot demonstration. Improve the environment, occupational health and safety management system of the API industry, and create an internationally advanced green supply chain. To study and improve the energy efficiency standards of high energy consumption devices in API production, and improve the mechanism of carbon emission measurement and evaluation in the industry.

（8） We will promote high-level industrial openness and cooperation.

Optimize the export structure of API, increase the export proportion of high value-added products, and deeply embed into the global value chain. We will guide high-quality enterprises to strengthen the international registration and quality system certification of APIs to better meet the needs of the international market. We will improve the supply of production factors, build international pharmaceutical industry cooperation parks, and achieve openness, innovation, open cooperation, and win-win results.

3、 Safeguard measures

（1） Strengthen the awareness of corporate responsibility.

API manufacturing enterprises should aim to ensure the health of the people, improve the production quality management system, and ensure stable product quality and orderly supply. Guide enterprises to actively carry out environmental, occupational health and safety audit management, strengthen quality and safety training, and improve safety and environmental protection production level. Promote enterprises to take the initiative to carry out carbon footprint analysis and improve the enterprise carbon emissions and energy efficiency evaluation system.

（2） Broaden industrial financing channels.

Relying on the existing support channels, promote the industrialization of major innovative achievements in the field of API and the promotion and application of green low-carbon technology and equipment. Innovate the way to use funds and use market-oriented industrial investment funds to support the development of backbone enterprises and the construction of key common technology platforms in the industry. We will encourage advantageous enterprises to use diversified investment and financing channels such as listing and bond issuance to enhance their ability to support industrial innovation and development.

（3） Strengthen the construction of talent team.

To meet the needs of industry development, improve the talent training mechanism, and focus on training professional, high-level and complex talents in API process development, safety and environmental protection, international registration and marketing. Encourage enterprises to cultivate and introduce high-end talents, improve the internationalization level of the team, and enhance the international market operation ability. We will promote in-depth cooperation between enterprises and institutions of higher learning and scientific research institutes, carry out pilot demonstration of integration of production and education, and improve the ability of talents to solve practical problems.

（4） Strengthen organization, coordination and management.

The National Development and Reform Commission, the Ministry of Industry and Information Technology, together with relevant units, will strengthen the organization and coordination of the implementation of the plan, implement the major project of high-quality development of APIs, entrust relevant institutions to evaluate the implementation in due time, and coordinate and solve problems in the implementation process in a timely manner. The development and reform commissions at all levels and the competent departments of industry and information technology should consider the industrial base, market demand, environmental capacity and other factors as a whole, make scientific plans and fully demonstrate, and orderly promote the high-quality development of the region's API industry.