All API companies involved! Four departments printed and distributed guidance on promoting green development of API industry

The industrial and information technology, ecological environment, health, and drug supervision and administration departments of all provinces, autonomous regions, and municipalities directly under the central government, relevant industry associations, and relevant enterprises are now printing and distributing the guidance on promoting the green development of API industry to you Please carefully implement it in combination with the actual situation Guidance of the Ministry of industry and information technology, the Ministry of ecology and environment, the State Health Commission, the State Drug Administration, December 20, 2019 on promoting the green development of API industry API is located in the upstream of the pharmaceutical industry chain, which is the basis of ensuring drug supply and meeting the drug demand of the people In recent years, the rapid development of API industry in China has played an important role in protecting people's health and promoting economic development At the same time, there are some problems in API industry, such as serious product homogeneity, low industrial concentration, relatively backward production technology and high environmental cost In order to further promote the green upgrading of API industry and promote the high-quality development of pharmaceutical industry, the following suggestions are put forward 1、 General requirements (I) guiding ideology Adhering to the socialist ideology of China with the characteristics of socialism in Xi Jinping's new era, we must fully implement the spirit of the nineteen and nineteen sessions of the party's second, third and fourth plenary sessions, adhere to the new concept of development, and further promote structural reforms in the supply side We must constantly promote industrial agglomeration through adjusting the industrial structure, optimizing the industrial layout, promoting technological innovation, implementing green standards, and strictly supervising the industry Improve the green production level and realize the high-quality development of API industry （2） The basic principles are market-oriented and government guided Strengthen the dominant position of enterprises in the market, form an effective incentive and restraint mechanism, force backward production capacity to exit, and promote the transformation and upgrading of enterprises We should give full play to the guiding role of policies in promoting the green development of industries, improve industrial policies and regulatory standards, and create a good market environment Adhere to the optimization of layout and cluster development Strengthen the industrial layout planning, accelerate the upgrading of API enterprises, and promote the coordinated development of API industry and regional environment We will integrate the industry's advantageous resources, improve the infrastructure support capacity, and promote the agglomeration of API enterprises in regions with strong environmental carrying capacity and good production supporting conditions Adhere to innovation driven and green development Accelerate the development of green products and technological progress, eliminate backward production capacity according to laws and regulations, and promote the level of green development of the industry Integrate industry innovation resources, build green pharmaceutical technology alliance, and break through the technical bottleneck restricting the green development of API Adhere to improving quality and ensuring supply Strengthen the supervision of ecological environment, drug quality and occupational health, establish the management concept of quality first, implement the main responsibility of the enterprise, and improve the quality of API products We will promote the integration of upstream and downstream resources in the industrial chain, establish a pharmaceutical supply assurance alliance, and improve the supply assurance capacity of APIs （3） Main objectives By 2025, the industrial structure will be more reasonable, the proportion of APIs produced by green technology will be further increased, and the market share of high-end specialty APIs will be significantly increased; the industrial layout will be more optimized, and APIs will basically achieve park based production and build a batch of API centralized production bases; the technical level will be effectively improved, more than 20 green key generic technologies will be broken, and the industry green will be basically realized Color production technology is replaced; green standards are continuously improved; evaluation system of green factories, green parks and green management standards for APIs is established to play a leading role in green development of advantageous enterprises; cleaner production level is significantly improved, and energy consumption per unit industrial added value, carbon dioxide emissions, water consumption, sulfur dioxide, nitrogen oxides, volatile organic compounds and other major pollutants are discharged The intensity decreased gradually 2、 Key tasks (1) adjustment of industrial structure Encourage the optimization of industrial resource allocation, promote the transformation of green production technology, increase the proportion of bulk API green products, accelerate the development of characteristic API and high-end customized API, and eliminate backward technologies and products according to laws and regulations We will improve the access standards for the API industry, strictly enforce the quality, environmental protection and health standards, strengthen the market competition mechanism and backpressure mechanism, reduce low-level duplication, and gradually improve the concentration and scale-up production level of the API industry （2） Optimize industrial layout According to the requirements of the red line of ecological protection, the bottom line of environmental quality, the online utilization of resources and the list of ecological environment access, the layout of industrial areas should be reasonably planned The new projects should be located in the legally established industrial parks, and meet the requirements of the environmental impact assessment of industrial park planning and construction projects Gradually improve the green development level of the main API producing areas, accelerate the upgrading and transformation of enterprises and industrial transfer in environmentally sensitive areas, and establish more strict access standards for cities whose ambient air quality is not up to standard （3） Accelerate technological innovation and application Strengthen the main position of technological innovation of enterprises, improve the collaborative innovation system of industry, University, research and application, gather innovative technical talents, stimulate the vitality of innovation main body, and enhance the ability of original innovation and integrated innovation Focus on the demand of green industry development, accelerate the research and application of green technology, promote green processes such as efficient extraction and purification, green enzyme synthesis, microchannel reaction, break through a batch of key core green technologies, cultivate a batch of high-quality innovative enterprises, and build a batch of innovation platforms, strategic alliances and demonstration bases （4） Promote green production standards With the focus on improving quality, energy conservation and consumption reduction, cleaner production, pollution control, recycling and ecological protection, we have formulated and implemented green factories, green parks and green management standards for APIs, and built a green production system with resource conservation, environmental friendliness and ecological civilization We will improve the green production evaluation system, organize industry associations to carry out benchmarking evaluation, encourage enterprises to apply for green factories, give play to the leading role of high-quality enterprise benchmarking, and promote the green development level of the industry 3、 Organize and implement (1) increase policy support We should make full use of existing capital channels, support the construction of technological innovation platforms, promote technological transformation of production, and develop new green products Innovate financial service products and service methods, promote the development of green credit business, and increase financial support for green production of APIs Priority should be given to the review and approval of APIs that are urgently needed in clinical practice and short of market Support the centralized clean production and industrial cluster development of API by promoting the implementation of differential peak shifting production For the short pharmaceutical preparations or API production lines that need to be shut down for remediation due to environmental protection factors such as excessive discharge, the reasonable production transition period shall be given according to law to ensure the stable production and supply of the short pharmaceuticals （2） Implement the main responsibility of the enterprise Strengthen the main responsibility consciousness of green development of enterprises, urge enterprises to improve the environmental protection, occupational health and social risk management system, take the initiative to strengthen risk prevention and control, and regularly issue social responsibility reports We will promote enterprises to establish and improve internal management systems for environmental protection, occupational health, energy conservation and consumption reduction, and improve the professional quality of employees Establish and improve the credit evaluation mechanism, implement the joint punishment for dishonesty, and create a good development environment （3） Strict industry regulatory standards Strictly enforce environmental access, strengthen the emission permit management of API production enterprises, strictly carry out the emission with and according to the permit, implement the emission standard of air pollutants in pharmaceutical industry, implement the special emission limit in key areas, strengthen the comprehensive measures such as source prevention, process control and end treatment, do a good job in unorganized emission control, and ensure the stable emission up to the standard Strengthen the quality supervision of API production, strictly investigate and deal with all kinds of illegal behaviors, and ensure the continuous compliance production of API enterprises （4） We will promote the construction of a centralized production base for APIs Reasonably plan the layout of API industry, guide the formulation of evaluation standards for green industrial parks, support local governments to rely on the existing pharmaceutical and chemical industrial parks, carry out the construction of API centralized production base through structural adjustment, industrial upgrading and layout optimization, and realize public system sharing, comprehensive utilization of resources, centralized pollution control and industrial agglomeration development In case of drug shortage caused by API problems, API can be included in the scope of matching when the state organizes to carry out matching, and the base shall be guided to undertake the production task of API shortage All departments and units should strengthen organization and leadership, pay attention to coordination and cooperation, and earnestly implement The trade association should give full play to the role of bridge and link, do a good job in the publicity and guidance of industrial policies, pay attention to the establishment of advanced models, organize the exchange of experience, participate in the formulation of green standards, organize the implementation of industry evaluation, and create a good atmosphere to comprehensively promote the green development of API industry 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