Four ministries and commissions jointly promote the green development of API industry
2020-01-02
The Ministry of Industry and Information Technology, the Ministry of Ecology and Environment, the National Health Commission, and the State Drug Administration recently jointly issued the ''Guiding Opinions on Promoting the Green Development of the API Industry'', clarifying the main goals: by 2025, the industrial structure will be more reasonable, The proportion of APIs produced by green technology has further increased, and the market share of high-end characteristic APIs has increased significantly; the industrial layout has been more optimized, and the production of APIs has basically realized in parks, to build a number of API centralized production base, the technical level effectively improved, breakthrough more than 20 green key common technologies, the basic realization of the industry green production technology replacement;
The Ministry of Industry and Information Technology, the Ministry of Ecology and Environment, the National Health Commission, and the State Drug Administration recently jointly issued the ''Guiding Opinions on Promoting the Green Development of the API Industry'', clarifying the main goals: by 2025, the industrial structure will be more reasonable, The proportion of APIs produced by green technology has further increased, and the market share of high-end characteristic APIs has increased significantly; the industrial layout has been more optimized, and the production of APIs has basically realized in parks, build a batch of centralized production bases for API; effectively improve the technical level, break through more than 20 green key common technologies, and basically realize the replacement of green production technology in the industry; continuously improve the green standards, establish the evaluation system of green factories, green parks and green management standards for API, and give full play to the leading role of green development of superior enterprises; the level of clean production has been significantly improved, energy consumption per unit of industrial added value, carbon dioxide emissions, water consumption, and the emission intensity of major pollutants such as sulfur dioxide, nitrogen oxides, and volatile organic compounds have gradually decreased.
Appendix: Notice on Issuing the Guiding Opinions on Promoting the Green Development of API Industry
Ministry of Industry and Information Technology Lian Consumption [2019] No. 278
The departments of industry and information technology, ecological environment, health and drug supervision and administration of all provinces, autonomous regions and municipalities directly under the Central Government, relevant industry associations and relevant enterprises:
The Guiding Opinions on Promoting the Green Development of the API Industry are hereby issued to you, please combine with the actual situation and earnestly implement them.
Ministry of Industry and Information Technology
Ministry of Ecology and Environment
National Health Commission
State Drug Administration
December 20, 2019
Guiding Opinions on Promoting the Green Development of API Industry
API is in the upstream of the pharmaceutical industry chain, which is the basis for ensuring the supply of drugs and meeting the needs of the people. In recent years, the rapid development of China's API industry has played an important role in protecting people's health and promoting economic development. At the same time, the API industry still has problems such as serious product homogeneity, low industrial concentration, relatively backward production technology, and high environmental costs. In order to further promote the green upgrading of the API industry and help the high-quality development of the pharmaceutical industry, the following opinions are put forward.
General 1. requirements
(I) 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, and Fourth Plenary Sessions of the 19th Central Committee, adhere to the new development concept, and deepen the supply-side structural reform. Structure, optimize industrial layout, promote technological innovation, implement green standards, strictly supervise the industry, continuously promote industrial agglomeration, improve the level of green production, and achieve high-quality development of the API industry.
(II) basic principles
Adhere to market-led, government guidance. Strengthen the dominant position of enterprises in the market, form an effective incentive and restraint mechanism, force the withdrawal of backward production capacity, and promote the transformation and upgrading of enterprises. 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 optimize the layout, cluster development. Strengthen industrial layout planning, accelerate the upgrading and transformation of API enterprises, and promote the coordinated development of API industry and regional environment. Integrate the advantageous resources of the industry, improve the infrastructure guarantee capacity, and promote the agglomeration of API enterprises to 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 in accordance with laws and regulations, and promote the improvement of the industry's green development level. Integrate industry innovation resources, build a green pharmaceutical technology alliance, and break through the technical bottleneck restricting the green development of API.
Insist on improving quality and ensuring supply. Strengthen the supervision of ecological environment, drug quality and occupational health, establish the business philosophy of quality first, implement the main responsibility of enterprises, and improve the quality of API products. Promote the integration of upstream and downstream resources in the industrial chain, establish a drug supply guarantee alliance, and improve the supply guarantee capacity of API.
(III) main objectives
By 2025, the industrial structure will be more reasonable, the proportion of raw materials produced by green technology will be further increased, and the market share of high-end characteristic raw materials will be significantly increased; the industrial layout will be more optimized, the production of raw materials will be basically realized in parks, and a number of centralized production bases for raw materials will be built; the technical level will be effectively improved, breaking through more than 20 green key common technologies, and basically realizing the replacement of green production technology in the industry, establish an evaluation system for green factories, green parks, and green management standards for APIs, and give full play to the leading role of advantageous enterprises in green development; the level of cleaner production has been significantly improved, and the energy consumption per unit of industrial added value, carbon dioxide emissions, water consumption, and sulfur dioxide, nitrogen oxides, and volatile The emission intensity of major pollutants such as organic compounds has gradually decreased.
2. key tasks
(I) adjust the industrial structure. Encourage the optimization of the allocation of industrial resources, promote the transformation of green production technology, increase the proportion of green products for bulk APIs, accelerate the development of specialty APIs and high-end customized APIs, and eliminate outdated technologies and products in accordance with laws and regulations. We will improve the access standards for the API industry, strictly enforce the standards of quality, environmental protection and hygiene, strengthen the market competition mechanism and reverse force mechanism, reduce low-level repetition, and gradually improve the concentration of the API industry and the level of large-scale production.
(II) optimize the industrial layout. In accordance with the requirements of the red line of ecological protection, the bottom line of environmental quality, the online use of resources and the list of ecological environment access, the layout of the industrial area shall be reasonably planned, and the new projects shall be located in the industrial park established according to law, and shall meet the requirements of the environmental impact assessment of the industrial park planning and the environmental impact assessment of the construction project. Gradually improve the level of green development in the main production areas of APIs, accelerate the upgrading and transformation of enterprises and industrial transfer in environmentally sensitive areas, and cities with substandard ambient air quality should formulate stricter access standards.
(III) accelerate technological innovation and application. Strengthen the dominant position of enterprises in technological innovation, improve the collaborative innovation system of industry, university, research and application, gather innovative technical talents, stimulate the vitality of innovation subjects, and enhance the ability of original innovation and integrated innovation. Focus on the needs of industrial green development, accelerate the promotion of green technology research and industrial application, promote efficient extraction and purification, green enzymatic synthesis, microchannel reaction and other green processes, break through a number of key core green technologies, cultivate a number of high-quality innovative enterprises, and create a number of innovation platforms, strategic alliances and demonstration bases.
(IV) the implementation of green production standards. With the focus on improving quality, energy saving and consumption reduction, clean production, pollution control, recycling and ecological protection, we will formulate and implement green factories, green parks and green management standards for raw materials, and build a green production system that is resource-saving, environment-friendly and ecological civilization. Improve the green production evaluation system, organize industry associations to carry out benchmarking evaluation, encourage enterprises to declare green factories, play the leading role of high-quality enterprises, and promote the improvement of the green development level of the industry.
3. organization implementation
(I) increased policy support. Make full use of existing funding channels to support the construction of technological innovation platforms, the implementation of production technology transformation, and the development of new green products. Innovate financial service products and service methods, promote the development of green credit business, and increase financial support for the green production of raw materials. Priority review and approval of APIs that are urgently needed clinically and in short supply in the market. By promoting the implementation of differentiated peak production and other ways to support the centralized clean production of API and the development of industrial agglomeration. For the shortage of pharmaceutical preparations or API production lines that need to be stopped for remediation due to environmental factors such as excessive emissions, the stable production and supply of the shortage of drugs will be guaranteed by giving a reasonable production transition period in accordance with the law.
(II) implement the main responsibility of enterprises. Strengthen the awareness of the main responsibility of the green development of enterprises, urge enterprises to improve environmental protection, occupational health and social risk management systems, actively strengthen risk prevention and control, and regularly issue social responsibility reports. 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 joint punishment for breach of trust, and create a good development environment.
(III) strict industry regulatory standards. Strict environmental access, strengthen the management of pollution discharge permits for API manufacturers, strictly license and license discharge, implement air pollutant emission standards for the pharmaceutical industry, implement special emission limits in key areas, and strengthen comprehensive measures such as source prevention, process control, and end treatment, Do a good job in unorganized emission control to ensure stable emission standards. Strengthen the quality supervision of API production, strictly investigate and deal with all kinds of violations of laws and regulations, and ensure the continuous compliance of API enterprises.
(IV) promote the construction of a centralized production base for raw materials. Reasonably plan the layout of the API industry, guide the formulation of industry green park evaluation standards, support local governments to rely on existing pharmaceutical and chemical industrial parks, and carry out the construction of centralized API production bases through structural adjustment, industrial upgrading, and optimization of layout, so as to achieve public system sharing and comprehensive resources Utilization, centralized pollution control and industrial cluster development. For the shortage of drugs caused by the problem of API, the API can be included in the scope of matching when the national organization carries out the matching, and guide the base to undertake the production task of the shortage of API.
All departments and units should strengthen organization and leadership, pay attention to coordination and cooperation, and earnestly implement them. Industry associations should give full play to the role of bridges, 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 for comprehensively promoting the green development of the API industry.
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