The Ministry of Industry and Information Technology, the Ministry of Ecology and Environment, the National Health and Health Commission, and the State Drug Administration jointly issued the "Guiding Opinions on Promoting the Green Development of the Raw Material Medicine Industry", which clarified the main goal: By 2025, the industrial structure will be more reasonable The proportion of APIs produced by green processes has been further increased, and the market share of high-end specialty APIs has been significantly increased; the industrial layout has been further optimized, and the APIs have basically realized park-based production, creating a batch of API production bases; the technological level has been effectively improved and exceeded 20 The above-mentioned green key common technologies basically realize the industrial green production technology replacement; the green standards are continuously improved, and the green drug factory, green park, and green management standard evaluation system is established to give play to the leading role of green development of leading companies; the level of clean production has improved significantly, and the unit Industrial value-added energy consumption, carbon dioxide emissions, water consumption, and emissions of major pollutants such as sulfur dioxide, nitrogen oxides, and volatile organic compounds have gradually declined.
Attached: Notice on Printing and Distributing the Guiding Opinions on Promoting the Green Development of the API Industry
Ministry of Industry and Information Technology (2019) No. 278
工业 Industrial and informatization, ecological environment, health, and drug supervision and administration departments, relevant industry associations, and related enterprises in each province, autonomous region, and municipality:
Issuance of the Guiding Opinions on Promoting the Green Development of the API Industry, please implement it carefully in accordance with the actual situation.
Ministry of Industry and Information Technology
Ministry of Ecology and Environment
National Health Council
State Drug Administration
December 20, 2019
Guiding Opinions on Promoting the Green Development of the API Industry
The raw material medicine is at the upstream of the pharmaceutical industry chain, which is the basis for ensuring the supply of medicines and meeting the needs of people in drug use. In recent years, the rapid development of China's bulk drug industry has played an important role in protecting people's health and promoting economic development. At the same time, the bulk drug 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 upgrade of the API industry and help the high-quality development of the pharmaceutical industry, the following opinions are proposed.
I. General requirements
(A) guiding ideology
Guided by Xi Jinping's thoughts on socialism with Chinese characteristics in the new era, fully implementing the spirit of the 19th CPC National Congress and the 2nd, 3rd, and 4th Plenary Sessions of the 19th CPC Central Committee, adhering to the new development concept, pushing forward supply-side structural reforms, and adjusting industries Structure, optimize industrial layout, promote technological innovation, promote green standards, strict industry supervision, continuously promote industrial agglomeration, improve green production levels, and achieve high-quality development of the API industry.
(2) Basic principles
Adhere to market leadership and government guidance. Strengthen the dominant position of the enterprise market, form an effective incentive and restraint mechanism, force the withdrawal of backward production capacity, and promote the transformation and upgrading of enterprises. Give play to the guiding role of policies in promoting the green development of the industry, improve industrial policies and regulatory standards, and create a good market environment.
Insist on optimizing layout and gathering development. Strengthen industrial layout planning, accelerate the upgrading and transformation of API companies, and promote the coordinated development of API industry and regional environment. Integrate the industry's advantageous resources, improve the infrastructure support capabilities, and promote the bulk drug companies to gather in regions with strong environmental carrying capacity and good production supporting conditions.
Insist on 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 promotion of the industry's green development level. Integrate industry innovation resources, create a green pharmaceutical technology alliance, and break through technical bottlenecks that restrict the green development of APIs.
Insist on improving quality and ensuring supply. Strengthen the supervision of the ecological environment, drug quality and occupational health, establish the business philosophy of quality first, implement the corporate responsibility, 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 ability to support the supply of raw materials.
(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 optimized, and the APIs will be basically produced in parks, creating a batch of API production centers ; The technical level has been effectively improved, breaking through more than 20 key green common technologies, and basically realizing the replacement of green production technology in the industry; the green standards are constantly being improved, and the green drug factory, green park, and green management standard evaluation system is established to play a leading role in the green development of advantageous companies ; The level of cleaner production has increased significantly, energy consumption per unit of industrial added value, carbon dioxide emissions, water consumption, and emissions of major pollutants such as sulfur dioxide, nitrogen oxides, and volatile organic compounds have gradually decreased.
II. Key Tasks
(1) Adjusting the industrial structure. Encourage the optimization of industrial resource allocation, promote the transformation of green production technology, increase the proportion of green products of bulk APIs, accelerate the development of specialty APIs and high-end customized APIs, and eliminate backward technologies and products in accordance with laws and regulations. We will improve access standards for the bulk drug industry, strictly enforce standards for quality, environmental protection, and hygiene, strengthen market competition mechanisms and counterforces, reduce low-level duplication, and gradually increase the concentration and large-scale production of the bulk drug industry.
(2) Optimize the industrial layout. According to the requirements of the ecological protection red line, the environmental quality bottom line, the online use of resources, and the ecological environment access checklist, rationally plan the industrial area layout. New projects should be located in industrial parks established in accordance with the law, and meet the requirements of industrial park planning and environmental assessment. Gradually improve the level of green development in major API production areas, accelerate the upgrading and transformation of enterprises in environmentally sensitive areas, and industrial transfer. Cities with substandard ambient air quality should formulate stricter access standards.
(3) Accelerate technological innovation and application. Strengthen the status of enterprises as the mainstay of technological innovation, improve the collaborative innovation system for production, education, and research, gather innovative technical talents, stimulate the vitality of innovations, and enhance the original and integrated innovation capabilities. Focus on the needs of industrial green development, accelerate the advancement of green technology research and industrialization, promote green technologies such as efficient extraction and purification, green enzyme synthesis, and microchannel reactions, break through a number of key core green technologies, and cultivate a number of high-quality innovative enterprises. Build a number of innovation platforms, strategic alliances, and demonstration bases.
(4) Promote green production standards. With the focus on improving quality, saving energy and reducing consumption, cleaner production, pollution control, recycling and ecological protection, we have formulated and implemented standards for green factories, green parks, and green management of raw materials, and established a green production system that is resource-saving, environment-friendly and ecologically civilized. . Improve the green production evaluation system, organize industry associations to conduct benchmarking evaluations, encourage enterprises to apply for green factories, give play to the leading role of high-quality enterprise benchmarks, and promote the promotion of the industry's green development level.
Three, organization and implementation
(1) Strengthen policy support. Make full use of existing funding channels to support the construction of technological innovation platforms, the promotion 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 green production of APIs. Priority review and approval will be given to APIs that are urgently needed in clinical situations and that are in short supply in the market. By promoting the implementation of differentiated peak shift production and other methods, we support centralized clean production of APIs and industrial cluster development. For the shortage of pharmaceutical preparations or drug substance production lines that need to be suspended and rectified due to environmental factors such as excessive emissions, a reasonable production transition period is provided in accordance with the law to ensure the stable production and supply of shortages of drugs.
(2) Implement the main corporate responsibility. Strengthen the corporate responsibility awareness of green development, urge enterprises to improve environmental protection, occupational health and social risk management systems, proactively strengthen risk prevention and control, and regularly release social responsibility reports. Promote enterprises to establish and improve internal management systems such as environmental protection, occupational health, energy conservation and consumption reduction, and improve the professional quality of employees. Establish a sound credit evaluation mechanism, implement joint punishment for dishonesty, and create a good development environment.
(3) Strict industry regulatory standards. Strict environmental access, strengthen the management of pollution permits for API manufacturers, strictly hold the permit, discharge in accordance with the permit, implement the emission standards for air pollutants in the pharmaceutical industry, implement special emission limits in key areas, and strengthen comprehensive prevention at source, process control, and end-of-line Measures to do a good job in the management and control of fugitive emissions to ensure stable and up-to-standard emissions. Strengthen the supervision of the quality of API production, strictly investigate and deal with all kinds of violations of laws and regulations, and ensure the continued compliance production of API companies.
(4) Promote the construction of centralized production bases for bulk drugs. Reasonably plan the layout of the bulk drug industry, guide the formulation of industry green park evaluation standards, support local reliance on existing pharmaceutical and chemical industrial parks, and carry out the construction of centralized bulk drug base production bases through structural adjustments, industrial upgrades, and optimized layouts to achieve public system sharing and resources Comprehensive utilization, centralized pollution control and industrial agglomeration development. For drug shortages caused by problems with the drug substance, when the state organizes the matching, the drug substance shall be included in the matching range, and the base shall be guided to undertake the task of producing the drug substance that is in shortage.
All departments and units should strengthen organizational leadership, pay attention to coordination, and effectively implement it. Industry associations should give full play to the role of bridges, do a good job in propagating and guiding industrial policies, focus on establishing advanced models, organize the exchange of experiences, participate in the formulation of green standards, organize the implementation of industry evaluations, and create a good atmosphere to promote the green development of the API industry.