The four departments including 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" (hereinafter referred to as the Opinions). The above-mentioned key green common technologies have basically realized the industrial green production technology replacement, the establishment of green drug factory, green park, green management standard evaluation system, and the emission intensity of major pollutants has gradually decreased.
It is understood that the drug substance is at the upstream of the pharmaceutical industry chain, which is the basis for ensuring the supply of drugs and meeting the demand for drug use by the people. In order to further promote the green upgrade of the API industry and help the high-quality development of the pharmaceutical industry, opinions suggest that by 2025, the industrial structure will be more reasonable, and the proportion of APIs produced by green processes will be further increased; the technological level will be effectively improved, and more than 20 green keys will be broken Common technologies basically realize the replacement of green production technologies in the industry; green standards are constantly being improved; an evaluation system for green factories, green parks, and green management standards for APIs is established to play a leading role in the green development of superior companies; the level of cleaner production has increased significantly, and the value-added performance of unit industries Consumption, carbon dioxide emissions, water consumption, and emissions of major pollutants such as sulfur dioxide, nitrogen oxides, and volatile organic compounds have gradually declined.
Opinions emphasize that 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. Insist on optimizing layout and gathering development. 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. 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 ecological environment, drug quality and occupational health, and improve the quality of API products.
Opinions put forward 4 key tasks. The first is to adjust 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.
The second is to optimize the industrial layout. In accordance with the requirements of the ecological protection red line, the environmental quality bottom line, the on-line use of resources, and the ecological environment access checklist, rationally plan the industrial area layout. 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.
The third is to accelerate technological innovation and application. Promote green technologies such as efficient extraction and purification, green enzymatic synthesis, and microchannel reactions, break through a number of key core green technologies, cultivate a group of high-quality innovative enterprises, and create a number of innovative platforms, strategic alliances, and demonstration bases.
The fourth is to promote green production standards. Focusing on improving quality, saving energy and reducing consumption, cleaner production, pollution control, recycling and ecological protection, we will build a green production system that is resource-saving, environment-friendly, and ecologically civilized.
Opinions require that local and relevant departments strengthen organizational leadership, focus on coordination and coordination, increase policy support, implement corporate responsibility, implement strict industry regulatory standards, and promote the construction of centralized production bases for active pharmaceutical ingredients, and earnestly implement them. 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.