China is one of the world's largest producers and exporters of active pharmaceutical ingredients (API), also known as raw materials for drugs. With the development of the industry, China's regulatory policies on API manufacturing have gradually become more comprehensive.
Looking at the evolution of China's national economic plans, the 9th Five-Year Plan in the 1990s called for strengthened management of the pharmaceutical market, the development of new products and an improvement in the quality of drugs. Subsequently, the 10th to 12th Five-Year Plans emphasized the enhancement of self-developed capabilities for APIs, the establishment of an improved drug guarantee system, and other relevant strategies.
In the 13th Five-Year Plan, the gradual elimination of drug markups and the promotion of medical service price reforms was a focal point. In the recently released 14th Five-Year Plan, the cultivation of advanced manufacturing industry clusters and the promotion of innovation and development in the pharmaceutical and medical equipment sectors were clearly stated.
According to the "Guidelines for Promoting the Green Development of the API Industry" issued by the Ministry of Industry and Information Technology, the Ministry of Ecology and Environment, the National Health Commission, and the National Medical Products Administration of China, by 2025, the structure of the API industry will become more reasonable, and the proportion of green process-produced APIs will be further increased. High-end featured APIs will gain a significant market share. The industrial layout will be further optimized, and APIs will be produced essentially in industrial parks, with a few key production bases. The technological level will be effectively promoted, with over 20 green key shared technologies breakthroughs, basically realizing the industry's green production technology replacement. The green standards will continue to improve, establishing an API green production factory, green industrial park, and green management standard evaluation system, playing the role of leading green development of the advantageous enterprises. The clean production level will be significantly improved, with the intensity of major polluting discharge such as unit industrial value-added energy consumption, carbon dioxide emission, water consumption, sulfur dioxide, nitrogen oxide, and volatile organic compounds gradually reduced.
The Chinese government's policies on API manufacturing are aimed at improving the quality and safety of drugs while promoting the development of the industry in a more sustainable way. By creating policies aimed at green development, China's API manufacturing sector will continue to grow and contribute to the health and well-being of people worldwide.C