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This book, i.e. the 2020 Report on China’s Pharmaceutical Industry Development, consists of seven chapters, namely, General Report, Policies and Regulations, Keynote Reports, Technological Innovation, Green Pharmaceuticals, Regional Development, and Appendices. There are 27 reports in all.
The General Report analyzes the economic situation in 2019, elaborates the significances of the newly revised “Drug Administration Law”, discusses the impact of the adjustment of the catalog of medicines covered by national medical insurance system and the centralized volume-based procurement of drugs in “4+7” regions on the development strategy of the pharmaceutical industry, and lists ten major tasks for the development of China’s pharmaceutical industry in 2020. The Tripartite Medical System Reform will gradually get deepened, the pharmaceutical industry is faced with structural adjustment, transformation and upgrading, and “innovation-quality + compliance” will become the main theme of the development of the pharmaceutical industry.
The chapter of Policies and Regulations introduces the 2019 edition of the catalog of medicines covered by national medical insurance system, the policy background, problems to be solved, and its scope, focuses, procedures, supervision mechanisms, etc. This chapter elaborates the measures of the new version of the “Drug Administration Law” to encourage research and development innovation and ensure the accessibility of drugs and a new drug supervision model with credit management as the core. Through the analysis of reimbursement policies for innovative drugs abroad, policy recommendations are made for the improvement of our country’s medical insurance policies for domestic innovative drugs. It also interprets the development of China’s social security system. The chapter of Keynote Reports collects policies related with the consistency evaluation of injections in 2019, predicts the development prospects of the world’s major therapeutic drug markets in the next few years, analyzes the situation of diabetes drug market, anti-thrombotic drug market and vitamin C market, and introduces new preparations approved for marketing abroad. The chapter of Technological Innovation points out that directed evolution technology of enzymes, high-throughput screening, AI-assisted evolution and other cutting-edge technologies scientifically boost the biological enzyme catalysis. Pharmaceutical companies use their own development stories to show that innovation is the company’s core competitiveness. The development process of centrifuge products in the past 50 years is also shared. Starting with the common problems in the application materials for the consistency evaluation of generic drugs, it interprets the official requirements, and based on years of experience in research and development and review of generic drugs, it offers some suggestion. It explores the research and development methods and key points of quality improvement of high-end pharmaceutical excipients (high-end excipients), and predicts the innovation of high-end excipients. The chapter of Green Pharmaceuticals expounds the technology and practice of wastewater treatment techniques in the pharmaceutical industry. Based on the principle of uniform treatment of high concentration and special wastewater after the pretreatment in the workshops, it proposes a general technical route for wastewater treatment in the pharmaceutical industry. On the basis of the concept of residual antibiotic titer in high-concentration wastewater from antibiotic production, it explains the idea of removing the antibiotic titer in the wastewater through the enhanced hydrolysis pretreatment method and then combining biological and physical and chemical methods to remove conventional pollutants. Enterprises start to construct demonstration projects of harmless treatment of antibiotic residues by electron beam irradiation (daily treatment capacity is about 5000 tons of wet residues). Ionizing irradiation can not only degrade the antibiotics remains in the residues, but also kill drug-resistant bacteria and eliminate the resistance gene pollution, so as to achieve the harmless treatment of antibiotic residues. It pays attention to the research on the pollution problem of antibiotic residues, the development of harmless and recycling technologies, and the safe use of recycling products. It introduces the application of ceramic membranes in fermentation broth clarification, traditional Chinese medicine refining and pharmaceutical wastewater treatment, and molecular sieve membranes for solvent dehydration and PDMS composite membranes for the recycling of VOCs.