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"The development of traditional Chinese medicine has ushered in a new historical opportunity." Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, made the above statement at the National Traditional Chinese Medicine Scientific Supervision Conference held recently. He believes that the supervision of traditional Chinese medicine is entering a new stage in all aspects. In the historical development stage of China, it is necessary to take greater courage and more pragmatic actions to activate the potential of traditional Chinese medicine inheritance, innovation and development, and effectively promote the high-quality development of traditional Chinese medicine.

In recent years, the scale and level of my country's traditional Chinese medicine industry has been significantly improved, but the development of the industry has not kept pace with the scale. Many industry insiders said that the traditional Chinese medicine industry has ushered in a period of rapid development, and it is necessary to further improve the traditional Chinese medicine supervision system and focus on tackling key technologies for the high-quality development of the traditional Chinese medicine industry, including improving the quality of traditional Chinese medicine, mining ancient prescriptions, strengthening new drug research and development, and upgrading. Traditional Chinese medicine equipment, etc., truly promote the high-quality development of the modernization of traditional Chinese medicine.

The quality control of traditional Chinese medicine industry has improved significantly

The traditional Chinese medicine industry involves agriculture, industry, and service industries. The product chain, technology chain, and service chain are long, and the production, circulation, and use processes are complex. At the same time, the quality of traditional Chinese medicine directly affects the efficacy of the drug, and also affects the health of the user. From decoction pieces to formula granules, to Chinese patent medicines, the quality source of Chinese medicinal materials is all Chinese medicinal materials. Quality control in processing, packaging, storage, transportation and other links is the key.

In 2021, the State Food and Drug Administration will further standardize the production order of traditional Chinese medicine by comprehensively using special rectification, special inspection, cause-based inspection and random inspection, monitoring and other means. Ma Shuangcheng, director of the Institute for the Control of Traditional Chinese Medicine and Ethnic Medicine of the China Academy of Food and Drug Control, said that after strict rectification and supervision, the quality of traditional Chinese medicinal materials that existed in the past has deteriorated, the processing of traditional Chinese medicine pieces is not standardized, heavy metal and pesticide residues, adulteration and adulteration. Problems such as the mixed use of medicinal materials of different species have been effectively curbed.

The data shows that in 2021, 31 provinces and cities across the country (excluding Hong Kong, Macao and Taiwan) will sample 51,194 batches of Chinese herbal medicines and Chinese herbal decoction pieces, of which 49,807 batches are qualified. . Among the adverse reaction reports of traditional Chinese medicine, the proportion of serious adverse reactions decreased significantly. Ma Shuangcheng said frankly that although the quality awareness of the traditional Chinese medicine industry has improved, it is still weak as a whole.

In this regard, Xu Jinghe said that the next step will continue to strengthen the quality and safety supervision of traditional Chinese medicines, and multiple departments should work together to promote the cultivation and quality management of traditional Chinese medicines, and the construction of the whole chain traceability system of traditional Chinese medicines. Cooperation to promote the inheritance and innovation of traditional Chinese medicine and the development of traditional Chinese medicine.

The innovation and research and development of traditional Chinese medicine need further efforts

Chen Kaixian, an academician of the Chinese Academy of Sciences and a researcher at the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, said that the combination of Chinese and Western medicine, the combination of Chinese and Western medicine, and the combined use of Chinese and Western medicine are important guidelines for the development of Chinese medicine in my country. The integration of traditional Chinese and western medicine, complementary advantages, complementary and coordinated development, will not only greatly improve the ability and level of medical and health work to serve people's health, but also will lay the foundation for the gradual formation of a new medicine that integrates traditional Chinese and Western medicine in the future.

"Entering a new historical period, the modernization and innovation of traditional Chinese medicine are facing higher requirements." Chen Kaixian said, the protection and sustainable utilization of traditional Chinese medicine resources, the research on the material basis and mechanism of the action of traditional Chinese medicine, the research on the standardization and control technology of traditional Chinese medicine, the compound prescription of traditional Chinese medicine New drug research, efficacy evaluation and clinical research of new traditional Chinese medicine drugs, modernization research of traditional Chinese medicine industry technology, etc., are the main tasks and key directions of the modernization of traditional Chinese medicine.

At the same time, build and improve the product R&D innovation chain and efficacy evaluation evidence chain of "clinical experience-basic research-clinical application" of traditional Chinese medicine, attach importance to building a high-end technology platform system for traditional Chinese medicine, strengthen key technologies for quality assurance of high-quality traditional Chinese medicine, and strengthen the innovation of traditional Chinese medicine pharmaceutical equipment. Pay attention to the research on innovative methods for the research and development of new traditional Chinese medicines, and accelerate the modernization of the traditional Chinese medicine industry.

Huang Luqi, academician of the Chinese Academy of Engineering and president of the Chinese Academy of Chinese Medical Sciences, said that we should focus on the key technologies for the high-quality development of the traditional Chinese medicine industry, provide corresponding technical support, and strive to solve the constraints on the sustainable development and comprehensive utilization of traditional Chinese medicine, quality improvement and quality assurance of traditional Chinese medicine. The research and development of new traditional Chinese medicines, the intelligent production of traditional Chinese medicines, and the bottlenecks in the development of core technologies such as traditional Chinese medicine equipment, promote the modernization and high-quality development of traditional Chinese medicine, so as to achieve the goal of making people feel at ease to eat traditional Chinese medicine and eat good traditional Chinese medicine.

In fact, innovation not only comes from the drive of new technology, but also the focus of innovation is to better achieve "the ancient recipes for treating modern diseases are used by me". Tong Xiaolin, Academician of the Chinese Academy of Sciences and Chief Physician of Guang'anmen Hospital of the Chinese Academy of Chinese Medical Sciences, said that the holistic view, individualization and pre-treatment of traditional Chinese medicine are not only the ideological essence of traditional medicine, but also play a guiding role in modern medicine. influences.

"In the past, traditional Chinese medicine was limited by the conditions of the times, and it was very difficult to observe chronic disease patients from the beginning to the end for decades, and the group data was even more scarce. It allows TCM to carry out staged diagnosis and treatment research on modern chronic diseases.” Tong Xiaolin pointed out that the holistic view of TCM focuses on the relationship between diseases and diseases, diseases and people, and people and the environment, but it lacks the treatment of diseases, Especially the understanding of the whole process of chronic disease development and the future situation. Therefore, modern Chinese medicine should reclassify, stage and differentiate modern diseases based on the homogeneity of current medical diagnosis research and use the thinking of Chinese medicine, and then construct a modern Chinese medicine diagnosis and treatment system to solve the problem that ancient prescriptions cannot cure modern diseases.

The Chinese medicine industry is on the "fast track" of development

In recent years, various departments have promoted the innovation of traditional Chinese medicine industry through continuous reform and optimization of traditional Chinese medicine regulatory policies, systems and measures, and the scale and level of my country's traditional Chinese medicine industry have been significantly improved.

According to the "2020 Statistical Annual Report on Drug Supervision and Administration" issued by the State Food and Drug Administration, as of the end of 2020, there were 2,160 companies producing Chinese patent medicines within the validity period in the country, accounting for 28.1% of the total national drug production, and 4,357 Chinese medicine manufacturers (including Chinese medicine decoction pieces). 2197 manufacturing enterprises), accounting for 56.7% of the national pharmaceutical manufacturing enterprises.

In terms of operating conditions, both revenue and profit have risen. According to the statistics of the national pharmaceutical industry, the revenue of proprietary Chinese medicines in 2021 will be 486.2 billion yuan, a year-on-year increase of 11.2%, and the total profit will reach 75.5 billion yuan, a year-on-year increase of 23.2%. The Chinese herbal medicine industry has also entered the 200 billion mark for the first time. In 2021, the operating income of the traditional Chinese medicine decoction pieces industry will reach 205.7 billion yuan, a year-on-year increase of 13.7%, and the total profit will double to 102%.

At the same time, the research and development of new Chinese medicines has been continuously strengthened. In recent years, the number of clinical trials and marketing applications for new Chinese medicines has increased. The data shows that in 2021, my country will review 47 innovative drugs, of which 12 are new traditional Chinese medicines, including 9 category 1 innovative drugs, which is 2.25 times that of 2020; 3 category 2 ancient classic prescriptions. At the same time, 34 new Chinese medicines were approved for clinical trials, all hitting a five-year high.

He Yaqiong, director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, said that the Ministry of Industry and Information Technology attaches great importance to and actively promotes the high-quality development of the traditional Chinese medicine industry. The "14th Five-Year Plan for the Development of Traditional Chinese Medicine" released in early 2022 points out the direction for the development of the traditional Chinese medicine industry in the next five years. It will provide technical support for the construction of traditional Chinese medicine production bases, the advanced manufacturing of large varieties of traditional Chinese medicine, and the construction of public service platforms for the traditional Chinese medicine industry in various ways.

"This year, the Ministry of Industry and Information Technology has set up the research direction of the Chinese medicine technology platform for the whole industry chain of traditional Chinese medicine for the first time." He Yaqiong said that the next step will continue to increase support for the traditional Chinese medicine industry, actively serve traditional Chinese medicine enterprises, support leading traditional Chinese medicine enterprises to become bigger and stronger, and improve the traditional Chinese medicine industry. At the same time, enterprises are strictly required to assume the main responsibility and firmly adhere to the bottom line of quality and safety of traditional Chinese medicine from the source.

Xu Jinghe said that to promote the innovation of traditional Chinese medicine, it is necessary to fully respect the experience and accumulation of traditional Chinese medicine for thousands of years, and to accelerate the transformation of high-quality traditional Chinese medicine preparations in the direction of ancient classics. research and practice. It is necessary to deepen the construction of a review and approval system that conforms to the characteristics of traditional Chinese medicine, conduct in-depth scientific research on the supervision of traditional Chinese medicine, strengthen the building of regulatory capacity, promote the integration of medicine, production, academia, research, and supervision, and support the research and development of new traditional Chinese medicines and high-quality manufacturing.

"The inheritance, innovation and development of traditional Chinese medicine is a systematic project, which requires overall layout, systematic planning, multi-party participation, overall promotion, and orderly implementation." Xu Jinghe said that it is necessary to give full play to the role of expert consultation and in-depth research and judgment on the pain points and obstacles faced by the high-quality development of traditional Chinese medicine. Points and difficulties, timely adjust and improve relevant policies, and continuously improve the foresight and guidance of policies. It is necessary to strengthen information exchange and interaction among all parties, do a good job in policy publicity, interpretation and guidance, gather a strong force for the inheritance, innovation and development of traditional Chinese medicine, and stimulate the vitality of the development of traditional Chinese medicine.