Vitalizing Traditional Chinese Medicine And Solving Difficult Problems In Clinical Evaluation And Quality Control

In this year's government work report, it is clearly stated that "we should attach equal importance to both traditional Chinese and Western medicine and implement the major project of revitalizing and developing traditional Chinese medicine", which has been mentioned in the government work report for four consecutive years.

Up to now, the state and local governments have also issued a number of relevant policies to support the development of traditional Chinese medicine, and the Chinese medicine industry is continuing to develop well. In February 2021, the general office of the State Council issued a number of policies and measures on accelerating the development of Chinese medicine with characteristics, and launched 28 policies and measures to comprehensively boost the development of traditional Chinese medicine.

According to the public data, the market scale of Chinese patent medicines has increased from 625.2 billion yuan in 2015 to 814.9 billion yuan in 2019. According to the current development trend, it is estimated that the market scale of Chinese patent medicine in 2022 is expected to exceed trillion yuan.

However, there are still many problems in the development of traditional Chinese medicine, such as obvious deficiencies in the evaluation system, quality control and basic research of traditional Chinese medicine. At this year's national two sessions, many representatives including academician Zhang Boli also put forward relevant suggestions and proposals to promote the development of traditional Chinese medicine.

Among them, some representative members proposed to speed up the centralized procurement of traditional Chinese medicine and formula granules, and proposed to formulate a special centralized procurement policy for innovative traditional Chinese medicine according to the innovation of traditional Chinese medicine, and the relevant government departments should establish a centralized procurement management mode in line with the complex characteristics and unique attributes of traditional Chinese medicine.

Information map.

Construction of clinical evaluation system of traditional Chinese Medicine

The government work report has mentioned the development of traditional Chinese medicine for four consecutive years. In the 2018 government work report, it is proposed to "support the inheritance, innovation and development of traditional Chinese medicine". We should encourage the integration of traditional Chinese and Western medicine. In 2019, it has been clearly proposed to "support the inheritance, innovation and development of traditional Chinese medicine". In 2020, it is proposed to "promote the revitalization and development of traditional Chinese medicine and strengthen the integration of Chinese and Western medicine". By 2021, the work report of the government proposes "attaching equal importance to both Chinese and Western medicine, and implementing the major project of revitalizing and developing traditional Chinese medicine".

In the government work report, the core statement has changed from "integrated traditional Chinese and Western medicine" to "paying equal attention to both Chinese and Western medicine". This great leap in status is inseparable from the important role played by traditional Chinese medicine in the fight against the epidemic. Academician Zhang Boli pointed out that the "combination of traditional Chinese and Western medicine and the combination of Chinese and Western medicine" proposed by the Central Committee is not only a magic weapon to fight the epidemic, but also the basis for the construction of "healthy China".

At the 2021 "voice and responsibility" forum of CPPCC members of the National People's Congress, deputy to the National People's Congress and director of Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd., also pointed out to the 21st century economic reporter that there are still obvious deficiencies in the evaluation system, quality control and basic research of traditional Chinese medicine in China, mainly due to the imperfect clinical evaluation system of traditional Chinese medicine, In particular, the characteristics of multi-target, multi-dimensional and overall regulation of traditional Chinese medicine treatment are difficult to reflect in the animal model of clinical trials, which is an important reason for the low passing rate of new drug evaluation.

At the same time, the reference drugs of "generic drugs" of traditional Chinese medicine are not clear, and the basic information of "reference drugs" catalogue and classic famous prescriptions are lack, which makes the research and innovation of traditional Chinese medicine full of uncertainty. In addition, the foundation of Chinese herbal medicine resource evaluation is weak, and there is a lack of authoritative research and evaluation platform and achievements at the national level.

Professor Yang Shuyu, chairman of diabetes branch of the Chinese society of traditional Chinese medicine and the First Affiliated Hospital of Xiamen University, also pointed out to the reporter of the 21st century economic report that only by improving the clinical evaluation system of traditional Chinese medicine can Chinese medicine go further and be further in line with international standards.

Pang Guoming, deputy to the National People's Congress, executive chairman of the Alliance for promoting the construction of a strong province of traditional Chinese medicine in Henan Province, and former president of Kaifeng Hospital of traditional Chinese medicine, pointed out that traditional Chinese medicine is fundamentally different from western medicine in terms of thinking, theory, method and clinical practice. To follow the development law of traditional Chinese medicine, we must first solve the problem of inheriting the essence of traditional Chinese medicine and establish independent clinical efficacy and scientific research of traditional Chinese medicine according to law The index evaluation system is the only standard to test the vitality of traditional Chinese medicine and the basis to solve the problem of eliminating the false and retaining the true and inheriting the traditional essence.

In this regard, Fang Tonghua suggested that according to the law of traditional Chinese medicine, opinions on promoting the inheritance, innovation and development of traditional Chinese medicine and other laws and regulations, the clinical evaluation system of traditional Chinese medicine should be comprehensively constructed, the "reference drugs" catalogue of traditional Chinese medicine should be formulated at the national level, so as to promote the real implementation of research and development of traditional Chinese medicine, accelerate the research of classic prescriptions, and provide theory, dosage, and quality for the development of traditional Chinese medicine products Quality and other comprehensive work guidance and support. At the same time, we should build a national evaluation platform for medicinal materials resources, strengthen the information construction of public platforms, and continue to create a "green channel" for the research and development of traditional Chinese medicine, so that the research and development institutions of traditional Chinese medicine have rules to follow, avoid detours in research and development, and inject vitality into the research and innovation of traditional Chinese medicine.

"We should formulate and promulgate supporting policies for the dispensing and use of hospital preparations in medical institutions, encourage hospitals at all levels to develop hospital preparations, accelerate the selection and application of hospital preparations, especially encourage and support hospitals to carry out clinical research activities of preparations, enrich the product structure of hospitals, create a good environment for the development of hospital preparations, vigorously carry out the dispensing and use of hospital preparations, and promote the use of hospital preparations Preparations should be included in clinical drug management to prevent quality risks and ensure the safety of drug use by the masses. " Fang Tonghua further proposed.

Speed up the collection of traditional Chinese medicine and formula granules

In addition to the establishment of clinical evaluation system of traditional Chinese medicine, Fang Tonghua also suggested that under the supervision of laws and regulations, we should strengthen the formulation of supporting measures for the standardization of traditional Chinese medicine, especially the decoction pieces and formula granules, so as to form a system for evaluating the safety and effectiveness of traditional Chinese medicine preparations, standards and quality evaluation, and accelerate the development of standardization of traditional Chinese medicine.

However, Lu Qingguo, deputy to the National People's Congress and chairman of Chenguang Biotechnology Co., Ltd., said in an interview with the 21st century economic reporter that the current situation faced by the Chinese medicine industry is not optimistic, and the production of traditional Chinese medicine is small, scattered and disorderly. There are more than 5000 traditional Chinese medicine factories, more than 10000 batches of traditional Chinese medicine, and the annual drug revenue is about 800 billion yuan. Vicious competition, low-level duplication, emphasis on marketing rather than technology and management are widespread, which not only wastes social resources, but also increases the difficulty of government supervision.

According to the data of the Ministry of industry and information technology, the market scale of Chinese Herbal Pieces in 2018 is about 220 billion yuan, of which TCM formula granules account for about 8.4%, and the market scale is about 18.5 billion yuan, which still has great growth potential. On February 10, the State Food and drug administration, the State Administration of traditional Chinese medicine, the National Health Commission and the State Medical Insurance Bureau jointly issued the announcement on the end of the pilot work of traditional Chinese medicine formula granules, announcing that the pilot work of traditional Chinese medicine formula granules, which has been continued since 1993, will be terminated on November 1 this year.

This means that a 27 year trial policy is about to become a full-fledged one, and the market of tens of billions is facing changes.

With the liberalization of the market of traditional Chinese medicine formula granules, more and more enterprises will pour into the market in the future. On February 18, the State Food and Drug Administration disclosed that the national standards for 160 commonly used formula granules had been reviewed. By November 2020, according to incomplete statistics of Xinhua news agency, more than 60 pharmaceutical enterprises in China have obtained the production qualification of traditional Chinese medicine formula granules. Among the A-share listed companies alone, more than 30 pharmaceutical enterprises have laid out or will soon lay out TCM formula granules.

Therefore, Lu Qingguo suggested that the centralized procurement bidding of traditional Chinese medicine and formula granules could effectively promote the large-scale production and operation of traditional Chinese medicine enterprises, reduce the cost of traditional Chinese medicine, and promote the healthy development of Chinese medicine industry. We will create conditions to enable Chinese patent medicines to enter the mechanism of centralized bidding and procurement of drugs as soon as possible, so that more Chinese medicine manufacturers can participate in fair competition. The standard system should be improved, and the traditional Chinese medicine formula granules should be included in the bidding and purchasing system of drug concentration and quantity, so as to promote the better development of Chinese medicine formula granules.

In fact, the State Council has issued a document to promote the normalization and institutionalization of state-owned centralized mining with volume.

On March 8, the State Medical Insurance Bureau released the "2020 medical security development statistical bulletin", which showed that in 2020, the total amount of online purchase orders through provincial drug centralized procurement platform was 931.2 billion yuan, which was 60.1 billion yuan lower than that in 2019. Among them, Western Medicine (chemical and biological products) was 752.1 billion yuan, and Chinese patent medicine was 179.1 billion yuan, down 59.4 billion yuan and 700 million yuan respectively compared with that in 2019.

Up to now, traditional Chinese medicine has not been brought into the scope of centralized purchase on a large scale, but in the view of the industry, the future trend may not be avoided.

On December 1, 2020, the state medical insurance bureau made a public reply to the issue of bringing Chinese patent medicines into centralized procurement in the reply letter of "proposal on implementing the supporting policies for Chinese patent medicines": it has promoted the expansion of the pilot nationwide and the second and third batch of national drug centralized procurement, and achieved remarkable results. At the same time, we should guide and promote the local exploration of drug collection for Chinese patent medicines and other drugs. At present, Qinghai Province, Jinhua of Zhejiang Province, Puyang of Henan Province and other places have actively carried out centralized purchase exploration for some Chinese patent medicine varieties with large demand and high amount of money, and have achieved remarkable results in price reduction.

However, it is worth noting that due to the characteristics of Chinese patent medicines, there are still some unique problems in the procurement of traditional Chinese medicines. Luo Zhibo, the current chief engineer of the Institute of pharmaceutical research of Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., points out that the planting capacity of medicinal materials is easily affected by the climate, and the price of Chinese medicinal materials fluctuates greatly, which is low under the condition of carrying volume procurement The price of winning the bid, a little careless, may force the enterprise into the plight of losing money production.

Luo Zhibo, for example, said that at present, the price of Panax notoginseng is 195 yuan (based on the commonly used scissors), and Xuesaitong manufacturers still have about 30% profit margin. But if the price of Panax notoginseng rises by 50%, the production enterprises must adjust the price, otherwise they may face the loss of production. "In this kind of state collective purchase, how can you adjust the price at will? On the other hand, how to investigate the responsibility for breach of contract due to force majeure such as floods and production reduction in disaster years will become a difficult problem to be solved. "

In this regard, Xiao Wei, deputy to the National People's Congress, director of the State Key Laboratory for new technologies in traditional Chinese medicine pharmaceutical process, and chairman of Jiangsu Kangyuan Group Co., Ltd., also pointed out that the raw materials of Chinese patent medicines come from nature, and its multi-component complex system puts forward higher technical requirements for quality control in the production process and quality assurance of finished products. Due to historical reasons, most of the existing quality standards of Chinese patent medicines mostly use single component for content determination and quality control, without forming the overall control of effective components. Moreover, in the actual production process, there are great differences in the quality of the same product produced by different manufacturers, the production process is different, and the parameters are different, resulting in the uneven quality of the same product produced by different manufacturers, and the clinical curative effect is not the same stable. For this reason, Xiao Wei suggested that the quality level standard should be set when the centralized procurement rules are formulated. The traditional Chinese patent medicines with the above-mentioned technical characteristics should be distinguished from those produced by traditional technology and technology, and the Chinese patent medicines with the above-mentioned technical characteristics should be judged and compared in groups, and the high-quality and good price should be given to avoid the phenomenon of bad money driving out good money.

Xiao Wei suggested that, according to the innovation of traditional Chinese medicine, it was suggested to formulate a special centralized procurement policy for innovative traditional Chinese medicine, and the relevant government departments should establish a centralized procurement management mode in line with the complex characteristics and unique attributes of traditional Chinese medicine. "According to the complexity of Chinese patent medicine, take the general name as the unit, fully consider the implementation of high quality and good price of Chinese patent medicine on the basis of quality stratification; according to the innovation of traditional Chinese medicine, it is suggested to formulate a special centralized procurement policy of innovative Chinese medicine; according to the particularity of clinical application of Chinese patent medicine, it is suggested to formulate special protection policy to ensure the clinical drug demand; according to the production of Chinese patent medicine, it is suggested to formulate special protection policy to ensure the clinical drug demand It is suggested to establish a scientific drug cost price evaluation system

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