For example, the simplified registration of the classic prescription compound preparations is taken as an example. In order to implement the relevant provisions of the Chinese Medicine Law, in October 2017, the CFDA organized the drafting of the “Regulations on the Simplified Registration and Approval of Traditional Chinese Medicine Classic Compound Preparations (Draft for Comment)” and The draft regulations on the two filing materials were open to the public for comments, but no official documents have yet been released.

Although the State Administration of Traditional Chinese Medicine has recently published the "Ancient Classics Catalogue", the specific implementation policy for the simplified registration of the traditional Chinese medicine compound preparations has not yet reached the stage, and the Chinese medicine enterprises are still waiting for an anxious wait.
 
Article 5 of the Chinese Medicine Law “The competent department of Chinese medicine under the State Council is responsible for the management of Chinese medicine in the country. Other relevant departments of the State Council are responsible for the work related to the management of Chinese medicine within their respective functions and responsibilities.” Basically clarified the CFDA and the management of Chinese medicine. The industry"s regulatory status of the bureau, while other relevant departments did not clearly state. With the opening of a new round of institutional reforms by the State Council, the institutional setup and functions related to the pharmaceutical industry have also undergone major changes, reflecting the transformation of the pharmaceutical industry"s regulatory thinking at the national level. The Chinese medicine industry will also face new challenges and development dilemmas. .
 
1. Who should take this responsibility for the supervision of the whole industry chain of Chinese medicine?
 
The State Council’s new round of institutional reforms established the “National Market Supervision and Administration Bureau”. Its main responsibilities are: responsible for comprehensive market supervision and management, organizing comprehensive market law enforcement, standardizing and maintaining market order, and responsible for industrial product quality and safety, food safety, and special equipment. Safety supervision, etc. The establishment of the "National Drug Administration", managed by the General Administration of Market Supervision, is mainly responsible for the registration and implementation of supervision and management of drugs, cosmetics and medical devices. From the description of the basic functions of the newly established market regulators, we do not seem to see the affiliation of the departments involved in the cultivation and distribution of Chinese herbal medicines in the front end of the Chinese medicine industry chain, while the functions of the SFDA are mainly the Chinese medicine decoction pieces and preparations. Supervision, the quality of Chinese herbal medicines will remain the regulatory blank of the entire Chinese medicine industry chain.

1. The Chinese medicine industry chain is long and complicated, and the supervision is difficult.
 
Chinese medicine is different from chemical medicines. Its industrial chain is longer and the industry spans a lot. From Chinese medicine seedlings to Chinese medicine decoction pieces and Chinese patent medicines used by patients, it has to go through many aspects such as planting and breeding, collection, storage, decoction processing, and preparation production. In particular, it has to go through multiple logistics links. The Chinese medicine industry chain spans a number of functional departments such as agriculture, forestry, food, drug supervision, Chinese medicine bureau, and the Ministry of Commerce. The supervision of the Chinese medicine industry is much more difficult than chemical drugs.
 
Chinese herbal medicines have both the dual attributes of agricultural products and medicinal materials, which poses severe challenges to the management of traditional Chinese medicine. Poor supervision will seriously threaten the healthy development of the entire Chinese medicine industry. Although the "Chinese Medicine Law" clearly stipulates the quality management of further strengthening the cultivation, collection, storage and primary processing of Chinese medicinal materials, and clearly sets out the specific requirements for the protection of traditional intellectual property rights of traditional Chinese medicine. However, there are still no operational implementation rules for actual implementation.
 
In 2009, the Ministry of Commerce began to build a nationwide circulation system for the circulation of Chinese herbal medicines, but mainly focused on the traceability of circulation information. There was a lack of third-party quality inspection and control in the middle, and the traceability of the medicines was open, and no closed loop was formed. The quality of the medicines was difficult to guarantee. Some experts have suggested that if the government can introduce the system and build a platform, encourage enterprises to establish a traceability system for the whole quality of medicinal materials, use information technology to force the source of medicinal materials to be managed, and through third-party testing and full-course traceability mechanism, explore the establishment of a Chinese herbal medicine that can talk to the world. The industry chain standard system will eventually achieve "the source can be checked, the destination can be traced, the responsibility can be studied", and it is expected that this traceability mechanism can play its due role.

2. The quality of Chinese herbal medicine directly affects the development of Chinese medicine
 
Chinese herbal medicines are the source of the Chinese medicine industry, but there have been loopholes such as unclear standards and lax supervision. Due to the scattered planting of Chinese medicinal materials, the original production methods, and the lack of uniform standards and testing methods in various links, which are greatly affected by natural conditions, the quality of collected medicinal materials is uneven.
 
In recent years, Chinese herbal medicine dyeing, sub-filling, sulfur fumigation, mildew and anti-corrosion, excessive pesticide residues and other chaos have emerged endlessly, seriously restricting the development of traditional Chinese medicine decoction pieces and preparations based on this. Even the centuries-old enterprise Tongrentang has been repeatedly exposed. The quality of the Chinese-style pieces caused by unqualified Chinese herbal medicines. Industry experts say that "Chinese medicine will die in Chinese medicine" is not sensational, and "Chinese medicine will be destroyed in medicine" is not impossible!
 
The rapid development of Kampo medicine in Japan in recent years is worthy of reference based on its emphasis on the quality standard system. Tsumura Co., Ltd. is a company mainly engaged in the production of Kampo medicine. Its products account for 84% of the medical Chinese medicine market, but its medicines are highly dependent on purchasing from China. In order to control the quality of Chinese herbal medicines, Tsumura has set up branches in China and established a quality control system for raw materials. It can register and manage producers, and planting, harvesting and processing of medicinal plants, all have standard operating procedures, and can be traced throughout. It guarantees the controllable quality of its Chinese preparations and provides guarantees for the efficacy and safety of the drugs.
 
3. Industry chain supervision loopholes will torture the supervision ability of the SFDA
 
The quality problems of Chinese herbal medicines that have occurred frequently in recent years reflect the complexity and regulatory difficulty of the Chinese herbal medicine industry on the one hand, and the lack of supervision over Chinese herbal medicines on the other hand.
 
The quality problems of Chinese herbal medicines directly lead to the efficacy, safety and quality of traditional Chinese medicine decoction pieces and proprietary Chinese medicines. The damage is the efficacy and medication safety of the majority of 

patients. In the face of the regulatory difficulties of Chinese medicine caused by the loopholes in the upstream industrial chain of Chinese medicine, the drug regulatory department is also in an awkward position.
 
According to the newly established medical supervision bureau, the main scope of supervision is Chinese herbal medicines and traditional Chinese medicine preparations. Although Chinese herbal medicines have pharmaceutical properties, there is no clear departmental commitment to their supervision, and the existing human resources and capabilities of the Food and Drug Administration. It is obviously not enough to take up the supervision of the entire industrial chain of Chinese medicine.
 
If the regulatory problems at the front end of the Chinese medicine industry chain cannot be effectively solved, the quality of Chinese medicine decoction pieces and preparations is difficult to guarantee, and relevant departments must act as soon as possible to ensure the sound development of the Chinese medicine industry.
 
Second, deepening the reform of the medical insurance system will further impact the Chinese medicine industry
 
The State Council’s institutional reforms newly established the “National Medical Insurance Bureau”, which opened the era of “big medical insurance” in the pharmaceutical industry, perfected the basic medical insurance system for urban and rural residents, ensured the rational use of medical insurance funds, and controlled safety, and coordinated medical and medical insurance. The reform of the "three medical linkages" of medicines is of great significance to ensure the medical needs of the majority of insured personnel more efficiently. New changes will occur in the reform of basic medical insurance supervision and payment mechanisms.
 
First of all, the Medical Insurance Bureau will attack the illegal behavior of the medical insurance industry, severely crack down on various forms of fraudulent medical insurance fund behavior, focus on the behavior of doctors to induce patients" needs, and the phenomenon of medical institutions providing excessive medical services.

Second, strengthen medical insurance control fees, cost accounting will provide reference for medical insurance cost control. With the advancement of the medical insurance system for the single-patient payment and the DRG payment system, the implementation of the clinical path docking accounting standard cost will make the drugs with evidence-based medical research evidence and pharmacoeconomic advantages more clinical advantages. The so-called "magic drugs" and some drugs with a wide range of treatments, ineffective or even ineffective, and large clinical doses will be further monitored.
 
Third, the Medical Insurance Bureau has become a large purchaser of the pharmaceutical market, undertaking the formulation and adjustment of drugs, medical service prices and charging standards, formulating bidding procurement policies for drugs and medical consumables, and supervising implementation, etc., and is strong in drug pricing and bargaining. The status has been improved. With the speeding up of the reform of the medical insurance payment system, the method of closely binding the price of the drug to the standard of medical insurance will definitely reduce the price of the drug.
 
In summary, the pharmaceutical industry will be affected in the “big medical insurance” environment, and the first to be the traditional Chinese medicine sub-industry.
 
1. Traditional Chinese medicine generally lacks evidence-based medical research data.
 
The concept of evidence-based medicine was put forward in the 1990s, which has had a tremendous impact on the development of world medicine. It has become an important method for medical science decision-making in many countries and an inevitable trend in the development of modern medicine. Western medicine is evidence-based medicine. In recent years, with the advanced diagnosis and treatment equipment and drugs continuously applied to domestic clinical, the development of western medicine in China has basically achieved synchronization with developed countries, and evidence-based medical research results have become more and more clinically used. An important reference basis has gradually become one of the elements of medical cost accounting.

Traditional Chinese medicine is an empirical medicine accumulated over thousands of years. It emphasizes dialectical treatment and attention to overall treatment. Although many traditional Chinese medicine varieties have been clinically applied for decades or even hundreds of years, their efficacy can be generally recognized by doctors and patients. However, due to the lack of large-scale evidence-based medical research, there is a certain degree of limitation in clinical use. Under the theoretical system of traditional Chinese medicine, the efficacy of traditional Chinese medicine is often difficult to judge with clear indicators, which is one of the difficulties in the implementation of evidence-based medicine research.
 
Traditional Chinese medicine, which lacks evidence-based medical evidence, has become a shortcoming in clinical use. With the implementation of a more stringent medical insurance control system, the promotion of disease-based payment and DGR payment system, Western medicine with evidence-based medicine support will have a more obvious advantage, while Chinese medicine may face further restrictions and be weakened. The trend of being marginalized.
 
2. Most of the ingredients of traditional Chinese medicine have complex functions and mechanisms are unknown.
 
Traditional Chinese medicine compound generally has problems such as inaccurate active ingredients, unclear path of action, and unclear mechanism of action. This not only brings difficulties to the choice of doctors who are accustomed to the characteristics of targeted drug delivery in Western medicine, but also becomes a huge obstacle for Chinese medicine to go abroad. Due to the inaccurate composition, the toxic side effects of Chinese medicines have been tortured to Chinese medicine companies. A doctor from the First Affiliated Hospital of Guiyang Hospital said in his article "Accurately Understanding the Hepatotoxicity of Traditional Chinese Medicine" that although the research on hepatotoxicity of traditional Chinese medicine has received more and more attention, 90% of the toxicity of traditional Chinese medicine has not yet been mastered, and there is a lack of systematic research.
 
3. Traditional Chinese medicine has not yet established a complete clinical drug guidance system.

After years of accumulation, Western Medicine has already established a relatively complete system for the diagnosis and treatment of diseases. The guidelines on the first-line medication, second-line medication, combined medication, clinical efficacy criteria, and treatment standards are clearly defined, and have high clinical drug guidance. significance. Traditional Chinese medicine is relatively backward in this respect. In recent years, the Chinese Society of Chinese Medicine, the Chinese Pharmacy Association and the Chinese Association of Integrative Medicine have done a lot of work, and published some guidelines for the diagnosis and treatment of traditional Chinese medicine combined with traditional Chinese medicine, but adopted in clinical practice. Limited, the current stage of clinical drug guidance is not significant.
 
4. The results of re-evaluation of traditional Chinese medicine cannot be certified by relevant departments in time.
 
Some excellent Chinese medicine companies have been making unremitting efforts for many problems in the Chinese medicine industry. The re-evaluation of traditional Chinese medicine injections started in 2009 has received positive response from many pharmaceutical companies such as Buchang Pharmaceutical, Jiuzhitang, Kang Enbei, Tasly, Shanghai Kaibao, Shanxi Vibration and Shenwei Pharmaceutical. However, the results of the work done by the enterprise to invest a lot of manpower and financial resources have been shelved due to the lack of top-level design of the relevant management departments. So far, no variety has been reviewed and approved.
 
Faced with the difficulties in the research of evidence-based medicine in traditional Chinese medicine, some Chinese medicine companies have also actively tried and done a lot of research work, and some research results are enough to support the further optimization of product specifications. At the same time, with the continuous upgrading of Chinese medicine extraction and preparation technology, a large number of Chinese patent medicine preparation processes have also been greatly improved, but the registration of changes should be made to the regulatory authorities according to law. It is reported that many companies have applied for revision of the specifications and process optimization changes for five years without fruit, seriously damaging the enthusiasm of enterprises to carry out re-evaluation research.
 
Third, related recommendations

First, in order to ensure the implementation of the "Chinese Medicine Law" truly achieves the legislative purpose, it strongly urges the State Council to promulgate the "Regulations on the Implementation of the Chinese Medicine Law" as soon as possible, further refine the relevant legal provisions in the "Chinese Medicine Law", and clarify the relevant ministries and commissions in Rights and responsibilities in the implementation of the Medical Law. The State Council takes the lead in urging relevant government departments and local government departments to clearly implement the objectives and tasks of the Chinese Medicine Law to ensure that the Chinese Medicine Law is implemented.
 
Second, it is recommended that the State Council urge the State Administration of Market Supervision to take the lead in the supervision departments of agriculture, forestry, food and medicine, and jointly carry out the supervision and quality standard system construction of the whole industry chain of Chinese medicine to ensure the sound development of the Chinese medicine industry from the source. For the re-evaluation of the efficacy and safety of traditional Chinese medicine, the agenda of the relevant departments should be mentioned. In particular, the re-evaluation of traditional Chinese medicine injections should establish a quality evaluation system and an evaluation expert system as soon as possible. For enterprises and varieties that have passed the review first, the medicines and prices are used in medical insurance. The government should be biased towards policy.
 
Third, it is recommended that the State Council urge the State Drug Administration, the State Administration of Traditional Chinese Medicine, the State Health and Health Commission, and the Ministry of Science and Technology and other relevant departments to attach great importance to the many difficulties faced by the development of Chinese medicine at this stage, and to implement the Chinese Medicine Law. Inheriting and developing good Chinese medicine, aiming at improving the clinical value of traditional Chinese medicine, constructing research strategies and technical methods that conform to the overall concept of Chinese medicine and the characteristics of traditional Chinese medicine compound, establish and improve the clinical diagnosis and treatment guidelines system for Chinese medicine diseases, in order to cope with the new medical insurance supervision The impact of the Chinese medicine industry under the system may truly play a role in the prevention and treatment of Chinese medicine.

Fourth, it is recommended that the NPC initiate the legislative procedure of the Pharmacist Law as soon as possible to clarify the functions of clinical pharmacists in prescribing, regulating and guiding the use of prescription drugs, so that pharmacists can become janitor of rational drug use and safe drug use. The pharmacist system is also the best choice to resolve the practical problems of 80% of Chinese medicine prescription drugs prescribed by Western medicine doctors.