The national standard is coming! Traditional Chinese medicine formula granule opens a new industrial pattern

On November 8, the comprehensive Department of the State Food and Drug Administration solicited opinions from the public on the technical requirements for quality control and standard formulation of traditional Chinese medicine formula granules (Draft for comments) (hereinafter referred to as the draft for comments) On the basis of the 2016 national pharmacopoeia commission's comments, the draft has more detailed requirements For example, under the guidance of the theory of traditional Chinese medicine, the traditional Chinese medicine formula granules are required to be prepared and used by patients according to the clinical formula of traditional Chinese medicine, and their clinical efficacy should be consistent with the corresponding pieces of decoction The introduction of the opinion draft means that there is a guide for the formulation of unified national standards for traditional Chinese medicine formula granules On the same day, the national pharmacopoeia commission publicized 160 unified standards for the pilot varieties of traditional Chinese medicine formula granules It is understood that at present, the industry of traditional Chinese medicine formula granules in China is mixed, and adverse reactions caused by traditional Chinese medicine formula granules occur from time to time in clinical practice After the national unified standard formulation guidelines are clear, and on the basis of successful pilot projects before this, the complete unified standard of traditional Chinese medicine formula granules is expected to accelerate the release, which will be conducive to reducing the incidence of clinical adverse reactions, and also conducive to further development Step by step standardize the development of the industry Medical Observer: Traditional Chinese medicine formula granules is a modern innovation of traditional Chinese medicine pieces At present, its growth rate has exceeded that of traditional Chinese medicine pieces, but the controversy has been continuous First of all, please introduce the current situation of the field of traditional Chinese medicine formula granules? What are the problems? Tan Ruizheng: Traditional Chinese medicine formula granule is a kind of granule preparation for clinical use, which is made from traditional Chinese medicine pieces through a series of preparation processes by using advanced production technology and specific production process Because it is convenient to carry and drink, it can achieve the curative effect by directly taking it, which can meet the modern people's medication habits and ways At the same time, the clinician can control the dosage of the medicine when issuing the prescription of the traditional Chinese medicine, which is convenient to increase and decrease the dosage of the medicine Therefore, the granule preparation of traditional Chinese medicine has brought convenience to patients and doctors, and is welcomed by both doctors and patients Although traditional Chinese medicine formula granules are convenient, there are many problems First, the equivalence with traditional Chinese medicine The chemical composition of traditional Chinese medicine is very complex Traditional Chinese medicine is made into soup by boiling In the process, there are conditions for heating and boiling, and different chemical substances may react with each other However, traditional Chinese medicine formula granules are taken directly without the reaction process under heating conditions, so there is no very reliable clinical evidence to support whether they are equivalent Second, the issue of processing standards Some traditional Chinese medicine pieces need to be processed by frying, frying, forging, baking, vinegar, wine and other processing procedures to increase efficiency and reduce toxicity, but the formula particles are mainly extracted directly, and its efficacy needs evidence-based Third, production process Different enterprises have different production standards and production equipment For example, the extraction solvent is water, so the amount of water, extraction times, temperature, time and so on will have different effects on drugs How to control? Fourth, regulatory positioning The genuine medicinal materials in different provinces are not necessarily the same, and the direction of local supervision and law enforcement may be different In addition, there is no unified standard as the basis Shen Yong: now we can use a word to describe the current situation of the market of traditional Chinese medicine formula granules, which is "a pot of braised pork that all the people in the pharmaceutical industry envy" Data shows that the sales volume of "proprietary Chinese medicine products" of Chinese traditional medicine enterprises in China decreased from 669.7 billion yuan in 2015 to 465.5 billion yuan in 2018, and the sales volume decreased by 30.5% in four years However, the development of the market of traditional Chinese medicine formula granules is "against the trend", and the annual growth rate in the past three years has been up to 25% Due to the three characteristics of "high gross profit", "reimbursable" and "no proportion of medicine", the market of traditional Chinese medicine formula granules is now "a pot of appetizing braised pork" At present, there are two major problems First, "bus phenomenon", people under the car want to get on, people who have already got on don't want to let others get on At present, the market of traditional Chinese medicine formula granules adopts the management principle of "access system", so the market presents the situation of "separation of five countries" Most of the market share of about 30 billion yuan is owned by five enterprises, including Chinese traditional medicine, kangrentang, China Resources Sanjiu, Sichuan new green and Nanning Peili Secondly, in the face of "braised pork", many traditional Chinese medicine enterprises are eager to try and strive for early layout Some enterprises have quietly entered the formula granule market, and many enterprises hope that the market will evolve from the past "separation of five countries" to "sharing of eighteen route Princes", and then share market dividends Sun YUEWU: there are three major problems First, due to some characteristics of traditional Chinese medicine itself, it is different from western medicine The composition of Western medicine is very clear, while traditional Chinese medicine is more understood from the traditional Chinese medicine theory, and there is no complete unity in dosage, requirements, standards and other aspects Therefore, when it is used, there may be problems in efficacy and other aspects Second, the new drug administration law puts forward a lot of new requirements, and it really needs to introduce relevant standards, otherwise it will not be able to conduct more supervision on drugs Third, in the process of the rapid development of the industry, there are many new problems, which need to be further improved Medical Observer: since the implementation of the pilot policy of traditional Chinese medicine formula granules in 2001, there has been a call for "national unified standards" from all walks of life What is the significance of the formulation of "technical requirements for quality control and standard formulation of traditional Chinese medicine granules"? What will be the impact on this area? Shen Yong: the significance of the formulation is three: first, it reflects the state's attention to the industry; second, it standardizes the reasonable and scientific development of the industry, because the development time of the formula particle industry is very short, and only after 2000, the variety of traditional Chinese medicine formula particles appeared in the market; third, it unifies the industry threshold, avoids the confusion of fish and dragons, and prevents major problems in the future There are two impacts: first, all the enterprises that want to enter this industry segment have "laws to follow and rules to follow"; second, the future formula granule enterprises will compete on the "legal and normative" runway Tan Ruizheng: the main goal is to unify the norms and have evidence After the national standard is unified, a batch of new manufacturers of traditional Chinese medicine granules are bound to spring up, making the market competition very full, breaking the current few competition patterns mainly formed by China Resources 39, new green, etc Sun YUEWU: the significance of the formulation matches the problems Formula granules lack clear ingredients, unified dose, unified standards, etc., so the state needs to formulate relevant technical standards to regulate the quality, otherwise, drug treatment can not only achieve good results, but also may affect other aspects of patients The impact is more standardized, in line with the requirements of the new drug administration law, and also a very important sign of responsibility for patients Medical Observer: according to the opinion draft, standards for Chinese herbal medicines, Chinese herbal pieces, intermediates (extract or dry powder) and finished products should be established respectively Generally speaking, traditional Chinese medicine has its own standards Why does traditional Chinese medicine formula granules require the establishment of quality control standards in the whole process, rather than only the establishment of finished product standards? Shen Yong: first, the production of formula granules used to be based on "enterprise standard", which is not conducive to the control of product quality and quality inspection department; second, after formula granules enter the circulation market, unlike traditional pieces of decoction, they have four identification characteristics (color, shape, taste and taste), which are difficult for drug inspection department to identify and difficult for supervision, so it is necessary to add Strengthen the whole process quality control in the production field; third, the category of formula particles is still a new thing at present, and the regulatory experience of the national regulatory authorities is insufficient, so it needs to develop steadily in the specification Tan Ruizheng: according to the characteristics of traditional Chinese medicine formula granules, strengthen the specific identification and multi-component and overall quality control, it is necessary to establish the content determination items of active ingredients or extracted ingredients related to the efficacy, and use the methods such as characteristic chromatogram / fingerprint for overall quality evaluation, and if necessary, establish the biological activity evaluation method Only when the whole process is strictly controlled and standardized can there be unified quality requirements for finished products Medical Observer: all along, people inside and outside the industry have called for the formulation of national standards for Chinese herbal formula granules as soon as possible, but it has been difficult to land What are the main reasons? With the release of the opinion draft, is the national standard of traditional Chinese medicine formula granules expected to be fully implemented? Sun YUEWU: the reasons are complicated, mainly including the following: first, technical factors There is a certain degree of complexity in the process related to formula granules At the same time, it is difficult to unify the effective content of drugs in each region Some standards of products themselves are different Second, the production technology links in each region are different Some production links of traditional Chinese medicine formula granules are confidential, so it is difficult to standardize them with unified standards Third, formula granule manufacturers in each region want their own products as standards, which will bring more help to local product production, economic development and other aspects From technology to products to the consideration of regional economic factors, if a country wants to establish a unified standard, it must choose among these factors, so this is a relatively complex and long process Shen Yong: there are two main reasons why it is difficult to land: first, it is difficult for enterprises to unify each other for various reasons Each enterprise has its own standards, so it is difficult to reach a consensus Moreover, there are more than 800 kinds of formula granules commonly used in China, so it is even more difficult to reach a consensus Second, there are disagreements between government and industry experts on some aspects In my opinion, our traditional Chinese medicine enterprises are very politically aware and listen to the party's words I believe that with the release of the opinion draft, the national standard of traditional Chinese medicine formula granules will be implemented nationwide Medical Observer: on the same day of the release of the opinion draft, the national pharmacopoeia commission publicized 160 unified standards for the trial of traditional Chinese medicine formula particles, including 160 common traditional Chinese medicine formula particles, such as Morinda formula particles, Paeonia Alba formula particles, baishoupi formula particles, Salvia miltiorrhiza formula particles The pilot standards of these varieties are developed by relevant enterprises Do you think it's appropriate for an enterprise to study and formulate standards? Should more interested parties be involved in the formulation of national standards for TCM formula granules? Shen Yong: from the perspective of international practice, it's better to leave professional problems to professionals At present, it is in line with the actual situation that the standard of formula granules is completely formulated by the enterprise Because in the actual situation, the government agencies and scientific research institutes do not have the conditions for the whole process production line of traditional Chinese medicine formula granules, and there is no need to spend a lot of money to buy a set Even if the production line is bought, it is difficult to complete all the process personnel, and a set of production line must go through a small period before it is officially put into operation Test, pilot test and other links In the face of hundreds of traditional Chinese medicine varieties, the government and scientific research institutes are simply unable to carry out the operation, so at present, it is scientific and practical to adopt the method that enterprises formulate standards according to the actual situation, and then the government and experts approve them I believe that with the development of the industry, it will gradually transition from "enterprise + industry"