What is the reason for the rapid decline in the number of new Chinese medicine on the market?

[market analysis of chinapharma.com] it is stipulated in the current drug administration law that for the development of new drugs, relevant data and samples such as research methods, quality indicators, pharmacological and toxicological test results must be submitted, and clinical trials can only be conducted after approval This means that the current Chinese medicine and Western medicine must follow a unified approach to pharmacology, toxicology, pharmacokinetics and animal experimental research (what are the reasons for the rapid decline in the number of new Chinese medicine on the market? The industry generally believes that the current new drug approval system is not compatible with the characteristics of traditional Chinese medicine, which is the core reason for the difficulty of new drug approval, which also leads to the phenomenon of "dystocia" In recent years, the number of new Chinese medicine on the market is not optimistic According to the 2017 annual drug review report, of the 394 drugs approved for marketing, there are only two traditional Chinese medicines, one is new traditional Chinese medicine and the other is generic traditional Chinese medicine From 2012 to 2016, the number of new Chinese medicine approved for marketing shows a trend of rapid decline It is reported that from 2012 to 2016, the number of new Chinese medicine drugs approved for marketing was 21, 15, 11, 7 and 2 respectively In fact, for a long time, both the approval speed and the approval quantity of new Chinese medicine are significantly lower than that of chemical new drugs, and the approval of new Chinese medicine is increasingly "marginalized" In response, some experts said that traditional Chinese medicine follows the overall concept, and its treatment corresponds to syndrome rather than a disease, aiming at multiple targets But the current evaluation system is a unified requirement for single target research, this evaluation system actually ignores the characteristics of traditional Chinese medicine Some people also think that new Chinese medicine is always "dystocia" also has its own reasons The basic research of traditional Chinese medicine is still very weak, lacking scientific basis in the mechanism of efficacy and side effects At the same time, the prescriptions applied by some enterprises are similar and repeated, which is also a main reason According to the person in charge of a large listed pharmaceutical company, there are few new traditional Chinese medicines under research in the company, and the application for listing new medicines has been repeatedly frustrated, which has hit the confidence of the company The person in charge said that since 2006, the enterprise has invested tens of millions of yuan in the research and development of three kinds of five new drugs, but eventually all failed to get the production number in the "clinical" link According to the current situation in the industry, it is suggested that the relevant policies on encouraging the innovation of medical devices and accelerating the review and approval of new medical devices on the market and the supporting documents of traditional Chinese medicine law should be implemented as soon as possible, so as to establish a Chinese medicine approval mechanism in line with the characteristics of traditional Chinese medicine It is also suggested that the Ministry of science and technology, the health and Health Commission, and the drug administration should jointly establish a "production, learning and research management" linkage mechanism for the R & D and approval of new traditional Chinese medicine, pay attention to policy coordination and guide the healthy development of the traditional Chinese Medicine industry We can rely on modern technologies such as big data to establish the clinical efficacy evaluation system of traditional Chinese medicine, strengthen the quality control of traditional Chinese medicine, develop the "orange peel book" of traditional Chinese medicine, and continue to create the "green channel" of classic famous prescriptions In order to encourage the secondary development of new traditional Chinese medicine and traditional Chinese medicine classical prescription, some places have introduced favorable policies For example, the government of Anhui Province has printed and issued several policies to support the development of modern medical and pharmaceutical industry For major medical equipment projects such as new Chinese medicine (1-4 categories) and the second development of traditional Chinese medicine classic prescription produced in Anhui Province, 20% of the development cost is subsidized for clinical research, 10% of the development cost is subsidized for clinical trials, and 10 million yuan is subsidized for a single project In addition, Anhui Province also supports the construction of basic capacity for major medical and pharmaceutical innovation and development, such as big data center of traditional Chinese medicine, and grants 10% of the investment in key equipment for the projects that have been reviewed and identified, with a high of 20 million yuan.