Safety assessment system of traditional Chinese medicine industry is expected to be improved

2013-11-01 source: Securities Daily recently, the International Conference on post IPO reassessment of traditional Chinese medicine closed in Beijing, and the Professional Committee on post IPO reassessment of traditional Chinese medicine of the World Federation of Chinese Medicine Societies was officially established The establishment of the committee, which includes many academicians such as Wang Youyan, Zhang Boli, Chen Keji, Li Lianda and other authoritative experts in the field of traditional Chinese medicine, means that China has another national level academic organization for re evaluation of traditional Chinese medicine listing, and the safety evaluation and risk prevention and control system after the listing of traditional Chinese medicine is expected to be further improved The rapid growth of traditional Chinese medicine industry is closely related to the special efficacy of traditional Chinese medicine in many major diseases In recent years, in the process of disease prevention and treatment, especially in the field of malignant tumors, autoimmune diseases and some viral epidemic diseases, as well as some chronic diseases with poor efficacy of chemical drugs, the role of traditional Chinese medicine is increasingly obvious Some natural drugs derived from traditional Chinese medicine but with clear efficacy, clear ingredients and full mechanism of action have gradually been internationally recognized But on the other hand, in recent years, the adverse reactions of traditional Chinese medicine, especially traditional Chinese medicine injection, also make the media question the safety of traditional Chinese medicine again and again Especially in 2008, many accidents of traditional Chinese medicine injection made the safety of traditional Chinese medicine widely concerned by the public Since then, there has been a lot of negative voices Ren Dequan, former deputy director of the State Food and drug administration, believed that in recent years, under the regulatory requirements of the state drug regulatory authorities, some traditional Chinese medicine injection production enterprises have made remarkable progress in improving product quality standards, strengthening the construction of raw materials base for traditional Chinese medicine, and improving production technology and management, including the establishment of modern production quality online control system In this process, some backward enterprises withdraw from the production of traditional Chinese medicine injection, and a number of backward varieties are eliminated At present, the safety of the existing traditional Chinese medicine injection has been significantly improved According to the statistics of adverse reactions of the State Food and drug administration, injection accounts for nearly 60% of the adverse reactions in China in the past two years, of which chemical injection accounts for about 85% and traditional Chinese medicine injection less than 15%“ The occurrence of some adverse events is related to the low quality standards of products Now the national drug regulatory department has made clear the new quality standards of traditional Chinese medicine injection The traditional Chinese medicine injection enterprises are improving and improving the product quality standards according to the requirements of the national drug regulatory department, which is right However, the improvement of quality standard cannot be separated from the improvement of process technology At the same time, it is allowed to improve the process technology to improve the quality standard " According to the reporter, the newly established post marketing safety evaluation committee of traditional Chinese medicine will be a professional evaluation organization integrating production, learning and research The organization is led by the Institute of clinical basic medicine of Chinese medicine, Chinese Academy of traditional Chinese medicine It combines well-known scientific research institutions, universities and hospitals at home and abroad, as well as large pharmaceutical enterprises such as Qingfeng pharmaceutical, Bubu pharmaceutical and Kangyuan pharmaceutical, to establish a scientific and rigorous safety assessment and risk prevention system for major traditional Chinese medicine varieties A person in charge of participating pharmaceutical enterprises, who did not want to be named, told reporters that due to historical reasons, a small number of traditional Chinese medicine quality control methods are single, the level of production technology is extensive and low, and there is a lack of rigorous pre market safety evaluation, which has a certain degree of safety risks, which just needs to be reevaluated through standardized post market evaluation of its clinical significance, and it is true after evaluation If clinical needs but there are safety risks, control measures and warning instructions shall be formulated for those that need to be controlled to guide clinical risk avoidance, and those that need to be delisted shall be resolutely delisted It is understood that since the guidance issued by the State Food and Drug Administration in 2009, the safety re evaluation system of traditional Chinese medicine injection has been continuously improved Most of the existing traditional Chinese medicine preparations, especially the products with single product sales of more than 1 billion, have been proved safe and effective in long-term clinical application, and have been widely accepted by the society