Risk assessment and management system should be established for the healthy development of traditional Chinese medicine industry

[market analysis of chinapharma.com] on June 19, the State Drug Administration issued the technical guidelines for clinical evaluation of drug-induced liver injury of traditional Chinese medicine and the drafting instructions for the technical guidelines for clinical evaluation of drug-induced liver injury of traditional Chinese medicine, aiming to control the safety risks of traditional Chinese medicine, promote the research and development of new traditional Chinese medicine, and promote the healthy development of traditional Chinese medicine industry According to the drafting notes, drug-induced liver injury is one of the common serious adverse reactions of drugs, which can cause acute liver failure or even death; drug-induced liver injury is also an important reason for the failure of drug research and development at home and abroad, increase of warning and withdrawal from the market It is reported that at present, the clinical diagnosis and research methods of drug-induced liver injury at home and abroad are mainly developed for clinical diagnosis, and the target users are mainly clinicians The clinical evaluation of drug-induced liver injury of traditional Chinese medicine in new drug development has certain limitations   The main limitations are that due to the complexity of the composition and use of traditional Chinese medicine, it is difficult to score each drug separately, the absence of key evidence for the causal relationship evaluation may cause significant bias to the evaluation results, and / or it is difficult to determine the positive correlation with the diagnosis according to the score, and the judgment strength and reliability of the causal relationship evaluation of traditional Chinese medicine drug-induced liver injury It needs to be improved According to the drafting notes, due to the complexity of the material basis and mechanism of action of traditional Chinese medicine, the weakness of non clinical safety research, the lack of clinical unreasonable use of drugs and the lack of specific diagnostic indicators of drug-induced liver injury and other factors, the drug-induced liver injury of traditional Chinese medicine has a greater concealment and higher misdiagnosis rate, so the prediction and prevention and control of drug-induced liver injury of traditional Chinese medicine are facing great difficulties In addition, China's medical and health security conditions have some imbalance in the allocation of resources, the public awareness of the safety of traditional Chinese medicine is relatively weak, and the construction of drug safety risk prevention and control capacity is relatively lagging behind Therefore, it is urgent to establish a set of risk assessment and management system of drug-induced liver injury in line with China's national conditions and characteristics of traditional Chinese medicine   According to the risk assessment and management system, it can further guide and help relevant personnel in the research and development, review, supervision and use of traditional Chinese medicine, effectively capture and identify the risk signals of drug-induced liver injury of traditional Chinese medicine, scientifically determine the causal relationship between patients' liver injury and traditional Chinese medicine, systematically evaluate the safety and risk-benefit ratio of relevant traditional Chinese medicine, and formulate targeted drug-induced liver injury of traditional Chinese medicine Risk control measures shall be taken to improve the success rate of research and development of new traditional Chinese medicine, realize the safety risk management and control of the whole life cycle of traditional Chinese medicine products, and promote the healthy and sustainable development of Chinese medicine industry Experts in the industry said that traditional Chinese medicine is not, nor can it be totally denied because some traditional Chinese medicine contains harmful substances The drafting principle mentioned that this guiding principle is aimed at risk identification and assessment of liver injury in the whole life cycle of drugs (pre clinical, clinical trial and post marketing), which is used to guide the development and clinical use of new drugs to effectively prevent and control drug-induced liver injury of traditional Chinese medicine, for the use of research and development, production, medical and regulatory agencies of traditional Chinese medicine Therefore, we must face up to the problem of liver injury of traditional Chinese medicine.