Chinese medicine approval standard should pay attention to characteristics and avoid copying western medicine model

The drug administration law of the people's Republic of China will "overhaul", and the revision of this law has been incorporated into the legislative plan of the National People's Congress Experts in the traditional Chinese medicine industry called that the overhaul should be legislated according to the characteristics of traditional Chinese medicine, and the examination and approval standards should not be the same as those of Western medicine, so as to provide legal development space for traditional Chinese medicine Recently, the Institute of pharmaceutical law of Tsinghua University issued the Research Report on the reform of China's drug regulatory legal system, arguing that the existing drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law) should be revised and improved, pointing out that it is urgent to reconstruct China's drug regulatory legal system It is understood that the current "Drug Administration Law" was revised in 2001, which is no longer suitable for the current needs of drug development There is a big gap between the level of independent research and development of drugs in China and that in the world 50% of drugs in hospitals are foreign-funded and joint venture products, and the remaining 50% are mostly imitations "The current drug administration law is not suitable for the development and innovation of traditional Chinese medicine." Chen qiguang, a researcher of the Chinese Academy of Social Sciences and executive director of the research group on the national conditions of traditional Chinese medicine, pointed out According to Article 29 of the drug administration law, when developing new drugs, relevant data and samples such as research methods, quality indicators, pharmacological and toxicological test results must be truthfully submitted in accordance with the provisions of the drug regulatory department under the State Council, and clinical trials can only be carried out with the approval of the drug regulatory department under the State Council "The current pharmacological and toxicological tests of traditional Chinese medicine and Western medicine are carried out in accordance with the unified method, which is not in line with the characteristics of traditional Chinese medicine." According to Chen qiguang, it is unscientific to judge whether a Chinese patent medicine is toxic by the content of some components China is the birthplace of traditional Chinese medicine Traditional Chinese medicine is the wisdom crystallization of our ancestors after thousands of years of practice It pays attention to personalized formula and the compatibility of prescriptions according to the emperor and his subjects Some drugs are toxic, but when combined with other traditional Chinese medicines, there is no toxicity For example, the mercury content in Tongrentang's Chinese patent medicine exceeds the standard, which is required by the molecular standard of Western medicine, and does not conform to the characteristics of traditional Chinese medicine Traditional Chinese medicine is different from western medicine in that it has the same source of medicine and food, with small side effects "The adverse reactions of traditional Chinese medicine account for more than ten percent of the total number of traditional Chinese medicine, which is relatively small." Chen qiguang thinks In the end of the Eastern Han Dynasty, Zhang Zhongjing, the medical saint, passed down the prescriptions in Treatise on febrile diseases The prescriptions have the characteristics of rigorous compatibility, simple taste, low price and high safety But at present, according to the current drug administration law, Chinese medicine experts still need to carry out pharmacological and toxicological tests according to the modern drug analysis methods "There is no need to test the formula, it has been practiced by hundreds of millions of people in thousands of years by the Chinese nation, and its security is very high," Chen said According to Japanese Chinese medicine, more than 300 prescriptions in Zhang Zhongjing's treatise on typhoid and miscellaneous diseases do not need modern drug analysis methods for pharmacological and toxicological tests " For example, Jinhua Qinggan granules, developed by experts organized by Beijing Municipal Administration of traditional Chinese medicine, is made up of many experts according to the research and configuration of classical prescriptions It does not need to carry out pharmacological and toxicological analysis according to the analysis standards of Western medicine Fu Yanling, Dean of the International College of Beijing University of traditional Chinese medicine, once told the Beijing Business Daily: "for example, if we don't have the energy to study the ingredients of ginger and why we treat vomiting, we won't do this research for the time being This method can be used Some prescriptions can be inherited according to the clinical experience of the ancestors It is unnecessary to spend energy, time and material resources to complete scientific analysis before using them " At present, the number of new drug research and development in China is very small, innovative drug research and development is difficult and slow, lack of core technology The survey shows that the approval of clinical trials for new drug registration in China takes an average of 1-1.5 years, much longer than in most other countries "The R & D time of drugs is too long, and the capital requirements are also very high Enterprises have a high voice for revising the drug administration law to shorten the time of new drug approval and registration." Tian Shuyan, President of Yiling Pharmaceutical Research Institute, said "Hospital preparation is a path of innovation of traditional Chinese medicine and an excessive stage of decoction becoming Chinese patent medicine Some old Chinese doctors have made hospital preparations according to their own experience for many years, but now the drug administration law stipulates that the hospital preparations cannot change the dosage form and need to be approved if they are changed Pill powder paste pill is pill, and need to be approved if they are made into paste, which is some machinery " Chen qiguang told the Beijing Business Daily that the cost of obtaining the batch number of the preparations in the hospital after approval is very high, which costs about 500000 yuan Article 25 of the drug administration law stipulates that the preparations prepared by medical institutions shall be the varieties that are needed by their own clinical units but not available on the market, and can only be prepared with the approval of the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where they are located The prepared preparations must be subject to quality inspection in accordance with the regulations, and shall be used in this medical institution with the prescription of a doctor after passing the inspection Under special circumstances, with the approval of the drug regulatory department of the State Council or the people's Government of the province, autonomous region or municipality directly under the central government, the preparations prepared by medical institutions may be used among designated medical institutions Cao Dongyi, director of Hebei Academy of traditional Chinese medicine, expressed his opinion: "for the traditional Chinese medicine preparations of hospitals and old Chinese medicine, do not use the approval system, just use the filing system Some old Chinese doctors, based on their many years of practical experience, will use different traditional Chinese medicine preparations according to different patients, and this preparation is not widely used in the market for the time being, so it is advisable to use the filing system Or the State Food and Drug Administration will check the qualification of doctors who are qualified to make traditional Chinese medicine preparations, which is much simpler and more convenient than the drug approval system "