Study On Supervision Problem Of The Safety Of Traditional Chinese Medicine Injection

As a typical representative of the modernization of traditional Chinese medicine, Traditional Chinese Medicine Injection is a product of the basic theory of TCM and modern science and technology innovation. Once TCMI is considered one of the most development potential varieties of traditional Chinese medicine, solving the difficulties that the traditional Chinese medicine work slowly and some diseases are not convenient for oral administration. To a great extent,it overcomes the shortcoming of the traditional Chinese medicine and Western medicine injection. However, with the increase of varieties of traditional Chinese medicine injections, the questions of safety of traditional Chinese medicine injection which including the quality and credit of pharmaceutical production enterprises gradually emerge out of situations that good and bad intermingled, coupled with existence that unknown mechanism of action of some of the compound Chinese medicine injections, phenomenon of unreasonable clinical use, adverse drug events of traditional Chinese medicine injection surge in recent years, Cause the extensive concern of the social from all walks of life.Traditional Chinese medicine injection safety issues mainly from five sectors of traditional Chinese medicine injections chain from research to regulatory. Each aspects of the regulation is not in place likely to lead to the generation of adverse events. As a whole, Chinese medicine injection safety supervision mainly has two problems:First,Traditional Chinese medicine injection itself has problems that composition is not entirely clear and mechanism is unknown, development level still needs to increase. Second,the drug regulatory system is flawed,not only confined to the traditional Chinese medicine injections, mainly regulatory problems for the regulators themselves.How to folly give play to the regulator’s role, improve the efficiency of the government, deal with the drug problem well, which is still a serious subject.Through analyzing the problem of traditional Chinese medicine injections "five rings a chain" and drug regulatory system,the conclusion was drawed that most of traditional Chinese medicine injection safety of adverse events are due to non-pharmaceutical reasons, but all aspects of supervision caused.Try to ensure that qualified, stable injection of Chinese medicine through regular distribution channels so that rational use ultimately, which is the direction that traditional Chinese medicine injection safety supervision. The above analysis are summarized and combined with the overall relevant drug regulatory approach of TCM injections so as to provide some ideas of safety of TCM injections regulatory regimes.