Study On The Risks And Legal Control Of Traditional Chinese Medicine Preparations Under The Record System

For a long time,China has implemented the same control measures for Chinese medicine preparations and Western medicine.The Chinese medicine hospital preparations are also the same as the Western medicine hospital preparations.The medical institutions that have obtained the preparation qualifications are required to report to the competent department for approval,and then the Chinese medicine hospital preparations can be prepared.However,this indiscriminate approval system,due to the long approval period,high cost and the application materials do not meet the characteristics of traditional Chinese medicine preparations,has led to the reluctance of medical institutions to formulate Chinese medicine hospital preparations,which hinders the development of Chinese medicine hospital preparations.Since many scholars and experts have criticized and questioned the approval system for Chinese medicine preparations in the hospital,the Chinese Medicine Law of the People's Republic of China promulgated in 2016 will only change the traditional Chinese medicine preparations prepared by traditional techniques from the examination and approval system to the filing system.However,such changes have raised new questions.On the one hand,some people think that although the approval system for some Chinese medicine preparations has been changed to the filing system,the filing procedures for Chinese medicine preparations are almost the same as the original approval procedures,and there is no substantial deregulation.On the other hand,some people believe that the relaxation of pre-existing supervision will increase the risk of preparations in Chinese medicine hospitals.In the event of a safety accident,the image of Chinese medicine in the public mind may be seriously damaged.The reason for the controversy is that,first of all,there are differences in the risk perceptions of traditional Chinese medicine preparations by different subjects.Secondly,there is no clear classification of the risks of traditional Chinese medicine preparations in China.Therefore,in order to improve the legal system for risk control of traditional Chinese medicine preparations under the filing system,the source of risk should be clarified first,and the degree of risk should be graded so that the subjects' awareness of different levels of risk is basically consistent.Secondly,the legal regulation target of traditional Chinese medicine preparations under the filing system should be clearly defined,and the principle of controlling the risk of Chinese medicine and promoting the development of Chinese medicine should be clearly defined.Finally,according to the specific links of specific risk regulation,according to the regulatory objectives,the regulatory principles of Chinese medicine preparations under the record-making system are established,and the corresponding risk regulation model and its implementation path are matched,supplemented by a reasonable accountability mechanism.Effective implementation of risk regulation tools.