A Comparative Study On The Management Of Chinese Patent Medicines, American Botanicals, And Japanese Kampo Drugs In Non-prescription Drugs

Since the 1950s,due to the "sulfonamide"," thalidomide" and other international phytotoxicity incident,triggering the world for drug safety concerns,countries began to pay attention to drug safety and toxicity,addiction Drug sales use of the supervision and management.The United States,Japan and other countries have established drug classification management system to ensure that national drug safety,effective,convenient and economical.China began to implement the drug classification management system in 2000,with the progress of China's social science and technology,the deepening of medical system reform,non-prescription drugs has become a common way of national self-medication and health care.OTC Chinese medicine occupy the main position of non-prescription drugs in China,accounting for 80%of non-prescription drugs directory,and in the public basic medical care,chronic disease prevention play an irreplaceable role,with broad market prospects.China's drug classification management system started late,there are still many parts to be improved,should keep pace with the times,and actively learn from foreign excellent management experience,and promote the development of OTC Chinese medicine.Objectives:The FDA is global drug management benchmark and the first country to establish drug classification management system.Japanese herbal medicine and traditional Chinese medicine with the same root different flow,close relationship.In this paper,the aim of this study is to learn the non-prescription management policies of herbal medicine in the United States and Kampo medicine in Japan,find out the logic and reference points of non-prescription drug management.Finally,the paper puts forward some suggestions on the management of OTC drugs,and provides reform ideas for OTC Chinese patent medicine management.Methods:This study used literature research method,comparative analysis method and questionnaire survey method.First of all,through the literature research review the US herbal medicine,Japanese Kampo medicine non-prescription drug management policy,and then with OTC Chinese patent medicine management policy comparative study,summed up management experience of Chinese non-prescription medicine.Finally,through the questionnaire survey,collecting the views of the drug regulatory department and the production enterprises on present situation and suggestions of non prescription drugs,and put forward some suggestions to improve the management of OTC Chinese patent medicines.Results:The establishment of the US and Japanese drug classification management system were earlier than china,the relevant policies are more mature,in the non-prescription drug registration,switches,supporting management measures can learn from the part.In addition,the survey results show that drug regulatory authorities and manufacturers think that the status quo of Chinese patent drugs management is ok,but there are also many needs to be improved.China should combine the national conditions,reasonable to absorb non-prescription drug management experience form the United States and Japan,and establish non-prescription drug management system with traditional Chinese medicine characteristics.Conclusion:On the basis of non-prescription drugs management policies of American herbal medicine and Japanese Kampo medicine,combined with questionnaire survey results,this paper puts forward the following policy suggestions on the reform of non-prescription drugs for Chinese patent medicine:Improve the legal system of drug classification management;establish China's OTC monograph;reevaluation non-prescription drugs directory;Improve the Rx-OTC switch requirements;enhance the openness and transparency of non-prescription drug review;standardize sales links,improve pharmacy services;strengthen self-medication related knowledge of publicity and education.