A Preliminary Study On The Application Of Human Experience In Chinese Medicine Regulatory Science

Object: The purpose of this thesisis to take the research of traditional medicine regulatory science in the United States,European Union,Japan and South Korea as a reference,and mainly draw ontheconsideration of the application of prior human experience in traditional drug registration and licensing procedures and the application of RWS in drug review and approval regulation.This thesismakes an in-depth study on the human experience of traditional Chinese medicine(TCM)on the basis ofsystematically combing the formation and development of the regulatory science of TCM,the current drugsupervision system in China,the laws andregulation document of TCM,and the development of human experience in the registration of new traditional Chinese medicine.Suggestions and ideas were provided for the key points of inspection of human experience and the construction of standard system for human experience in regulatory science for TCM.Methods: In this thesis,the methods of literature research,comparative analysis and induction were used to sort out the development of traditional medicine regulatory science in major developed countries at home and abroad,analyze and summarize the consideration of human experience in traditional medicine supervision and the enlightenment of RWS to the rational application of human experience of TCM in our country.On this basis,the questionnaire was designedmainly according to the support and encouragement policies,guiding principles/draft of soliciting opinions for human experience,then perfectedthrough the interview method.After the questionnaire is completed,Statistical analysis and summary of each item in the collected questionnaire were conducted.Results: Major developed countries and regions abroad recognize the safety and effectiveness of human experience of traditional medicine,and attach great importance to the application of human experience in traditional drug registration and licensing procedures.Traditional drugs with human experience will have relaxed requirements for new drug registration.The great thing is that RWS accords with the development rules and characteristics of TCM,and the application of RWS in drug evaluation and approval in foreign coutries also provides a reference for the application of human experience of TCM.In addition,through the analysis and summary of the questionnaire on human experience,in the human experience of the license,the data sources,the conditions under which the study was carried out,the ethical review,the informed consent,subject selection and protocol implementation,safety information and reporting,data recording and reporting,data traceability,clinical medication,clinical data collection and management,this thesisgives some preliminary suggestions on the key points of inspection of human experience.Based on the above research,suggestions on the construction of standard system for human experience were put forward in the aspects of drawing and improving the relevant policies and regulations on human experience of TCM and establishing a cloud platform of human experience data of TCM,and so on.Conclusion:In this thesis,with combing the application of human experience in domestic and foreign regulatory science,and in response to the challenges of human experiencein registration and licensing procedures of TCM,the questionnaire survey was conducted to give some preliminary suggestions on the key points of inspection of human experience.At the same time,this thesisrefers to the application of RWS in drug evaluation and approval in major developed countries,and gives suggestions on the construction of standard system for human experience,which provided reasonable suggestions for the establishment of technical guiding principles related to human experience in the evaluation and approval of TCM in China,and lays a foundation for promoting the application of human experience in the registration of new Chinese medicine.