| Objective: Through sorting out and analyzing the application and approval of new Chinese medicine new drug registration,to explore the main problems of the blocked development of new Chinese medicine new medicine in Jilin province,and according to the status of Jilin province in the application and approval of new Chinese medicine new medicine registration,to comprehensively analyze the main factors affecting the development of new Chinese medicine new medicine in Jilin province,and to put forward reasonable Suggestions.Methods: Literature analysis was used to find the literature that was consistent with the title words of "new Chinese medicine".Application of EXCEL to drug intelligence network(https://www.yaozh.com/)as well as the state drug administration drug approval center(http://www.cde.org.cn/index.jsp)the data in mathematical statistics analysis;A comparative study of domestic data and Jilin province data;The factors affecting the development of new traditional Chinese medicine in Jilin province were collected and sorted out,and the SWOT analysis was carried out based on the actual situation of Jilin province,and finally the opinions on the development of new traditional Chinese medicine in Jilin province were obtained.Results: According to literature metrology,2015 was the low point for the publication of papers related to TCM new drugs.From the perspective of drug registration,the number of application and approval of domestic new traditional Chinese medicine has decreased significantly since 2016,which is closely related to a series of national policies.However,the registration and approval of new traditional Chinese medicine in Jilin province conforms to the domestic environment,but the number is not optimistic.No matter in China or Jilin province,the registration application of new drugs tends to be one-sided to pharmaceutical enterprises.Conclusion: If Jilin province wants to stand in the forefront of TCM new drug research anddevelopment,it must start from itself,find out the advantages and disadvantages,see the opportunities and challenges clearly,develop TCM industry according to local conditions,and promote the development of TCM new drug research and development to more professional,more in line with clinical needs and more characteristic of Jilin province. |