ABSTRACT
Objective:To explore the implementation effect and problems of the policy of encouraging generic drug list in China,in order to further improve the policy of generic drug list.Methods:The selection principle of encouraging generic drug list in China,the characteristics and implementation status of included drugs,and the existing problems are analyzed.Results:The therapeutic fields of drugs included in the two batches of catalogs are relatively concentrated in the nervous system,respiratory system,tumor,en-docrine and metabolic diseases and infectious diseases.Among the 50 drugs,there are 24 new applications for generic drugs,2 drugs are included in the priority review,19are approved for listing,and 20 are included in the medical insurance catalog.At present,there are still problems in the development of the two batches of catalogs,such as the ineffective implementation of the second batch of cata-log policies,the phenomenon of"polarization"in the research and development of some generic drugs,the lack of priority review sys-tem,and the coordination and linkage between departments to be strengthened.Conclusion:It is necessary to improve the system de-sign,strengthen the selection management of reference preparations,improve the supporting incentive measures,mobilize the enthusi-asm of enterprises in research and development,dynamically adjust the generic drug catalog,and strengthen the coordination and link-age of departments.
ABSTRACT
The system of compassionate drug use in China is in the preliminary exploration stage， and the formal management methods and specific implementation rules have not been promulgated， which needs to be further optimized and perfected. Japan realizes the advanced use of unapproved drugs by expanded access clinical trial system， and makes clear provisions on information acquisition， target patient， informed consent， subject of application， implementation plan， handling of refusal to administer medication， drug expenses， implementation deadline， compensation for accidental damages， post-approval data review after expanded access clinical trials. When the enterprise refuses to give drugs because of the “legitimacy reasons of the system”， the attending physician can also apply to the Ministry of Health， Labor and Welfare， and the Ministry of Health， Labor and Welfare will conduct the licensing evaluation to maximize the drug for patients. This “refusal to administer” reprocessing is a unique regulation in Japan， which ensures the accessibility of drugs to the greatest extent possible. Based on the analysis of the expanded access clinical trial system in Japan， it is found that our country could further build the information platform for compassionate drug use， play the leading role of physicians， protect the interests of enterprises， pay attention to the ethical review， and make drug cost payment problems further clear in order to improve and optimize the system of compassionate drug use.
ABSTRACT
ObjectiveTo understand the current status and development of research on the subject of domestic violence， and to grasp the main research hotspots in the field. MethodsThe literature in the core database of Web of Science were retrieved， and 20 417 literature related to domestic violence from January 1966 to September 2021 were sorted by using the CiteSpace software， and the number of literature， authors， research institutions and keywords were analyzed. Results①The volume of literature on domestic violence grown rapidly since 2015. ②Among the authors， Kelsey Hegarty， Gene Feder and others had large number of publications on domestic violence， moreover， the authors' cooperation formed some small collaborative groups and research groups of a certain scale. ③The research institutions were closely collaborating， among which University of North Carolina was the institution of highest number of publications， and Boston University was the institution with the strongest research centrality. ④Hot keywords kept developing and changing， and the current hot keywords were mainly dating violence， sexual violence and the perception and perpetration of domestic violence. ConclusionThe field of domestic violence has been studied by a large number of researchers and has given rise to many research hotspots.