Aim To realize the present situation of drug purchase, supply, and use in the health service organizations and drug distributors in rural areas, and to put forward some suggestions. Methods An interview survey was con...Aim To realize the present situation of drug purchase, supply, and use in the health service organizations and drug distributors in rural areas, and to put forward some suggestions. Methods An interview survey was conducted in 20 township hospitals, 26 countryside drugstores, and 84 village dispensaries in Hainan, Anhui, Henan, and Sichuan Provinces. Results （1） The main drug supplying organizations in the countryside are township hospitals and village dispensaries. （2） The personnel in the drug supplying organizations are rather inadequately educated. （3） The drug resources in the grass-roots countryside are complex and disordered. （4） Most of the countryside retail drugstores are small, and the number of drugstores is small, but their development potential is great. Conclusion （1） A basic drug catalogue for rural areas should be made up. （2） Legitimate drug wholesale companies should be encouraged to supply drugs for vast countryside. （3） Development of drug distributionstations in townships should be promoted. （4） The administration of drugs in the countryside should be strengthened.展开更多
Regulatory status of drug inserts in China is described in terms of its legalsystem, administrative ramifications and existing problems. Lack of government regulatoryenforcement, industry self-control mechanisms and a...Regulatory status of drug inserts in China is described in terms of its legalsystem, administrative ramifications and existing problems. Lack of government regulatoryenforcement, industry self-control mechanisms and academic research are blamed to be the root ofthese problems. The trend of regulatory policies on the issue is outlined and suggestions on severalimportant issues are made.展开更多
Organic sulfone compounds,exhibiting interesting bioactivities,were widely applied in the field of pharmaceutical and medicine.And numerous of sulfuryl group-involved drugs were approved by the Food and Drug Administr...Organic sulfone compounds,exhibiting interesting bioactivities,were widely applied in the field of pharmaceutical and medicine.And numerous of sulfuryl group-involved drugs were approved by the Food and Drug Administration(FDA).Odevixibat,maralixibat chloride and belzutifan approved in 2021 could be applied in the treatment of progressive familial intrahepatic cholestasis(PFIC),cholestatic pruritus and clear cell renal cell carcinoma(ccRCC),respectively.In 2022,abrocitinib,pyrukynd and voquezna were approved for the treatment of atopic dermatitis,pyruvate kinase deficiency(PKD)and acid-related disorders,respectively.Defencath for preventing bloodstream infections,sparsentan for treatment of proteinuria related to IgA nephropathy,and xacduro for treatment of hospital-acquired bacterial pneumonia(HABP)were approved in 2023.In this review,the synthesis and therapies of these sulfuryl group-involved drugs approved from 2021 to 2023 are discussed in details.展开更多
This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities（DRC） and their relationship with regulatory performance. Based on the theories on organizational capability a...This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities（DRC） and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows： a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.展开更多
Four rapid spectral comparison methods are introduced in mobile labs.They are conformity test method,general correlation coefficient method,reverse correlation coefficient method and correlation coefficient method usi...Four rapid spectral comparison methods are introduced in mobile labs.They are conformity test method,general correlation coefficient method,reverse correlation coefficient method and correlation coefficient method using characteristic spectral ranges.The first method is used for tracking the movements of drugs in the distribution channels;the second is used for quickly identify new counterfeit drugs;the last two are used to screen drugs illegally added in Traditional Chinese Medicine （TCM）.The applicability of the four methods is evaluated with counterfeit and authentic drugs.Our results show that these methods can be quickly constructed and used to identify counterfeit drugs accurately.展开更多
This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, ...This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.展开更多
Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China＇s drug regulation.In addition,suggestions were provided to enhance the capaci...Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China＇s drug regulation.In addition,suggestions were provided to enhance the capacity of drug regulation,including a clearer functional positioning for drug regulation,increased resource inputs in drug regulation at central level,a more rational allocation of vertical drug regulatory functions,and an improved supervision mechanism for regulatory departments.展开更多
文摘Aim To realize the present situation of drug purchase, supply, and use in the health service organizations and drug distributors in rural areas, and to put forward some suggestions. Methods An interview survey was conducted in 20 township hospitals, 26 countryside drugstores, and 84 village dispensaries in Hainan, Anhui, Henan, and Sichuan Provinces. Results （1） The main drug supplying organizations in the countryside are township hospitals and village dispensaries. （2） The personnel in the drug supplying organizations are rather inadequately educated. （3） The drug resources in the grass-roots countryside are complex and disordered. （4） Most of the countryside retail drugstores are small, and the number of drugstores is small, but their development potential is great. Conclusion （1） A basic drug catalogue for rural areas should be made up. （2） Legitimate drug wholesale companies should be encouraged to supply drugs for vast countryside. （3） Development of drug distributionstations in townships should be promoted. （4） The administration of drugs in the countryside should be strengthened.
文摘Regulatory status of drug inserts in China is described in terms of its legalsystem, administrative ramifications and existing problems. Lack of government regulatoryenforcement, industry self-control mechanisms and academic research are blamed to be the root ofthese problems. The trend of regulatory policies on the issue is outlined and suggestions on severalimportant issues are made.
文摘Organic sulfone compounds,exhibiting interesting bioactivities,were widely applied in the field of pharmaceutical and medicine.And numerous of sulfuryl group-involved drugs were approved by the Food and Drug Administration(FDA).Odevixibat,maralixibat chloride and belzutifan approved in 2021 could be applied in the treatment of progressive familial intrahepatic cholestasis(PFIC),cholestatic pruritus and clear cell renal cell carcinoma(ccRCC),respectively.In 2022,abrocitinib,pyrukynd and voquezna were approved for the treatment of atopic dermatitis,pyruvate kinase deficiency(PKD)and acid-related disorders,respectively.Defencath for preventing bloodstream infections,sparsentan for treatment of proteinuria related to IgA nephropathy,and xacduro for treatment of hospital-acquired bacterial pneumonia(HABP)were approved in 2023.In this review,the synthesis and therapies of these sulfuryl group-involved drugs approved from 2021 to 2023 are discussed in details.
文摘This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities（DRC） and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows： a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.
基金National Key Technologies R&D Program Foundation of China(Grant No.2008BAI55B06).
文摘Four rapid spectral comparison methods are introduced in mobile labs.They are conformity test method,general correlation coefficient method,reverse correlation coefficient method and correlation coefficient method using characteristic spectral ranges.The first method is used for tracking the movements of drugs in the distribution channels;the second is used for quickly identify new counterfeit drugs;the last two are used to screen drugs illegally added in Traditional Chinese Medicine （TCM）.The applicability of the four methods is evaluated with counterfeit and authentic drugs.Our results show that these methods can be quickly constructed and used to identify counterfeit drugs accurately.
文摘This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.
文摘Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China＇s drug regulation.In addition,suggestions were provided to enhance the capacity of drug regulation,including a clearer functional positioning for drug regulation,increased resource inputs in drug regulation at central level,a more rational allocation of vertical drug regulatory functions,and an improved supervision mechanism for regulatory departments.
