Objective To empirically analyze the relationship between Government R&D funding and R&D investment of the enterprises in different sub industries of pharmaceutical industry,and to provide reference for the de...Objective To empirically analyze the relationship between Government R&D funding and R&D investment of the enterprises in different sub industries of pharmaceutical industry,and to provide reference for the development of policies related to R&D funding input.Methods Granger causality test was performed using the data of relevant indicators in different sub industries of China’s pharmaceutical industry from 1995 to 2019 based on the theory of covariance.Results and Conclusion The funding of R&D from the government had a significant positive effect on their R&D funding inputs to enterprises with chemo products,Chinese patent products,and biological products.It means the improvement of government funding was beneficial in promoting the R&D investment from various sub industries of pharmaceutical industry.The order of this influence was biological products,chemo products,and Chinese patent drugs.As to chemical drugs and biological products,the government’s R&D funding and enterprises R&D funding input showed a good trend of mutual promotion in a certain lag period.The government can fully leverage its funding to promote the investment of all sub industries of pharmaceutical industry.Meanwhile,regulatory mechanisms should be refined for government funding.For the inheritance,innovation,and development of traditional Chinese medicine,the government should give more policy support than financial support.展开更多
Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensi...Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.展开更多
Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the inves...Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the investment.Methods The panel data of pharmaceutical industry in 25 provinces and cities in China from 2009 to 2019 were selected to conduct empirical analysis by establishing a threshold regression model,and a better export trade interval was obtained.Results and Conclusion There is a threshold value for the effect of new product export on both internal and external R&D expenditures,and the threshold values are 845.2788 million yuan and 318.4198 million yuan,respectively.There is a single threshold effect of export trade on both internal and external R&D investment in China’s pharmaceutical industry,and the effect of export trade on internal and external R&D investment changes from negative to positive as the export trade develops from low to high.展开更多
Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the sim...Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.展开更多
Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was us...Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.展开更多
Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right t...Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.展开更多
文摘Objective To empirically analyze the relationship between Government R&D funding and R&D investment of the enterprises in different sub industries of pharmaceutical industry,and to provide reference for the development of policies related to R&D funding input.Methods Granger causality test was performed using the data of relevant indicators in different sub industries of China’s pharmaceutical industry from 1995 to 2019 based on the theory of covariance.Results and Conclusion The funding of R&D from the government had a significant positive effect on their R&D funding inputs to enterprises with chemo products,Chinese patent products,and biological products.It means the improvement of government funding was beneficial in promoting the R&D investment from various sub industries of pharmaceutical industry.The order of this influence was biological products,chemo products,and Chinese patent drugs.As to chemical drugs and biological products,the government’s R&D funding and enterprises R&D funding input showed a good trend of mutual promotion in a certain lag period.The government can fully leverage its funding to promote the investment of all sub industries of pharmaceutical industry.Meanwhile,regulatory mechanisms should be refined for government funding.For the inheritance,innovation,and development of traditional Chinese medicine,the government should give more policy support than financial support.
文摘Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.
基金Research on Innovation and Development Strategy of Pharmaceutical Industry in Liaoning Province(2020lslktyb-095).
文摘Objective To study the threshold effect of export trade on internal and external R&D investment in China’s pharmaceutical industry,and to provide reference for some pharmaceutical enterprises to improve the investment.Methods The panel data of pharmaceutical industry in 25 provinces and cities in China from 2009 to 2019 were selected to conduct empirical analysis by establishing a threshold regression model,and a better export trade interval was obtained.Results and Conclusion There is a threshold value for the effect of new product export on both internal and external R&D expenditures,and the threshold values are 845.2788 million yuan and 318.4198 million yuan,respectively.There is a single threshold effect of export trade on both internal and external R&D investment in China’s pharmaceutical industry,and the effect of export trade on internal and external R&D investment changes from negative to positive as the export trade develops from low to high.
基金supported by the Special Foundation of Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.
基金Special Fund for Academy of Pharmaceutical Regulatory Sciences of Research Base for Drug Regulatory Science of National Medical Products Administration-Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.
基金Liaoning Pharmaceutical Industry Innovation and Development Strategy Research and Funding Project(2020lslktyb-095)National Medical Products Administration-Special Fund of Drug Regulatory Research Institute of Shenyang Pharmaceutical University(2021jgkx004)+1 种基金Shenzhen Maternity&Child Healthcare Hospital Science Foundation(2022(73))Shenzhen Health Economics Society Research Fund Project(202333).
文摘Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.
