The publisher would like to draw the reader's attention to the following errors.Ethics approval statements were not included in the published version of the following articles that appeared in previous issues of G...The publisher would like to draw the reader's attention to the following errors.Ethics approval statements were not included in the published version of the following articles that appeared in previous issues of Grain&Oil Science and Technology.The authors were contacted after publication to request ethical approval statements for the following articles.展开更多
Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the...Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the accelerated review,conditional approval and breakthrough therapy between China and the United States.Combined with the implementation of accelerated pathway in China,some suggestions were put forward.Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development,which will improve the accessibility of innovative drugs.However,there are some problems in the review procedures and the implementation of supportive documents in China.In view of the above problems and combined with the experiences of US FDA,we should strengthen the construction of institutional system and reviewer team,and improve the efficiency of drug research and development.展开更多
The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategi...The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategies to expedite drug development,the use of single-arm trials(SATs)is emerging as a promising avenue with substantial potential to shorten drug approval timelines and accelerate market entry.展开更多
This paper describes the required testing and approval procedures of new track systems operated in Europe. To begin with, test methods and performance specifications according to European Standard （EN） are outlined....This paper describes the required testing and approval procedures of new track systems operated in Europe. To begin with, test methods and performance specifications according to European Standard （EN） are outlined. These include the repeated loading test, the determination of the static and dynamic stiffness of rail pads, clamping force and longitudinal rail resistance. The fact that labor tests are unable to simulate all the conditions in situ shows that these labor tests are not sufficient for the evaluation of the long term behaviour of a new track system： a test track of sufficient length must be constructed and exposed to traffic loads. In Europe to be accredited as a new system, a new slab track system must have a trial time of more than two years, during which the features of the whole system can be recognized. In the second part of this paper, the experience of the Institute of Road, Railway and Airfield Construction of TUM concerning the measuring methods of slab track systems carrying traffic are outlined. Also the approval procedure of the new slab tracks in Germany is discussed.展开更多
Purpose:The aim of the study was to investigate the actual benefits of the electronic official document online submission and approval system and the satisfaction of hospital staff in a medical center in southern Taiw...Purpose:The aim of the study was to investigate the actual benefits of the electronic official document online submission and approval system and the satisfaction of hospital staff in a medical center in southern Taiwan,and to find out whether there are any differences between medical institutions and general government personnel.Methods:A cross-sectional study was conducted to investigate satisfactory outcome with questionnaires.The subjects were administrators,healthcare professionals and medical personnel of a medical center in the southern part of Taiwan who had signed electronic documents online.A total of 395 questionnaires were sent out,147 of which were valid,and the rate of collecting data survey was 37%.We analyzed with SPSS version 20.Results:The official document approval system was mainly used by administrative units and contractors,accounting for more than 50%of users.Besides,the frequency of use was at least more than once a week.As for the user’s perception of operating system,most people thought that it is easier to choose the format of official document and to set up the duty agent on leave,but in the part of the signing and approval process setting or modifying,it was considered more difficult,accounting for 38.1%.In terms of perceptual usefulness,the average value was 3.81,which showed that the user agreed that the system has met the needs of daily official documents.When some users of service area encountered problems with their use,the clerical staff were able to provide services immediately and have the professional ability to resolve problems,in order to agree to the majority,accounting for 53.7%.In addition,nearly 60%of users rated the official document system positively,with an average of 3.84 satisfaction,which was higher than the certified value of 3,conforming to the standards for satisfaction with the use of official documents.In addition,the role authorization,perceptual easy-to-use and service area were significant(p<0.05).The perceptual usefulness of Subordinate units was also significant(p=0.016).The frequency of use,perceptual easy-to-use,perceptual usefulness,service area and satisfaction were significantly different(p<0.05).The correlation coefficient between perceptual usefulness and user satisfaction was 0.833,indicating that there was a high correlation.The daily usage frequency of contractors was higher than supervisors.However,supervisors had the highest frequency of use every quarter(p=0.135).There was no significant difference between contractors and supervisors in the frequency of use.Conclusion:It is suggested that education and training on the operation of the electronic official document on-line submission and approval system should be conducted,which can enhance the education and training of supervisors and medical personnel.Continually,invite supervisors and medical personnel to provide advices on the official document system as a reference for future improvements of the system.展开更多
Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European ...Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.展开更多
文摘The publisher would like to draw the reader's attention to the following errors.Ethics approval statements were not included in the published version of the following articles that appeared in previous issues of Grain&Oil Science and Technology.The authors were contacted after publication to request ethical approval statements for the following articles.
文摘Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the accelerated review,conditional approval and breakthrough therapy between China and the United States.Combined with the implementation of accelerated pathway in China,some suggestions were put forward.Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development,which will improve the accessibility of innovative drugs.However,there are some problems in the review procedures and the implementation of supportive documents in China.In view of the above problems and combined with the experiences of US FDA,we should strengthen the construction of institutional system and reviewer team,and improve the efficiency of drug research and development.
基金supported by grants from the China Society for Drug Regulation(Grant No.2023-Y-Y-002)。
文摘The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategies to expedite drug development,the use of single-arm trials(SATs)is emerging as a promising avenue with substantial potential to shorten drug approval timelines and accelerate market entry.
文摘This paper describes the required testing and approval procedures of new track systems operated in Europe. To begin with, test methods and performance specifications according to European Standard （EN） are outlined. These include the repeated loading test, the determination of the static and dynamic stiffness of rail pads, clamping force and longitudinal rail resistance. The fact that labor tests are unable to simulate all the conditions in situ shows that these labor tests are not sufficient for the evaluation of the long term behaviour of a new track system： a test track of sufficient length must be constructed and exposed to traffic loads. In Europe to be accredited as a new system, a new slab track system must have a trial time of more than two years, during which the features of the whole system can be recognized. In the second part of this paper, the experience of the Institute of Road, Railway and Airfield Construction of TUM concerning the measuring methods of slab track systems carrying traffic are outlined. Also the approval procedure of the new slab tracks in Germany is discussed.
文摘Purpose:The aim of the study was to investigate the actual benefits of the electronic official document online submission and approval system and the satisfaction of hospital staff in a medical center in southern Taiwan,and to find out whether there are any differences between medical institutions and general government personnel.Methods:A cross-sectional study was conducted to investigate satisfactory outcome with questionnaires.The subjects were administrators,healthcare professionals and medical personnel of a medical center in the southern part of Taiwan who had signed electronic documents online.A total of 395 questionnaires were sent out,147 of which were valid,and the rate of collecting data survey was 37%.We analyzed with SPSS version 20.Results:The official document approval system was mainly used by administrative units and contractors,accounting for more than 50%of users.Besides,the frequency of use was at least more than once a week.As for the user’s perception of operating system,most people thought that it is easier to choose the format of official document and to set up the duty agent on leave,but in the part of the signing and approval process setting or modifying,it was considered more difficult,accounting for 38.1%.In terms of perceptual usefulness,the average value was 3.81,which showed that the user agreed that the system has met the needs of daily official documents.When some users of service area encountered problems with their use,the clerical staff were able to provide services immediately and have the professional ability to resolve problems,in order to agree to the majority,accounting for 53.7%.In addition,nearly 60%of users rated the official document system positively,with an average of 3.84 satisfaction,which was higher than the certified value of 3,conforming to the standards for satisfaction with the use of official documents.In addition,the role authorization,perceptual easy-to-use and service area were significant(p<0.05).The perceptual usefulness of Subordinate units was also significant(p=0.016).The frequency of use,perceptual easy-to-use,perceptual usefulness,service area and satisfaction were significantly different(p<0.05).The correlation coefficient between perceptual usefulness and user satisfaction was 0.833,indicating that there was a high correlation.The daily usage frequency of contractors was higher than supervisors.However,supervisors had the highest frequency of use every quarter(p=0.135).There was no significant difference between contractors and supervisors in the frequency of use.Conclusion:It is suggested that education and training on the operation of the electronic official document on-line submission and approval system should be conducted,which can enhance the education and training of supervisors and medical personnel.Continually,invite supervisors and medical personnel to provide advices on the official document system as a reference for future improvements of the system.
文摘On February 26, 2010, the Ministry of Commerce of China ("MOFCOM")issued the Guiding Opinions on 2010 Outbound Investment and Coo-peration indicating
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.
