This paper will discuss the computerised developm en t control and approval system being developed for the Planning and Development C ontrol Department, City Hall of Kuala Lumpur, with stress on the GIS architectur e ...This paper will discuss the computerised developm en t control and approval system being developed for the Planning and Development C ontrol Department, City Hall of Kuala Lumpur, with stress on the GIS architectur e developed within the system. The prospects and challenges towards implementati on of the system are also discussed.展开更多
In this paper,we study 169 IPO samples after Approval System is brought into effect.On the basis that we compare the degree of IPO underpricing in different underwriters and the underpricing condition between prestigi...In this paper,we study 169 IPO samples after Approval System is brought into effect.On the basis that we compare the degree of IPO underpricing in different underwriters and the underpricing condition between prestigious and non-prestigious underwriters,we go further to make regression analysis of the underwriter prestige and IPO underpricing which they underwrite.Finally we conclude that the offering price marketalization is still very low and the underwriter prestige does system is put into effect.not significantly impact on IPO underpricing after approval system is put into effect.展开更多
Special equipment is a kind of equipment with great danger to life safety. Once it cant be safely operated and used in the society, it will seriously affect the healthy development of the society. Due to the complicat...Special equipment is a kind of equipment with great danger to life safety. Once it cant be safely operated and used in the society, it will seriously affect the healthy development of the society. Due to the complicated process of the current administrative license examination and approval system, the application process of special equipment examination and approval is slow, so the relevant government departments should reasonably apply information technology to the administrative license examination and approval system in combination with the current information background, so as to realize the efficient processing of special equipment business.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
For carrying out the Industrial Policy of the Motor Industry, competent authorities concerned are working intensely in the transition from mandatory standards to technical regulations, which includes the formulation o...For carrying out the Industrial Policy of the Motor Industry, competent authorities concerned are working intensely in the transition from mandatory standards to technical regulations, which includes the formulation of auto products (including motorcycles) according to the technical regulations, any products without type approval shall not be permitred to sell, import and use. To expedite the展开更多
Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the e...Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.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
Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(...Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(late)development,regulatory approval,and marketing(Thong,2015).This had significant consequences for financing and executing research,resulting in a larger role for funding by governments and patient-organizations and a shift of research to academia(Mazzucato,2013).展开更多
Environmental approval management system for engineering construction projects is an important implementation tool for environmental protection departments at present. It is necessary to carefully analyze the implemen...Environmental approval management system for engineering construction projects is an important implementation tool for environmental protection departments at present. It is necessary to carefully analyze the implementation requirements of environmental protection work during the system construction, analyze various problems existing during the construction project approval management, and further enhance the application level of environmental approval management system. Based on this, this paper takes the significance of the construction of the environmental examination and approval management system of engineering construction projects as the starting point, puts forward the construction characteristics of the system, and finally analyzes the existing problems and specific construction points of the environmental examination and approval management system of engineering construction projects for reference.展开更多
The official release of the“Drug Registration Management Measures”in January 2020 marked a new milestone in the classification management of traditional Chinese medicine(TCM)registration,ushering in a new era for th...The official release of the“Drug Registration Management Measures”in January 2020 marked a new milestone in the classification management of traditional Chinese medicine(TCM)registration,ushering in a new era for the registration and application of innovative TCM drugs.This article provides a detailed analysis of the approval status of innovative TCM drugs,improved new drugs,and ancient classic prescription compound preparations from 2020 to 2024,revealing the significant achievements made in the inheritance and innovation of TCM in China.The study found that the number of New Drug Applications(NDAs)and Investigational New Drug Applications(INDs)have increased annually,with a particularly notable surge in the submission of applications for classic prescription compound preparations.The approval rates for innovative TCM drugs and improved new drugs have significantly increased,along with the streamlining of review and approval process,leading to shorter development cycles and reduced costs.Key findings include:(1)Enterprises demonstrate strong enthusiasm for the research and development of innovative and improved TCM drugs,actively engaging in various types of drug R&D and submissions;(2)Classic prescription compound preparations have become a focal point for enterprises due to their shorter development cycles and lower costs;(3)Improvement to the“three-combined”evidence system has accelerated the R&D process by incorporating real-world data.Through this study,we aim to provide valuable insights for TCM R&D enterprises and policymakers,promoting the sustained prosperity and development of the TCM sector.展开更多
2025年8月6日,北京大学药学院药事管理与临床药学系管晓东研究员团队与美国耶鲁大学、哈佛大学、英国伦敦政治经济学院的合作研究成果Strength of evidence supporting cancer drug approvals in China, 2017–21:a retrospective analy...2025年8月6日,北京大学药学院药事管理与临床药学系管晓东研究员团队与美国耶鲁大学、哈佛大学、英国伦敦政治经济学院的合作研究成果Strength of evidence supporting cancer drug approvals in China, 2017–21:a retrospective analysis在国际肿瘤学权威期刊《柳叶刀·肿瘤学》(The Lancet Oncology)在线发表。该研究系统评估了2017年至2021年中国获批肿瘤药物的关键临床试验证据质量,是目前首个针对支持中国肿瘤药物监管决策证据强度的实证研究。展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the following 360 voluntary national standards as well as 9 voluntary national standards with amendment.
State Administration for Market Regulation and National Standardization Administration of China have approved the following 354 voluntary national standards as well as 7 voluntary national standards with amendment.
The technical problems and approval standards for the regional test of soybean varieties in Liaoning Province were discussed. The technical key points for the soybean regional trials were the selection of trial fields...The technical problems and approval standards for the regional test of soybean varieties in Liaoning Province were discussed. The technical key points for the soybean regional trials were the selection of trial fields, preparations in lab be-fore sowing, preparations in regional trial field before sowing, sowing in suitable time and strict with sowing process, field management and survey record, harvest and sampling as wel as lab test and summary. In addition, the approval standards for common varieties and quality varieties for the soybean regional trials in Liaoning were introduced, with the aim to provide accurate and scientific theoretical basis for the approval of soybean varieties.展开更多
Androgens have an intense consequence on the human scalp and body hair.Scalp hair sprouts fundamentally in awol of androgens whereas the body hair hike is vulnerable to the activity of androgens.Androgenetic alopecia(...Androgens have an intense consequence on the human scalp and body hair.Scalp hair sprouts fundamentally in awol of androgens whereas the body hair hike is vulnerable to the activity of androgens.Androgenetic alopecia(AGA)invoked as males emulate Alopecia due to the cause of the dynamic reduction of scalp hair.Androgens are medium of terminus growth of hair although the body.Local and system androgens convert the extensive terminal follicles into lesser vellus like structure.The out start of this type of alopecia is intensely irregular and the reason behind this existence of enough circulating steroidal hormones androgens and due to genetic predisposition.Effective treatments are available in the market as well as under clinical and preclinical testing.Many herbal formulations are also available but not FDA approved.Different conventional and NDDS formulations are already available in the market.To avoid various systemic side effects of both Finasteride and Minoxidil,topical formulations and natural products(nutrients,minerals,vitamins)now a days are being widely used to treat Androgenic alopecia.CAM(complementary and alternative medicine)provides the option to elect favorable,low-risk,adjuvant and alternative therapies.Herein,we offer a widespread review of topical marketed formulations,natural products,and CAM treatment options for AGA.展开更多
China＇s economic growth miracle despite complicated administrative approval formalities prompted us to raise the following question： ls it true that reforming administrative approval will promote economic growth？ B...China＇s economic growth miracle despite complicated administrative approval formalities prompted us to raise the following question： ls it true that reforming administrative approval will promote economic growth？ Based on our analysis on market entry, we discovered that reforming administrative approval will spur economic growth by reducing transaction cost for firms. Administrative approval may suppress social cost and propel China＇s economic growth; China＇s gradualist approval reforms may indeed propel economic growth by reducing transaction cost for firms. With the data of prefecture-level cities during 2000-2013 and data of companies listed on the SME board during 2010-2014, we tested the effects of approval reforms on economic growth and on transaction cost, and employed instrumental variable and PSM for the treatment of the endogeneity problem - all these tests led to robust and consistent results. Moreover, we discovered that difference in government policy implementation in the approval process is the root cause of corruption and rent seeking.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
Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the q...Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.展开更多
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
文摘This paper will discuss the computerised developm en t control and approval system being developed for the Planning and Development C ontrol Department, City Hall of Kuala Lumpur, with stress on the GIS architectur e developed within the system. The prospects and challenges towards implementati on of the system are also discussed.
文摘In this paper,we study 169 IPO samples after Approval System is brought into effect.On the basis that we compare the degree of IPO underpricing in different underwriters and the underpricing condition between prestigious and non-prestigious underwriters,we go further to make regression analysis of the underwriter prestige and IPO underpricing which they underwrite.Finally we conclude that the offering price marketalization is still very low and the underwriter prestige does system is put into effect.not significantly impact on IPO underpricing after approval system is put into effect.
文摘Special equipment is a kind of equipment with great danger to life safety. Once it cant be safely operated and used in the society, it will seriously affect the healthy development of the society. Due to the complicated process of the current administrative license examination and approval system, the application process of special equipment examination and approval is slow, so the relevant government departments should reasonably apply information technology to the administrative license examination and approval system in combination with the current information background, so as to realize the efficient processing of special equipment business.
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For carrying out the Industrial Policy of the Motor Industry, competent authorities concerned are working intensely in the transition from mandatory standards to technical regulations, which includes the formulation of auto products (including motorcycles) according to the technical regulations, any products without type approval shall not be permitred to sell, import and use. To expedite the
文摘Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.
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.
基金funded by the FWO(1S34321N)the Fondation Charcot Stichting(to TV and RS)。
文摘Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(late)development,regulatory approval,and marketing(Thong,2015).This had significant consequences for financing and executing research,resulting in a larger role for funding by governments and patient-organizations and a shift of research to academia(Mazzucato,2013).
文摘Environmental approval management system for engineering construction projects is an important implementation tool for environmental protection departments at present. It is necessary to carefully analyze the implementation requirements of environmental protection work during the system construction, analyze various problems existing during the construction project approval management, and further enhance the application level of environmental approval management system. Based on this, this paper takes the significance of the construction of the environmental examination and approval management system of engineering construction projects as the starting point, puts forward the construction characteristics of the system, and finally analyzes the existing problems and specific construction points of the environmental examination and approval management system of engineering construction projects for reference.
文摘The official release of the“Drug Registration Management Measures”in January 2020 marked a new milestone in the classification management of traditional Chinese medicine(TCM)registration,ushering in a new era for the registration and application of innovative TCM drugs.This article provides a detailed analysis of the approval status of innovative TCM drugs,improved new drugs,and ancient classic prescription compound preparations from 2020 to 2024,revealing the significant achievements made in the inheritance and innovation of TCM in China.The study found that the number of New Drug Applications(NDAs)and Investigational New Drug Applications(INDs)have increased annually,with a particularly notable surge in the submission of applications for classic prescription compound preparations.The approval rates for innovative TCM drugs and improved new drugs have significantly increased,along with the streamlining of review and approval process,leading to shorter development cycles and reduced costs.Key findings include:(1)Enterprises demonstrate strong enthusiasm for the research and development of innovative and improved TCM drugs,actively engaging in various types of drug R&D and submissions;(2)Classic prescription compound preparations have become a focal point for enterprises due to their shorter development cycles and lower costs;(3)Improvement to the“three-combined”evidence system has accelerated the R&D process by incorporating real-world data.Through this study,we aim to provide valuable insights for TCM R&D enterprises and policymakers,promoting the sustained prosperity and development of the TCM sector.
文摘2025年8月6日,北京大学药学院药事管理与临床药学系管晓东研究员团队与美国耶鲁大学、哈佛大学、英国伦敦政治经济学院的合作研究成果Strength of evidence supporting cancer drug approvals in China, 2017–21:a retrospective analysis在国际肿瘤学权威期刊《柳叶刀·肿瘤学》(The Lancet Oncology)在线发表。该研究系统评估了2017年至2021年中国获批肿瘤药物的关键临床试验证据质量,是目前首个针对支持中国肿瘤药物监管决策证据强度的实证研究。
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 360 voluntary national standards as well as 9 voluntary national standards with amendment.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 354 voluntary national standards as well as 7 voluntary national standards with amendment.
基金Supported by the Research Station Program of the National Soybean Industrial Technology R&D System of China(CARS-04)~~
文摘The technical problems and approval standards for the regional test of soybean varieties in Liaoning Province were discussed. The technical key points for the soybean regional trials were the selection of trial fields, preparations in lab be-fore sowing, preparations in regional trial field before sowing, sowing in suitable time and strict with sowing process, field management and survey record, harvest and sampling as wel as lab test and summary. In addition, the approval standards for common varieties and quality varieties for the soybean regional trials in Liaoning were introduced, with the aim to provide accurate and scientific theoretical basis for the approval of soybean varieties.
文摘Androgens have an intense consequence on the human scalp and body hair.Scalp hair sprouts fundamentally in awol of androgens whereas the body hair hike is vulnerable to the activity of androgens.Androgenetic alopecia(AGA)invoked as males emulate Alopecia due to the cause of the dynamic reduction of scalp hair.Androgens are medium of terminus growth of hair although the body.Local and system androgens convert the extensive terminal follicles into lesser vellus like structure.The out start of this type of alopecia is intensely irregular and the reason behind this existence of enough circulating steroidal hormones androgens and due to genetic predisposition.Effective treatments are available in the market as well as under clinical and preclinical testing.Many herbal formulations are also available but not FDA approved.Different conventional and NDDS formulations are already available in the market.To avoid various systemic side effects of both Finasteride and Minoxidil,topical formulations and natural products(nutrients,minerals,vitamins)now a days are being widely used to treat Androgenic alopecia.CAM(complementary and alternative medicine)provides the option to elect favorable,low-risk,adjuvant and alternative therapies.Herein,we offer a widespread review of topical marketed formulations,natural products,and CAM treatment options for AGA.
文摘China＇s economic growth miracle despite complicated administrative approval formalities prompted us to raise the following question： ls it true that reforming administrative approval will promote economic growth？ Based on our analysis on market entry, we discovered that reforming administrative approval will spur economic growth by reducing transaction cost for firms. Administrative approval may suppress social cost and propel China＇s economic growth; China＇s gradualist approval reforms may indeed propel economic growth by reducing transaction cost for firms. With the data of prefecture-level cities during 2000-2013 and data of companies listed on the SME board during 2010-2014, we tested the effects of approval reforms on economic growth and on transaction cost, and employed instrumental variable and PSM for the treatment of the endogeneity problem - all these tests led to robust and consistent results. Moreover, we discovered that difference in government policy implementation in the approval process is the root cause of corruption and rent seeking.
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Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.
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.
