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本期目录

    2019年, 第14卷, 第3期 刊出日期:2019-09-20 上一期    下一期
    Regulation of Drug Clinical Trials in China: Course and Development Trend
    Zhang Xu, Tian Lijuan
    2019 (3):  87-91. 
    摘要 ( 383 )   PDF(2691KB) ( 538 )  
    Objective To provide a basis for future regulation reform of drug clinical trials in China in the context of the continuous deepening of drug regulation reform. Methods Literature review and regulation study were conducted to analyze the course and development trend of drug clinical trial regulation in China. Results and Conclusion It is found that the regulation system and the standardization for clinical trials in China are gradually improving, but there is still a gap compared with developed countries. In the future, the regulation authorities still need to further improve relevant regulations, clarify regulation responsibilities, and to improve the drug clinical trial review system to ensure the quality of clinical trials and the safety and effectiveness of listed drugs.
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    Analysis of Laws and Regulations on Vaccine Quality Control in China
    Zhi Yuanyuan, Wang Shuling, He Yalan
    2019 (3):  92-99. 
    摘要 ( 447 )   PDF(4148KB) ( 593 )  
    Objective To analyze laws, regulations and the responsibilities of relevant authorities for vaccine quality control and to provide suggestions for improving vaccine quality control system in China. Methods Laws and rules issued by related authorities were classified and studied. Results and Conclusion There are still some problems in the basic laws and regulations, including the lack of legal basis, the unclear responsibilities of relevant authorities and so on. We should improve the current laws, regulations as well as the responsibilities of the authorities so as to build up a sound system of vaccine traceability gradually.
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    Group Purchasing Organizations (GPOs) in the U.S.: Development and Reform
    Jin Jing, Xiong Jiamei, Yang Yue, Huang Zhe
    2019 (3):  100-109. 
    摘要 ( 706 )   PDF(2783KB) ( 5214 )  
    Objective To study the characteristics, specific functions and policy improvement process of the Group Purchasing Organizations (GPOs) in the U.S. and to provide references for drug group purchasing practices in China. Methods Domestic and foreign relevant literatures, websites were reviewed or searched to analyze the functions and policy improvement process of the GPOs in the U.S. so as to provide references for drug group purchasing practices in China. Results and Conclusion As a third party in the U.S. GPOs has formed a relatively integrated business process and projects service system after long-term development. Supported by corresponding policies and industrial regulations, GPOs have made a great contribution to control the growth of medical and healthcare expenses and improve the efficiency of medical institutions, and its development experience can enlighten the practices in China.
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    Risk Control Strategy in the Research and Development of Pediatric Drugs
    Tang Ying, Chen Yuwen
    2019 (3):  110-118. 
    摘要 ( 442 )   PDF(4065KB) ( 324 )  
    Objective To analyze the risk control strategy in the research and development of pediatric drugs and to provide references for pharmaceutical enterprises to avoid the risks so that they can produce more and much better drugs for children in China. Methods An expert questionnaire and expert interviews were conducted to identify the specific risks and the key factors, and valuable advices were put forward. Results and Conclusion There are four risk factors in the research and development of pediatric drugs. The first is that parents are concerned and they are unwilling to allow their children to participate in drug trial. Secondly, adult drug safety data cannot support pediatric drug study. Thirdly, pediatric drugs often have adverse events. Last, regulations for pediatric drugs clinical trials are not perfect. Some valuable recommendations are provided to control these risks.
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    Empirical Study of the Relations between Executive Compensation Gap and R&D Investment in Pharmaceutical Manufacturing Enterprises
    Hu Liuyan, Liu Nanping, Xing Hua
    2019 (3):  119-125. 
    摘要 ( 549 )   PDF(2752KB) ( 894 )  
    Objective To study the correlation between executive compensation gap and R&D investment of pharmaceutical manufacturing enterprises in China by taking 53 pharmaceutical manufacturing companies in Shanghai and Shenzhen stock exchanges from 2015 to 2017 as research samples. Methods Multiple linear regression methods was used to study the relationship and influence between executive compensation gap and R&D investment in pharmaceutical manufacturing industry based on championship theory and principal-agent theory. Results and Conclusion There is a significant positive correlation between executive compensation gap in pharmaceutical manufacturing industry and enterprise R&D investment. Listed pharmaceutical manufacturing enterprises should design reasonable salary gap between senior executives and carry out reasonable research and development activities to promote the sustainable development of pharmaceutical manufacturing enterprises. This study provides theoretical basis for optimizing executive compensation gap and increasing R&D investment in pharmaceutical manufacturing industry.
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    Analysis of the Current Situation of Active Pharmaceutical Ingredient (API) Export in China
    Kong Deqiang, Dong Li
    2019 (3):  126-134. 
    摘要 ( 584 )   PDF(3643KB) ( 702 )  
    Objective To analyze the problems of API export in China and to study the current international and domestic trading environment. Methods Data statistical analysis was used to study the export situation of APIs, and PEST was applied to analyze the current export problems. Results and Conclusion API export in China is now experiencing a growth period and the international trading environment is constantly improving.
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    Licensed Pharmacists in Pharmaceutical Retail Enterprises in China: Problems and Countermeasures
    Wang Shuling, De Xianhui, An Lianyu, Shi Ping
    2019 (3):  135-143. 
    摘要 ( 521 )   PDF(5897KB) ( 517 )  
    Objective To analyze the status and problems of licensed pharmacists in pharmaceutical retail enterprises in China, and to put forward suggestions for improving licensed pharmacists’ abilities. Methods Literature review and questionnaire survey were used to analyze the basic status of licensed pharmacists in pharmaceutical retail enterprises and fishbone diagram was used to find out the problems. Results and Conclusion Pharmaceutical retail enterprises have the following problems when they employ pharmacists, such as lack of assessment system, too general incentive policies. The causes of problems lie in four aspects, including system, environment, pharmacy and pharmacists. As to the above problems, the government should make policies to encourage and regulate enterprises to explore remote prescription service through Internet. Furthermore, pharmaceutical retail enterprises can take the advantage of Internet to develop a comprehensive performance appraisal system for licensed pharmacists. The assessment information platform will reflect the true level of pharmacists and enhance their professional value.
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    Pharmacy Service in Private Hospitals: Problems and Countermeasures
    Lu Yiyang, Sun Lihua
    2019 (3):  144-150. 
    摘要 ( 595 )   PDF(3435KB) ( 463 )  
    Objective To improve the quality of pharmacy service in private hospitals on the background of the fact that hospital pharmacy service is an important guarantee to promote rational drug use and the government encourages social capital to enter the field of pharmacy and healthcare, therefore, private hospitals are facing a new stage of development. Methods Questionnaire survey was used to sample and analyze 10 representative private hospitals in local area, and comparisons were made with the status of pharmacy service in level 3 public hospitals. Results and Conclusion It can be found that private hospitals have many problems in pharmacy services, such as the low level of professional skills of pharmaceutical personnel, low recognition and trust from patients, and the imperfect pharmaceutical management system. Some countermeasures and suggestions are put forward to promote the level of pharmacy services in private hospitals on the basis of this study.
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