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On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.
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Objective:To provide a basis for improving the design and implementation of policies for ensuring the supply of pediatric drugs in China.Method:Based on the perspective of pharmaceutical enterprises,reviewed literature and conducts questionnaire surveys to identify the constraints in the development of pediatrict drugs throughout the entire drug lifecycle,and analyzes the constraints'concentration and urgency.Result:The main constraints include:difficulty in conducting clinical trials for children;the current registration and approval rules lack consideration for the specificity of pediatric drugs and specific requirements for application materials;lack of implementation rules and measures in the implementation process of incentive policies for pediatric drug production;The market interest mechanism of pediatric drugs is not yet perfect.Among them,research and development and payment for use are currently relatively concentrated issues.Discussion and suggestions:It is recommended that China fully utilize existing clinical trial data of pediatric and broaden sources,take multiple measures to increase investment in pediatric drug R&D;Develop special guidelines for pediatric drug application and encourage adult drug registration to submit pediatric research plans;Explore the optimization path of pediatrict drug production and supply based on typical cases;Provide more space for pediatric drugs in the rules of drug use and payment.
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{L-End}Objective To analyze the current status of occupational stress and its influencing factors among workers in pharmaceutical enterprises in Beijing City. {L-End}Methods A total of 860 employees from six pharmaceutical enterprises in Beijing City were selected as the research subjects using convenience sampling method. The Chinese version of the New Brief Job Stress Questionnaire was used to evaluate the occupational stress, and multiple linear regression analysis was used to analyze the influencing factors of occupational stress. {L-End}Results The detection rate of high occupational stress was 1.40% (12/860). The results of multiple linear regression analysis showed that the workers with higher education level and longer length of service had a higher risk of high occupational stress (all P<0.01). Workers who were satisfied with their jobs had a lower risk of high occupational stress than those who were unsatisfied with their jobs (P<0.01). Workers who were satisfied with life had a significantly lower risk of high occupational stress than those who were unsatisfied with life (P<0.01). {L-End}Conclusion The detection rate of high occupational stress in workers of pharmaceutical enterprises is relatively low. Occupational stress is mainly affected by individual factors such as education level and length of service, and work and life satisfaction. Improving job and life satisfaction is helpful to reduce occupational stress level.
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OBJECTIVE：To provide reference for pharmaceutical enterprises to better fulfill their social responsibilities . METHODS：Taking the pharmaceutical enterprises listed in Shanghai and Shenzhen stock markets as the research objects ，the social responsibility texts and environmental protection texts of the included enterprises from 2017 to 2019 were classified and analyzed according to the three dimensions of time ，ownership and drug production type by using ROST Content Mining 6.0 software. The semantic network and node centrality were analyzed. RESULTS ：From the social responsibility texts of the included enterprises，it could be seen that from the perspective of time dimension ，the included enterprises paid more attention to “employees”，“social responsibility ”and“development”in 2017-2019，and the high-frequency words in the three years were relatively stable. From the perspective of ownership ，state-owned holding enterprises paid more attention to “development”and “targeted poverty reduction ”，while private holding enterprises paid more attention to “employees”，and collective holding enterprises paid more attention to “social responsibility ”. From the perspective of drug production type ，the word frequency of “targeted poverty reduction ”of TCM pharmaceutical enterprises was higher. From the environmental protection texts of the included enterprises，it could be seen that from the time dimension ，the included enterprises paid more and more attention to environmental protection in recent years ，and the description of environmental protection in the texts was more detailed. From the perspective of ownership，private holding enterprises paid more attention to environmental protection than collective holding enterprises and state-owned enterprises. From the perspective of drug production type ，due to the different types of drugs ，chemical drugs ，TCM， biological drugs and active pharmaceutical ingredients enterprises had their own characteristics in pollutants and their treatment processes. The results of semantic network and node centrality analysis showed that ，“development”，“protection” and “targeted poverty reduction ”were three high-frequency words with high centrality in the semantic analysis network of social responsibility text ，the middle centrality was 5.555，1.695，1.521 respectively；“emission”and“testing”were two key words with high centrality in the semantic analysis network of environmental protection texts ，the middle centrality was 3.856， 1.914 respectively，which further reflected that the included enterprises paid more attention to the above issues in terms of social responsibility performance and environmental protection. CONCLUSIONS ：The listed pharmaceutical enterprises have a broad consensus on social responsibility in China ，and have well fulfilled their social responsibility ，which is well combined with the current social hot spots. For environmental protection ，as a high pollution industry ，the pharmaceutical enterprises also performs the responsibility of environmental protection.
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OBJECTIVE：To pro vide reference for improving i nnovation and development capability of pharmaceutical enterprises in China. METHODS ：Based literature review ，10 measurement indexes （growth rate of net profit ，the growth rate of total assets ，the growth rate of revenue ，the net interest rate of sales ，the gross profit rate of sales ，the rate of return on net assets ， the current ratio ，the asset liability ratio ，the proportion of R&D personnel ，and R&D intensity ）were selected from aspect of growth ability ，profitability，solvency and innovation capability to establish evaluation system. Pharmaceutical enterprises with A-share listing time of no less than 5 years and R&D investment of no less than 100 million yuan in 2018 were selected as the research objects ，the data of above-mentioned indexes of included enterprises were collected during 2015-2019 by means of their public corporate annual reports and stock trading software Tonghuashun ；factor analysis method was used to extract the principal components to establish a model ；principal component factors were determined according to factor characteristic root and variance contribution rate ，ranked and analyzed the average comprehensive score of included enterprises during 2015-2019. RESULTS & CONCLUSIONS：Four principal components including market development capability ，enterprise growth ability ，operation development capability and product innovation capability were determined ，and the cumulative variance contribution rate was 72.385％. A total of 44 pharmaceutical enterprises were included. Among them ，40.91％，43.18％，38.64％，72.73％ and 52.27％ showed an upward trend in the market development capability ，onterprises growth capability ，operational development capability ， product innovation capacity and total innovation and development capability. The highest score of innovation and development capability of pharmaceutical enterprises was 0.612，and the lowest score was － 1.132. There were 8 enterprises whose comprehensive score was 0.3-＜0.7，accounting for 18.18％； pharmaceutical enterprises in this range had good innovation and development capability. There were 21 enterprises whose qq.com comprehensive score was －0.1-＜0.3，accounting for 47.73％； pharmaceutical enterprises in this range had fair good innovation and development capability. There were 11 enter- prises whose comprehensive scor e was －0.5-＜－0.1，accounting for 25.00％；pharmaceutical enterprises in this range had poor innovation and development capability. There were 4 enterprises whose comprehensive score was ＜－0.5，accounting for 9.09％； pharmaceutical enterprises in this range had very poor innovation and development capability. The innovation and development capabilities of pharmaceutical enterprises in China are polarized ，the development of enterprises in China has entered a period of fluctuation with opportunities and challenges coexisting. Pharmaceutical enterprises with a certain number of medical insurance varieties or exclusive core varieties have strong competitiveness in their subdivided pharmaceutical field. Biopharmaceuticals have entered the active period. Pharmaceutical enterprises have shifted from generic drugs to innovative drugs. It is suggested that Chinese pharmaceutical enterprises should implement intelligent management ， develop R&D strategy scientifically ， attach importance to developing international market so as to improve their innovation and development ability.
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OBJECTIVE：To improve the willin gness of chinese pharmaceutical enterprises to participate in drug patient assistance programs ，improve the level of drug use and access to innovative drugs in China and fully evaporate the supplementary role of the medical security system. METHODS ：Through grounded theoretical analysis of the interview results ，the theoretical framework of the factors affecting the implementation of drug patient assistance programs by pharmaceutical companies was proposed. The above theoretical framework was empirically studied through questionnaire survey on the personnel who understood or participated in drug patient assistance program in Chinese pharmaceutical enterprises. Based on partial least squares structural equation model ，Smart PLS 3.0 software was used for data processing to analyze the influence of different factors on the willingness of pharmaceutical companies to participate in drug patient assistance programs ，and the relevant suggestions were put forward. RESULTS & CONCLUSIONS ：Economic benefits ，market competition ，social benefits and policy environment have significants impacts on the willingness of pharmaceutical enterprises to implement drug patient assistance programs. The path coefficients were 0.244 （P＜0.01），0.236 （P＜0.01），0.235 （P＜0.05），0.228 （P＜0.01）. Human resource efficiency and cooperation unit have no significant effects on the willingness of pharmaceutical enterprises to implement drug patient assistance programs（P＞0.05）. Economic benefits are in line with the nature of enterprises ’profit-making and have the most close influence. Therefore，the pricing strategy of drugs and the tax policies of government departments are very important for enterprises. Participation in market competition is also an important factor for enterprises to participate in patient assistance programs. The earlier the implementation of patient assistance ，the more opportunities of relevant drugs will be to seize more markets. The social benefits manifest as reducing the economic burden of patients ，improving the quality of life ，and promoting the social and economic development. At the same time ，enterprises have set up good social image and forms a word-of-mouth effect. The policy environment generally includes the legal environment and medical insurance policies. The legal provisions restrict the donations of pharmaceutical enterprises to a certain extent ，but corresponding regulatory measures are still essential. Medical insurance policies are closely related to the establishment and adjustment of patient assistance programs ，and the connection between medical insurance access and patient assistance programs needs to be further improved. Therefore ，from the perspective of enterprises ，it is recommended to establish a cost and benefit calculation system for drug patient assistance programs ，and broaden the publicity channels and increase the publicity intensity of patient assistance programs. From the perspective of the government ，it is recommended that tax incentives for donations should be increased，the patient assistance supervision system should be improved ，the access and adjustment rules for the drugs of patient assistance programs in medical insurance list should be clarified ，so as to promote pharmaceutical enterprises to actively participate in patient assistance programs and improve the drug use level and drug accessibility of patients.
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OBJECTIVE：To study the influential factors for green innovation in pharmaceutical enterprises based on grounded theory so as to provide reference for pharmaceutical enterprises to enhance their green innovation ability and the government to issue relevant green policies. METHODS ：The grounded theory research methods were used to select enterprise samples and follow-up research. Firstly ，56 staffs from 22 sample enterprises （all were pharmaceutical companies ）were interviewed in depth one-on-one and face-to-face on issues related to the influential factors for green innovation. Then ，open coding ，spindle coding and selective coding were carried out on the conversation record data ，and conduct theoretical saturation testing was conducted. Finally ， the influential factor model of green innovation in pharmaceutical enterprises was constructed ，and its main influential factors were analyzed. RESULTS & CONCLUSIONS ：The government demand ，social demand ，industry demand ，green innovation ability ， environmental awareness of leaders and overall vision of leaders have significant influence on the green innovation of pharmaceutical enterprises. Among them ，leadership decision （including leaders ’environmental awareness and leadership pattern ） is the internal decisive factor ，green innovation ability （including green innovation investment capacity ，green innovation research and development capacity ，green innovation transformation capacity and green innovation production capacity ）is the internal driving factor ，social system （including government needs ，social needs and industry needs ）is the external factor ；they are the main factors affecting the green innovation of pharmaceutical enterprises ，and they all have a positive effect on the green innovation of pharmaceutical companies.
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OBJECTIVE： To provide reference for pharmaceutical enterprises to enhance the R&D capability and improve the R&D investment strategy. METHODS： The annual report data of 13 listed pharmaceutical enterprises in southwest China were collcted. Taking fixed assets， operating costs， the number of employees in service and the amount of R&D investment as input indicators， net profit， operating income and earnings per share as output indicators， the efficiency values were calculated by using MyDEA 1.0 software based on super-efficiency DEA model. The operating efficiency of enterprises with or without R&D input were compared； the contribution rate of R&D investment to enterprises were calculated. Finally， Wilcoxon symbolic rank test was carried out by using SPSS 20.0 software to compare the difference. RESULTS： From 2013 to 2015， 10 of the 13 listed pharmaceutical enterprises had increased their R&D investment， which indicated that listed pharmaceutical enterprises in southwest China paid more attention to R&D investment. For three consecutive years， the efficiency value of R&D investment of the 13 listed pharmaceutical enterprises was significantly higher than that of the enterprises without R&D investment， and the number of the former reaching DEA efficiency was more， indicating that R&D investment was positively correlated with the operational efficiency of pharmaceutical enterprises. The Wilcoxon symbol rank test also confirmed that R&D investment was an effect input. After three enterprises joined the R&D input index， their operational efficiency was improved， and their R&D contribution was greater. Five enterprises had zero R&D contribution， their efficiency value remained unchanged whether or not they joined R&D input. The R&D contribution of other listed pharmaceutical enterprises varied greatly in each year. CONCLUSIONS： At the overall level of the industry， enterprises should increase their R&D investment and pay attention to improving R&D efficiency， establish a sound R&D innovation system and R&D personnel training mechanism， establish an integrated training mode of production， learning and research； the government should create an environment to support R&D activities of pharmaceutical enterprises. For individual enterprises， different strategies should be adopted based on practical situation in order to improve the pulling effect of R&D input on the operational efficiency of enterprises.
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OBJECTIVE:To provide a reference for promoting the effect of government subsidies to the R&D conducted by pharmaceutical enterprises,increasing enterprises’internal input to R&D and improving innovation performance. METHODS:By building the theoretical model of the relation of the government subsidies and internal input to R&D and the innovation performance on the basis of the assumptions,the empirical study was conducted on the pharmaceutical enterprises in Jiangsu Province though re-gression analysis and mediating effect analysis. RESULTS & CONCLUSIONS:The scale designed had good reliability and validity. The final model was obtained after empirical test. Giving considerations to relevant coefficients,the results showed that all assump-tions were verified except 3. Where,government subsidies to the R&D promoted enterprises’internal input to R&D and innovation performance,and internal input to R&D served as a complete mediator between government subsidies to the R&D and innovation performance,that is to say,government subsidies to the R&D had indirect promotion influence on innovation performance,with the influence coefficient as 0.405. It is suggested that the government should increase subsidies to R&D conducted by pharmaceuti-cal enterprises in a reasonable manner to make full use of the guiding function of government funds,and pharmaceutical enterprises should attach importance to internal input to R&D and establish its principal status in innovation system.
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OBJECTIVE:To investigate the profitability of listed pharmaceutical enterprises in China,and to investigate the ba-sic profitability path. METHODS:With the help of DuPont financial analysis system,the financial data of the listed companies and other manufacturing industry during 2007-2013 were collected and compared in terms of the return on equity(ROE),profit margin (PM),asset turnover (ATO) and equity multiplier (EM),etc. RESULTS & CONCLUSIONS:During 2007-2013,average ROE and PM of listed pharmaceutical companies both were higher than those of other manufacturing industry(10.00% vs. 6.40%, 11.50% vs. 6.49%);while average ATO and EM were lower than other manufacturing industry (0.65 vs. 0.73,1.90 vs. 2.19), with statistical significance(P<0.05). It has advantages in core earnings and product profitability while disadvantage in asset turn-over and financial leverage for the listed pharmaceutical companies. Listed pharmaceutical companies’gross margin was higher (42.87% vs. 22.07%),but was offset by the higher ratio of expenses to sales(18.24% vs. 5.61%)and insufficient utilization ratio of circulating assets. To change this situation,listed pharmaceutical enterprises should focus on circulation cost saving and the im-provement of assets operation ability,especially enhancing the utilization ratio of current assets.
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OBJECTIVE:To provide reference for the selection of marketing strategy for post-marketing drugs.METHODS:?2 test was employed to analyze the number of 4 marketing strategies(flank attack strategy,guerrilla strategy,defensive strategy and attack strategy)used for the 100 well-known drug brands(74 from domestic versus 26 from abroad),meanwhile the regular marketing strategies for the domestic vs.foreign drug enterprises and for the OTC drugs vs.prescribed drugs were analyzed.RESULTS & CONCLUSIONS:There were significant differences between domestic and foreign pharmaceutical enterprises in the use of guerrilla strategy and attack strategy,20 of the domestic brands(27.03%)vs.none of the foreign brands used guerrilla strategy(0.00%),however,the foreign enterprises prefer attack strategy than domestic enterprises(14 foreign brands(53.85%)vs.13 domestic ones(17.57%)).There were no significant differences between domestic and foreign brands in the application of flank attack strategy and defensive strategy,the same is true between OTC and prescription drugs in the four strategies mentioned above.
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OBJECTIVE:To provide a new idea for enhancement of core competitiveness of pharmaceutical enterprises in China and supply advice for building virtual marketing network.METHODS:The concept and theory of virtual management and virtual marketing network were interpreted and analyzed according to the status quo of pharmaceutical enterprises in China.RESULTS & CONCLUSION:Virtual marketing network is a new idea for the development of pharmaceutical enterprises.Enterprises should establish a standard cooperative relation with the dealers in order to prevent risks and promote core competitiveness of enterprises.
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OBJECTIVE: To promote Chinese pharmaceutical enterprises to understand their social responsibility clearly and to fulfill it actively.METHODS: The category of social responsibility of pharmaceutical enterprises was analyzed as well as the main approaches to perform corporate social responsibility.RESULTS: Chinese pharmaceutical enterprises should figure out their responsibility to consumers,employees,investors,society,community and other stakeholders.In recent years,the approaches to perform social responsibility based on force system of law and regulations and the improvement of enterprises' consciousness.These are unfavorable to Chinese pharmaceutical enterprises to undertake social responsibility actively.CONCLUSION: There are two approaches to promote Chinese pharmaceutical enterprises to perform their social responsibility,which are external supervision and internal governance.
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OBJECTIVE:To probe into the evaluation method on technological capability of pharmaceutical enterprises.METHODS:The connotation of pharmaceutical enterprises'technological capability was expounded;the characteristics of each evaluation index,i.e.output index and input index of technological capability of pharmaceutical enterprises were ana?lyzed.RESULTS:Detailed and complete information on the evaluation of pharmaceutical enterprises'technological innovation capability was unavailable from the output index and input index only.CONCLUSION:The evaluation on pharmaceutical enterprises'technological innovation capability should include more comprehensive,more dynamic and more integral evaluation indexes.
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OBJECTIVE:To discuss the outsourcing strategy of pharmaceutical enterprises.METHODS:The feasibility and the necessity of carrying out outsourcing strategy in pharmaceutical enterprises were analyzed based on value chain theory;and the current outsourcing strategies carried out in China pharmaceutical enterprises were evaluated.RESULTS&CON?CLUSION:Outsourcing is a feasible choice for our pharmaceutical enterprises,by which their competitive edge can be im?proved effectively.
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OBJECTIVE:To cultiveate and development of Research &Development(R &D)abilities for new drugs for Chinese pharmaceutical enterprises.METHODS:The experiences on new drugs' R&D of some Indian pharmaceutical enterprises were analyzed.RESULTS &CONCLUSION:To improve R &D abilities for new drugs,Chinese pharmaceutical enterprise should try to explore effective ways and measures by not only emphasizing the strategic value of R&D for new drugs,but also strengthening the cooperation with outside,attracting the overseas talents,cultivating the integrative capa-bility,etc.
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OBJECTIVE:To enhance the competitive edge of Chinese pharmaceutical enterprises.METHODS:Patents problems confronted by Chinese pharmaceutical enterprises were analyzed in terms of the research and development and patent protection of the original new drugs,the administrative protection and patent protection of drugs,patent documentation in?formation,patent strategy and patent talents,etc.RESULTS&CONCLUSION:Chinese pharmaceutical enterprises should highlight the patent problems and apply patent strategy to achieve competitive advantage.
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OBJECTIVE: To discuss the competitive intelligence(CI) development strategies in Chinese pharmaceutical enterprises. METHODS: The CI in Chinese pharmaceutical enterprises was overviewed and the problems were analyzed. Then development strategies of CI were put forward. RESULTS & CONCLUSION:CI is one of the powerful competitive tools in pharmaceutical enterprises; development strategies of which should be further explored.
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OBJECTIVE: To provide reference for Chinese pharmaceutical enterprises to promote marketing strategy under the new condition of medical system reform.METHODS: The marketing strategies for pharmaceutical enterprises under the new condition of medical system reform were analyzed systematically from aspects of the pharmaceutical target market,marketing concepts and pricing system.RESULTS & CONCLUSIONS: Under the new medical system,the pharmaceutical enterprises have to reconsider their marketing strategies such as by marching into primary level market,adjusting their marketing concepts from aspects of strengthening brand innovation construction and reorganizing the staff structure of marketing team etc,and adjusting pricing strategy etc to achieve a sustainable satisfactory development.
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OBJECTIVE:To enhance pharmaceutical enterprises' awareness on social responsibility and facilitate their understanding of their social responsibility.METHODS:The motivations for pharmaceutical enterprises to bear social responsibility and their social responsibility at different levels were analyzed by combining theory with practice.RESULTS & CONCLUSIONS:The motivations for pharmaceutical enterprises to bear social responsibility arise from both interior and exterior factors.In order to facilitate the understanding of pharmaceutical enterprises at different stages of development about their social responsibility and achieve a long-term development by realistically assuming their responsibility meanwhile promoting social welfare,it is advisable to divided their social responsibility into 3 levels:basic level,medial level and high level.