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@#Objective To establish CNC(controlled not classified)area microbial database of pharmaceutical enterprises,conduct correlation analysis with microbial distribution in clean area to achieve good microbial control in the clean area,especially in the core aseptic operation area,and improve the sterility assurance level of pharmaceutical enterprises.MethodsThe CNC area of a manufacturing workshop from pharmaceutical enterprise was selected as the research object,the airborne microbe,settling microbe,personal and environmental surface microorganisms were sampled one by one in the CNC area according to the route of personnel and materials entering the clean area. After the microorganisms were cultured and purified,the 16S rRNA sequencing method was used to identify the strains. Microbiomeanalyst online analysis software was used for data analysis.ResultsThe number of microorganisms in the CNC area of pharmaceutical enterprises was large and the species were rich. A total of 4 080 microorganisms were collected,which distributed in 47 genera. Gram-positive bacteria accounted for 84. 4%,mainly belonging to Staphylococcus,Micrococcus,Microbacterium. Gram-negative bacteria accounted for 15. 6%,and the distribution of Acinetobacter was much higher than other gram-negative bacteria. The Alpha diversity index was used to characterize the richness of microbial populations. The richness of microbial populations of airborne microbe and settling microbe was the highest,followed by environmental surface microorganisms,and the microbial population richness of personnel surface microorganism was the lowest. The number of microorganisms in the personnel's hood and chest was relatively small,and the number of microorganisms in the personnel's soles of feet and hands was relatively large. There were relatively few types of microorganisms on the surface of personnel,and staphylococcus showed an absolute advantage. The microbial distribution in CNC area was correlated with the microbial distribution in Class B and C clean areas of the same production workshop. Most of the microorganisms collected in Class B and C clean areas were included in the microbial population in CNC area. Class B and C clean areas were similar to CNC area,both of which were dominated by Staphylococcus and Micrococcus. The distribution proportion of Acinetobacter in Class B and C clean areas decreased compared with that in CNC area.ConclusionThe CNC area microbial database of the pharmaceutical enterprises has been established and the microbial population that is easy to enter the clean area has been determined,providing reliable technical support for the good microorganism control in the clean area
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OBJECTIVE To provide reference for developing pharmacovigilance and constructing an active surveillance system with extensive participation of pharmaceutical enterprises in China. METHODS Retrieving the literature and data from databases such as CNKI ，PubMed，and the official website of observational medical outcomes partnership （OMOP），the mechanism of pharmaceutical enterprises ’participation and its operation mode were investigated ，while specific path and code of conduct for pharmaceutical enterprises to participate in active surveillance system were analyzed. Finally ，the corresponding suggestions were put forward according to the actual situation of China. RESULTS & CONCLUSIONS Pharmaceutical enterprises in OMOP participated in project construction and operation through public private partnership （PPP）mechanism，and played the role of project funding ，project governance and project research. Pharmaceutical enterprises participating in OMOP need to carry out activities in accordance with the code of conduct of extensive cooperation ，transparency and openness and the protection of patient privacy. In the future practice of active surveillance system in China ，it is necessary to promote the relevant legislation of active monitoring system ，emphasize the responsibility of active surveillance of pharmaceutical enterprises ，establish a PPP mechanism of industry-university-research integration ，form a good governance ecology and strengthen the protection of patients ’privacy.
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OBJECTIVE：To provide reference for the better implementation of National Drug Centralized Procurement Policy （hereinafter referred to as the“National Centralized Procurement Policy”）. METHODS：Based on the stakeholder theory， combining with literature research and interview research methods，the role orientation，interest demands and mutual relations of the main stakeholders involved in National Centralized Procurement Policy，such as government departments，pharmaceutical enterprises，medical institutions and patients were analyzed. RESULTS & CONCLUSIONS：Government departments include medical insurance department，health department，drug supervision department and other departments，which plan and lead the National Centralized Procurement Policy；their main interest demand is to ensure the orderly implementation of the policy，the rational use and supply guarantee of the selected varieties in clinic，etc. Pharmaceutical enterprises include pharmaceutical production enterprises and pharmaceutical circulation enterprises，which directly participate in the National Centralized Procurement Policy； the main interest demand of drug production enterprises is to ensure reasonable profits to support their product R&D and promote enterprise transformation；that of pharmaceutical circulation enterprises is to obtain the variety distribution right， so as to improve the market share of enterprises，expand the breadth and depth of marketing，and obtain operating profits，etc. As the main provider of medical services and drugs， medical institutions are responsible for implementing the selected category results of the National Centralized Procurement Policy；their main interest demand is to improve its own popularity and reputation. Patients are not only the demanders of medical services and drugs，but also the main beneficiaries of the reform of National Centralized Procurement Policy；their main interest demand is to reduce the drug burden and ensure that the drugs used are safe and effective. In order to better promote the National Centralized Procurement Policy，it is suggested to give play to the leading role of the government and promote the reform of“tripartite system reform”in coordination with other policies；optimize the drug procurement mechanism and guide the reasonable formation of market price；encourage enterprises to continuously improve the quality of varieties through generic drug consistency evaluation，and strengthen quality supervision.
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OBJECTIVE：To provide reference for optimizing resource allocation and precise investment of China ’s pharma- ceutical industry. METHODS ：The number of invention patent applications in China ’s pharmaceutical industry was searched from China Intellectual Property Netwerk ，and the status quo and structure of patent applications in China ’s pharmaceutical industry were analyzed. SPSS 23.0 software was used to analyze the input-output correlation of the number of invention patent applications with R&D investment and main business income of pharmaceutical enterprises in China. RESULTS ：The number of invention patent applications in China ’s pharmaceutical industry increased year by year. From 2000 to 2015，225 861 invention patents had been applied by domestic applicants and 43 149 invention patents had been applied by foreign applicants in China ；only 49.94％ domestic applicants applied for professional invention ，while 96.79％ of foreign applicants applied for professional invention. There was a positive correlation between the R&D expenditure of pharmaceutical enterprises and the number of invention patent applications，which indicated that the R&D investment of pharmaceutical industry in China was beneficial to the invention patent applications. The number of invention patent applications of pharmaceutical enterprises was also positively correlated with the main business income ，indicating that the increase of invention patent applications of pharmaceutical enterprises also effectively expanded the economic scale of pharmaceutical industry. CONCLUSIONS ：Compared with foreign countries ，the structure of patent applicants in domestic pharmaceutical industry needs to be adjusted urgently. Pharmaceutical enterprises have not yet become the main applicants. The continuous R&D investment of pharmaceutical enterprises effectively promotes the application of invention patent，expanded the economic scale of the pharmaceutical industry.
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Objective The study was focused on the current situation of human resources of pharmaceutical enterprises in Heilongjiang Province, to solve the problems of workforce shortage in small- and medium-sized pharmaceutical enterprises, and put forward corresponding countermeasures. Methods A convenient sampling method was used to investigate the basic situation of 12 pharmaceutical enterprises in Heilongjiang Province in June - November 2016, and interviews and questionnaire survey were conducted with the employees of human resources departments. The basic situation of the survey included: the general situation, the demand for talent, the development of pharmaceutical enterprises and so on. Staff interviews included: the number of talents introduced and the number of outflows in the past 3 years, human resources needs, knowledge and ability of pharmaceutical enterprises. The staff survey included: employee job satisfaction, turnover tendency and career development prospects. Results The number of employees in the 12 pharmaceutical enterprises was 22065. Employees' age was in 34 - < 44 years old, with low education qualifications, 74.6% (16456/22065) of employees attended junior college or below . There were 6246 technical personnel , most of them (3678) received college education. In the interviews with 36 employees, it was found that the pharmaceutical enterprises were short of workforce. The unstable sources for the workforce and brain drain were the biggest problem in the development of pharmaceutical enterprises. In the 591 questionnaires, 24.6%(145/591) of employees had the idea of changing jobs in the past year. Conclusion Pharmaceutical enterprises should pay attention to the introduction and training of talented staff, and develop a series of preferential conditions to attract them, so as to achieve the goal of thriving enterprises by talented workforce.
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OBJECTIVE:To provide reference for the sustainable development of pharmaceutical enterprises in Guizhou prov-ince. METHODS:A questionnaire was conducted for 55 pharmaceutical enterprises in Guizhou province,the basic situation of en-terprises,familiarity of related directors to Good Manufacture Practice of Drugs(GMP)and relevant policy,the current situation of implementing the new version GMP were investigated and statistically analyzed,problems were found,and corresponding coun-termeasures were put forward. RESULTS & CONCLUSIONS:Totally 55 questionnaires were sent out,49 valid ones were received with effectively recovery of 85.1%. The results showed 43 enterprises(87.8%)had passed the GMP authentication;only 13 enter-prises(26.5%)directors were very familiar with the new version GMP. In terms of personnel management,the head of production management and quality management and the authorized person of quality and personnel had not yet met related requirements of the new version GMP fully;in terms of equipment and production management,production area transformation(clean areas,lounges, warehouses,water use) and air purification system design in most enterprises met related requirements of the new version GMP, 23 enterprises (46.9%) still can not conduct fully inspection to products and materials;in terms of document management,there were still some enterprises not meeting the new version GMP standards fully,enterprises'documents(health area layout,air purifi-cation layout,management procedures,operating procedures,etc.) of production site were imperfect. According to the investiga-tion,the main existing problems included lack of funds in implementing the new version GMP reform,not enough understanding or familiarity with the new version GMP,relevant personnel management not reaching the designated position,equipment and pro-duction management needing to be strengthened,document management systemic being poor,risk management being not sound, etc. It is suggested that government should give all forms of capital policy and strengthen the training of the new version GMP;en-terprises should attach great importance to the relevant personnel management,strengthen the equipment and production manage-ment,set up perfect document management system and a sound system of risk management.
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After the functions and requirements of medical information officers and the distribution of enterprises were described, the problems in domestic education of medical informatics ( such as insufficient class hours for medical course and unclear orientation of subjects) were analyzed according to the status quo in training of medical informatics students, and some suggestions were put forward for the orientation of medical informatics education in China.
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OBJECTIVE:To study the characteristics of patent behaviors of Chinese pharmaceutical demonstration enterprises for intellectual property,and to provide reference for the improvement of patent behaviors in Chinese pharmaceutial enterprises. METHODS:After retrieving the applicants(patentees)from China Intellectual Property Right Net on the basis of taking 7 pharma-ceutical demonstration enterprises chosen through appraisal by State Intellectual Property Office of the P.R.C in 2013 as the study samples,empirical study was conducted on their patent behaviors during 1985 and 2013,including the number and type of the pat-ents for which applications were made,international patent classification and legal status. RESULTS:The number of patent applica-tions of the 7 pharmaceutical demonstration enterprises demonstrated a growing trend(an annual increase up to 79.0%). The appli-cations were dominated by the inventive patent(84.9%). Many patents were in an authorized legal status(46.7%). All of these en-terprises paid more attention to the maintenance of the authorized patent. The technology patent applications were mainly about chemical compound,composition,and preparation methods,including the technical proposal containing the active ingredients and properties of the pharmaceutical preparation (A61K),particularly the application of the technical proposal related to the treatment with the preparation (A61P). CONCLUSIONS:All the 7 pharmaceutical demonstration enterprises were aware of patent competi-tion and protection and characterized by a higher proportion of the application for the inventive patent,perfect patent information management institution and high-quality patent applications. Chinese pharmaceutical enterprises can enhance their competitiveness and creativity through adjusting patent behaviors and increasing their awareness of patent competition.
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OBJECTIVE: Drug safety regulation is throughout the entire life cycle of drugs. However, the government regulation for the drug post-marketing risk of enterprises have some shortcomings. The research of the impacting factors of government regulation can provide some background reference for the drug post-marketing risk regulation.
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OBJECTIVE:To provide reference for pharmaceutical enterprises responding to the challenge of new health reform.METHODS:The impact and challenge caused by new health reform,which pharmaceutical enterprises faced,were analyzed in order to put forward countermeasures positively.RESULTS & CONCLUSIONS:Pharmaceutical enterprises should adopt some measures such as regulating strategy,reducing cost,developing modern logistics and expanding rural market so as to seize the opportunity and develop enterprise rapidly and satisfactorily.
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OBJECTIVE: To offer reference for Chinese pharmaceutical enterprises in formulating a physicians' prescription behavior-based marketing strategy. METHODS: A survey and analysis was carried out by reviewing pertinent literature and interviewing experts. RESULTS: Physicians' prescription behavior was influenced by many factors. Most pharmaceutical enterprises had inertia thinking in formulating marketing strategies in that they put an emphasis on the quantity rather than the quality of information available to physicians, which has caused the unsatisfactory sales performance. CONCLUSIONS: The pharmaceutical enterprises could improve the efficiency of sales performance by analyzing physicians' prescription behavior, getting rid off inertia thinking and taking corresponding strategies.
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OBJECTIVE: To provide references for the establishment of academic promotion mode in domestic pharmaceutical enterprises. METHODS: The advantage and disadvantages of two chief academic promotion modes were analyzed,and the key points in the the plan for the the academic promotion were exounded. RESULTS & CONCLUSIONS: The self-construction of enterprises and academic promotion outsourcing have their own advantages and disadvantages. Suitable orientation of products and definite product promotion information,the definition of audiences for the promotion,alignment of promotion activity with market orientation,the adaptation of promotion activity to product cycle etc were the keys in making the academic promotion plan. Under the new situation,establishing academic promotion mode suitable for the development of the enterprises is indispensable for the promotion of marketing of prescription drugs.
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OBJECTIVE:To provide references for Chinese pharmaceutical enterprises in selecting reasonable directions for the R&D of new drugs.METHODS:The internal&external influential factors and the competitive status of pharma?ceutical enterprises were analyzed from the aspect of characteristics of the R&D of new drugs so as to choose a reasonable di?rection for the R&D of new drugs.RESULTS&CONCLUSION:Chinese pharmaceutical enterprises should take the internal&external influential factors in the R&D of new drugs into full consideration and give evaluation to their technical competitive status so as to make a breakthrough in the R&D of new drugs.
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OBJECTIVE:To provide praticable and feasible competition strategy for reference of Chinese pharmaceutical enterprises METHODS:On the basis of domestic pharmaceutical enterprises,the external circumstances and current situation of the pharmaceutical enterprises were analysed in detail RESULTS & CONCLUSION:Our pharmaceutical enterprises have both chance and challenge under the conditions of market economy Only through creativity integration of science and technology,management,organization,fields and marketing can Chinese pharmaceutical enterprises be in an invulnerable position in competition
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OBJECTIVE:To discuss the developing strategy of pharmaceutical enterprises run by private citizens in China.METHODS:Based on China’s realities,the confronting problems in pharmaceutical enterprises run by private citizens in China were analyzed.RESULTS&CONCLUSION:The privately running enterprises should take advantages of flexible or?ganization to strengthen innovation capacity,to achieve scale management with capital operation and to fasten the establishment of mordern product circulation.
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OBJECTIVE:To discuss about the developmental strategy of Chinese pharmaceutical enterprises after entering WTO METHODS:To put forward the developmental strategy of Chinese pharmaceutical enterprises,through analyzing the present conditions of Chinese pharmaceutical enterprises and the facing challenges after entering WTO RESULTS & CONCLUSION:Chinese pharmaceutical enterprises can adopt integral strategy,attack strategy,brand strategy,scientific research innovation strategy to improve their market competitive ability
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OBJECTIVE:To provide reference material for improving the competitive capacity of pharmaceutical enter?prises in China.METHODS:Using the general principle of internationized management theory,the present situation,superiority and inferiority of China's pharmaceutical enterprises in management were analysed,and the strategy of internationized man?agement was put forward.RESULTS&CONCLUSION:China's pharmaceutical enterprises are facing opportunity and chal?lenge,only through rational,large-scaled,concentrated and internationized management can their market competitive power be raised.
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OBJECTIVE:To provide a human resources management reference model of pharmaceutical enterprises in new situation in China METHODS:Consulting relevant literature and data of investigation,we analysed the changes and development of human resources management in pharmaceutical enterprises since the founding of our republic RESULTS & CONCLUSION:We put forward an idea of modern management model Only when human resources management model conforming to the reality in China is adopted can pharmaceutical enterprises subsist and develop
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OBJECTIVE:To study the strategy of technical innovation and the mode of R&D of pharmaceutical enterprises in China METHODS:Analysis was based on the domestic and foreign literature combined with the actual situation of pharmaceutical enterprises in China RESULTS & CONCLUSION:Pharmaceutical enterprises in China should be on the basis of their distinguishing feature to find out the points of breakthrough in technical innovation,and accordingly decide their strategies of technical innovation;In addition,they should adopt the appropriate mode of R&D in the light of specific conditions,which include their own features,the specialties of pharmaceutical industry and the environment of the market and technique
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OBJECTIVE:To discuss about the development strategy of pharmaceutical enterprises in our country in the new century.METHODS:To expound the developing strategy that domestic pharmaceutical enterprises should adopt in respect to technical innovation,development of product,exploitation of market,human capital and enterprise culture.RESULTS & CONCLUSION:Facing the new management environment,the pharmaceutical enterprises in our country should achieve new breakthrough in development strategy to adapt to trend of the times,grasp opportunity and face challenge.