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Research on Incentive Policies for Chinese Innovative Drug R&D - Taking Innovative Anti-tumor Drugs as an Example Wang Yuejun, Yang Yue, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (4): 303-314.   Abstract （186）      PDF（pc） （2658KB）（1738）       Knowledge map    Save Objective To provide reference for improving Chinese innovative drug research and development incentive policies. Methods Based on investigating the incentive policies for innovative drug research and development in clinical research, evaluation and approval in China, anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis. Results and Conclusion Driven by a series of incentive policies for innovative drug R&D, great achievements have been made on anti-tumor drugs. However, there are problems such as concentration of drug targets, homogenization of clinical trials, and gaps in some drugs with large clinical needs. To improve incentive policies for innovative drug R&D, China should adhere to the orientation of clinical value, focusing on basic research and translational research, improving evaluation and approval capabilities, and establishing a sound ecosystem for innovative drugs. Related Articles | Metrics | Comments（0）

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Research on the Status Quo and Optimization of Centralized Procurement of Coronary Stents Zhang Yuting, Liu Xiaoxi Asian Journal of Social Pharmacy    2024, 19 (1): 20-28.   Abstract （173）      PDF（pc） （433KB）（1579）       Knowledge map    Save Objective To study the impact of the first national centralized procurement of coronary stents on patients’ psychology, the economy of medical institutions, and the survival and development of the coronary stents industry, and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents. Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital. Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients, but it has many problems. Therefore, this paper proposes some suggestions, such as promoting the orderly development of the coronary stent industry, improving the evaluation link of the centralized procurement of coronary stents, adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services. Related Articles | Metrics | Comments（0）

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Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU Lv Xiaowen, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (1): 17-23.   Abstract （494）      PDF（pc） （358KB）（1329）       Knowledge map    Save Objective To provide suggestions for further improvement of China’s drug post-approval change management system. Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA, EU and China were compared and analyzed. Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs. However, there are still some problems in China’s current post-approval change management systems. According to the model and requirements of the post-approval change management systems of the USA and EU, this paper proposes the following suggestions for the improvement of China’s post-approval change management system. Firstly, electronic files for licensed products should be created. Then, regulatory standards at the national level must be unified. Lastly, the concept of product life cycle management should be implemented. Related Articles | Metrics | Comments（0）

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Analysis of Drug Medical Insurance Access Pricing Based on the Perspective of Binary Equilibrium Zhang Junjun, Wang Shuling Asian Journal of Social Pharmacy    2024, 19 (2): 117-125.   Abstract （122）      PDF（pc） （882KB）（1220）       Knowledge map    Save Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective, and to provide reference for the harmonious management of drug pricing in China. Methods Through the literature analysis and policy review, the pricing subject, pricing basis and price control system in the pricing process of medical-accessed medicines were analyzed from the perspective of binary equilibrium and harmonious management. Results and Conclusion It is found that four balances in the drug pricing process, two balances in pricing basis and three balances in price control system need to be considered, respectively. Drug pricing is the key content of national medical insurance access, which is also the hotspot of the policy in the pharmaceutical fields in recent years. Drug pricing not only reflects the value of drugs, but also reflects a lot of top-level designs of binary equilibriums in medical insurance policy. While the rational design of drug pricing requires the joint efforts of the government, pharmaceutical companies and relevant experts to comprehensively consider many equilibriums, so as to improve the relevant systems. Related Articles | Metrics | Comments（0）

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Quantitative Analysis of the Policy of Centralized Drug Procurement Based on PMC Index Model Duan Xiaoxiang, Wang Shuling Asian Journal of Social Pharmacy    2025, 20 (3): 222-235.   Abstract （95）      PDF（pc） （6829KB）（1179）       Knowledge map    Save Objective To quantitatively analyze the policy of centralized drug procurement centralized drug procurement in order to provide reference for the subsequent policy formulation and improvement. Methods Text mining method was used to process 15 centralized drugs procurement policies issued at the national level during 2015-2022, and a PMC index evaluation model of centralized drug procurement policies was established. Then, 15 centralized drug procurement policies were quantitatively analyzed from the overall and comparative perspective through an evaluation model. Results and Conclusion The average PMC index of 15 centralized drug procurement policies was 6.95, which was acceptable on the whole. Among them, eight were excellent and seven were acceptable. As to the first-order variables, the centralized drugs procurement policy still lacks incentives and constraints. The comparative results show that there are differences in the content and structure of policies, but they are strongly related to each other. Chinese centralized drug procurement policy has been basically formed, which is closely related to medical insurance and medical policies. However, it is still necessary to pay attention to the structure of the policy to ensure the elaboration of the policy content. Related Articles | Metrics | Comments（0）

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Thoughts on the Innovative Design of the Integrated Service Mode of Pharmacies and Elderly Care Centers Yu Lina, Xing Miaomiao, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (1): 78-86.   Abstract （269）      PDF（pc） （380KB）（1153）       Knowledge map    Save Objective To evaluate the service model that integrates medical treatment and elderly care to provide a reference for the development of pharmacies and elderly care centers. Methods Through the literature investigation and case analysis, the domestic integrated medical treatment and elderly care service model was analyzed, and new ideas for the integration of pharmacies and elderly care centers were provided. Results and Conclusion The integrated service model of pharmacies and elderly care centers is designed and the integration mode of pharmacies, hospitals and elderly care centers is proposed by analyzing their advantages. The “pharmacy + elderly care” mode and the “pharmacy + medical treatment + elderly care” mode that integrates pharmacies, hospitals, and elderly care centers are put forward to predict its new development opportunities in the future. Related Articles | Metrics | Comments（0）

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Rapid Health Technology Evaluation of Off-label Use of Magnesium Isoglycyrrhizinate Injection Yao Lan, Li Lin, Tian Lijuan Asian Journal of Social Pharmacy    2025, 20 (1): 80-87.   Abstract （122）      PDF（pc） （429KB）（1015）       Knowledge map    Save Objective To evaluate the preventive drug use of magnesium isoglycyrrhizinate injection beyond the instructions by rapid health technology, and to provide reference for its rational clinical application. Methods The databases such as PubMed, Embase, the Cochrane Library, HowNet, Wanfang, VIP and HTA websites were searched. Two researchers screened the literature to extract data according to the inclusion and exclusion criteria. If necessary, a third researcher was consulted. The included literature was analyzed and concluded through corresponding quality evaluation. Results and Conclusion Four meta-analysis articles and five pharmacoeconomics articles were included. In terms of effectiveness, compared with the blank group and the control group (diammonium glycyrrhizinate, glutathione, and polyene phosphatidylcholine), the preventive use of magnesium isoglycyrrhizinate injection had a lower incidence of drug-induced liver injury with a more significant reduction in the levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total bilirubin. In terms of safety, except for an economic study in which some patients had a transient increase in blood pressure during the use of magnesium isoglycyrrhizinate injection, other studies did not show the increasing risk of adverse reactions due to preventive medication. In terms of economy, the use of magnesium isoglycyrrhizinate injection for prevention of different diseases did not necessarily have economic advantages over the control group (blank group and reduced glutathione, polyene phosphatidylcholine injection, traditional Chinese medicine combined with magnesium isoglycyrrhizinate injection). In the prevention of drug induced liver injury, magnesium isoglycyrrhizinate injection used beyond the instructions has certain efficacy and safety, but it may not be the economic optimal for other different diseases. Related Articles | Metrics | Comments（0）

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Inspiration of Foreign Innovative Drug Pricing Methods and Medical Insurance Payment Standards to China Rao Xiuli, Sun Lihua Asian Journal of Social Pharmacy    2023, 18 (4): 365-373.   Abstract （153）      PDF（pc） （352KB）（971）       Knowledge map    Save Objective To study the innovative drug pricing methods and medical insurance payment standards in foreign countries and to provide reference for China’s government. Methods The official websites were searched for information and related literature, and literature review was used. Results and Conclusion In foreign countries, the clinical value of innovative drugs and their impact on medical insurance funds were comprehensively evaluated based on factors such as quality-adjusted life years, clinical benefit, and improvement of clinical benefit. Then, the evaluation results were taken as an important basis for whether innovative drugs were admitted to the medical insurance catalog and establishing medical insurance payment standards. By using international experience for reference, innovative drug pricing methods and medical insurance payment standards for China’s national conditions can be improved by establishing a basic database of clinical value and drug economic evaluation of innovative drugs, as well as innovative drug payment models based on decision thresholds. Related Articles | Metrics | Comments（0）

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Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces Cui Yihang, Chen Binbin, Sun Lihua Asian Journal of Social Pharmacy    2023, 18 (2): 107-115.   Abstract （580）      PDF（pc） （899KB）（970）       Knowledge map    Save Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces. Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021, combined with the current provisions and implementation of drug spot check management in China. Results and Conclusion At present, there are some problems in the drug spot check of Chinese herbal pieces, such as fewer varieties of Chinese herbal pieces in the national drug spot check, the unreasonable sampling links, the insufficient territorial management in some areas, and error-prone sample extraction. It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan. Besides, the variety coverage of drug spot check of traditional Chinese medicine should be strengthened. In the planning, the sampling links shall be made as a whole, and the credit rating and distribution of drug production, operation and use units within the jurisdiction shall be fully combined. While strengthening the sampling management at the production end in areas with concentrated industries, regional special drug spot check should be carried out or the administrative forces at the provincial, municipal and county levels should be fully mobilized to avoid local protection. In the assigned tasks, the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods. Related Articles | Metrics | Comments（0）

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Implementation of the Guidelines for Oncolytic Viruses in China Meng Qinghe, Wang Shuling, Yang Mo Asian Journal of Social Pharmacy    2024, 19 (4): 344-350.   Abstract （111）      PDF（pc） （370KB）（802）       Knowledge map    Save Objective To study related guidelines such as “Guidelines for Clinical Trial Design of Oncolytic Viruses” “Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products” and “Technical Guidelines for Pharmacological Research and Evaluation of Oncolytic Viruses (OVs) Products” issued by the Center for Drug Evaluation (CDE) on OV and offer some suggestions for further improvement of the policies and regulations. Methods Literature comparison and questionnaire survey were used in this paper to investigate the difficulties encountered in the practical work of domestic companies that have conducted clinical trials, thus drawing some lessons to help the subsequent implementation of the guidelines. Results and Conclusion According to the characteristics of specific varieties and the published laws, regulations and guidelines, companies can adopt more suitable and scientific strategies to accelerate the development of anti-cancer drugs. In the future, as more clinical studies and product development for various cancers expand, regulatory requirements are expected to become more specialized and complex. Learning from the regulatory experience of developed countries and regions, we can improve the regulatory system by adapting it to national conditions and development status of China. Additionally, some ideas and useful inspirations can be provided after reviewing the content of the relevant guidelines and the obstacles in the practice of corporate R&D process can be addressed. These efforts will facilitate the speed of R&D and allow enterprises to work more smoothly and efficiently. Related Articles | Metrics | Comments（0）

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The Problems and Countermeasures of Four Community Pharmacies on Drug Quality Management in Kangping County Zhang Jie, Tian lijuan Asian Journal of Social Pharmacy    2023, 18 (1): 64-70.   Abstract （207）      PDF（pc） （394KB）（672）       Knowledge map    Save Objective To study the drug quality management of four community pharmacies and provide countermeasures and suggestions for improving the drug management level in Kangping County. Methods Literature research and investigation research were adopted in this paper to analyze the current situation and problems of drug management in four community pharmacies in a town of Kangping County. Results and Conclusion The problems of four community pharmacies in a town of Kangping County are low level of drug quality management, insufficient quality and capability of the practitioners and physician’s illegal act such as some licensed pharmacists paid from the linked pharmacies. There are also problems in facilities and equipment, drug display and storage, and document management, which reflects the lack of local drug supervision. Based on the above problems, some countermeasures and suggestions are put forward to strengthen the drug quality management of four community pharmacies in Kangping County. Related Articles | Metrics | Comments（0）

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Study on the Market Environment of Heparin and Development Suggestions in China Based on the PEST Model Han Chengcheng, Dong Li Asian Journal of Social Pharmacy    2025, 20 (1): 38-46.   Abstract （108）      PDF（pc） （393KB）（666）       Knowledge map    Save Objective To analyze the market environment of heparin, and to provide reference for the development of the heparin industry in China. Methods The international market size and competition pattern of heparin was investigated first. Then, environmental analysis of it was made based on the PEST model. Results and Conclusion There is room for optimization of the relevant policies for the development of heparin industry in China. The use of heparin drugs and regulation should be further improved. In addition, the research and development ability of pharmaceutical enterprises should be enhanced, and the development strategy of heparin industry needs to be adjusted. Related Articles | Metrics | Comments（0）

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Suggestions on the Good Development of Pharmaceutical Cold Chain Logistics in China Wang Mingzheng, Wang Shuling Asian Journal of Social Pharmacy    2024, 19 (3): 263-271.   Abstract （109）      PDF（pc） （837KB）（653）       Knowledge map    Save Objective To study the characteristics and problems of the development of cold chain logistics in pharmaceutical industry, and to provide a reference for the development of China’s drug logistics. Methods Literature analysis was used to investigate the development of drug cold chain logistics, relevant laws and regulations, and policies in China. Then, the problems of industry development were summarized and some suggestions were put forward by referring to the mature concept of international drug cold chain logistics system. Results and Conclusion China’s cold chain logistics in pharmaceutical field is growing, but it is still in the development stage. By increasing government support, scientific research investment and professional training, the comprehensive strength of drug cold chain logistics can be improved to a certain extent, and the safety of drugs can be guaranteed for the people. Related Articles | Metrics | Comments（0）

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Evaluation Criteria and Rationality Analysis of Drug Utilization of Meropenem in a Tertiary Medical Institution in Beijing Zhang Qiming, Huang Zhe Asian Journal of Social Pharmacy    2025, 20 (1): 1-9.   Abstract （218）      PDF（pc） （386KB）（644）       Knowledge map    Save Objective To establish a drug use evaluation (DUE) standard for meropenem in a tertiary medical institution in Beijing, and to analyze the use of meropenem for promoting the rational use of antibiotics. Methods A criteria of DUE of meropenem was established based on drug instructions, related guidelines and experts’ opinions. Then, 120 cases of meropenem use from January to December 2021 were selected to carry out a retrospective study. Results and Conclusion 120 cases of meropenem use involved 8 clinical departments, including 38 cases in the Department of Respiratory Medicine, 25 cases in the Department of Tuberculosis, and 20 cases in the Department of Gastroenterology. The detection rate of pathogenic microorganisms before first use was 79.17%, and the clinical treatment effectiveness rate was 81.67%. The irrational use of meropenem included poor grasp of usage indications, excessively high starting points, inappropriate usage and dosage, non-standard treatment courses, and excessive combination medication. Pharmacists should strengthen the monitoring and evaluation of carbapenem drugs such as meropenem, provide timely feedback on relevant situations, and promote rational clinical medication. Related Articles | Metrics | Comments（0）

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Research on the Optimization of the Registration Classification of Biological Products in China Li Zhiyi, Huang Zhe Asian Journal of Social Pharmacy    2025, 20 (2): 99-105.   Abstract （118）      PDF（pc） （842KB）（637）       Knowledge map    Save Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products, and to establish a continuously improved registration classification system. Methods Based on literature research, the specific classification methods, classification principles and considerations of biological registration in China, the United States and the European Union were studied to form a complete comparative analysis. Results and Conclusion It is recommended that the division between therapeutic and preventive use should be removed from the registration classification of biologics. The therapeutic, preventive and diagnostic use of the product should be limited as part of the product specification, and the registration should be classified according to the development of biotechnology, innovation, modification and bio-similar drugs. In addition, the supervision of registration of advanced therapeutic products should be different from that of traditional biologics. Related Articles | Metrics | Comments（0）

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Improving the Selection Model of Essential Medicines in China by Evidence-based Thinking Sun Huanzheng, Fan Jianing, Dong Li, Sun Lihua Asian Journal of Social Pharmacy    2024, 19 (2): 99-105.   Abstract （109）      PDF（pc） （789KB）（627）       Knowledge map    Save Objective To sort out the problems in the selection model of essential medicines in China, and to put forward some suggestions to optimize the selection model to ensure the rationality of the medicines in the essential medicines list. Methods The domestic and foreign literature on the selection of essential medicines was reviewed. Then, the opinions on the selection methods and results of essential medicines from foreign literature were investigated to make a comparison with the selection of essential medicines in China. Finally, the general and special laws of the selection process of the essential medicines were explored. Results and Conclusion It is recommended that the selection model of essential medicines in China should be further optimized, and the evidence-based thinking and methods should be utilized to enhance the scientific nature of the selection process. Related Articles | Metrics | Comments（0）

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Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme - PIC/S Hu Shigao, Wu Zhiang Asian Journal of Social Pharmacy    2023, 18 (3): 206-212.   Abstract （179）      PDF（pc） （673KB）（615）       Knowledge map    Save Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme (PIC/S) audit checklist, find out the key improvement items, and revise them pertinently, which will promote the process of China joining PIC/S. Methods The general situation of PIC/S organization and audit checklist were introduced first, and then the accession of several countries that joined the organization was analyzed. Meanwhile, the process of China’s participation in PIC/S was sorted out. After referring to the contents of PIC/S audit checklist, the problems of GMP inspection system in China were studied. Results and Conclusion There are still many problems in GMP inspection in China. Some suggestions are put forward for improvement and change, which can provide reference for the development of drug inspection agencies at all levels in China. Related Articles | Metrics | Comments（0）

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Investigation on the Current Situation of China’s DTP Pharmacy and Suggestions for Its Development Wen Dong, Dou Lele, Sun Yuyuan, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (2): 165-176.   Abstract （531）      PDF（pc） （1965KB）（591）       Knowledge map    Save Objective To summarize the main characteristics and development approaches of direct-to-patient (DTP) pharmacies, and to explore its future development trend. Methods Firstly, relevant policies of DTP pharmacies were sorted out based on some documents on the government website, and related articles were studied. Secondly, 499 DTP pharmacies were investigated. Finally, the current status of the industry was summarized and analyzed. Results and Conclusion Policies on China’s DTP pharmacy have been constantly improved. According to industry standards, the current compliance rate of DTP pharmacies is about 46.09%. In terms of varieties, the market share concentration rate of biological products is higher than that of chemical drugs. The regional distribution of these drugs is mainly concentrated in the central and eastern provinces. However, 63.45% of DTP pharmacies have less than 50 product specifications. DTP pharmacies have an average of 7.3 pharmacy technicians and 2.3 licensed pharmacists, which is higher than that of ordinary pharmacies. Due to the policy promotion, DTP pharmacies will be paid more attention by the public and the government, and the market share will become larger than before. Patients shifting from hospitals to drug-to-pharmacies can make them better layout. Besides, pharmaceutical services will become more specialized, and disease division will be more detailed. With the deepening of medical reform and the continuous improvement of national medical security as well as drug procurement and medical insurance payment methods, DTP pharmacies can play an important role in the national basic medical security system. Related Articles | Metrics | Comments（0）

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Foreign Experience and Enlightenment of Reimbursement Management of Multi-indication Drugs Wang Huiyan, Yu Hanshuang, Sun Lihua Asian Journal of Social Pharmacy    2023, 18 (4): 352-358.   Abstract （135）      PDF（pc） （391KB）（505）       Knowledge map    Save Objective To provide reference for China’s medical insurance reimbursement plan of multi-indication drugs. Methods By referring to relevant foreign literature, the implementation process and conditions of different reimbursement management modes of multi-indication drugs were analyzed to provide suggestions for reimbursement of multi-indication drugs in China. Results and Conclusion It is suggested to further explore the suitable conditions and select the corresponding mode in China. Payment standards should be set according to value pricing and budget impact analysis. Besides, data collection and analysis mechanism must be improved. Lastly, reward and punishment mechanism can be adopted to improve management efficiency. Related Articles | Metrics | Comments（0）

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Supervision of Public Opinion under the Background of Social Co-governance - Take the Changsheng Vaccine Incident as an Example Ma Xiaonan, Tian Lijuan Asian Journal of Social Pharmacy    2023, 18 (3): 198-205.   Abstract （205）      PDF（pc） （465KB）（496）       Knowledge map    Save Objective To provide reference for the news media to give play to the role of public opinion supervision in time based on the background of drug safety and social co-governance. Methods The method of case analysis was used to make a retrospective study on the Changsheng vaccine incident in 2018. Then the role of mainstream media, pharmaceutical media, and self-media in the supervision of public opinion was investigated. Results and Conclusion Both mainstream and pharmaceutical media played an excellent role in supervising the Changchun Changsheng vaccine incident. However, the content published by some pharmaceutical media was hard to understand by ordinary people. Besides, the role of self-media in public opinion supervision was polarized. Some self-media closely kept pace with mainstream media in public opinion supervision. Other self-media unilaterally pursued the click rate, publishing false information to guide wrong public opinion. The news media should optimize the supervision efficiency of drug safety. On the one hand, pharmaceutical media should pay attention to the fact that readers may not understand the difficult terms because they are not professional. On the other hand, self-media practitioners should improve their professional quality so that they will not publish some fake news to mislead public opinion. Related Articles | Metrics | Comments（0）

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Suggestions on Improving China’s Breakthrough Therapy Designation System Wang Zuguang, Chen Yuwen Asian Journal of Social Pharmacy    2024, 19 (3): 232-236.   Abstract （119）      PDF（pc） （941KB）（425）       Knowledge map    Save Objective To analyze the characteristics of breakthrough therapy designation (BTD) and its implementation in China, and to provide reference for the optimization of BTD system. Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States, Japan and the European Union. Then, the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China. Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved. At the same time, there are problems such as insufficient guidance and communication from the agency to applicants, a broad application condition, single review mode, and lack of full-time personnel. Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China. There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies. Therefore, based on our national conditions, we should strengthen the guidance of evaluation agency to applicants, optimize the eligibility criteria of BTD system, introduce the rolling review, and increase the number of professional liaisons, which can accelerate the development and marketing process of drugs with obvious clinical value, and finally to address unmet medical need. Related Articles | Metrics | Comments（0）

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Research and Enlightenment of Accelerated Approval Pathway in China Li He, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (1): 1-7.   Abstract （489）      PDF（pc） （323KB）（387）       Knowledge map    Save Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs. Methods A comparative analysis was made to study the accelerated review, conditional approval and breakthrough therapy between China and the United States. Combined with the implementation of accelerated pathway in China, some suggestions were put forward. Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development, which will improve the accessibility of innovative drugs. However, there are some problems in the review procedures and the implementation of supportive documents in China. In view of the above problems and combined with the experiences of US FDA, we should strengthen the construction of institutional system and reviewer team, and improve the efficiency of drug research and development. Related Articles | Metrics | Comments（0）

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Research on the Status Quo and Countermeasures of Human Resource Management Outsourcing in China’s Pharmaceutical Enterprises Wang Jianing, Wang Shuling Asian Journal of Social Pharmacy    2024, 19 (1): 64-71.   Abstract （195）      PDF（pc） （420KB）（375）       Knowledge map    Save Objective To explore the current situation of human resource management outsourcing in China’s pharmaceutical enterprises, and to put forward some suggestions for enterprises and the government. Methods The current situation of human resource management outsourcing in China’s pharmaceutical enterprises was analyzed through the method of literature research. Results and Conclusion At present, the status of human resource management outsourcing in China’s pharmaceutical companies is that the level of human resource outsourcing companies is not high, and there are no relevant industry norms and laws. The information asymmetry between pharmaceutical enterprises and outsourcing companies results in adverse selection and moral hazard. Besides, the different culture of pharmaceutical enterprises and outsourcing companies leads to inefficient communication between enterprises and employee. To solve these problems, the government should promote and improve industry norms and laws to regulate the market. In addition, enterprises should clarify the motivation for outsourcing and make good decision on the outsourcing content. Meanwhile, enterprises should strengthen communication with employees to eliminate employees’ concerns. Related Articles | Metrics | Comments（0）

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Strategic Planning for Drug Regulatory Science in the United States and Its Enlightenments to China Chang Yingnan, Gong Jingran, Chang Senhao, Chen Yuwen Asian Journal of Social Pharmacy    2023, 18 (2): 91-97.   Abstract （571）      PDF（pc） （805KB）（374）       Knowledge map    Save Objective To study the strategic planning of drug regulatory science, the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in China. Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States. Results and Conclusion Drawing on the US experience, China should set goals based on mission and vision and identify problems, knowledge gaps, and key areas, then concrete measures can be taken to advance regulatory science. Related Articles | Metrics | Comments（0）

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An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China Lin Hansen, Tian Lijuan Asian Journal of Social Pharmacy    2024, 19 (1): 50-57.   Abstract （156）      PDF（pc） （428KB）（369）       Knowledge map    Save Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China. Methods Literature research, case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines. Results and Conclusion From the perspective of the sponsor, investigators and the third-party technical service company, the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found. Then, the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed, including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel. Related Articles | Metrics | Comments（0）

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Analysis and Enlightenment of Big Data Platform for Adverse Drug Reaction Supervision in China and the United States Chang Senhao, Chang Yingnan, Gong Jingran, Chen Yuwen Asian Journal of Social Pharmacy    2023, 18 (3): 213-220.   Abstract （146）      PDF（pc） （1730KB）（359）       Knowledge map    Save Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the “14th five-year plan” to deepen the reform of medical and health system. Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process, operation mode, practical significance and characteristics of the big data platform for FDA regulatory science, which would help China to establish a perfect big database. Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States. It is necessary to build data platforms in line with China’s national conditions through efforts in law, talents, standards, and other aspects. Related Articles | Metrics | Comments（0）

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Study on Public Health Behavior against the Background of COVID-19 Pandemic - Based on Bandura Reciprocal Determinism Di Haopu, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (4): 359-364.   Abstract （198）      PDF（pc） （378KB）（343）       Knowledge map    Save Objective To explore the factors influencing public health behaviors in China in the context of COVID-19 pandemic, and to propose suggestions and countermeasures for enhancing public health behaviors. Methods A public health behavior system based on Bandura’s reciprocal determinism was constructed, and public health behavior was analyzed from the perspective of the interaction of health awareness, health behavior and environment. Results and Conclusion The public health behavior was analyzed through the public health behavior system based on Bandura’s reciprocal determinism, and the results and conclusions were draw. The public can be urged to develop better health beliefs and form better health behaviors by strengthening publicity and interventions, improving personal awareness, and increasing government investment. Related Articles | Metrics | Comments（0）

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Analysis on the Revenue Status of the “Fourth Terminal” Industry of Ali Health Sun Xiaohua, Gao Jingyi, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (1): 40-48.   Abstract （232）      PDF（pc） （383KB）（336）       Knowledge map    Save Objective To analyze the revenue status of the “fourth terminal” industry of Ali Health, and to explore the opportunities of the “internet and medical health” model and provide some suggestions for China’s medical e-commerce industry. Methods Through literature research and network collection methods, a large number of literature and network materials were studied in detail, and the revenue status of the “fourth terminal” of Ali Health in different fiscal years was compared and analyzed. Results and Conclusion According to the revenue of different fiscal years, the “fourth terminal” industry of Ali Health has developed rapidly, and the revenue gap between different business is large, so the “fourth terminal” industry should be improved. Related Articles | Metrics | Comments（0）

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The Development and Experience of American Pharmaceutical Industry Associations and Its Enlightenment to China Zhang Yuanyuan, Tian Lijuan Asian Journal of Social Pharmacy    2024, 19 (3): 237-243.   Abstract （110）      PDF（pc） （401KB）（331）       Knowledge map    Save Objective To study the development history and current situation of pharmaceutical industry associations in the United State and to provide reference for China’s pharmaceutical industry associations. Methods Literature research and comparative study were used to investigate the development history and current situation of pharmaceutical associations in the United States. Then, their characteristics and experiences were summarized. Some countermeasures and suggestions were put forward for the existing problems of pharmaceutical associations in China. Results and Conclusion The institutional environment of pharmaceutical associations in the United States is relatively good, reflecting the characteristics of emphasizing process management and neglecting entrance management with and the help of public supervision. At the same time, the government advocates market competition by adhering to the market-oriented services for the public. American pharmaceutical industry associations have strong innovation capacity and perfect credit system. Drawing on the experience of pharmaceutical industry associations in the United States, China should strengthen the construction of pharmaceutical industry associations. Firstly, the supervision mechanism should be improved. Secondly, these associations should have good partnerships with the government and offer the public the best services. Finally, the fund-raising mechanism of pharmaceutical industry associations should be optimized to ensure the innovative development of the pharmaceutical industry. Related Articles | Metrics | Comments（0）

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Comparative Analysis of Profit Model of Typical Pharmaceutical O2O Enterprises in China Qu Simeng, Wang Shuling Asian Journal of Social Pharmacy    2024, 19 (1): 81-88.   Abstract （232）      PDF（pc） （523KB）（326）       Knowledge map    Save Objective To study the profit model of Chinese pharmaceutical O2O enterprises. Methods A case study of three typical pharmaceutical O2O enterprises was conducted, and their profit models were compared. Results and Conclusion The pharmaceutical O2O enterprises in China are divided into three categories according to the profit models. It is found that the current pharmaceutical O2O enterprises have problems such as simple profit model and low corporate profits. Based on these problems, it is recommended that relevant enterprises develop various business models to increase profit channels. Besides, they should establish and improve internal cost control systems. Related Articles | Metrics | Comments（0）

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Analytic Hierarchy Process for Technological Risks in the Process of Innovative Drug Development in China Diao Yuanyuan, Wu Zhiang Asian Journal of Social Pharmacy    2024, 19 (1): 29-42.   Abstract （141）      PDF（pc） （614KB）（319）       Knowledge map    Save Objective To identify the critical risks in the process of innovative drug research and development, and to provide reference for improving the efficiency of innovative drug development and risk control in China. Methods Expert investigation and analytic hierarchy process were used to determine the weights of different risks. Results and Conclusion The research and analysis results showed that the risks at different stages of development had different effects on the success rate of drug development, among which the risk at the drug discovery stage influenced the most. In the drug discovery stage, inappropriate target selection had the greatest impact on the success rate of drug development. The lack of appropriate cell tissue or animal models had the greatest impact on the success rate of drug development from the discovery of a compound to the application for clinical trials. The difference in changes between nonclinical and clinical studies had the greatest impact on the success rate of drug development from early clinical studies to pivotal clinical studies. Incorrect dose selection had the greatest impact on the success rate of drug development from pivotal clinical studies to marketing authorization applications. The biggest impact from the marketing authorization application to the approval stage was inadequate communication with regulators. After investigating the weight of risk factors in the process of innovative drug development based on scientific methods, a new perspective for the risk control of new drug development and improving the research and development efficiency is provided. Related Articles | Metrics | Comments（0）

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Research on Reimbursement Management of Innovative Drugs Abroad and Its Enlightenment to China Yu Hanshuang, Huang Xianqin, Wang Huiyan, Sun Lihua Asian Journal of Social Pharmacy    2024, 19 (1): 1-8.   Abstract （191）      PDF（pc） （486KB）（314）       Knowledge map    Save Objective To analyze the reimbursement policies of innovative drugs in some developed countries, and to provide reference for future reimbursement management in China. Methods Literature research method was used to study the policies related to the reimbursement management of innovative drugs in Germany, France and Japan, and their successful experience was summarized. Results and Conclusion China should establish an open and transparent value evaluation standard to improve the medical insurance reimbursement management of innovative drugs. Besides, the value of innovative drugs should be taken as an important basis for reimbursement decisions, and an independent third-party value evaluation agency must be established. Related Articles | Metrics | Comments（0）

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Research on the Influence of Government R&D Funding and Enterprise R&D Investment on the Innovation Efficiency of Pharmaceutical Industry Zhang Xuefeng, Jia Zheng, Fu Shuyong, Zhang Dawei, Xing Hua Asian Journal of Social Pharmacy    2024, 19 (4): 361-370.   Abstract （92）      PDF（pc） （453KB）（312）       Knowledge map    Save Objective To study the effect of government R&D funding and enterprise R&D input on innovation efficiency of China’s pharmaceutical industry. Methods Based on the inter-provincial panel data of China’s pharmaceutical industry from 2009 to 2019, the stochastic frontier analysis method was used to study the influence of government R&D funding and enterprise R&D input on the innovation efficiency. Results and Conclusion With 1% increase in government R&D funding, the innovation efficiency of enterprises will increase by 0.122%. When R&D investment increases by 1%, innovation efficiency will increase by 0.169%. Both government R&D funding and enterprise R&D investment promote the innovation efficiency of pharmaceutical enterprises, but the increase of enterprise R&D investment contributes more to the improvement of pharmaceutical innovation efficiency. Related Articles | Metrics | Comments（0）

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Study on the Impact of Digital Economy on Innovation of Pharmaceutical Companies Li Jingran, Zhang Dawei, Jia Zheng, Xing Hua Asian Journal of Social Pharmacy    2025, 20 (1): 57-67.   Abstract （93）      PDF（pc） （627KB）（296）       Knowledge map    Save Objective To study the importance of digital economy to promote the innovation development of enterprises under the background of the era of information technology reform. Methods The maximum entropy method was used to measure the comprehensive level of digital economy development at provincial level. Besides, the impact of digital economy on the innovation performance of pharmaceutical industry was investigated empirically by using A-share pharmaceutical companies listed in China from 2013 to 2020 as a research sample, and the mediating mechanism of R&D investment and financing constraints on the impact was examined. Results and Conclusion It is found that digital economy is significantly and positively related to the innovation performance of enterprises. The mechanism test shows that digital economy improves innovation performance through the expansion effect of R&D investment and alleviating financing constraints. In the context that digital economy has become a new driving force for enterprise innovation, the combination of digital economy and real economy should be actively promoted, R&D investment in pharmaceutical enterprises should be increased, and financing channels should be broadened. Related Articles | Metrics | Comments（0）

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Research on the Countermeasures for the Development of Biopharmaceutical Industrial Parks in China Zhang Zongjie, Wu Zhiang Asian Journal of Social Pharmacy    2023, 18 (3): 232-238.   Abstract （197）      PDF（pc） （352KB）（293）       Knowledge map    Save Objective To systematically analyze the current development status of biopharmaceutical industrial park in China, sort out the problems and put forward some countermeasures and suggestions. Methods Relevant literature was searched and reviewed to find out the problems faced by the development of biopharmaceutical industrial parks in China. Results and Conclusion Biopharmaceutical industrial parks are developing rapidly due to their unique industrial clustering advantages, but there are problems such as lack of overall planning at the top level, insufficient government support, imperfect talent support services and weak innovation capacity of the parks. It is recommended to promote the rapid development of biopharmaceutical industrial parks and biopharmaceutical enterprises by strengthening top-level design, increasing government support, focusing on talent introduction, and enhancing the innovative strength of the parks. Related Articles | Metrics | Comments（0）

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Enlightenment and Suggestions on the Construction of Information Platform and Processing Mechanism of Drug Shortages in Developed Countries to China Cui Li, Xing Hua Asian Journal of Social Pharmacy    2023, 18 (2): 177-186.   Abstract （361）      PDF（pc） （817KB）（292）       Knowledge map    Save Objective To study how to improve and perfect the information platform and processing mechanism of drug shortages in China. Methods By searching the relevant policies from official websites of FDA, European Medicines Agency (EMA), Health Canada (HC) and National Health Commission, the good experience of the United States, the European Union and Canada in the construction of information platform and processing mechanism of drug shortages was summarized for reference in China. Results and Conclusion China has initially established the processing mechanism of drug shortages, but the platform construction should be improved, and the information disclosure of drug shortages varies from province to province. We should improve the information platform of drug shortages, strengthen the disclosure and communication of information, enrich the processing tools and measures after the drug shortages occurs, and strengthen the cooperation with relevant associations and other non-governmental departments. Related Articles | Metrics | Comments（0）

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Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas Li Qiao, Wang Aili, Wu Di, Chen Yuwen Asian Journal of Social Pharmacy    2023, 18 (1): 8-16.   Abstract （270）      PDF（pc） （398KB）（292）       Knowledge map    Save Objective To explore the rules and characteristics of the adverse drug reactions (ADRs) of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19, and to provide a reference for clinical safe medication. Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed, Web of Science, Springer Link, CNKI, Wanfang and VIP database were retrieved from December 2019 to May 2021. Then we extracted and analyzed the effective information included in the literature. Results and Conclusion According to the pre-developed retrieval plan, a total of 136 documents were obtained, and a total of 6 documents met the inclusion criteria finally. 553 patients used three Chinese patent medicines and three herbal formulas, and there were 133 cases of adverse reactions. The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine, and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine. Related Articles | Metrics | Comments（0）

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Research on Patent Situation of Medical Devices in China Wu Chenxia, Yuan Hongmei Asian Journal of Social Pharmacy    2023, 18 (1): 30-39.   Abstract （293）      PDF（pc） （899KB）（290）       Knowledge map    Save Objective To study the patent situation of medical device industry in China based on patent data. Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives: The overall situation and the technical level. Results and Conclusion At present, China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation, but only 16% of patents are authorized. In addition, the technology distribution of medical device industry is mainly related to diagnostic, surgical and identification medical devices and implantable devices, accounting for 59% of the main technology distribution, and their technical effects are mainly related to improving convenience, reducing complexity, and improving safety. The quality of patents related to medical device industry in China is low, the technology distribution is not rich enough, and the level of technical efficacy is low. Related Articles | Metrics | Comments（0）

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Research on the Construction of Evaluation Model for the Development of Biopharmaceutical Park in China Zhang Zongjie, Wu Zhiang Asian Journal of Social Pharmacy    2023, 18 (4): 387-397.   Abstract （115）      PDF（pc） （464KB）（288）       Knowledge map    Save Objective To study the influencing factors on the development of biopharmaceutical park, and to construct an evaluation model of the influencing factors for biopharmaceutical park in China. Methods By analyzing various factors affecting biopharmaceutical parks, an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established. Results and Conclusion Factors such as research and development (R&D) funding investment, incentive for transformation of scientific and technological achievements, and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China. Local governments should increase the investment in R&D funding. Besides, they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises. Meanwhile, they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China. Related Articles | Metrics | Comments（0）

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Current Situation and Prospect of the Application of Real-World Evidence in Health Care Xiao Feiyi, Zhang Fang, Li Xue, Dong Li Asian Journal of Social Pharmacy    2023, 18 (4): 374-386.   Abstract （174）      PDF（pc） （403KB）（274）       Knowledge map    Save Objective To summarize the application of real-world evidence (RWE) in the medical and healthcare field of various countries, including relevant policies, application scenarios and application methods. Methods Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’ healthcare institutions. Systematic literature retrieval was adopted to search PubMed, EMBASE, Cochrane Library, CNKI, CBM and Wanfang databases, and all papers related to real-world study and application were included. Then, these papers were classified and analyzed by country and application method. Results and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug, expanding drug indications, accelerating approval or supporting conditional marketing authorizations and drug safety evaluation, etc. The United Kingdom, the United States, Germany, the Netherlands, Italy, Sweden, and France admitted RWE, but they treated the data obtained from RWE with caution. After systematic literature retrieval, a total of 701 articles were obtained, including relevant studies from 36 countries, among which the United States published 264 in total. The most common study was about using real-world data (RWD) to calculate treatment-related costs, which had a total of 259 studies. Secondly, 158 articles were used for epidemiological analysis. Then, 138 articles were about establishing risk models to analyze disease risk factors. A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes, 54 articles were about pharmacoeconomic evaluation with RWD as parameters. A total of 29 articles used RWD to build predictive models, and 15 articles used RWD to evaluate the health-related quality of life in patients. The application of RWE has been used widely in the medical and healthcare field of various countries. The application scenarios are gradually diversified, the application methods of RWD become mature, and the evidence quality of RWE is also improved greatly. Related Articles | Metrics | Comments（0）