亚洲社会药学

本期目录

2026年, 第21卷, 第3期　刊出日期：2026-09-15 上一期   

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Research on problems and countermeasures of China’s Drug Conditional Marketing Authorization System Zhao Na, Sun Lihua 2026 (3):  257-264.  摘要 ( 30 )   PDF(860KB) ( 471 )   Objective To review relevant documents on China’s drug conditional marketing authorization system and its implementation, and to provide suggestions for improving the conditional marketing authorization system. Methods The regulations and guiding principles issued by relevant departments were summarized from the implementation of the conditional marketing authorization system in China. The annual drug evaluation report and conditionally approved drug information released by the Center for Drug Evaluation of the National Medical Products Administration from 2020 to 2023 were searched to analyze the problems in the implementation process. Results and Conclusion There were some problems in China’s drug conditional marketing authorization system, such as unclear requirements after listing, individual conditionally approved drugs exceeding the research time limit, and some drug instructions not conforming the specifications. Due to some shortcomings in the implementation process of China’s conditional marketing authorization system, it is recommended that the drug regulatory department improve the research time limit and post market requirements of the drug conditional marketing authorization system as soon as possible, and strengthen the post market supervision of drugs. 相关文章 | 计量指标

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Analysis on the Implementation of Real Time Release Testing (RTRT) Abroad Wang Yue, Tian Lijuan 2026 (3):  265-271.  摘要 ( 25 )   PDF(400KB) ( 51 )   Objective To study the history of international implementation of RTRT, and to extract the relevant experience for decision-makers in China. Methods Literature research and comparative research methods were used to analyze the opportunities and challenges faced by China’s implementation of real-time release testing combined with the history of real-time release testing in pharmaceutical enterprises abroad. Results and Conclusion Although there was technical support for China’s implementation of real-time release testing, the lack of corresponding regulatory documents and implementation guidelines made it hard to carry out. Real-time release testing can accelerate the production process of pharmaceutical products and save resources, but it is difficult to implement comprehensively in the field of pharmaceutical industry. Therefore, it is necessary to break down technical barriers. Accelerating the development of process analytical technology can also speed up the implementation of real-time release testing. 相关文章 | 计量指标

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Analysis of the Obligations and Responsibilities of Marketing Authorization Holders in China Cui Zhishuang, Dong Li 2026 (3):  272-280.  摘要 ( 18 )   PDF(382KB) ( 438 )   Objective To study the obligations and responsibilities that market authorization holders in China should bear, identify the problems that exist under the current system where MAH is the subject of obligation responsibility, and to put forward some solutions. Methods Literature review was used to analyze the regulatory documents related to the market authorization holder system issued by the government in the past five years to conclude the obligations and responsibilities that should be taken by MAHs. Besides, the obligations and responsible parties before and after the implementation of the MAH system were compared to identify the advantages of MAH as the first responsible person. Results and Conclusion It is critical for China to implement the MAH system in the field of drug regulation, but there are still many problems when MAHs assume obligations and responsibilities. Therefore, MAHs should improve their management capabilities, legal awareness and actively buying commercial insurance to respond to risks. 相关文章 | 计量指标

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Research on the Development of Genetically Engineered Vaccines Based on Patent Analysis Pan Longhui, Yuan Hongmei 2026 (3):  281-289.  摘要 ( 21 )   PDF(2876KB) ( 30 )   Objective To identify the core technical topics and innovative development paths in the field of genetically engineered vaccines, study the potential technological development opportunities, and to provide suggestions for enterprises and the government to plan strategically and gain advantage in a highly competitive market. Methods Based on patent information, patent analysis was carried out from three aspects: technological innovation trend, life cycle, and technical layout, and the development status of the field was summarized. Then, the topic model was used to mine the important technical topics. Finally, the subject-action-object (SAO) structural chain was extracted to construct and visualize the development path of technological innovation. Results and Conclusion Genetically engineered vaccines are in the growth stage with great development potential. The innovative development paths of three technical themes include four aspects: Immune response, immune adjuvant, humanized transformation, carrier and delivery. In this regard, the government should actively make overall planning and scientific guidance to improve the efficiency of technological innovation and promote the long-term development of the industry. 相关文章 | 计量指标

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Research on the Application Strategy of the “Technical Guidelines for Supporting the Development and Evaluation of Pediatric Drugs in Real-World Study (Trial)” Zhao Yue, Huang Zhe 2026 (3):  290-295.  摘要 ( 42 )   PDF(378KB) ( 12 )   Objective To explore the application status of the “Technical Guidelines for Supporting the Development and Evaluation of Pediatric Drugs in Real-World Study (Trial)”, and to propose application strategies and practical and feasible guidance for better supporting the development and evaluation of pediatric drugs in China. Methods Through literature collection and data analysis, the existing issues of real-world study on pediatric drugs in China were found. Results and Conclusion Currently, there are some problems in the application process of the “Guidelines”, such as few sources and low quality of real-world data. Besides, the technology and methods of applying real-world evidence should be improved. Therefore, we should strengthen the collection of clinical data on pediatric drugs, accelerate the establishment of quality control standards for real-world data, and improve the application technology of real-world evidence. In addition, it is also necessary to promote the construction of a real-world evidence evaluation system to accelerate the research and evaluation of pediatric drugs and solve the shortage of drugs for children in China. 相关文章 | 计量指标

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The Impact of Government Subsidies on the R&D Investment of Pharmaceutical Enterprises Sun Xiaowen, Zhao Xingyu, Song Yu, Wang Su, Chen Yuwen 2026 (3):  296-303.  摘要 ( 21 )   PDF(461KB) ( 38 )   Objective To analyze the impact of government subsidies on the R&D investment of pharmaceutical companies. Methods A two-way fixed-effect model was constructed by taking Chinese-listed pharmaceutical companies from 2012 to 2021 as research samples. Results and Conclusion Government subsidies have an incentive effect on enterprise R&D investment, and financial subsidies can effectively promote enterprise R&D investment. 相关文章 | 计量指标

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Issues and Suggestions on the Implementation of China’s Centralized Drug Procurement by Generic Pharmaceutical Companies Song Xiaoyu, Lian Guiyu 2026 (3):  304-314.  摘要 ( 27 )   PDF(441KB) ( 1841 )   Objective To analyze the participation level of pharmaceutical companies and explore the problems faced by generic pharmaceutical companies in implementing national centralized drug procurement policies based on the rules of the nine rounds of national centralized drug procurement, and to provide some suggestions for the development of generic pharmaceutical companies in China. Methods Literature analysis was performed to systematically review relevant papers on national centralized drug procurement. Results and Conclusion National centralized drug procurement has been normalized, with domestic generic drug companies being the main selected enterprises for each round. The selected generic drug companies face issues such as substandard quality, insufficient supply capacity, and inadequate promotion efforts in implementing national centralized drug procurement policies. Some suggestions are made to ensure drug quality and strengthen management, coordinate supply guarantees, expand promotional activities, and conduct research accordingly.  相关文章 | 计量指标

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The Influence of Pharmaceutical Information Frameworks on Consumers’ Behavior in the Internet Model Xu Anqi, Liu Xiaoxi, Huang Zhe 2026 (3):  315-325.  摘要 ( 22 )   PDF(2732KB) ( 13 )   Objective To study whether pharmaceutical operators can increase consumers’ purchase intentions through appropriate information release mode so as to promote the development of online pharmacies. Methods Based on the “S-O-R” theory and “self-construal” theory, the impact mechanism of internet information frameworks on consumer behavioral intentions was investigated. To validate the feasibility of the ground theory, a quantitative research method was also employed. Results and Conclusion The findings of the study indicate that consumers are more inclined to buy pharmaceuticals online based on the perception of risk. Trust tendency plays an intermediary role between the information framework and purchase intention. Self-construal plays a moderating role between the information framework and purchase intention, and the influence of dependent self-construal is more significant.  相关文章 | 计量指标

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Study on Quality Risk Management of Online Prescription Drugs Based on ICH Q9 Guidelines Sun Jingyi, Lian Guiyu 2026 (3):  326-332.  摘要 ( 25 )   PDF(493KB) ( 14 )   Objective To explore the quality risk management of online prescription drugs based on the ICH Q9 guidelines, and to improve the safety and quality of medicines for protecting the rights of consumers. Methods Literature review was used to analyze the risk factors of online prescription drug sales, and the corresponding risk control countermeasures were provided. Results and Conclusion In the distribution phase of prescription drugs sold online, we should focus on high-risk indicators such as drug purchase on sales platforms and issuing e-prescriptions. It is necessary to formulate scientific and effective risk response strategies in advance. Besides, risk events should be monitored, recorded and handled in a timely manner. Through this study, we can effectively identify, assess and control the main risks in online prescription drug sales.  相关文章 | 计量指标

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Investigation and Analysis of the Current Situation of Outpatient Pharmacy in Shenyang Wang Jianing, Wang Shuling 2026 (3):  333-344.  摘要 ( 22 )   PDF(470KB) ( 1192 )   Objective To understand the status quo and service quality of outpatient pharmacy in Shenyang, identify existing problems, and put forward suggestions for its development. Methods Combined with online survey and offline observation, including mysterious customer experience method, 191 secondary and tertiary hospitals in Shenyang were investigated. The survey period was from December 2023 to January 2024, and stratified sampling method was used to study the outpatient pharmacy facilities and services in 21 hospitals. At the same time, the comprehensive outpatient pharmacy department of Shengjing Hospital was selected for in-depth comparison. Results and Conclusion The online survey showed that there were 10 hospitals in Shenyang carrying out outpatient pharmacy service, including 8 tertiary hospitals and 2 secondary hospitals. Outpatient pharmacy included comprehensive pharmacy, multidisciplinary team (MDT) clinic and Internet + pharmacy. The offline survey showed that pharmacists had a positive attitude, but they usually did not take the initiative to provide drug education. The mysterious customer experience showed that the comprehensive outpatient pharmacy of Shengjing Hospital had the same service nature as other hospitals, which failed to meet the hardware requirements of the Implementation Standard of Outpatient Pharmacy. The problems of inconsistent service standards and unsound management system are common in outpatient pharmacy in Shenyang, so unified service standards and charging standards should be formulated.  相关文章 | 计量指标

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Progress in Research on the Mechanism of Hepatotoxicity Induced by Epimedium Wang Jian 2026 (3):  345-353.  摘要 ( 22 )   PDF(2195KB) ( 108 )   Objective To study the complex composition of epimedium and its mechanisms of inducing liver injury, and to provide clinical recommendations for reference. Methods Relevant literature from the past decade was reviewed to summarize the chemical components and mechanisms by which epimedium caused liver injury. Results and Conclusion Eight potentially hepatotoxic substances in epimedium were identified, including icariin, epimedin B, 2-Rhamnosyl Icariside II, icariside I, icariside II (baohuoside I), baohuoside II, sagittatoside A, and sagittatoside B. The mechanisms underlying epimedium-induced hepatotoxicity were primarily attributed to oxidative stress, specific enhancement of NLRP3 inflammasome activity, cholestasis, drug interactions that affected target sites and the immune microenvironment, and idiosyncratic hepatotoxicity.  相关文章 | 计量指标