亚洲社会药学

本期目录

2026年, 第21卷, 第1期　刊出日期：2026-03-25 上一期   

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Research on the Establishment of Selection Criteria for Essential Medicines in China Zhu Qian, Sun Lihua 2026 (1):  1-7.  摘要 ( 36 )   PDF(1668KB) ( 1866 )   Objective To establish selection criteria for essential medicines list, and to provide reference for the scientific and reasonable selection of essential medicines in China. Methods The selection criteria for essential medicines in WHO, India, Kenya and South Africa were compared and analyzed through literature research. Results and Conclusion It is found that the selection criteria for essential medicines in the above countries and organizations are consistent in such aspects as safety, efficacy, economic efficiency, and drug quality. However, there are different criteria in other aspects as well. The selection criteria for China’s essential medicines are preliminarily constructed by drawing on the joint criteria of WHO and the above-mentioned countries combined with our national conditions. Finally, fishbone diagram analysis method is used to refine and improve the selection criteria. 相关文章 | 计量指标

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Inspiration from the Development of Regulatory Science in the USA Xu Zhenyi, Tian Lijuan 2026 (1):  8-17.  摘要 ( 38 )   PDF(1645KB) ( 1904 )   Objective To study the development of regulatory science in the USA and draw some useful experience, so as to provide suggestions for the development of regulatory science in China. Methods The policy documents of the Food and Drug Administration of USA and the literature and data of relevant USA academic institutions were searched, the development history and latest progress of regulatory science in the USA were elaborated. Compared to the current status of regulatory science in China, some suggestions to promote its development were put forward. Results and Conclusion Currently, regulatory science has become increasingly important for food, drug and medical devices testing and regulatory control. The Food and Drug Administration of USA attaches great importance to the development of regulatory science, releasing several regulatory science strategic plans, funding the Centers of Excellence in Regulatory Science and Innovation, cooperating with universities and enterprises to promote the construction of regulatory science disciplines and targeted training of talents. The development of regulatory science in China started relatively late and it still has a certain gap with the USA. Therefore, the top-level design of regulatory science should be strengthened and the strategic goals of regulatory science should be clarified. In addition, more attention should be paid to cooperation with universities and research institutes, some relevant disciplines should be set up, and the high-quality regulatory science personnel should be cultivated. 相关文章 | 计量指标

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Problems and Countermeasures for Children’s Drug in China Fan Jianing, Sun Lihua 2026 (1):  18-28.  摘要 ( 31 )   PDF(874KB) ( 910 )   Objective To study the current status and main problems of children’s drug in China by taking children’s essential and non-essential drugs as the research objects, and to analyze the causes and put forward countermeasures so as to provide reference for the subsequent formulation of children’s drug policies. Methods Through literature research and statistical description, the relevant data of drugs marketed before December 2021 in China were investigated, and the types, dosage forms, specifications and clinical use of children’s drugs were clarified. Results and Conclusion The species, dosage forms and specifications of drugs for children only are lacking, and the disease areas covered are relatively concentrated. essential drugs are missing in the description of children’s medications, and off-label medication is normal. Then, four suggestions are put forward in a targeted manner. Firstly, we should continue to improve the corresponding policies and encourage manufacturers to actively carry out the research and development of new drugs for children with suitable dosage forms. Secondly, we should strengthen the approval of products whose yield can meet clinical needs. Thirdly, clinical trials can be simplified for children’s off-label use of drugs that have been in clinical use for many years and no serious adverse reactions have been found. Fourthly, a children’s medication database should be built to promote enterprises to strengthen real-world data research and improve children’s medication instructions. 相关文章 | 计量指标

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Study of Accelerated Review and Approval Policies for Drug Registration between China and the United States Based on Comparative Case Analysis of Osimertinib and Almonertinib Wang Shufang, Tian Lijuan, Yao Wei 2026 (1):  29-35.  摘要 ( 32 )   PDF(2369KB) ( 775 )   Objective To provide reference for improving the accelerated review and approval policies of drug registration in China. Methods A comparison was made to analyze the accelerated review and approval policies of drug registration between China and the United States. A case analysis of Osimertinib and Almonertinib was taken to study the application effect of the accelerated review and approval policies in China and the United States. Results and Conclusion The combination program of breakthrough therapy and accelerated approval took only two and a half years to make Osimertinib the fastest-marketed anti-tumor drug in the history of the FDA. Meanwhile, Osimertinib was the fastest-approved imported drug in China with the priority review and approval program. It took Almonertinib two years and ten months to obtain marketing approval using the programs of priority review and approval and conditional approval, suggesting that the acceleration effect was also remarkable. The accelerated review and approval policies in the United States and China can speed up the marketing approval of clinically urgent drugs with significant efficacy. 相关文章 | 计量指标

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Research on the Relationship between Corporate Social Responsibility and Innovation Performance in Pharmaceutical Enterprises - Moderating Effect of Economic Policy Uncertainty Tang Yaning, Zhu Jialin, Wang Su, Chen Yuwen 2026 (1):  36-48.  摘要 ( 22 )   PDF(1300KB) ( 741 )   Objective To provide empirical enlightenment for pharmaceutical enterprises to fulfill their corporate social responsibility and improve their innovation performance. Methods The Poisson panel regression model was used to investigate the impact of corporate social responsibility on innovation performance and the moderating effect of economic policy uncertainty by taking the data of China’s pharmaceutical industry from 2010 to 2020. Results and Conclusion There is an inverted U-shaped relationship between corporate social responsibility and innovation performance, and economic policy uncertainty a negative moderating role in this relationship. In addition, there is an inverted U-shaped relationship between corporate social responsibility and innovation performance of state- owned enterprises and non-state-owned enterprises, but the threshold of state-owned enterprises is larger. 相关文章 | 计量指标

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Research on the Adoption of Continuous Manufacturing Technique in China’s Pharmaceutical Enterprises Shi Hui, Huang Zhe 2026 (1):  49-59.  摘要 ( 30 )   PDF(907KB) ( 855 )   Objective To help China’s pharmaceutical enterprises better understand continuous manufacturing, and to promote the development of new technologies and innovation in the pharmaceutical industry. Methods The advantages and challenges of continuous manufacturing were summarized through literature research. Then, a comprehensive comparative analysis was conducted on the application of continuous manufacturing of approved and listed varieties by querying the evaluation documents of Europe, the USA, Japan, and China. Results and Conclusion The issues that Chinese pharmaceutical enterprises should pay attention to when applying continuous manufacturing technique were discussed from four aspects: feasibility analysis, variety selection, process research, and communication with regulatory authorities. Continuous manufacturing is an innovative technique that can change the production of the pharmaceutical industry. However, the uncertainty of new technique and the various changes brought about by continuous manufacturing models pose many challenges to its application. Implementing continuous manufacturing requires enterprises to have technological knowledge in quality management, research and development, and regulatory aspects. Enterprises should take advantage of the opportunity period before and after the emergence of new technique to seize the breakthrough of innovation so that continuous manufacturing can be better implemented in China. 相关文章 | 计量指标

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Study on Risk Management of API Starting Materials Based on FMEA Chen Xiaofeng, Chen Yuwen 2026 (1):  60-69.  摘要 ( 20 )   PDF(876KB) ( 313 )   Objective To reduce the risk of choosing API starting materials incorrectly since the rationality of its selection and the scientific justification of quality research have a significant impact on the quality control of API. Methods Failure mode and effects analysis (FMEA) strategy was used to do the risk management of API starting materials of D company. Results and Conclusion The FMEA method can improve the risk management of the research of API starting materials for D company, which is still effective to apply the method to C company and R company. 相关文章 | 计量指标

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Research on Optimization of Talent Training in Biomedical Enterprises Based on Goldstein Model Di Huiwei, Zhang Haixin, Wang Shuling 2026 (1):  70-75.  摘要 ( 30 )   PDF(1935KB) ( 794 )   Objective To analyze the training status of biomedical enterprises, and to provide practical guidance for optimization of personnel training, so as to enhance the overall competitiveness of enterprises. Methods An Goldstein model was established to analyze the training needs of biomedical enterprises from three aspects: Organization analysis, task analysis and personnel analysis. Then, the problems existing in the training process were found out. Results and Conclusion The common problems in China’s biomedical enterprises were the shortage of talents and the structural contradiction of talents. Therefore, a training system for talents should be set up and the course arrangement should be enriched. Meanwhile, a team of high-quality lecturers should be established. Training and evaluation measures should be optimized to enhance the knowledge and skills of employees in biomedical enterprises to strengthen their competition in the market. 相关文章 | 计量指标

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Study on the Characteristics and Influencing Factors of Multinational Cooperation Network of Digital Technology in the Pharmaceutical Industry from the Perspective of Patents Liang Xi, Liu Xinrui, Wu Tong, Yuan Hongmei 2026 (1):  76-91.  摘要 ( 31 )   PDF(7804KB) ( 19 )   Objective To study the characteristics and influencing factors of the transnational innovation cooperation network of digital technology in the pharmaceutical industry and to promote the construction of a new pattern of global digital pharmaceutical innovation cooperation. Methods An international cooperative innovation network was constructed based on the digital patents of the pharmaceutical industry jointly invented by 79 countries from 2009 to 2020. The overall structural characteristics, status evolution characteristics, spatial evolution characteristics, and influencing factors of the transnational cooperation network of digital technology in the pharmaceutical industry were analyzed using the social network analysis method and the time-exponential random graph model (TERGM). Results and Conclusion The main body of the digital technology transnational cooperation network in the pharmaceutical industry presents diverse forms and has the characteristics of a “small world”. Innovation entities have formed stable cooperative relations, but cooperation needs strengthening. The United States and Germany are strong cooperative countries, while some developing countries such as China, India, and Russia have been weak cooperative countries for a long time. The cooperation network is greatly affected by external environmental factors, showing a three-pronged pattern of Europe, Asia, and North America. The cooperation network tends to form triples and has strong polarization characteristics, which is driven by per capita, national income, population size, technological proximity, and geographical distance. 相关文章 | 计量指标

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Study on Setting up and Improving China’s Drug Testing Data Protection System Li Sirui, Yuan Xiaoliang, Dong Li 2026 (1):  92-97.  摘要 ( 24 )   PDF(850KB) ( 586 )   Objective To study the drug test data protection system in foreign countries, and to foster pharmaceutical innovation and increase drug accessibility in China. Methods The development history of drug test data protection was analyzed to examine and evaluate China’s current drug test data protection system so as to offer recommendations for its improvement. Finally, the drug test data protection system in China can be officially implemented. Results and Conclusion The drug test data protection system aims to promote innovation by protecting the trial data of innovative drugs. In a broad sense, this belongs to intellectual property protection, but it is different from patent protection. Although China has established a drug testing data protection system after joining the “Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)”, the relevant provisions and regulations have not yet been formally formed, and the system has not yet been implemented. Therefore, some suggestions for improving China’s drug testing data protection system are proposed to achieve good social benefits. 相关文章 | 计量指标

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Meta-analysis of Safety and Efficacy of Mechanical Thrombectomy for Ischemic Stroke Si Xu, Dong Li, Zhang Fang 2026 (1):  98-110.  摘要 ( 17 )   PDF(5848KB) ( 434 )   Objective To study the safety and effectiveness of mechanical thrombectomy and intra-arterial thrombolysis for ischemic stroke, and to provide reference for its clinical application. Methods By searching Chinese and English databases and collecting relevant clinical trial data, some articles were screened according to the inclusion and exclusion criteria, and relevant data were extracted. Then, a meta-analysis was performed. Results and Conclusion A total of 20 randomized controlled trial (RCT) studies were included, and the safety of mechanical thrombolysis was not significantly different from that of intra-arterial thrombolysis. In terms of effectiveness, the revascularization rate of mechanical thrombolysis was higher than that of intra-arterial thrombolysis, and there was no significant difference in mRS score and 14-day National Institute of Health Stroke Scale (NHISS) score. Mechanical thrombectomy, as an intravascular interventional therapy for ischemic stroke, has certain clinical advantages in improving vascular recirculation rate, but more clinical research evidence is still needed. 相关文章 | 计量指标