亚洲社会药学

本期目录

2026年, 第21卷, 第2期　刊出日期：2026-06-20 上一期   

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Comparative Study on Regulatory Models for Drug Safety in the United States, Japan, and European Union Hao Guiying, Huang Zhe 2026 (2):  115-123.  摘要 ( 45 )   PDF(852KB) ( 29 )   Objective To provide reference for optimizing China’s drug regulatory model and ensuring public medication safety. Methods Literature review was used to investigate drug regulatory models in the United States, Japan, and the European Union. Then, a comparative analysis was made. Results and Conclusion The comprehensive legal frameworks, centralized regulatory authorities, specialized regulatory personnel, and multi-stakeholder regulatory structures in these countries and regions offer valuable insights for improving and advancing China’s drug supervision. 相关文章 | 计量指标

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Study on the Selection Criteria of Essential Medicines of the World Health Organization Lao Limei, Sun Lihua 2026 (2):  124-133.  摘要 ( 30 )   PDF(895KB) ( 34 )   Objective To study the selection criteria of essential medicines of World Health Organization (WHO) and to provide reference for further improving the scientific level of the selection of essential medicines in China. Methods The concept and selection criteria of essential medicines of the WHO from 1977 to 2023 were comprehensively analyzed through literature research. Results and Conclusion Five versions of the concept of essential medicines (1977, 1982, 1999, 2001 and 2002) and five versions of selection criteria (1977, 1982, 1993, 1999 and 2002) were released by WHO. Through these iterations, the content has undergone consolidation and updating. After 2007, four functional working groups were established by WHO, which reviewed and formulated selection criteria for pediatric medicines, antibiotic and cancer medicines respectively. China should have the selection criteria of essential medicines according to the national conditions and referring to the experience of WHO. 相关文章 | 计量指标

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Thinking on the Implementation Environment of Value-Based Payment Policy for TCM Ding Liman, Guo Feng, Tong Xiaolian, Zhang Jielin, Liu Xiaoping 2026 (2):  134-141.  摘要 ( 16 )   PDF(879KB) ( 18 )   Objective To analyze the operation of value-based payment for traditional Chinese medicine (TCM) in the pilot hospital, and to identify possible constraints in its implementation environment. Methods Single-case analysis and quantitative data description were used to study the multi-dimensions of hospital grade promotion, national examination indicators, and talents support. Results and Conclusion The requirements of performance assessments of national public hospital, high-quality development evaluations and grade promotion for hospitals made them continuously increase the number of surgeons and the percentage of high-level surgeries, which was contradictory to the conservative therapies of traditional Chinese medicine. Besides, the incentive mechanism of “the same disease, same efficiency, and same price” had defects. Lastly, conservative treatment of traditional Chinese medicine demanded TCM specialists, and the existing training methods could not meet the clinical needs. Value-based payment system for TCM provides an excellent opportunity for TCM hospitals in the DRG payment reform. However, the policy environment needs to be further improved, and the talent training model also should be adjusted accordingly. 相关文章 | 计量指标

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Analysis on the Registration of Biological Products with Priority Review and Approval Procedure in China Zhou Peng, Ren Sining, Huang Zhe 2026 (2):  142-155.  摘要 ( 30 )   PDF(2182KB) ( 25 )   Objective To summarize the registration of biological products (BPs) included in the priority review and approval procedure (PRAP) from 2016 to 2023 in China, analyze the characteristics of the registration classifications, and to find out the opportunities and challenges brought by the priority review and approval (PRA) system to biopharmaceutical enterprises. Methods Registration applications for the BPs in PRAP published in the “List of Products Included in Priority Review (LPIPR)” of the Center for Drug Evaluation (CDE) of National Medical Products Administration website by June 1st, 2023 (by acceptance number) were collected as raw data. Then, statistical analysis was conducted to investigate the basic information, dosage form, product information, therapeutic areas, regulatory basis of inclusion, and review conclusion of the BPs in PRAP. Results and Conclusion As of June 1st, 2023, a total of 287 BP registration applications (BPRAs) had been included in PRAP, including 238 marketing authorization applications (MAAs), and the number of domestic BPs was basically the same as that of imported BPs. Among the BPs in PRAP, injections were in absolute dominance. The number of recombinant monoclonal antibody drugs ranked first. Tumors, hematologic systemic disorders, and endocrine and metabolic system diseases were of the top three therapeutic areas. Innovation, therapeutic advantages, clinical needs, and pediatric and rare diseases were the most common reasons for inclusion. All clinical trial applications (CTAs) and supplementary applications (SAs) in PRAP were approved. Among the 238 MAAs, 216 applications were reviewed, of which 11 applications failed, with a passing rate of 94.9%. The PRA system has injected new impetus into China’s biopharmaceutical industry, brought development opportunities, and posed new challenges. Biomedical enterprises should seize opportunities, face challenges, and make greater progress through continuous innovation. 相关文章 | 计量指标

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Market Competition, Executive Incentives and R&D Investment - Empirical Evidence Based on Chinese Listed Pharmaceutical Companies Han Aiji, Chen Siyu, Wang Su, Chen Yuwen 2026 (2):  156-173.  摘要 ( 19 )   PDF(1019KB) ( 23 )   Objective To empirically test the effect of market competition on R&D investment, and to separately examine the moderating effect of executive compensation incentives and equity incentives on their relationship. Methods The data of some Chinese-listed pharmaceutical companies from 2013-2021 were used to make the investigation. Results and Conclusion Market competition had a facilitating effect on R&D investment in Chinese pharmaceutical companies, and the level of executive compensation incentives and equity incentives positively moderated their relationship. Further heterogeneity tests revealed that a fiercely competitive market environment promoted R&D investment more in non-state enterprises and larger enterprises. The findings of the study are important for pharmaceutical companies to improve their independent research and development as well as to implement the right model of executive incentives in the face of external market competition. 相关文章 | 计量指标

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Research on the Impact of General Purpose Technologies and Key Enabling Technologies on Innovation in Biomedical Enterprises Zhang Yimeng, Liu Xinrui, Tian Huijing, Yuan Hongmei 2026 (2):  174-189.  摘要 ( 18 )   PDF(1765KB) ( 29 )   Objective To analyze the influencing factors of innovation in biomedical enterprises from the perspective of technological resources and to provide reference for the layout of technological resources and the strategic innovation development of biomedical enterprises. Methods 243 biomedical enterprises were analyzed using econometric models for the influencing factors of innovation performance. Results and Conclusion The use of both general-purpose technologies (GPTs) and key enabling technologies (KETs) in biomedical enterprises significantly improves enterprise innovation performance. Besides, the level of technological diversification of an enterprise partially mediates the relationship between GPTs and innovation performance, and the level of technological specialization of an enterprise partially mediates the relationship between KETs and innovation performance. Lastly, firm’s absorptive capacity positively moderates the relationship between GPTs and firms’ technological diversification and the relationship between KETs and technological specialization. 相关文章 | 计量指标

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Analysis and Suggestions on the Implementation of the Early Settlement Mechanism of Drug Patent Disputes in China Jia Siyao, Yuan Xiaoliang, Dong Li 2026 (2):  190-204.  摘要 ( 15 )   PDF(5767KB) ( 199 )   Objective To analyze the present situation and problems of the early settlement mechanism of drug patent disputes in China, and to provide reference for further promoting and perfecting the system. Methods Firstly, comparative method was used to analyze the drug patent linking system between China and the United States, and then a questionnaire was designed by literature research and expert interviews. The survey results were statistically analyzed to find out the problems in the implementation of the early settlement mechanism of drug patent disputes in China. Finally, some solutions were put forward. Results and Conclusion There are some problems in the implementation of the early settlement mechanism of drug patent disputes in China, which need to be solved as soon as possible. In view of these problems, countermeasures and suggestions are put forward to provide reference for further optimization of the system. 相关文章 | 计量指标

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Research on Quality Risk Management of Non-Clinical Tests of Traditional Chinese Medicines and Natural Medicines Zhou Yue, Tian Lijuan 2026 (2):  205-213.  摘要 ( 28 )   PDF(1264KB) ( 24 )   Objective To better understand the quality risks in non-clinical tests of traditional Chinese medicines (TCMs) and natural medicines (NMs), and to provide suggestions and reference for improving the quality of TCMs and NMs in both non-clinical tests and successful marketing. Methods According to the “Good Laboratory Practice (GLP)” “Provisions of Drug Registration” “Requirements for the Classification and Application of Traditional Chinese Medicine Registration” “Technical Requirements for the Research of New Natural Drugs” and the “Quality Management Standards to Produce Chinese Medicinal Materials”, etc., the quality risks of TCMs and NMs in non-clinical tests were analyzed. Results and Conclusion In the non-clinical trial stage of traditional Chinese medicines and NMs, the quality risks for pharmaceutical companies came from the sources of herbs and simple quality identification method of active ingredients. Clinical research organization (CRO) had many experimental personnel that caused the uneven experimental level. Besides, due to the poor standardization of pharmacodynamic experiments in research institutes of universities, the original records were imperfect, and the experience in exploring drug safety experiments was insufficient. Therefore, quality risks in non-clinical tests of TCMs and NMs should be controlled. Pharmaceutical companies should be the main body of research and development of TCMs and NMs. However, research institutes of universities and CRO companies can provide corresponding technical support to jointly promote the development of non-clinical tests of TCMs and NMs. 相关文章 | 计量指标

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Study on the Impact of Financial Flexibility on Financial Performance in Listed Pharmaceutical Enterprises Wang Xiaojing, Lian Guiyu 2026 (2):  214-227.  摘要 ( 27 )   PDF(964KB) ( 23 )   Objective To explore the intrinsic relationship among financial flexibility, research and development (R&D) investment, and financial performance in pharmaceutical enterprises, and to provide reference for enterprises to formulate better financial flexibility management policies. Methods Some listed pharmaceutical enterprises in China were used as samples, and relevant panel data of these enterprises were collected. A multiple regression model was established to examine the impact of financial flexibility on financial performance in these sample enterprises. Results and Conclusion Financial flexibility had a significant positive impact on financial performance of enterprises, and this impact was sustainable. There was heterogeneity in the extent of influence on enterprises with different performance levels. R&D investment played a mediating role with a lag. Through empirical analysis, this study provides theoretical evidence support for enterprises to carry out financial flexibility reserves and scientific management.  相关文章 | 计量指标

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Exploration and Practice of Employment Competence of Management Graduate Students from the Perspective of Iceberg Model of Competencies Yin Yilin, Zhang Haixin, Wang Shuling 2026 (2):  228-241.  摘要 ( 37 )   PDF(2366KB) ( 32 )   Objective To study the current situation of employment competence of management graduate students, and to put forward some suggestions to optimize the training method. Methods Based on the iceberg model of competencies, Python crawler technology was used to collect information on enterprises’ employment demands for graduate students from the campus recruitment data of Zhilian Campus. Questionnaires were designed to collect extensive data, and SPSS and AMOS were used for analysis. After screening and multiple rounds of expert evaluation, a competence model for management graduate students was constructed. Results and Conclusion The study found that the current competence level of management graduate students was generally consistent with the demand of enterprises, but there was still a certain gap. To better meet the needs of enterprises, educators need to strengthen the comprehensive capabilities of management postgraduate students across disciplinary knowledge, research competence, talent demonstration and adaptability, management skills, and personality traits. At the same time, targeted training and educational guidance should be carried out to comprehensively improve the overall quality of graduate students. 相关文章 | 计量指标

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Social Security System for Patients with Mucopolysaccharide Type II in the USA and UK Zhang Yu, Li Kexin, Zhang Fang, Dong Li 2026 (2):  242-251.  摘要 ( 42 )   PDF(886KB) ( 19 )   Objective To review social security system for patients with mucopolysaccharidosis type II (MPS II) in UK and USA, including policy and social assistance, and to provide reference for abthe relevant policy makers in China. Methods Literature review was used to search the domestic and foreign MPS II related policies. Then, the results were analyzed Results and Conclusion In the United States and the United Kingdom, MPS II was regarded as a rare disease and a relatively complete protection policy had been formulated, and organizations for MPS related disease had been established. In recent years, the construction of social security system for patients with MPS II in China has developed rapidly. The foreign security system for patients with MPS II is relatively perfect, which can provide reference for the construction of China’s welfare security system. It is necessary to form a social security system for patients with MPS II in combination with China’s national conditions, so as to improve the patients’ quality of life. 相关文章 | 计量指标