20 February 2026, Volume 40 Issue 2
    

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    Supervision & Administration
  • Yuan Junli, Feng Zhipei, Yang Hupo, Wang Ying
    Chinese Pharmaceutical Affairs. 2026, 40(2): 127-134. https://doi.org/10.16153/j.1002-7777.2025-08-0001
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    Objective: To analyze the current development status of traditional Chinese medicine (TCM) value chain, clarify the internal logic and implementation pathways through which AI enhances TCM value chain, and provide theoretical guidance for the formulation of relevant policies for TCM industry. Methods: Based on an analysis of the connotation and characteristics of TCM industry value chain, the current development status of TCM industry value chain was analyzed using quantitative research methods, and the value chain theory was applied to theoretically examine the underlying internal logic and pathways through which artificial intelligence drives the upgrading of TCM value chain. Results and Conclusion: By sorting out the value chain in China’s TCM industry, it was found that China has a relatively complete TCM value chain, and its ability to capture added value in global value chain division of labour has been significantly improved. The width of the industrial value chain has been continuously expanding, but the high-value-added segments remain underdeveloped. The integration of AI with TCM industry can drive the upgrading of TCM industry value chain by promoting TCM enterprises to extend into high-value-added service and R&D segments, fostering TCM innovation and product upgrading, and improving the quality and production efficiency of TCM. Based on this, in the future, efforts should focus on advancing the digital and intelligent transformation of TCM industry, strengthening scientific and technological innovation in TCM, and enhancing both the quality of data elements and the cultivation of multidisciplinary talent. These measures will drive the application of artificial intelligence to upgrade the value chain of TCM industry.
  • Yu Miao, Wen Qinghui, Li Meng
    Chinese Pharmaceutical Affairs. 2026, 40(2): 135-140. https://doi.org/10.16153/j.1002-7777.2025-09-0051
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    Objective: To provide theoretical support for the construction of intelligent drug regulation in various regions of China and to facilitate the high-quality development of drug regulatory capacity. Methods: The practical achievements of information technology enabling intelligent regulation across China’s regions in recent years was summarized, the general patterns of informatization construction in drug regulation was extracted, and the challenges and problems currently faced by intelligent regulation was analyzed. Results: The development of intelligent regulation of drug was not achieved overnight. The informatization construction of drug regulation could be divided into three stages: system construction stage, system integration stage, and data application stage. New technologies had been widely applied in business scenarios such as review and approval, regulatory inspection, investigation and law enforcement, testing and inspection, and were transitioning from informatization to intelligence. However, challenges remained, including those posed by new technologies, data barriers and silos, data security issues, and a shortage of interdisciplinary professionals. Conclusion: Intelligent regulation of drugs should further strengthen top-level design, promote coordinated regional development; enhance data management capabilities, and strengthen big data analysis; deepen the application of artificial intelligence in drug regulation; foster multi-stakeholder collaboration to form synergies; and cultivate innovative talents for intelligent drug regulation in the new era, thereby promoting its high-quality development.
  • Li Xiaojuan, Tian Lijuan
    Chinese Pharmaceutical Affairs. 2026, 40(2): 141-147. https://doi.org/10.16153/j.1002-7777.2025-07-0005
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    Objective: To provide reference for improving the quality regulation system, policies, and procedures of drug clinical trials in China, ensuring the integrity, accuracy, and reliability of clinical trials data, and promoting coordinated development of quality regulation between domestic and international drug clinical trials. Methods: By sorting out the regulatory systems, supervision models, quality control and data management models of drug clinical trials in the United States, the European Union and China, the current problems in China were analyzed, and improvement strategies were proposed. Results and Conclusion: Although China has made certain achievements in the quality management of drug clinical trials, several challenges persist, including lagging informatization construction of clinical trials, difficulties in coordinating multi-center trials, and so on. To address these issues, it is suggested to adopt risk regulatory strategies based on the entire lifecycle and risk management and leverage extensive application of information technologies, drawing inspiration from the models established by the United States and the European Union, strengthen international cooperation, and promote global data mutual recognition, so as to enhance the international competitiveness of drug clinical trials in China. These measures will ensure the accuracy and reliability of trial data, thereby protect the rights and interests of participants, and ultimately increase public trust in drug clinical trials in China.
  • Li Mingyang, Pang Bo
    Chinese Pharmaceutical Affairs. 2026, 40(2): 148-153. https://doi.org/10.16153/j.1002-7777.2025-07-0011
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    Objective: To provide references for researchers and regulatory authorities in establishing a linkage mechanism between the research and review (R&D) of medical devices. Methods: The development of the linkage between the R&D of medical devices was reviewed, and the communication and exchange mechanisms promoting the R&D and development innovation of medical devices in China and the United States were summarized. The characteristics of such linkage in terms of characteristics, objects and intervention stages, service forms and collaboration methods were analyzed, and the implementation paths of the linkage between research and review of medical devices was explored. Results and Conclusion: The linkage between the R&D of medical devices serves as a crucial strategy to fulfill the requirements of the comprehensive deepening of the regulatory reform concerning drugs and medical devices. Moreover, it aligns with the needs of innovation and development of the current medical device industry. However, there are also problems such as limited review resources and unclear scope of the linkage between research and review. In the future, the implementation path of the linkage between R&D of medical devices needs to be refined in aspects such as strengthening the main responsibilities of enterprises, clarifying the scope of the linkage between R&D of medical devices, establishing multi-level communication channels, improving the capabilities of reviewers and enhancing the awareness of proactive action among regulatory authorities.
  • Xiao Yu, Peng Rui
    Chinese Pharmaceutical Affairs. 2026, 40(2): 154-159. https://doi.org/10.16153/j.1002-7777.2025-06-0010
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    Objective: To analyze the current situation and existing problems of drug supervision and sampling inspection in Shaanxi local municipalities, in order to provide reference for supervision and sampling inspection. Methods: Summarize the current situation and existing problems of drug supervision and sampling inspection, analyze the causes, and provide reasonable suggestions. Results: There were some problems in sampling inspection, such as insufficient standardization of sampling, insufficient sharing of information resources, insufficient coordination of sampling supervision, insufficient balance of coverage, and strengthening of result processing and risk prevention and control. Conclusion: It is suggested to start from strengthening personnel training, improving the information sharing mechanism, innovating the sampling mode, and strengthening exploratory research, to build a four-in-one system of “sampling-research-regulation-service”, ultimately promoting the development of sampling inspection, promoting the high-quality development of the pharmaceutical industry and public drug safety.
  • Wu Lianbin
    Chinese Pharmaceutical Affairs. 2026, 40(2): 160-166. https://doi.org/10.16153/j.1002-7777.2025-06-0037
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    Objective: Based on the analysis of causes for administrative penalties, this study aims to identify systemic vulnerabilities within medical institutions in drug management, to strengthen pharmaceutical quality and safety management capacity, and to ultimately establish novel regulatory mechanisms. Methods: A retrospective analysis was conducted on 202 pharmaceutical administrative penalty cases in Sanming City from 2020 to 2024, employing multidimensional analytical methods. Results: The number of pharmaceutical administrative penalty cases and associated monetary penalties in Sanming City showed an overall declining trend from 2020 to 2024. Notably, cases involving secondary-level and above public hospitals had significantly decreased in both volume and penalty amounts since 2022. In 2024, there were only two cases each for public hospitals at Level Ⅱ and above, township health centers, and community health service centers. The number of cases at community health service stations and other primary healthcare institutions decreased sharply from 51 cases in 2020 to 13 in 2024. Categorical analysis revealed that substandard drugs accounted for 32.7% of violations, while institutions’ failure to fulfill statutory obligations constituted the remaining 67.3%. Conclusion: The root cause of frequent incidents in medical institutions lies in the prioritization of medical treatment over medication quality, inadequate fulfillment of primary responsibilities, and the lack of mandatory enforcement standards. Traditional regulatory mechanisms suffer from inadequate awareness of responsibility binding, deficient grassroots oversight capacity, and ineffectual sanction mechanisms. Consequently, medical institutions should proactively establish accountability systems for pharmaceutical quality management, while regulatory authorities should establish a novel responsibility-binding mechanism by incorporating drug and medical device safety into hospital presidents’ performance-based compensation, develop a categorized guidance system to deliver proactive front-loaded support, formulate mandatory enforcement standards with aligned inspection tools, and strengthen oversight capabilities through cross-departmental and joint enforcement operations, thereby ensuring end-to-end accountability across the pharmaceutical regulatory chain.
  • Quality Management
  • Tang Yong, You Zhengqin, Song Chunping, Ren Pengyu, Li Wei
    Chinese Pharmaceutical Affairs. 2026, 40(2): 167-174. https://doi.org/10.16153/j.1002-7777.2025-07-0065
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    Objective: To provide practical references for Chinese herbal decoction pieces manufacturers to improve the management of processing technology validation, and to support the scientific regulation of Chinese herbal decoction pieces. Methods: Domestic regulatory requirements for the process validation of Chinese herbal decoction pieces were reviewed. Based on key issues identified in processing technology validation during on-site inspections in Guizhou Province over the past two years, a risk analysis was conducted, and strategies for managing processing technology validation were discussed. Results: Over the past 20 years, China’s regulations on pharmaceutical process validation have been progressively refined, providing guidances for both validation practices and on-site manufacturing inspections. Nevertheless, inspection practices in the industrial production of Chinese herbal decoction pieces indicated that the management of processing technology validation remains insufficient on the part of both manufacturers and drug regulatory authorities. At the manufacturer level, critical deficiencies exist: manufacturers often failure to conduct validation for cleaning and slicing processes based on product quality and safety risks, and lack tailored validation strategies. At the regulatory level, outdated regulations have reduced oversight effectiveness. Conclusion: Enterprises should establish a risk-based, lifecycle validation system, conduct systematic validation based on the impact of key steps such as cleaning and slicing on product quality. Targeted validation strategies must be specifically designed for these critical processes that significantly affect product quality. Regulatory authorities should accelerate the improvement of the legal framework governing Chinese herbal decoction piece production, promoting the establishment of unified, scientific, and operable inspection standards and risk assessment mechanisms. Through coordinated efforts between manufacturers and regulators, traditional processing techniques can be transformed into quantifiable and controllable process parameters, thereby ensuring the safety, efficacy, and quality control of Chinese herbal decoction pieces for public use.
  • Wang Yajun, Wang Yu, Liu Zeqian, Yin Huidong, Liu Mingli
    Chinese Pharmaceutical Affairs. 2026, 40(2): 175-181. https://doi.org/10.16153/j.1002-7777.2025-09-0009
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    Objective: Based on the core characteristics of radio frequency identification (RFID) technology, explored the practical paths for enhancing the intelligence level of the entire chain management of national drug reference standards, including production, warehousing, and supply. Methods: The current application status of RFID technology in the management of drug reference standards was systematically reviewed, and existing technical bottlenecks and management pain points were thoroughly analyzed. Results: Based on a comparative analysis of the current label management status of drug reference standards in foreign countries, the application of RFID technology in the management of drug reference standards in China demonstrated significant advantages. An implementation framework to accelerate the large-scale application of RFID technology was also proposed. Conclusion: The comprehensive implementation of RFID technology can significantly improve the management efficiency of national drug reference standards and provide technical support for achieving refined control.
  • Regulatory Technology
  • Zhou Tingting, Liu Yuanxi, Xie Xuan, Wang Dandan, Jin Hongyu, Wei Feng, Wang Miao, Wang Ying
    Chinese Pharmaceutical Affairs. 2026, 40(2): 182-193. https://doi.org/10.16153/j.1002-7777.2025-07-0077
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    Objective: To study the application effects of acetamiprid colloidal gold immunochromatographic test strips from different brands in the matrix of Lycii Fructus, optimize the pre-treatment conditions for Lycii Fructus, and establish a rapid colloidal gold immunochromatographic detection method for acetamiprid in Lycii Fructus. Methods: The detection limits, specificity, sensitivity, false positive and false negative rates of three different brands of colloidal gold immunochromatography test strips in the matrix of Lycii Fructus were examined. The pretreatment conditions for Lycii Fructus, including herbal medicine forms, extraction solvents, extraction solvents volume and dilution ratios were optimized, and the performance of the optimized method was evaluated. Results: The detection limits of the three brands of acetamiprid colloidal gold test strips in the matrix of Lycii Fructus were 0.25, 0.50, and 0.50 mg · kg-1, respectively. The results of specificity and cross reactivity were all negative, with a false negative rate of 0%, but the false positive rate was 50%. The optimal pretreatment conditions for Lycii Fructus involve extracting (1.00±0.05) g of ground sample using 4 mL of 0.01 mol·L-1 phosphate-buffered saline (PBS). After centrifugation, 20 μL of the supernatant was diluted with 980 μL of the extraction solvent to obtain the test solution. The performance evaluation results were satisfactory. Conclusion: The colloidal gold immunochromatography method has the advantages of simplicity and rapidity in the detection of acetamiprid pesticide residues, but there are generally high false positive rates in the detection of Lycii Fructus matrices. The rapid colloidal gold immunochromatography detection method established by optimizing pretreatment conditions in this study for acetamiprid in Lycii Fructus resolved the problem of false positive, and had the advantages of accurate and reliable determination results and simplicity in operation. It is suitable for on-site rapid detection of acetamiprid in Lycii Fructus, providing technical support for the quality and safety supervision of Lycii Fructus, as well as providing a technical reference for the application of colloidal gold immunochromatography in the rapid detection of pesticide residues in traditional Chinese medicine.
  • Research Progress
  • Niu Qianyi, Zhao Manman, Zhou Xiaobing
    Chinese Pharmaceutical Affairs. 2026, 40(2): 194-201. https://doi.org/10.16153/j.1002-7777.2025-07-0051
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    Objective: To review the current development of skin organ-on-chips and skin organoids as novel in vitro alternative models, with a particular focus on their application potential in skin-related areas of drug research and development. Methods: By systematically outlining the progress in skin organ-on-chips and organoids technologies within the context of drug development, this study analyzed representative application cases in the construction of transdermal absorption models, skin disease models, and immune responses. Based on the analysis, corresponding developmental recommendations were proposed. Results: The research summarized advances in skin organ-on-chips and organoids technologies in mimicking skin structure and function, demonstrated their specific application examples in transdermal absorption studies and disease modeling, and confirmed the potential of these models in improving the accuracy of drug evaluation. Furthermore, it pointed out current technological challenges and proposed future development directions. Conclusion: Through integration with various cutting-edge technologies, skin organ-on-chips and organoids systems are expected to further improve the complexity and predictive performance of the models, providing critical references for the construction of more reliable and biomimetic in vitro drug evaluation models and promoting their widespread application in both basic research and translational applications.
  • Li Xinxin, Han Xiaohong, Tian Hongbin
    Chinese Pharmaceutical Affairs. 2026, 40(2): 202-209. https://doi.org/10.16153/j.1002-7777.2025-04-0007
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    Objective: Glycosaminoglycan antithrombotic drugs include heparin, low molecular weight heparin, sulodexide, danaparoid, etc. This paper reviewed the progress in their regulation and quality control, providing a reference for the safer and more effective clinical application of glycosaminoglycan antithrombotic drugs. Methods: A large amount of relevant research literature was reviewed, and the review and discussion were conducted from the aspects of the structure-activity relationship of glycosaminoglycan antithrombotic drugs, regulatory requirements, the inclusion in various national pharmacopoeias, and the latest research progress of key indicators in quality standards. Results and Conclusion: Glycosaminoglycan antithrombotic drugs are natural polysaccharide mixtures, and their regulation is rather difficult. Regulatory authorities in various countries have started to control from the source of raw materials and compared generic drugs with original reference preparations of glycosaminoglycan antithrombotic drugs in the following aspects: animal species of the starting heparin raw material, depolymerization methods, molecular weight polydispersity, and biological activity, etc., for consistency research and evaluation. In the future, the clinical application of glycosaminoglycan antithrombotic drugs needs to be safer and more effective through the use of more accurate analytical techniques, improved quality control standards, and enhanced regulatory collaboration among countries.
  • Gong Zengyi, Wang Jing, Ma Shihong
    Chinese Pharmaceutical Affairs. 2026, 40(2): 210-216. https://doi.org/10.16153/j.1002-7777.2025-06-0051
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    Objective: To summarize the current application status and development potential of the growth curve method in the rapid microbiological examination system for pharmaceuticals. Methods: Relevant literature on the growth curve method was summarized, organized, and analyzed, with a focus on the basic principles, six mathematical fitting models, application cases, and development prospects of the growth curve methods. Results: The growth curve method could quantitatively analyze the growth behavior of microorganisms in a high-throughput, dynamic, rapid, and convenient manner, based on the changes of characteristic parameters, such as optical density, conductivity, fluorescence tagging, combined with mathematical model fitting analysis. This method could overcome the limitations of traditional pharmaceutical microbiological examination systems, such as long cultivation cycles, cumbersome operations, high labor costs, and subjective errors. Conclusion: The growth curve method provides an efficient, convenient, fast, and automated new detection strategy for pharmaceutical microbiology. In the future, by combining with artificial intelligence and multi omics technologies, it is expected to promote the digital and intelligent upgrading of the pharmaceutical microbiology quality management system and contribute to the high-quality development of the pharmaceutical microbiology field.
  • Foreign Pharmaceutical Affairs
  • Gao Jing, Zhang Wanliang, Wang Qiong, Zhou Lihong, Li Junming, Zhou Shuiping, Ma Xiaohui
    Chinese Pharmaceutical Affairs. 2026, 40(2): 217-225. https://doi.org/10.16153/j.1002-7777.2025-08-0004
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    Objective: To conduct a systematic study on the regulatory requirements and market entry compliance pathways for compound traditional Chinese medicines (TCMs) entering the United States (US) market as dietary supplements, thereby providing a basis for accelerated market entry of compound TCMs in developed markets and promoting internationalization of selected compound TCMs. Methods: By sorting out and systematically studying the regulatory framework, regulatory guidelines, and marketing compliance pathways for dietary supplements in the US, as well as conducting a comparative analysis of the entry requirements for compound TCMs classified as drugs, dietary supplements, or conventional foods in the US. The application and marketing strategies for compound TCMs as dietary supplements were discussed, with practical experience incorporated. Results and Conclusion: It is feasible for selected compound TCMs to be applied in the US as dietary supplements, but it is necessary to conduct ingredient screening and safety assessment, control manufacturing and quality, and especially to strictly control the labels and claims descriptions. Listing selected compound TCMs as dietary supplements can accelerate their rapid market entry in the US, facilitate their “going abroad”, and simultaneously accumulate evidence of human use history to support their application as drugs in the US.
  • Shao Shushu, Dong Qian, Meng Yun, Zhao Jia, Guo Yue, Zhu Jiong
    Chinese Pharmaceutical Affairs. 2026, 40(2): 226-234. https://doi.org/10.16153/j.1002-7777.2025-07-0004
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    Objective: To explore the the convergence of China’s medical device nomenclature system with international standards, in order to reduce the complexity of international market access for medical devices, and facilitate cross-border regulatory cooperation. Methods: A systematic comparison was made between the nomenclature terminology for general names of in China and the European Medical Device Nomenclature (EMDN) in terms of classification logic and coverage. Medical devices were sampled from the 22 technical fields that correspond to the subdirectories of the Classification Directory, guided by the General Naming Principles for Medical Devices. Semantic matching of their generic names with potential EMDN terms was performed, followed by terminology comparison. Results: The framework for the common naming of medical devices in China was basically consistent with the EMDN framework. Among mapped terms, 34% of product generic names showed direct correspondence with EMDN terms, 40% exhibited characteristic term discrepancies, while 26% demonstrated scope inconsistencies preventing direct alignment. Conclusion: It is feasible to establish a correlation mapping between China’s medical device generic terms and EMDN nomenclature, guided by the General Naming Principles for Medical Devices, further refining specific term mappings can support the international expansion of Chinese medical devices.
  • Hospital Pharmacy
  • Lei Zhenzhen, Liang Yan, Zhang Zhang, Ren Han, Lin Zhijian, Zhang Wenxiang
    Chinese Pharmaceutical Affairs. 2026, 40(2): 235-239. https://doi.org/10.16153/j.1002-7777.2025-08-0038
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    Objective: To explore the application pathways, challenges, and development directions of artificial intelligence (AI) in empowering pharmacy services, and to provide references for promoting the high-quality development of smart pharmacy and improving healthcare service standards. Methods: By analyzing the specific AI applications in pharmacy services (such as intelligent prescription review, automated dispensing, medication management, medication consultation and education, etc.), this study examined its technical empowerment mechanism, summarized the application effects based on actual cases, simultaneously analyzed the current challenges from the aspects of technology, law and ethics perspectives. Results: AI has already shown significant value in pharmaceutical services, including the interception of unreasonable prescriptions by intelligent prescription review systems and the increase in prescription volume by automated dispensing systems. However, there were still challenges such as incomplete technical standards, insufficient data quality and system compatibility, ambiguous accountability, and data privacy risks. Conclusion: AI provides an important opportunity for the transformation of pharmacy service models, which can significantly improve service efficiency and quality. However, challenges need to be addressed through measures such as improving technical standards, establishing legal frameworks, and strengthening ethical oversight to promote the maturation of AI-pharmacist collaborative service models, ensuring patient medication safety and enhancing healthcare service standards.
  • Ma Ruijuan, Pei Baofang, Duan Yanyan
    Chinese Pharmaceutical Affairs. 2026, 40(2): 240-246. https://doi.org/10.16153/j.1002-7777.2025-07-0049
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    Objective: To resolve the difficult issues in the establishment of personalized rule databases, and improve the clinical applicability of the prescription pre-review system. Methods: The outpatient and emergency warning prescriptions submitted by the hospital’s prescription pre-review system in the first half of 2024 (before intervention) at the Children’s Hospital of Zhengzhou University were collected and analyzed. For the “stubborn problems” that doctors refused to modify, combined with the regular public announcement of review results, standardized management of off-label medication and proprietary Chinese medicines, and monthly multi-disciplinary prescription reviews, review recommendations or hospital-wide consensus were formed, and the rules were refined based on evidence. The data were then compared with those in the first half of 2025 (after intervention). Results: Before intervention, the main issues with the prescriptions that doctors refused to modify were inappropriate indications, simultaneous prescription of three or more traditional Chinese medicines or similar-function drugs for the same patient, inappropriate dosage administration, and inappropriate medication selection. After intervention, through evidence-based practice, communication, and multi-disciplinary prescription reviews, hospital-wide consensus was formed. The rate of mandatory execution by doctors for inappropriate indication warnings decreased from 57.99% to 5.66%; the phenomenon of simultaneous prescribing three or more traditional Chinese medicines for the same patient no longer existed; after warnings about repeated medication, the rate of mandatory execution by doctors decreased from 34.64% to 1.40%; after warnings about inappropriate dosage instructions, the rate of mandatory execution by doctors decreased from 3.96% to 0.05%; after warnings about inappropriate medication selection, the rate of mandatory execution by doctors decreased from 33.89% to 5.94%. From the departmental perspective, the rate of mandatory execution of warning prescriptions in the internal medicine department decreased the most, while that in the traditional Chinese medicine department decreased the least. From the doctor’s perspective, senior doctors showed a greater decrease in the rate of mandatory execution of warning prescriptions. The rate of qualified prescription reviews in the hospital’s outpatient and emergency departments increased from 87.45% to 89.74%, and the intervention success rate increased from 77.81% to 93.75%. Conclusion: The management model based on the “regular public announcement of audit results + multi-disciplinary prescription reviews or questionable issues + evidence-based practice” can effectively intercept unreasonable prescriptions, while avoiding excessive intervention, making clinical diagnosis and treatment work smoother.