20 October 2025, Volume 39 Issue 10
    

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    Supervision & Administration
  • Zhao Manman, Zhou Xiaobing, Ai Xiaoni, Geng Xingchao, Huang Jie, Meng Shufang, Na Tao, Jin Hongtao, Gong Likun, Liang Qionglin, Zhu Chuhong, Cui Yimin, Yu Dongchuan, Wang Guihua, Bai Zhigang, Gao Mei, Xiao Rongrong, Lu Xinan, Rong Lijie, Hu Lei, Wang Qingli
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1089-1098. https://doi.org/10.16153/j.1002-7777.2025-07-0073
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    Objective:To improve the standardization and normalization of the in vitro evaluation of immune cell therapies and accelerate their clinical transformation process. Methods:An evaluation strategy for the anti-tumor effects of immune cell therapies, based on tumor organoid and organoid-on-chip models was formulated, through analyzing the characteristics of the evaluation of the effectiveness of immune cell therapies and the application potential of organoid and organ-on-chip technologies, and referring to internationally advanced guidelines for organoid and organ-on-chip evaluation, as well as the latest domestic and international research findings. Results and Conclusion:A consensus was formed on the application of tumor organoid and organoid-on-chip models in the evaluation of the anti-tumor effects of immune cell therapies. This consensus addressed their advantages, biological requirements, characterization criteria, experimental design and limitations: First, tumor organoid and organoid-on-chip models provide a more reliable and efficient tool for evaluating the efficacy of immune cell therapies. Second, the cell types and origins used in the model, culture conditions, and the tumor microenvironment should be taken into consideration before the evaluation. Third, the evaluation must include morphological, histopathological, genetic and biological functional characterization of tumor organoids, together with validation of anti-tumor effects. Fourth, the assay should set up appropriate control groups, determine the optimal ratio of effector cells to target cells, and select appropriate detection endpoints. Fifth, this approach still faces challenges such as insufficient pathological relevance and standardization of the models. In the future, it is necessary to further enhance the pathological relevance and standardization of tumor organoid and organoid-on-chip models to improve their predictive ability and to better facilitate the development and transformation of immune cell therapies.
  • An Fudong, Wang Gangli, Cao Jin, Yu Zhenxi, Liu Dandan, Ning Xiao, He Miao
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1099-1107. https://doi.org/10.16153/j.1002-7777.2025-09-0022
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    Objective:To identify the systemic risks to regulatory consistency and product safety stemming from inconsistencies in the implementation of general cosmetics filing and administration procedures across provincial medical products administrations in China. The research seeks to support the effective execution of territorial regulatory responsibilities for cosmetic safety at the provincial level, and to promote the modernization of regulatory functions, shifting from passive accepting applications to proactive guidance and service. Methods:Through an in-depth analysis of core regulatory documents and public data from cosmetic filing review practices, this study deconstructs local regulatory responsibilities into three dimensions: procedural, technical, and systemic. This framework reveals the risk transmission mechanisms resulting from regional discrepancies. Furthermore, a Failure Mode and Effects Analysis (FMEA) was applied to quantitatively assess the key risk points within the technical review process of filing documentation. Based on this analysis, the study proposes a modernization path for smart governance centered on data-driven approaches and risk management, which integrates capacity building, intelligent systems, and proactive services. Results:The findings revealed an imbalance in the technical capabilities and systemic oversight among local regulatory authorities when performing their unified statutory duties. While most regions can adequately fulfill procedural responsibilities, significant disparities existed in the execution of technical responsibilities, such as the review of product formulation label claims. The FMEA assessment identified “Improper technical review of safety assessment data”, which is directly related to technical responsibility capabilities, as the highest-priority systemic risk, with a Risk Priority Number (RPN) of 480. Conclusion:Provincial medical products authorities should proactively fulfill their territorial regulatory responsibilities, shift their focus from the passive receipt of documents to the active construction of an intelligent review system based on risk and big data. By strengthening the capacity of technical review teams, optimizing internal review processes and tools, and enhancing proactive services and pre-filing empowerment for applicants, regulatory bodies can guide and solidify the primary responsibility of enterprises for product quality and safety. This approach will ultimately lead to a dual enhancement of both regional regulatory efficiency and industrial development within the framework of national unified regulations.
  • Xue Jing, Zhong Xuanwei, Huang Baobin, Li Ying, Jiang Yingjun
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1108-1113. https://doi.org/10.16153/j.1002-7777.2025-05-0019
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    Objective:To investigate issues in the implementation of post-marketing quality sampling and testing requirements for pharmaceutical products and medical devices, and propose targeted optimization suggestions. Methods:Through the analysis of sampling and testing practices in recent years, critical operational deficiencies in the sampling records and voucher entry, sample return and refund process, drug inserts and labels as well as medical device registration certificates and product identifications management were deeply analyzed. Results:Based on quality control theory, risk management theory and system change theory, optimization suggestions were proposed, including unifying the standards of filling in sampling records and vouchers, establishing clear specifications for sample return and refund, implementing corporate responsibilities and enhancing supervision. Conclusion:By optimizating post-marketing sampling and testing requirements, the identified issues can be effectively solved, scientificity and standardization in pharmaceutical regulation would be further enhanced, and then, the safety in use of pharmaceutical products and medical devices would be effectively guaranteed for public.
  • Quality Management
  • Li Yanan, Wu Dawei, Meng Lijun, Cheng Shaowei
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1114-1120. https://doi.org/10.16153/j.1002-7777.2025-07-0010
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    Objective:To analyze and discuss the development trends and research frontiers of decentralized clinical trials (DCTs) in the context of digital medicine, and to provide suggestions for their standardized implementation. Methods:The CiteSpace was used to conduct cluster and time trend analysis of the literature on DCTs. Results:With the advancement of digital healthcare technologies, drug clinical trials are increasingly emphasizing participant engagement, guided by the principle of patient-centered research. Technologies such as virtual reality and artificial intelligence serve as the operational framework and essential tools for DCTs, providing the necessary technical foundation and support for their implementation. The application of DCTs have gradually expanded from cardiac rehabilitation and psychological therapy to complex disease areas such as neuroscience. Conclusion:Due to the unique characteristics of digital technologies, DCTs still face multiple challenges regarding data reliability, ethics and safety. The successful implementation of DCTs requires meticulous strategies and planning. It is recommended to enhance data management, protect the personal information of research participants, enhance the digital tool application capabilities of investigators and their teams, clarify the responsibilities of all parties, and collaboratively promote the development of DCTs.
  • Pei Yunfei, Wang Meng, Wang Jinsong, Niu Qun, Li Junli, Chen Guoqing, Ni Xunsong, Guo Yaxin
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1121-1127. https://doi.org/10.16153/j.1002-7777.2025-06-0030
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    Objective:To provide constructive suggestions for the compilation of the management manuals for biosafety level Ⅲ laboratories. Methods:This study emphasized the purpose of compiling a biosafety level Ⅲ laboratory management manual. The compilation basis for both software and hardware was explained, the framework and content of the manual were analyzed in detail, and measures and suggestions for optimizing the compilation of the manual were proposed based on management elements, covering personnel, machinery, materials, methods, and environment. Results and Conclusion:Through detailed analysis of key elements such as regulatory and standard requirements, compilation framework, organizational management structure, management responsibilities, risk assessment and risk control, personnel training and qualifications, experimental operations and safety, laboratory equipment, facilities and materials, emergency plans and accident handling, laboratory environment and waste, supervision and continuous improvement, effective references and experience are provided for the optimization and the compilation of relevant biosafety level Ⅲ laboratory management manuals, promoting the comprehensive improvement of biosafety level Ⅲ laboratory management level.
  • Regulatory Technology: Column on Systematic Research and Application of Macroscopic and Microscopic Identification of Fruit-Based Chinese Medicinal Materials
  • Su Yulan, Shi Jia, Liu Tu, Liu Yueshuai, Huang Qingquan, Yu Jiandong, Kang Shuai, Cheng Xianlong, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1128-1147. https://doi.org/10.16153/j.1002-7777.2025-02-0023
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    Objective:To study the inclusion status of fruit-based Chinese medicinal materials in the 2020 edition of the Chinese Pharmacopoeia, the Chinese Ministry of Health’s Drug Standards for Chinese medicinal materials, the Quality Standards for 43 Imported Chinese Medicinal Materials Including Catechu, and 40 local Chinese medicinal material standards was studied; A retrieval table for the shape characteristics of a total of 216 primitive and 200 varieties of fruit based Chinese medicinal materials registered in the 2020 edition of the Chinese Pharmacopoeia and local standards for traditional Chinese medicinal materials, was compiled. Methods:The sources, types, and maturity of fruit based Chinese medicinal materials in the current standard were sorted out, statistically analyzed, summarized and expressed in the form of charts. On this basis, a retrieval table for fruit based Chinese medicinal materials was compiled in combination with the results of morphological research results and plant taxonomy. Results:The current standards included a total of 200 varieties of fruit-based medicinal materials, belonging to 216 species across 63 families. If counted by the principle of one source corresponding to one medicinal part, there were a total of 237 fruit-based Chinese medicinal materials. Analyzed by medicinal material varieties, in terms of origin, the larger number of varieties were from the Rosaceae family with 18 varieties, followed by the Rutaceae family with 15 varieties and the Cucurbitaceae family with 13 varieties. There were 35 varieties of medicinal materials with multiple sources, accounting for 17.5%, and 165 varieties with single source, accounting for 82.5%. Analyzed by medicinal material sources, in terms of fruit types, the largest number was of single fruits, with 201 pieces, accounting for 84.81%. According to the statistical analysis of medicinal parts, the proportion of intact fruits was the highest, with 194 pieces, accounting for 81.86%. According to the maturity level of fruits, the proportion of mature fruits was the highest, with 178 pieces, accounting for 75.11%. The compiled retrieval table covered 140 genera from 63 families, with a total of 532 entries. This retrieval table had certain scientific and practical significance. Conclusion:This study provides an experimental basis for the classification and identification of fruit based traditional Chinese medicinal materials, as well as the classification and morphological research of medicinal plants. It also has certain significance for the development, utilization, and protection of natural resources of traditional Chinese medicinal materials, as well as the market and intelligent supervision of traditional Chinese medicinal materials.
  • Shi Jia, Su Yulan, Liu Tu, Zhang Nanping, Yu Jiandong, Liu Yueshuai, Huang Qingquan, Kang Shuai, Cheng Xianlong, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1148-1163. https://doi.org/10.16153/j.1002-7777.2025-02-0025
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    Objective:To provide solid data support for the identification of fruit-based Chinese medicinal materials by focusing on the classification, as well as the morphological structural characteristics of fruit-based Chinese medicinal materials, and by summarizing and analyzing specific examples, combined with modern imaging technologies to characterize the key features. Methods:The study drawed upon botany theories and the unique attributes of Chinese medicinal materials, which offer a solid theoretical foundation for the classification and analysis of fruit-based Chinese medicinal materials. A series of cutting-edge imaging techniques, including stereomicroscopes, digital imaging technology, optical microscopes, and digital scanning sectioning instruments, were further used to observe and characterize the type characteristics of 200 varieties of fruit-based Chinese medicinal material varieties (covering 216 original sources) as delineated in current standards. Results:Based on classification of fruit types, through high-precision observation and analysis on the morphological structural characteristics, as well as the internal structures of representative varieties, corresponding high-definition imaging characterization features were generated, providing an intuitive and reliable visual basis for identification work. Conclusion:Through systematic classification of fruit-based Chinese medicinal materials and the application of integrating modern imaging technologies, this study can provide data support for the standardized management of Chinese medicinal materials, establish a foundation for the development of intelligent identification systems, aids in elevating the overall level of the Chinese medicinal materials industry, and promote the modernization of traditional Chinese medicine (TCM). By conducting in-depth research on the type characteristics and generating digital data of fruit-based Chinese medicinal materials, reliable references can be provided for regulatory authorities, enterprises, clinicians, pharmacists, and ordinary consumers. This, in turn, will significantly reduce the misidentification rate, ensure the authenticity and quality stability of medicinal materials, and thus ensuring the safety and efficacy of public medication at the source.
  • Shi Jia, Su Yulan, Liu Tu, Zhang Nanping, Huang Qingquan, Liu Yueshuai, Yu Jiandong, Kang Shuai, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1164-1173. https://doi.org/10.16153/j.1002-7777.2025-02-0026
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    Objective:To study comprehensive taxonomic, morphological, and anatomical studies of fruit-based Chinese medicinal materials, involving the summarization, exemplification, and high-definition imaging characterization of their fundamental shared traits, so as to provide a basis for the identification and classification of these medicinal materials. Methods:By applying modern imaging technologies such as stereomicroscopes, digital imaging technology, optical microscopes, and digital scanning sectioning instruments, the relevant morphological and structural characteristics of 200 variety of fruit-based Chinese medicinal materials(covering 216 original sources)collected from current standards were observed(with reasonable dissection if necessary), analyzed, induced, summarized, exemplified, and characterized by high-definition imaging characterization. Results and Conclusion:Combining the characteristics of traditional Chinese medicine (TCM), this study exemplified and conducted imaging characterization of the developmental process of fruit-based Chinese medicinal materials, along with the structures of their exocarps, mesocarps, and endocarps. It provided an experimental foundation for the identification, classification, standardized, and intelligent research of fruit-based Chinese medicinal materials. Additionally, this study contributed certain digital data for the Chinese medicinal materials market and intelligent supervision.
  • Su Yulan, Shi Jia, Liu Tu, Huang Qingquan, Liu Yueshuai, Yu Jiandong, Kang Shuai, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1174-1188. https://doi.org/10.16153/j.1002-7777.2025-02-0027
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    Objective:To systematically study on the tissue types of fruit-based Chinese medicinal materials and list their applications in the microscopic identification of Chinese medicinal materials. Methods:Morphological and anatomical studies were carried out on the fruit-based Chinese medicinal materials in the current standards, and their tissue types were studied, summarized and classified. Examples were selected for illustration, and images were collected in accordance with the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”. Results:The different characteristics and functions of the cells in the protective tissues, parenchyma tissues, mechanical tissues, conducting tissues and secretory structures of the fruit tissues were compared and their applications in the microscopic identification of Chinese medicinal materials were listed. Conclusion:The study of the tissue types of fruit-based Chinese medicinal materials not only deepens the understanding of their characteristics, but also promotes the development of Chinese medicinal material taxonomy, anatomy and identification. It also provides guidance for the quality and safety of medicinal materials. The application of tissue types in the microscopic identification of Chinese medicinal materials provides objective and quantifiable indicators for quality control, thereby better promoting the modernization of traditional Chinese medicine.
  • Shi Jia, Su Yulan, Liu Yueshuai, Huang Qingquan, Liu Tu, Yu Jiandong, Kang Shuai, Guo Linong, Cheng Xianlong, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1189-1199. https://doi.org/10.16153/j.1002-7777.2025-02-0028
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    Objective:To explain the significance of each item set in the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, which has been formed, for variety identification, and to discuss their application in traditional Chinese medicine(TCM)identification. Methods:Based on the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, specific varieties of fruit-based medicinal materials were selected as examples for image acquisition under two scenarios: without referring to the above the specifications, and with strict compliance. By comparing and analyzing the feature presentation effect of image acquisition, the intuitive impact of the the specifications on the variety identification of fruit-based medicinal materials was evaluated. Results:After applying the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, the feature presentation effect of image acquisition was significantly improved. In variety identification, the identification efficiency of samples processed in accordance with the specifications was enhanced, and the consistency of identification results among different professionals was also notably improved. Conclusion:Standardized image acquisition of fruit-based Chinese medicinal materials can not only improve the efficiency, accuracy, standardization, and systematicity of TCM identification, but also provide data for inspection and scientific research. Additionally, standardized image acquisition establishes a solid foundation for building reliable databases and the development of intelligent identification.
  • Chen Cuiling, Wei Riwei, Zhou Jinning, Liang Caimei, Zhang Yunping
    Chinese Pharmaceutical Affairs. 2025, 39(10): 1200-1208. https://doi.org/10.16153/j.1002-7777.2024-10-0008
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    Objective:To establish the specific identification method of Rubia cordifolia and Rubia magna by the ratio of characteristic peak area through HPLC technology and statistical methods. Methods:HPLC was performed on a Thermo Accucore AQ-C18 column (100 mm×2.1 mm, 2.7 μm) with a gradient mobile phase consisting of 0.1% phosphoric acid in water- acetonitrile. The flow rate was 0.3 mL·min-1, the detection wavelength was 250 nm, the column temperature was 30 ℃, and the injection volume was 2 µL. Fingerprint chromatogram analysis was performed, the results of the peak area of the common peaks were evaluated by cluster analysis (CA) and orthogonal partial least squares discriminant analysis (OPLS-DA), and the ratio of characteristic peak area was used for evaluation. Results:The common peak area could cluster Rubia cordifolia and Rubia magna into two categories respectively through CA and OPLS-DA. It was found through the ratio of characteristic peak area that the ratio ① of Rubia cordifolia was less than 0.36 and the ratio ② was less than 0.15, while the ratio ① of Rubia magna was more than 0.36 and the ratio ② was more than 0.15. Through the analysis of 20 batches of samples, the identification of the ratio ① and the ratio ② achieved 100%, respectively. Conclusion:The established method is simple, accurate and rapid, and can be used for the authenticity identification of Rubia cordifolia and Rubia magna, effectively improve the safety of Rubia cordifolia in clinical application.