20 June 2026, Volume 40 Issue 6
    

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    Supervision & Administration
  • Wang Xue, Zhao Jing, Lu Jiaqi, Dong Jing, He Wu
    Chinese Pharmaceutical Affairs. 2026, 40(6): 613-620. https://doi.org/10.16153/j.1002-7777.2026-03-0020
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    Objective: To systematically analyze the current application status of advanced manufacturing technologies in the field of cell therapy products, international regulatory progress, and challenges faced by China, and to explore the supporting role of regulatory innovation and technological synergy in high-quality industrial development. Methods: By combining domestic and international research literature and industrial practices, this paper reviewed the representative platforms and their application characteristics of five major technological pathways: end-to-end high-throughput platforms, integrated closed systems, robotic modular systems, key unit equipment, and point-of-care manufacturing models. Furthermore, this paper analyzed the regulatory policies of major regulatory authorities such as the US, EU, and Japan, and assesses the applicability and deficiencies of China’s current regulatory framework. Results: Advanced manufacturing technologies significantly improve production efficiency and batch consistency; The FDA, EMA, and Japan have formed differentiated regulatory pathways; Although China has issued relevant guidance principles, deficiencies remain in core components (online sensors, fluid control, and disposable consumables) and AI algorithm regulation. Conclusion: China should prioritize the domestic production and large-scale application of integrated closed systems, achieve breakthroughs in key components, improve guidelines for automated process changes, explore an incentive mechanism for advanced manufacturing technology designation, and promote synergy between regulatory and technological innovation to support independent industrial innovation.
  • Liu Yonghui, Dong Wujun, Ren Lianjie
    Chinese Pharmaceutical Affairs. 2026, 40(6): 621-627. https://doi.org/10.16153/j.1002-7777.2026-04-0001
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    Objective: To introduce the rationale in drafting the CMC Technical Guidelines for Chemically Synthesized Innovative Oligonucleotide Drugs (Interim) and its main contents, thereby facilitating better understanding of this documment and promote drug development in this area. Methods: The relevant literature, regulatory status, and information on marketed products were reviewed. Multiple communications and academic exchanges between regulatory authorities and pharmaceutical manufacturers were organized to discuss the pharmaceutical technical requirements. Results: Common research methods and technical requirements in the manufacturing, characterization, quality control, and pharmaceutical comparability studies of oligonucleotide drugs were defined. Conclusion: The guidelines specify the relevant technical requirements for oligonucleotide products, facilitating the research, development, registration, and application of innovative oligonucleotide drugs.
  • Zhang Chunqing, Wang Yue, Zhou Liangbin, Yang Pengfei, Zhu Jiong, Lu Yong
    Chinese Pharmaceutical Affairs. 2026, 40(6): 628-635. https://doi.org/10.16153/j.1002-7777.2026-01-0001
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    Objective: To compare the regulatory and innovation support policies for medical brain-computer interface (BCI) between China and the UK, thereby providing insights and references for the high-quality development of China’s BCI industry and the improvement of scientific regulatory practices. Methods: This study adopted text sorting and comparative analysis methods based on regulatory policies, guidelines, special regulatory reports, industrial planning documents and other relevant materials concerning the classification and application rules of BCI. It systematically analyzed the BCI regulatory framework, key regulatory requirements including enhanced clinical requirements, and innovation support measures in the UK, as well as the top-level design and local policy support for BCI regulation and innovation in China. Results: The UK implements risk-based classification regulation for medical devices, centers on recommendations from expert institutions, and carries out regulatory exploration focusing on pre-market definition, institutional capacity, clinical evidence, non-medical application scenarios and long-term use safety. China has established a full-chain top-level policy support system covering scientific research, clinical application, approval, and medical insurance. Multiple regions in China have issued targeted industrial support policies, and the world’s first invasive BCI medical device has been approved for marketing in China. Conclusion: The UK emphasizes micro-level, granular regulation, while China holds a stronger advantage in macro-level top-level design and industrial synergy. Drawing on the UK’s experience in data protection and innovation-oriented supporting supervision, China can further optimize its regulatory system and facilitate the high-quality development of BCI technology and related industries.
  • Hou Jia, Liu Songli, Li Shu
    Chinese Pharmaceutical Affairs. 2026, 40(6): 636-647. https://doi.org/10.16153/j.1002-7777.2025-09-0045
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    Objective: To focus on the cutting-edge progress of brain-computer interfaces (BCIs) and regulatory developments both domestically and internationally, providing references and insights for the technological innovation and compliant development of BCIs. Methods: By reviewing global literature and policy documents, this study analyzed and summarized the progress in key technologies, typical applications, and regulatory situations. Results and Conclusion: BCI technology has achieved significant advancements in neural interfaces, neural decoding, neural feedback, neural control, and application scenarios, while regulatory approaches in various countries showed differentiated paths in balancing innovation and risk. China should further clarify regulatory boundaries, accelerate the formulation of clinical trial guidelines, and strengthen data security governance based on international experiences and its own industrial advantages, so as to ensure the healthy and orderly development of BCI technology.
  • Dong Qian, Zhao Jia, Meng Yun, Shao Shushu, Tang Jinglong, Zhu Jiong
    Chinese Pharmaceutical Affairs. 2026, 40(6): 648-651. https://doi.org/10.16153/j.1002-7777.2025-07-0012
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    Objective: To propose targeted technical suggestions for the regulatory attributes and classification of tissue engineered medical products (TEMPs) from the perspective of medical device classification. Methods: Relevant regulatory policy requirements for TEMPs in China were sorted out. The regulatory attributes and classification elements were analyzed, and suggestions for determining different regulatory pathways were proposed based on the product composition and as-released state. Results and Conclusion: On the basis of the existing regulatory framework, this paper exploratorily proposes the basis for determining four regulatory pathways for TEMPs, namely as a new biomedical technology, a drug, a medical device, or a drug-device combination product.
  • Liu Yingying
    Chinese Pharmaceutical Affairs. 2026, 40(6): 652-660. https://doi.org/10.16153/j.1002-7777.2026-01-0008
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    Objective: To explore and construct a Training Needs Analysis(TNA) model for drug inspectors,and so as to provide precise and effective training education for drug inspectors. Methods: By integrating the Goldstein framework in TNA field with the classic Kirkpatrick model of four-level training effectiveness evaluation, the TNA model for drug inspectors was constructed, which comprises five modules: defining ‘ideal’ standards, evaluating ‘current’ performance, identifying ‘shortcomings’, planning ‘action paths’, and forming a ‘closed loop’, thereby establishing a PDCA cycle. Results and Conclusion: The preliminary construction of the TNA model for drug inspectors provides a theoretical framework and operational methods for accurately identifying the training needs of drug inspectors.
  • Fan Qile, Jiang Rong
    Chinese Pharmaceutical Affairs. 2026, 40(6): 661-673. https://doi.org/10.16153/j.1002-7777.2025-11-0023
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    Objective: To further understand the overall output, research subjects and content in the field of innovative drug medical insurance negotiation in China, and enrich the research methods in this field. Methods: Using the methods of co-occurrence analysis, cluster analysis and emergence analysis of CiteSpace, the relevant literature from the CNKI database spanning 2015 to 2024 in the field of innovative drug medical insurance negotiation in China were analyzed by metrology and visualization. Results: A total of 266 articles were included after retrieval and screening. The overall output of research results showed an increasing trend. “China Medical Insurance” was the main journal publishing articles in this field. Universities, as the main output body of the main results, played a dominant role in this field with scholars from China Pharmaceutical University and its units being the main force and support in this field. Through keyword co-occurrence and cluster analysis, relevant studies mainly involved the access strategies of medical insurance catalog, pricing standards of negotiated drug, and the implementation effect of medical insurance policies. Through keyword emergence and evolution analysis, related researches have been continuously refined and extended. The negotiation on innovative drugs and medical insurance access and their further subdivision research direction were the hot spots and key research contents now and in the future. Conclusion: The overall development trend of the field of innovative drug medical insurance negotiation in China is good, but the cooperation between scholars and institutions is not close enough. It is suggested that all research subjects should strengthen communication and cooperation based on grasping the constantly changing policy requirements and social demands in the future, and promote the further development of medical insurance negotiation of innovative drugs in China.
  • Chen Zhendong, Lin Xiuling
    Chinese Pharmaceutical Affairs. 2026, 40(6): 674-679. https://doi.org/10.16153/j.1002-7777.2025-08-0056
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    Objective: To systematically review the key research concerns pertaining to changes in injection packaging materials and containers, providing scientific references for drug marketing authorization holders to conduct change studies, and assisting regulatory authorities in achieving scientific and efficient review. Methods: Based on technical guidance principles and requirements for drug change management, combined with review practices, a systematic elaboration was conducted covering the current domestic and international research status, rationality of changes, assessment of equivalence and substitutability, compatibility studies, impact analysis of material changes, bridging strategies for expiration dates, and the quality of injection drugs. Results and Conclusion: Upon summarizing the research focus of changes in packaging materials and containers for injections, several issues were identified: insufficient justifications for changes, incomplete assessment of equivalence and substitutability, inconsistent quality of compatibility studies, and unscientific shelf-life bridging strategies. Additionally, changes in pharmaceutical packaging materials may impact drug quality. The established research framework offered a clear pathway for drug marketing authorization holders to conduct change-related studies, which is crucial for ensuring drug quality and enables regulatory authorities to implement scientific and efficient reviews.
  • Regulatory Technology
  • Yan Xia, Liu Weilin, Liang Xiaobing, He Songhua, Luo Yi
    Chinese Pharmaceutical Affairs. 2026, 40(6): 680-690. https://doi.org/10.16153/j.1002-7777.2025-04-0013
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    Objective: To establish quality standard of Dicliptera chinensis (L.) Ness. Methods: Thin layer chromatography (TLC) was used for qualitative identification of the medicinal materials. A characteristic chromatograms of Dicliptera chinensis (L.) Ness was established using HPLC method, and the contents of four identified characteristic peaks (Vicatin-2, Vicatin-1, Schaftoside, and Isoschaftoside) were determined to provide support for the quality control of Dicliptera chinensis (L.) Ness. Results: The TLC spots of the medicinal materials were clear and well separated. A total of six characteristic peaks were identified in the characteristic chromatograms of eighteen batches of Dicliptera chinensis (L.) Ness samples. The linear relationships of the four identified characteristic peaks were good within their respective ranges (r ≥ 0.9995), with average recovery rates of 95.96% to 101.50%, and RSD of 0.66% to 1.68%. The content ranges of Vicatin-2, Vicatin-1, Schaftoside, and Isoschaftoside were 0.0631-0.6917, 0.0269-0.3814, 0.0834-1.5406, and 0.0220-0.3680 mg · g-1. Conclusion: This method is simple, feasible, accurate and reliable, and can provide a reference for the establishment of the quality standard of Dicliptera chinensis (L.) Ness.
  • Sun Changying, Peng Yushuai, Zou Wenbo, Zhang Peipei, Zhao Wen, Yin Lihui
    Chinese Pharmaceutical Affairs. 2026, 40(6): 691-699. https://doi.org/10.16153/j.1002-7777.2025-11-0060
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    Objective: To clarify the core physicochemical properties of ziprasidone hydrochloride monohydrate reference standard, verify its suitability as a reference standard, and establish scientific and standardized usage. Methods: Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), loss on drying determination, and moisture content measurement were comprehensively employed to obtain relevant data. Meanwhile, dynamic vapor sorption (DVS) analysis, X-ray diffraction (XRD) analysis, nuclear magnetic resonance (NMR) analysis, and content determination were performed on the samples before and after drying. The optimal usage was determined by comprehensively analyzing the thermal properties, moisture state, structure, and composition. Results: Systematic experiments and comprehensive analysis demonstratedthat ziprasidone hydrochloride monohydrate exhibited superior chemical and physical stability when being maintained in the monohydrate form. Conclusion: Ziprasidone hydrochloride monohydrate possesses favorable stability and requires no prior drying when being used as a reference standard. This paper provides a sufficient scientific basis for the suitability and standardized usage of this monohydrate as a reference standard.
  • Research Progress
  • Su Anping, Hao Yunwei, Wang Xinyu, He Yuting, Cui Yi, Wang Jue, Niu Zhendong
    Chinese Pharmaceutical Affairs. 2026, 40(6): 700-706. https://doi.org/10.16153/j.1002-7777.2025-09-0044
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    Objective: To systematically review the structural characteristics of microbial communities in Mass Medicata Fermentata and Sojae Semen Praeparatum, and to explore their implications for the quality control and standardization system of fermented traditional Chinese medicines. Methods: A literature review was conducted to summarize and compare recent research progress and compositional features of microbial communities in Mass Medicata Fermentata and Sojae Semen Praeparatum. Results and Conclusion: The signature microorganisms of Mass Medicata Fermentata and Sojae Semen Praeparatum are relatively stable at the genus level but exhibit distinct characteristics at the species level. Accordingly, it is proposed that microbial quality control of fermented traditional Chinese medicines could adopt a unified standard at the genus level while accommodating regional specificity at the species level. Simultaneously, efforts should be made to advance the construction of core microbial resources and strengthen microorganism-centered whole-process control. This provides a theoretical basis for promoting high-quality development of the quality control system for fermented traditional Chinese medicines from a microbiological perspective.
  • Wu Hui, Wang Tianwen, Tian Lin, Zhao Yanjun, Ai Lun, Xie Langui, Zhao Xia
    Chinese Pharmaceutical Affairs. 2026, 40(6): 707-714. https://doi.org/10.16153/j.1002-7777.2026-01-0047
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    Objective: To systematically review the principles and progress of light scattering particle size analysis, summarize its applications in the pharmaceutical field, and provide references for the correct use of this method and technological development. Methods: Through literature research, the development history of the light scattering method was reviewed. Its instrument hardware, optical models, inversion algorithms, calibration procedures and pharmaceutical applications were described. The challenges and future directions it faces were also analyzed. Results: The light scattering method has been widely applied in drug research and development, manufacturing and quality control. However, its proper application requires a deep understanding of its principles and parameter settings. Currently, there are still challenges such as incomplete theoretical models for non-spherical particles, difficulties in multiple scattering correction, non-uniform calibration standards, and insufficient adaptation to extreme conditions for online monitoring. Conclusion: Future research should strengthen the integration of the light scattering method with multi-technique hyphenation, artificial intelligence-assisted analysis, reference particles development, and online monitoring applications. This will contribute to more accurate, efficient, and intelligent development of pharmaceutical analysis and the pharmaceutical industry.
  • Foreign Pharmaceutical Affairs
  • Li Bo, Liu Ming, Shang Yufu, Shen Mingrui, Zhao Shenglu, Bai Jian, Zhang Wei, He Yi
    Chinese Pharmaceutical Affairs. 2026, 40(6): 715-722. https://doi.org/10.16153/j.1002-7777.2025-12-0001
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    Objective: To provide references for the registration submitting indication applications to Health Canada for Traditional Chinese Medicines registered as Natural Health Products. Methods: A combination of literature research and case analysis of registered products was employed. Data were retrieved from databases including the Health Canada website and China National Knowledge Infrastructure (CNKI). The registration requirements for traditional/modern indications by the Natural and Non-Prescription Health Products Directorate (NNHPD) of Canada were investigated. A case analysis of traditional/modern indication registrations for 258 approved natural health products was conducted. Results: The registration of natural health product indications is categorized into traditional indications and modern indications. Traditional indications adopt pre-approved functional indications, while modern indications are classified into low, medium, and high risk levels based on safety assessment. Indications undergo technical review and approval according to authoritative evidence. Conclusion: Health Canada regulates natural health products with indications under an over-the-counter framework. Core evidence for the registration and review of traditional or modern indications includes national pharmacopoeias, modern clinical trials, scientific literature, historical use, and safety and efficacy data. Therefore, accurate risk level assessment and proper classification of indications are essential for successful registration of Traditional Chinese Medicines.
  • Liao Shiyu, Chen Yongfa
    Chinese Pharmaceutical Affairs. 2026, 40(6): 723-729. https://doi.org/10.16153/j.1002-7777.2025-08-0054
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    Objective: To draw on the experience of chronic disease pharmacy services in England’s community pharmacies, providing reference for exploring effective management strategies for chronic disease patients in China. Methods: The current status of chronic disease pharmacy services in England community pharmacies was examined, and the supporting elements for their provision were summarized. Based on this analysis, challenges in implementing chronic disease services in China’s community pharmacies were identified, and optimization recommendations were proposed. Results: In contrast to the well-established community pharmacy-centered chronic disease pharmacy management system in England, community pharmacies in China have made some progress. However, they continue to face numerous obstacles and challenges, such as insufficient policy support, inadequate professional competence, and low public awareness, making it difficult to meet the evolving demands for chronic disease pharmacy services. Conclusion: China could draw on the mature experience of England to broaden the scope of chronic disease pharmacy services through community pharmacies, supported by diversified economic incentives, strengthened continuing professional education and training, and public health education campaigns.
  • Hospital Pharmacy
  • Chen Min, Xiong Anran, An Wei, Zhou Zhi, Zhang Mingwei
    Chinese Pharmaceutical Affairs. 2026, 40(6): 730-734. https://doi.org/10.16153/j.1002-7777.2025-09-0010
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    Objective: To explore effective strategies for establishing a homogeneous pharmaceutical management model in tertiary Grade A public hospitals operating across multiple campuses, and to evaluate its practical outcomes, thereby providing a reference for ensuring consistent pharmaceutical care, medication safety, and enhancing the quality of pharmaceutical services. Methods: Using an action research methodology, this study took the Third People’s Hospital of Hubei Province as a case, systematically constructing a homogeneous pharmaceutical management model centered on the core principles of “uniform systems, integrated management, consistent standards, and homogeneous services.” To assess the model’s effectiveness, a comparative analysis was conducted on key indicators before and after (first half of 2024 vs first half of 2025) the implementation. The compared indicators included outpatient prescription appropriateness rate, internal medication dispensing error rate, average patient waiting time, medical staff satisfaction, and several overall efficiency metrics. Results: Following the implementation of the homogeneous pharmaceutical management model, the outpatient prescription appropriateness rate increased and remained stable above 99%. The internal dispensing error rate decreased by 30.0% compared to the same period in 2024. The average medication waiting time of patients decreased from (10.00±0.56) min to (6.33±0.12) min, with statistically significant difference (t=7.454, P<0.01). The overall distribution of medical staff satisfaction scores in the first half of 2025 was significantlyhigher than that in the first half of 2024, showing statistically significant difference (U=2708.5, P <0.001). Conclusion: The homogeneous pharmaceutical management model developed in this study, empowered by intelligent technologies, effectively broke down management and service barriers between campuses. It achieved optimized integration of pharmaceutical resources and overall improvement in service efficiency, thereby enhancing medication safety. This model can serve as a valuable reference for promoting high-quality development in multi-campus healthcare institutions.