20 May 2025, Volume 39 Issue 5
    

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    Supervision & Administration
  • Comparative Analysis of the Implementation of Wholesale and Retail Integration Policy of Drug Business in Some Provinces of China
    Qiu Yan, Liu Mingpu, Zhang Jihui, Huang Zekai, Du Liyun, Zhang Chuiliu
    Chinese Pharmaceutical Affairs. 2025, 39(5): 485-491. https://doi.org/10.16153/j.1002-7777.2025-03-0027
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To sort out the similarities and differences of the implementation documents of the policy of wholesale and retail integration of drug business in 12 provinces, including Jiangsu, Guizhou, Hainan, Shanxi, Chongqing, Shandong, Jiangxi, Inner Mongolia, Guangxi, Guangdong, Hunan and Hubei, so as to provide references for drug business enterprises and relevant regulatory authorities and promote the high-quality development of the industry. Methods: From the policy implementation document release time, subject requirements, drug business license issuance methods, quality management system, institutions and responsibilities, personnel requirements, facilities and equipment requirements, computer system requirements and other aspects of the above-mentioned local drug business wholesale and retail integration policy implementation documents for detailed comparative analysis. Results: It is clear that the implementation documents of the policy of the integration of drug business wholesale and retail in the above provinces require the integrated wholesale and retail enterprises are the same legal entity, but there are differences in the requirements of drug business license issuance, quality management system, institutions and responsibilities, personnel requirements, facilities and equipment requirements, computer system requirements and other aspects. Conclusion: Through a comparative analysis of the implementation documents of the above-mentioned drug wholesale and retail integration policies in various places, suggestions for the development of enterprises are put forward to provide strong support for the development of the industry.
  • Analysis of Risks and Suggestions on Online Drug Sales
    Xu Weixing
    Chinese Pharmaceutical Affairs. 2025, 39(5): 492-498. https://doi.org/10.16153/j.1002-7777.2025-02-0034
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    Objective: To put forward improvement suggestions in view of the risks arising in the process of online drug sales. Methods: Combining the current development status of online drug sales and the regulatory situation of existing laws and regulations, an empirical analysis of various issues that need to be improved throughout the entire process of online drug sales was conducted. Results: In view of the current problems that there are many risk points exposd in the process of online drug sales, and to enhance compliance of online drug sales with current regulations and address operational loopholes, it is imperative to refine regulatory requirements, improve corporate management practices and strengthen social collaboration. Conclusion: Quality control of the entire process of online drug sales could guarantee the continuous compliance of the process of online drug sales, ensure the safety and effectiveness of the process of drug use, and better protect public health.
  • Considerations for Pharmaceutical Research of Genome Editing Systems in Advanced Therapy Medicinal Products
    Yin Huifang, Wei Xuejing, Dai Yifei, Ma Xiaojuan, Zhang Jingchen
    Chinese Pharmaceutical Affairs. 2025, 39(5): 499-505. https://doi.org/10.16153/j.1002-7777.2024-12-0021
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    Objective: To provide suggestions and references for the pharmaceutical research of genome editing systems in advanced therapy medicinal products. Methods: Based on the pharmaceutical research, combined with the requirements of relevant regulation and guidance domestically and abroad, this article focused on the upstream design, production and quality research, use and risk management of genome editing systems. Results and Conclusion: In recent years, genome editing systems represented by CRISPR/Cas9 have risen rapidly as scientific research hotspot, and have been widely used in many fields such as medicine, agriculture, biotechnology and so on. In the field of therapeutics, genome editing systems can not only be used as active pharmaceutical ingredients or drug substances in vivo, but also play a therapeutic role after editing cells in vitro and returning to the human body. So it is an important concern in the evaluation of advanced therapy medicinal products. This article raised the current considerations for pharmaceutical research, hoping to promote the clinical transformation and application of genome editing products.
  • Application Practice and Reflection on Medical Device Product Technical Requirements
    Ye Chenghong, Li Jinfang, Wang Yongqing
    Chinese Pharmaceutical Affairs. 2025, 39(5): 506-510. https://doi.org/10.16153/j.1002-7777.2024-10-0026
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    Objective: To explore the application practice of product technical requirement documents for medical devices, and provide optimization suggestions for future applications. Methods: The evolution process of medical device regulations was sorted out. The background and status as well as the existing problems of product technical requirements for medical devices in the current regulatory use process were sorted out. Results and Conclusion: As a technical document bearing product quality characteristics, medical device product technical requirements run through product development, registration and post-market supervision, and is an important regulatory tool for medical device supervision. The technical requirements of medical device products play an important role in the process of improving the supervision of medical devices. With the continuous improvement of the development level of the industry, the technical requirements of products should be further modified and improved in order to meet the needs of the development of the industry and supervision.
  • Current Status and Countermeasures of Self-testing for in vitro Diagnostic Reagent Registration
    Cai Jiangbo, Cui Jia, Chang Yongsheng, Chen Yu, Qiu Jing, Yu Yang
    Chinese Pharmaceutical Affairs. 2025, 39(5): 511-516. https://doi.org/10.16153/j.1002-7777.2025-03-0005
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    Objective: To provide countermeasures and suggestions as references for regulatory authorities and enterprises by analyzing current status, influencing factors and existing problems of self-testing for in vitro diagnostic reagent registration since the implementation of self-testing system for registration. Methods: Based on the results of investigations and differences between requirements of self-testing for registration and finished product inspection of enterprises, a comprehensive analysis was conducted on the factors influencing self-testing for registration and the implementation status. Results and Conclusion: In order to better leverage the role of the self-testing system for registration in the innovation of medical device products and the high quality development of the industry, it is recommended that enterprises strengthen their own capacity building and enhance their quality management levels. Regulatory authorities should also intensify supervision and guidance, continuously promote the construction of the inspector team, and constantly refine the relevant regulations. These efforts will help ensure product quality and safety, thereby safeguarding the health of the public.
  • Analysis on the Current Situation and Problems of Geographical Indication Protection of Authentic Medicinal Materials in China under “Three-track System”
    Chen Yang, Kang Qi, Huang Qianqian
    Chinese Pharmaceutical Affairs. 2025, 39(5): 517-527. https://doi.org/10.16153/j.1002-7777.2024-11-0023
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    Objective: To analyze the situation in the protection of geographical indications of authentic medicinal materials in China, and to provide empirical references for the protection mode of geographical indications of authentic medicinal materials and the selection of the cultivation range of geographical indications of authentic medicinal materials in the later stage. Methods: Taking the 408 authentic medicinal materials included in the Atlas of Authentic Medicinal Materials as research samples, the official website was searched to analyze the distribution of geographical indication protection of authentic medicinal materials in China under three protection modes before the promulgation of the Administrative Measures for the Use of Special Geographical Indication (Trial) in 2020. The protection of geographical indications between different geographical areas (Southwest, East China and five other areas) and historical stages (traditional areas/modern areas) was compared. Results: The number of geographical indications of authentic medicinal materials in China showed a trend of first increasing and then decreasing, and many medicinal materials in non-authentic producing areas were protected by geographical indications. The geographical indication protection mode of authentic medicinal materials was mainly based on the “geographical indication products” approved by the former General Administration of Quality Supervision, Inspection and Quarantine. There were differences in the protection of geographical indications between the homologous medicinal materials of medicine and food and the ordinary (non-food) authentic medicinal materials. The number of geographical indications was unevenly distributed and the emphasis of protection was also different among the areas of authentic medicinal materials. Compared with the traditional areas of authentic medicinal materials, the protection of geographical indications in the newly changed modern areas of authentic medicinal materials was not enough. Conclusion: A separate identification mechanism for authentic medicinal materials should be established, and priority should be given to geographical indication products in the selection of geographical indication protection mode. According to the characteristics of geographical indication protection in various areas of authentic medicinal materials, the cultivation of geographical indication products of authentic medicinal materials in various areas should be strengthened, especially the exploration of modern geographical indications of authentic medicinal materials.
  • Enlightenment of “Hong Kong and Macao Medicine and Equipment Connect” and Lecheng Pilot Zone Policy on Anti-tumor Drug Regulation
    Chen Hongwei, Zhu Hong, Gao Meixiang, Cai Minxiang, Li Ya, Yang Jiaan, Yin Yiru, Feng Haohao
    Chinese Pharmaceutical Affairs. 2025, 39(5): 528-537. https://doi.org/10.16153/j.1002-7777.2024-12-0043
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    Objective: To analyze the core mechanisms and outcomes of China's “Hong Kong and Macao Medicine and Equipment Connect” policy and the Lecheng Pilot Zone policy, and summarize their implications for the reform of anti-tumor drug regulation in other regions of China, and propose targeted recommendations. Methods: A multi-source retrieval strategy was adopted, integrating policy documents published by the National Medical Products Administration and local government websites from 2018 to 2024, as well as literature from academic databases. Policy text analysis and quantitative data were combined to conduct a comparative study from the dimensions of policy connotation, system, implementation effects, and social value. Results: The “Hong Kong and Macao Medicine and Equipment Connect” policy streamlined the drug registration and market approval process, promoted the development of the pharmaceutical industry, improved patient access to innovative drugs, and optimized pharmaceutical service models in medical institutions, reflecting the significant social value of this policy. The “Special Medical Treatment” policy of the Lecheng Pilot Zone, through multi-departmental collaboration, advanced the “ultra-streamlined approval” reform for drugs, reduced patient waiting times, and facilitated drug clinical evaluation and innovation in the pharmaceutical industry, serving as a model for drug regulatory reform in China. Conclusion: The successful implementation of China's “Hong Kong and Macao Medicine and Equipment Connect” policy and the Lecheng Pilot Zone policy has provided valuable experience for the reform of anti-tumor drug regulation in other regions of China. Drawing on these two policies, recommendations include enhancing the innovation capacity of anti-tumor drugs, optimizing their market approval processes, promoting policy innovation and pilot initiatives, strengthening international cooperation and exchange, and introducing insurance mechanisms. China should continue to deepen drug regulatory reforms, advance the internationalization of drugs, improve patient access to medications and quality of life, and promote the overall health level of society.
  • Analysis of Key Points in Environmental Monitoring of Sterile Preparations Manufacturing Based on the GMP Inspection Perspective
    Li Lei, Ban Yongsheng
    Chinese Pharmaceutical Affairs. 2025, 39(5): 538-544. https://doi.org/10.16153/j.1002-7777.2024-12-0027
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    Objective: To analyze the key focuses of sterile production environmental monitoring and common defects in inspection, with the aim of providing references for improving the environmental monitoring capacity of sterile drug production enterprises and providing inspection ideas for the GMP sterile inspection of the environment. Methods: The regulations and contents of sterile drug production environmental monitoring were summarized, and the common confusing aspects in environmental control and air conditioning purification system confirmation during sterile inspection were analyzed. The establishment and implementation of the full life cycle environmental monitoring procedure were proposed, and the typical defects of environmental monitoring from the perspective of GMP sterile inspection were summarized. Results: Environmental monitoring and environmental control, air conditioning purification system confirmation correspond to different regulatory requirements and have their own monitoring focus. From the perspective of inspection, typical defects of environmental monitoring include imperfect establishment of environmental monitoring procedures, inaccurate assessment of risk points, doubts about the authenticity of monitoring data, and failure to make effective use of monitoring data. The establishment and implementation of the environmental monitoring procedure based on the full life cycle concept is a key link in ensuring the quality of sterile drugs. Conclusion: In order to ensure the quality of sterile drugs,sterile drug production enterprises need to comprehensively evaluate the implementation of environmental monitoring and improve the relevant program content. Sterile drug production environment monitoring is a key focus of GMP sterile inspection. As drug regulatory agency, adhering to the full life cycle inspection approach in inspection is an important inspection technique for objectively evaluating the sterile drug production enterprises' sterile protection capacity.
  • Research and Prospect on the Label Management of National Drug Standard Materials
    Wang Yajun, Yin Huidong, Liu Huanping, Liu Mingli
    Chinese Pharmaceutical Affairs. 2025, 39(5): 545-551. https://doi.org/10.16153/j.1002-7777.2024-10-0034
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    Objective: To review the development of national drug standard material label management and explore ways for improvement. Methods: The development of national drug standard material label management was reviewed, existing problems were analyzed, and a scientific and intelligent management strategy was proposed based on international experiences and technology trends. Results and Conclusion: After more than three decades of development, national drug standard material label management has achieved a leapfrog development from 3 varieties in 1956 to more than 5000 varieties in 2024 through improving the technical review system, optimizing the production process, and strengthening stability research. However, there are still problems such as label contents and forms, printing equipment and technologies, and information management system. By optimizing label contents and forms, introducing RFID technology, and drawing on international advanced experiences and standards, the transition of label management from standardization to intelligence is achieved. Drug standard material label management is an important part of ensuring drug quality and safety. Scientific, intelligent, and international management should be continuously promoted to provide solid and strong support for building a solid line of defense for drug quality and safety.
  • Analysis of the Current Situation of Drug Clinical Trial Institutions in Shanxi Province under the Registering System
    Zhu Zhichuan, Wang Shu
    Chinese Pharmaceutical Affairs. 2025, 39(5): 552-559. https://doi.org/10.16153/j.1002-7777.2025-01-0034
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    Objective: To understand the current development situation of drug clinical trial institutions in Shanxi Province, and to provide references for promoting the healthy and sustainable development of drug clinical trials in our province. Methods: The relevant data on drug clinical trial institutions in Shanxi Province were collected by logging into the drug clinical trial institution registering management information platform and the drug clinical trial registration and information publicity platform, and the statistical analyses were conducted from the aspects of institution number, regional distribution, professional categories, number of main researchers, number of projects undertaken, and completion status. Results and Conclusion: Since the implementation of the registering system, the number of drug clinical trial institutions in Shanxi Province has increased to 35, with a growth rate of 75.0%, mainly distributed in Taiyuan, Changzhi, Jincheng, Datong, Linfen, Jinzhong, Yuncheng, etc. The number of professional categories involved has increased from 50 to 112, with a growth rate of 124%. The number of drug clinical trial projects undertaken has increased from 868 to 3822, with a growth rate of 240.3%. After the implementation of the registering system, the development situation of drug clinical trial institutions in Shanxi Province is good, which has made positive contributions to the creation of new drugs. However, there is an imbalance in the number of drug clinical trial institutions and the number of clinical trial projects undertaken in various regions, and there are still many medical institutions that meet the conditions but have not applied for institutional registration, and the utilization rate of research resources for phase Ⅰ drug clinical trials is not high. It is recommended that government departments should introduce corresponding policies to support eligible medical institutions to participate in institutional registration. At the same time, medical institutions should pay attention to the quality of clinical trials, enhance the level of technology, optimize trial processes, improve work efficiency, formulate reasonable fee standards, assist in project implementation, and jointly promote the steady and healthy development of drug clinical trials in our province.
    • Regulatory Technology
  • Research on the Release Rate of Bupivacaine Multivesicular Liposomes
    Peng Yushuai, Guo Wendi, Sun Changying, Wen Qiang, Yin Lihui, Chen Hua
    Chinese Pharmaceutical Affairs. 2025, 39(5): 560-570. https://doi.org/10.16153/j.1002-7777.2025-02-0005
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    Objective: To establish a flow-through cell method for determining the release rate of bupivacaine multivesicular liposomes, and to explore the release mechanism of the multivesicular liposomes. Methods: Phosphate buffer solution (pH 7.0, containing 1% bovine serum albumin) was used as the release medium, with a volume of 100 mL. A dialysis tube with a molecular weight cut-off of 100 kDa was used in conjunction with a 22.6 mm tablet cell. The water bath temperature was maintained at 25 ℃. The flow rate was 16 mL · min-1.The model-dependent methods were applied to fit the release curves of bupivacaine multivesicular liposomes produced by different manufacturing processes, to compare the similarity of the release curves, and to explore the release mechanism of the multivesicular liposomes. Results: The BiDoseResp mathematical model provided a good fit for the release curves of the three preparations produced by different manufacturing processes. Statistical analysis showed that the variances of the mean values for parameters A2 and h2 among the three preparations are homogeneous (P=0.391 > 0.05,P=0.151 > 0.05). The LSD test in multiple comparisons revealed that there was no significant difference in parameter A2 between batch 1 and the original product, while there were significant differences in parameter A2 between batch 2 and both the original product and batch 1 (P < 0.05). However, there were no significant differences in parameter h2 among the three preparations. The release of bupivacaine in liposomes involved both diffusion and erosion processes. As the drug was released from the liposomes, the liposomes themselves underwent structural rearrangement and dissolution. Conclusion: The flow-through cell method for determining the release rate of bupivacaine multivesicular liposomes is established, and its release curves can reflect the release characteristics of multivesicular liposomes. It can also preliminarily distinguish the release behavior of multivesicular liposomes produced by different manufacturing processes. This method provides a reference for the screening of generic drug quality control and consistency evaluation.
  • Study on the Related Substances of Brimonidine Tartrate Eye Drops
    Jin Shu, Wang Li, Shen Lanhui
    Chinese Pharmaceutical Affairs. 2025, 39(5): 571-577. https://doi.org/10.16153/j.1002-7777.2025-02-0001
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    Objective: To investigate the related substances in brimonidine tartrate eye drops sampled in the market. Methods: An HPLC method for evaluating related substances in brimonidine tartrate eye drops was established. The chromatography was performed on Proshell C18 column with 0.01 mol · L-1 ammonium acetate(containing 0.2% formic acid) solution as mobile phase A and acetonitrile as mobile phase B under gradient elution. The detection wavelength was set at 260 nm at the flow rate of 1.0 mL · min-1, and the injection volume was 30 μL. 82 batches of brimonidine tartrate eye drops were evaluated using the established method, and impurities exceeding 0.1% were analyzed by Q Exactive Orbitrap HRMS. Results: The method established for the related substances demonstrated acceptable specificity, accuracy, precision and robustness. A total of six unknown impurities and four known impurities E、H、G、B were detected. And total impurities in all samples were less than 1.0%, with the maximum individual impurity (impurity Ⅵ ) quantified at 0.10%-0.36% in six samples. Conclusion: The related substances in brimonidine tartrate eye drops in the market meet the existing quality standards of this variety in China. However, it is found that some impurities are not effectively monitored in the existing quality standards. The method developed in this article can effectively monitor the impurities of brimonidine tartrate eye drops and obtain comprehensive impurity information. The method can be further applied to product quality control of brimonidine tartrate raw material and other brimonidine tartrate preparations.
  • Study on the Chemical Components of Counterfeit Clopidogrel Bisulfate Tablets
    Li Caixia, He Jiajia, Chen Shuang, Shao Peng
    Chinese Pharmaceutical Affairs. 2025, 39(5): 578-583. https://doi.org/10.16153/j.1002-7777.2025-03-0001
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    Objective: To establish a high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (HPLC-Q TOF MS) method for the structural identification of chemical components in a batch of suspected counterfeit clopidogrel bisulfate tablets submitted by the public security department, and to conduct quantitative studies on the identified components using high-performance liquid chromatography (HPLC). Methods: The separation was conducted on a Shimadzu Shim-packVPODS (250 mm×4.6 mm, 5 μm) column by isocratic elution with 20 mmol · L-1 ammonium acetate and acetonitrile (70 ∶ 30), and the detection wavelength was 276 nm. Furthermore, quadrupole time-of-flight mass spectrometry (Q TOF MS) was employed to determine the accurate molecular weights (MS1) and secondary fragment ions (MS/MS) of each component, followed by structural identification. Additionally, the structures of the identified chemical components were confirmed using reference standards and the quantitative determination of the confirmed components was performed by HPLC with an external standard method. Results: The labeled active ingredient of clopidogrel bisulfate was not detected in the sample, but instead contained a certain amount of aspirin and free salicylic acid, with concentrations of 11.4 mg per tablet and 3.04 mg per tablet, respectively. Conclusion: The established LC-MS technology can effectively identify the chemical components of this sample, and provide technical support for combating the market chaos of counterfeit clopidogrel bisulfate tablets.
    • Hospital Pharmacy
  • Analysis of the Allocation Status of Pharmacy Personnel in Secondary and Tertiary Hospitals in China, and Its Association with Resident Population and Regional GDP
    Wu Xue, Mei Long, Zhou Shuo, Zhang Wei, Zhen Jiancun
    Chinese Pharmaceutical Affairs. 2025, 39(5): 584-592. https://doi.org/10.16153/j.1002-7777.2025-01-0029
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    Objective: To analyze the composition and influencing factors of pharmacy personnel in secondary and tertiary hospitals across 31 provinces in China, and their association with resident population and regional GDP, in order to provide a scientific basis for optimizing pharmacy personnel allocation and improving pharmaceutical care quality. Methods: A multicenter cross-sectional survey design was adopted, covering 1130 hospitals in provinces represented by members of the Chinese Hospital Association's Pharmacy Committee. Data on pharmacy personnel numbers, professional title distribution, education levels, and departmental allocations (2021-2022) were collected via SoJump, which were analyzed correlation with resident population and regional GDP data from the National Bureau of Statistics. Non-parametric correlation statistical tests (two-tailed Spearman test) were applied. Results: The average proportions of pharmacists in tertiary and secondary hospitals in 31 provinces in 2022 were 4.21% and 5.15%, respectively, with 0.65 and 0.66 clinical pharmacists per 100 beds. Resident population showed positive correlations with actual available number of beds, annual number of discharged patients, average number of discharged patients per pharmacist, annual outpatient volume, average outpatient volume per pharmacist, average daily number of outpatient prescriptions, average number of outpatient prescriptions handled per pharmacist per day, total number of personnel involved in dispensing Chinese and Western medicines in outpatient and emergency departments and number of personnel in PIVAS and number of clinical pharmacists per 100 beds. Negative correlations were observed with the related factors of pharmacists specializing in quality and medication safety, informatics and clinical pharmacies. Regional GDP significantly correlated with pharmacist education, professional titles, and staffing in outpatient and emergency pharmacies as well as PIVAS. Conclusion: Current pharmacy personnel allocation in Chinese hospitals faces challenges such as insufficient staffing, unbalanced professional title structures, and delayed development of clinical pharmacy.
  • Funding Status and Analysis of the Awarded Pharmacy Administration Projects from National Natural Science Foundation of China from 2020 to 2023
    Wang Ziyi, Lu Hao, Zuo Genyong, Li Xin, Bai Xiangrong
    Chinese Pharmaceutical Affairs. 2025, 39(5): 593-599. https://doi.org/10.16153/j.1002-7777.2024-11-0012
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    Objective: To discuss the funding situation of pharmacy administration projects from the department of management science of National Natural Science Foundation of China (NSFC) from 2020 to 2023, and to provide references for pharmacists to apply for such projects. Methods: Searching was carried out on the official website of NSFC, Fanyan Global Research Project Database and Letpub to collect and dispose related information of awarded pharmacy administration projects. The information such as research direction, research content, theory/model and research methods were extracted and analyzed. Results: A total of 61 grants of pharmacy administration were selected by department of management science of NSFC from 2020 to 2023. The research directions of the projects were mainly pharmaceutical intervention/service (49.18%). The content of the study was consistent with the guidance of major national medical and health policies, among which “antibacterial drug management” appeared the most frequently (9 times). 46 projects (75.41%) matched the management theory/model, and “data mining” appeared the most frequently. Among the research methods, “mode construction” appeared the most frequently (9 times). Conclusion: It is suggested that hospital pharmacists should start from the aspects of pharmaceutical intervention/service, patient and drug safety, and pharmaceutical related policies. Based on the current hot contents of pharmaceutical care, they should actively use information technology to carry out their work, pay attention to the construction of the frontier in pharmaceutical policies and grassroots pharmaceutical care, design projects based on management theories/models, and refine the research contents to avoid conflicts, thereby improving the winning rate of pharmacy administration projects.
    • Research Progress
  • Development on Sterility Testing Methodology for Special Dosage Forms of Drugs
    Wang Jing, Wang Zhenbo, Dai Hui, Xiao Huang, Zhou Fayou, Ma Shihong
    Chinese Pharmaceutical Affairs. 2025, 39(5): 600-604. https://doi.org/10.16153/j.1002-7777.2025-03-0039
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    With the rapid development of the global pharmaceutical industry and the advancement of precision medicine concepts, special dosage forms of drugs continue to emerge. These types of drugs are often embedded in special materials or contain special excipients, resulting in difficulties in sample dissolution, filtration, and removal of antibacterial properties, which is a challenge in establishing sterility testing methodology. This article focuses on three dimensions：key parameter optimization, the construction of specific methodology for special dosage forms (microsphere preparation, liposome preparation, protamine containing preparation, ophthalmic gel preparation and chitosan based preparation) and application of rapid microbial detection technology, in order to provide references for the establishment of sterile testing methods and quality control of special dosage forms of drugs.
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