Objective：To provide a reference for practitioners to better understand and accurately implement the standards for compound and single herb preparation of traditional Chinese medicine (CSHP) in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I). Methods：The main contents and characteristics of the additions and revisions of the standards for CSHP in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I) were analyzed and summarized. Results and Conclusion：In Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I), 28 new monographs of CSHP have been added, over 200 monographs have been revised, and 19 monographs are no longer included. The standards for CSHP are added or revised to ensure the safety, effectiveness, and quality controllability of medication, which continuously improves the overall level of standards, refines the formation mechanism of standards, and strengthens the technical support role of scientific supervision. The new edition of Chinese Pharmacopoeia could provide stronger technical supports for further promoting the improvement of quality standards for CSHP, promoting the high-quality development of the Chinese medicine industry and ensuring the safety of people’s medication.

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.

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.

Objective: To develop a standardized Burkholderia cepacia complex (referred to as “Bcc”) testing method for the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, thereby enhancing the national standards for China's pharmaceutical microbial contamination control and improving regulatory oversight. Methods: A systematic methodological evaluation of Bcc detection protocols was conducted by referring to the international standards for pharmaceuticals, cosmetics, and related products. By collaborating with 11 drug control laboratories under a national pharmaceutical standards enhancement initiative, critical parameters were optimized, including enrichment conditions, selective media, and confirmatory assays. Methodvalidation was performed using both spiked and real-world samples, followed by iterative revisions based on interlaboratory verification. Results: The reference strains for quality control, an optimized enrichment and isolation system, and selective culture media with improved specificity were specified in the finalized Chinese Pharmacopoeia 2025 Edition Bcc test method. Additionally, a definitive species-level taxonomic list of Bcc members was incorporated to facilitate accurate strain identification. Conclusion: On the basis of aligning with global regulatory standards, the establishment and inclusion of the Bcc test method addresses critical gaps in China's pharmaceutical microbiological quality control. Its adoption in the Chinese Pharmacopoeia 2025 Edition represents a pivotal advancement in the compendium's microbial standards, ensuring enhanced detection of opportunistic pathogens in pharmaceutical products.

Objective：To construct an intelligent management and pharmaceutical service model for inpatient pharmacy, and systematically evaluate its application effectiveness. Methods：Based on the operational improvements and practices in the inpatient pharmacy, this study focused on the intelligent management and service across key pharmaceutical processes, including drug requisition, dispensing, delivery, and medication guidance. It elaborated on the operational status of specific systems and platforms, such as the intelligent drug requisition system, pre-prescription review system, automated drug dispensing platform, closed-loop drug delivery management system, home-based pharmaceutical logistics delivery service, core database for post-discharge medication guidance, and “Internet+” medication consultation services. Additionally, a comparative analysis was conducted to evaluate the error rates and work efficiency before and after the implementation of the intelligent management and pharmaceutical service model. Results：After implementing the intelligent management and pharmaceutical service model, the number of drug requisition personnel was streamlined from 6 to 3. There were significant reductions in the average total completion time of requisition plans, the total number of missed medication items, and the monthly total number of drug requisition submissions [(164.9 ± 3.4) vs. (63.2 ± 1.9) min (P<0.05); (21 ± 3.4) vs. (0 ± 0.0) items (P<0.05); (129 ± 6.9) vs. (35 ± 1.9) times (P<0.05)]. The number of inappropriate solvent selection orders for injectable medications dropped to zero. The average medication delivery time in the inpatient pharmacy was reduced by 69 minutes, and delivery efficiency improved by 39.3%. Patients’ awareness of safe medication use at home increased significantly. Conclusion：The whole-process intelligent management and pharmaceutical service model of the inpatient pharmacy has significantly shortened the drug dispensing and delivery time, improved the working efficiency of pharmacists, reduced the risk of medication errors, and ensured the safety of patients’ medication.

Objective: To strengthen the implementation of the main responsibility for microbial control of pharmaceutical water, and to enhance the guidance on the full life cycle microbial monitoring and control of pharmaceutical water in the industry, the “Guideline for Microbiological Monitoring and Control of Pharmaceutical Water” was established. Methods: Four institutes for drug inspection and many pharmaceutical manufactures were organized to sort out the key points of the guideline through the investigation of testing methods, exploration of the application of rapid microbial methods, comparison of regulations and standards, questionnaire surveys, and on-site investigations of enterprises. Results: A full-chain technical framework covering the microbial characteristics, monitoring methods, process control, and risk prevention and control of pharmaceutical water was constructed Chinese Pharmacopoeia 2025 Edition has newly added the “Guideline 9209 for Microbiological Monitoring and Control of Pharmaceutical Water”. Conclusion: This guideline is an important supplement to the revision and implementation of product standards and general rules for pharmaceutical water, and also represents a significant measure for aligning Chinese Pharmaceutical water standard system with international advanced technical concepts.

Objective: To address the deficiencies in the selection, validation, and application of disinfectants by pharmaceutical manufacturers, and in line with the core concept of “whole-process control” in the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, to establish a scientific and operational guideline for the evaluation of disinfectant efficacy. Methods: By integrating domestic and international pharmacopoeia standards (USP, JP) and national standards (GB/T series), technical specifications were systematically formulated, covering the classification of disinfectants, methods for efficacy evaluation, and criteria for result determination. Results: The application scope of chemical disinfectants in the pharmaceutical environment was clarified, and two test methods, the suspension method and the carrier method were listed, and the threshold for determining disinfection efficacy was set based on international standards (a reduction of ≥3 in the lg value for bacterial or fungal vegetative cells, and a reduction of ≥2 in the lg value for spores or spores). Conclusion: The establishment of this guideline has promoted the improvement of the microbial contamination control standard system and provided technical support for the microbial safety management in the pharmaceutical production process.

Objective：To analyze the key quality characteristics of widely used aluminum adjuvants and their influencing factors, and to propose suggestions for further optimization in quality control, so as to provide a reference for improving the quality standard of aluminium adjuvants. Methods：Based on the international and domestic research results in recent years, the current quality standards of aluminum adjuvants at home and abroad were taken as the starting point, and the different production processes of aluminum hydroxide and aluminum phosphate adjuvants were analyzed. Results：For the quality control of aluminium adjuvants, it was necessary to pay attention to the quality characteristics of aluminium adjuvants, including structure, zero-charge point, particle size and distribution, and phosphorus-aluminium ratio. Meanwhile, the formulation system and residual impurities in the production process would affect the quality characteristics of aluminium adjuvants. Conclusion：Aluminium adjuvants, as one of the most widely used adjuvants in the field of vaccines, should be paid more attention to their quality characteristics, which are directly related to the safety and efficacy of vaccines, and are greatly affected by the production process.

Objective: To explore the role and positioning of drug registration testing in China, analyze the situation and reform practices of registration testing, and propose paths for further deepening the reform of registration testing. Methods: By comprehensively applying literature research, policy analysis, and comparative research, this study reviewed the statutory responsibilities and practical roles of drug registration testing, analyzed the problems and challenges encountered druing the implementation of the 2020 version of the Specifications for the Working Procedures and Technical Requirements of Drug Registration Testing (referred to as the “Specifications”), and the reform practice of the 2025 version of the “Specifications”. It also considered the paths for further deepening the reform of drug registration testing from the aspects of stakeholders, the whole chain, and internationalization. Resultsand Conclusion: As an extension of the administrative licensing for drug registration, drug registration testing fulfills its statutory technical control responsibilities through sample testing and quality specification review. The 2025 version of the “Specifications” has effectively addressed the problems and challenges that emerged since its implementation in the 2020 version through reform measures such as expanding the scope of pre-registration testing, reducing sample amount, shortening the testing timeline, and strengthening communication. In the future, it is necessary to further strengthen the principal responsibility of enterprises, establish a coordinated and consistent work system among national drug testing agencies, strengthen the connection between registration testing, evaluation, inspection, and post-marketing supervision, and deeply align with international advanced rules to promote internationalization. This will build a scientific, efficient, and modern drug registration testing system, providing solid technical support for ensuring drug safety and promoting high-quality development of the drug industry.

Objective：Taking the active pharmaceutical ingredient A as an example, the risk assessment methods and strategies for reducing the microbial limit tests quantity were studied. Methods：By using a data model based on the Poisson distribution, the probability of misjudgment of results under different test amounts was simulated, and the impact of reducing the test quantity on the accuracy of the test results was analyzed. Different influencing factors and scoring rules were set for two dimensions: the quality stability of the active pharmaceutical ingredient and the degree of its impact on the pharmaceutical preparation. A risk assessment strategy was proposed to evaluate the microbial contamination risk of the active pharmaceutical ingredients. Results and Conclusion：When the manufacturing process of the active pharmaceutical ingredient A was stable and controllable, a test quantity of 10 mg could be used for accurate result judgment, which could meet the requirements for identifying and controlling the microbial contamination risk of this active pharmaceutical ingredients. The evaluation methods and strategies used in this paper can help determine the test quantity and test method when the microbial limit tests quantity of raw materials cannot meet the requirements of the pharmacopoeia.

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.

Objective：To analyze the challenges and difficulties faced by drug regulatory inspections with the widespread application of informatization and intelligent equipment in the field of drug production, and to propose suggestions on how to improve the capabilities and level of production inspection. Methods The documents issued by drug regulatory agencies and international drug cooperation organizations in various countries were analyzed, and the current development status and existing problems of intelligent manufacturing of drugs in China were investigated. Results and Conclusion：China’s drug enterprises have begun to implement intelligent manufacturing in some scenarios, but have not yet formed a scale and integration. There are still many challenges in regulatory inspection, it is suggested to continuously exert efforts in issuing relevant inspection guidelines, improving the professional quality of inspectors, continuously exploring the application risk management, and developing regulatory science, etc., to jointly promote the intelligent manufacturing of drug production in China to the world.

Objective：To reduce the quality risks in the multi-product co-production of CAR-T cell therapy products by CDMO enterprises and ensure product quality. Methods：Based on the characteristic that the operation procedures of the proposed co-produced CAR-T cell therapy products were roughly the same, failure mode, effects and criticality analysis (FMECA) method was adopted, combined with the literature analysis method and expert interview method, to establish a quality risk management model for co-production of CAR-T cell therapy products in CDMO enterprises. Results and Conclusion：The established process was applied to the proposed co-produced products. Using the feasibility assessment table, applicability assessment table, risk assessment and control table of the process, the new risks brought by multi-product co-production were evaluated from the aspects of personnel, machinery, materials, methods and environment. After adding control measures for medium and high risks, the final co-production risks could all be acceptable. After applying the process, the risk index of the co-production link had significantly decreased. The model provided a reference for the improvement of the risk management effect of co-production of CAR-T cell therapy products in CDMO enterprises.

Objective：To compare the pharmacokinetic differences of a total of 9 ganoderic acids(Ganoderic acid C2, C6, G, B, A, D2, C1, Luwdenic acid A and Gancderenic acid D) in rats after multiple administrations of sporoderm-broken and sporoderm-removed Ganoderma lucidum spore powder. Methods：Normal SD rats were randomly divided into sporoderm-broken G. lucidum spore powder group, sporoderm-removed G. lucidum spore powder high-dose group and low-dose group with 6 rats in each group, and were administered orally for 7 consecutive days, blood was taken from the inner canthus of the eye on the 7^th day at 0, 0.1, 0.2, 0.5, 1, 2, 3, 4, 6, and 12 h. Blood concentration was determined by UPLC-MS/MS, and the pharmacokinetic parameters were calculated by Winnonlin 8.1 pharmacokinetic software. Results：In the sporoderm-removed G. lucidum spore powder group, the time to peak (T_max) of 9 ganoderic acids was around 1 h, the half-life (t_1/2) was less than 6 h, and the accumulation factor (R_ac) was around 1.00, whereas no ganoderic acid was detected in the sporoderm-broken G. lucidum spore powder group. Compared with the sporoderm-removed G. lucidum spore powder low-dose group, the maximum concentrations (C_max) of 9 ganoderic acids in the high-dose group was significantly higher (P < 0.05 or P < 0.01), and the mean area under the blood concentration-time curve (AUC_0-t) was higher than that of the low-dose group by about 10-40 times. Conclusion：Sporoderm-removed G. lucidum spore powder maintains rapid absorption after multiple administrations, with no significant accumulation observed. Its bioavailability is significantly superior to that of sporoderm-broken spore powder, and it exhibits distinct dose dependency.

Objective：To provide references for optimizing the registration classification management of therapeutic biological products in China. Methods：The achievements since the implementation of the new registration classification of therapeutic biological products in China were analyzed through literature research; the issues and directions that need to be optimized in the new registration classification of therapeutic biological products in China were understood through questionnaire surveys. Results and Conclusion：The survey indicates the following issues need to be optimized in the implementation of new drug registration classification: the definition of registration category 1 (novel drugs); the recognition of clinical advantage of registration category 2 (improved drugs); classification overlap in registration category 3. Accordingly, this paper provides comments and suggestions regarding the above issues, including to introduce the concept of integrity of safety and effectiveness data as the key benchmark for novel drugs, to focus on the clinical value of improved drugs, and to further clarify the definition and scope of some drug registration classification.

Objective：To propose new ideas of the mechanisms of drug regulatory science research in China by leveraging the platform of the drug regulatory science research in the National Medical Products Administration. Methods：Firstly, both domestic and international literature on drug regulatory science were reviewed and relevant practices and experiences in this field were summarized. Then discussion sessions were organized. At last, existing challenges faced by China’s drug regulatory research mechanisms were analyzed to propose related suggestions for improvement. Results and Conclusion：The current challenges in mechanisms of drug regulatory science research in China include: scattered scientific research resources, insufficient grasp of the difficulties and pain points in innovative drug development, the lack of obvious role in promoting the transformation of innovative achievements, an urgent need for cultivating the compound talents in regulatory science, and a necessity to further deepen international cooperation with regulatory science organizations. Based on the above situation, it is recommended to establish the following mechanisms, including a multi-participation research mechanism, a convenient and efficient information-sharing mechanism, a cross-integrated system for talents team coordinated and improved, a coordinated training and communication network, a perfect graduate student selecting and training mechanism, and a mutual benefit and win-win international cooperation mechanism. These initiatives aim to accelerate the promotion of technological innovation and achievement transformation, form a novel New Quality Productive Forces, and serve the research and development of new drugs and drug marketing,so as to make drug regulatory research become a bridge between basic innovation and industrial transformation, and become the leader and booster of the development of the drug industry.

Objective：To analyze the changes in the clinical use structure of proton pump inhibitors for injection before and after the implementation of the “national-centralized drug procurement” and “national medical insurance negotiation” policies in Zhengzhou Second People’s Hospital, and to explore the potential drug use problems in the process of implementation of the “national-centralized drug procurement” and “national medical insurance negotiation” policies, so as to provide reference for promoting rational clinical use of drugs and optimizing policy implementation. Methods：The usage data of injectable proton pump inhibitors from 2019 to 2024 were extracted from the hospital drug usage database, the variations in key indicators, including the defined daily dose (DDDs) and its usage proportion, as well as the defined daily cost (DDDc) and the proportion of usage amount, specifically for injectable proton pump inhibitors were analyzed and compared. Results：Under the influence of the “national-centralized drug procurement” and “national medical insurance negotiation” policies, the use structure of injectable proton pump inhibitors in our hospital has undergone major changes, and unselected drugs have gradually been withdrawn from the hospital catalog. After 2023, the use of injectable proton pump inhibitors in our hospital were only selected drugs, temporary harvest varieties and “national medical insurance negotiation” varieties left. Among the selected drugs, [national-centralized drug procurement] Omeprazole B for injection DDDs and the proportion of usage are increasing year by year, but they account for a smaller proportion; [national-centralized drug procurement] Lansoprazole for Injection DDDs will be on the rise from 2022 to 2023, but due to the small tendency for clinical use, they will basically no longer be used in 2024; [national-centralized drug procurement] the proportion of DDDs and usage of pantoprazole for injection is increasing. In 2024, the proportion of DDDs and usage of pantoprazole ranks first in the hospital. The DDDs of the “national medical insurance negotiation” variety of iprazole for injection showed an increasing trend year by year from 2020 to 2023. After hospital control, the proportion of DDDs and usage has declined, but still accounts for a large proportion. Conclusion：The “national-centralized drug procurement” and “national medical insurance negotiation” policies have lowered the price of injectable PPIs, reduced patients’ medication burden, increased the accessibility of drugs, and saved a large amount of medical insurance funds. However, they have also derived some potential medication behaviors, only by strengthening the supervision of drug use can we ensure the rational use of drugs and promote the stable and long-term implementation of favorable policies.

Objective：To establish and optimize four animal models of gastric mucosal injury through the detection of the known positive agent, omeprazole magnesium salt, providing a basis for the revision of technical standards for drugs and health foods, etc. Methods：The groups with omeprazole magnesium salt at doses of 2.5, 5.0 and 10.0 mg·kg^-1 and deionized water model control group were set up to quantitatively refine four acute and chronic animal models, including gastric mucosal injury caused by water immersion stress in mice, gastric mucosal injury induced by absolute ethanol in rats, gastric mucosal injury caused by pyloric ligation in rats, and gastric mucosal injury impregnated with glacial acetic acid in rats. Results：The model control group exhibited clear and distinguishable gastric mucosal injury sites in the four optimized animal models, facilitating accurate counting of injury numbers or measurement of lesion areas. Omeprazole magnesium salt at all tested doses demonstrated significant protective effects on gastric mucosal injury in both mice and rats. When the dose was ≥2.5 mg·kg^-1, the inhibition rates of mucosal injury area in the first three models reached more than 63.5%, 50.0% and 47.5% , respectively and the inhibition rate of ulcer area ≥28.8% in the fourth model. When the dose was ≥5.0 mg·kg^-1, the inhibition rate of ulcer volume was ≥45.4% in the fourth model. There were significant differences in statistical analysis (P<0.05). Conclusion：During the modeling period, the fasting time and fasting method of rats and mice should be strictly implemented to ensure gastric emptying. Quantitative gastric filling and fixation with 1% formaldehyde solution effectively stretch the wrinkled gastric mucosa, enabling accurate observation, ulcer counting, and measurement of ulcer injury areas, thus minimizing misjudgment and significantly improving precision. The optimized method can be better applied to evaluate the protective effect of drugs or health foods on gastric mucosal injury. At the same time, it provides a basis for the dose selection of omeprazole magnesium salt.

Objective：To investigate the methods of determining water activity across global industries, aiming to promote the application of water activity in China’s pharmaceutical industry and provide references for improving related regulations. Methods：By summarizing and analyzing regulations related to water activity determination across various industries globally, combined with relevant literature and the current application status of water activity measuring instruments in the domestic market, the types of determination methods and their influencing factors were analyzed and compared. Results：The determination of water activity of drugs primarily relied on four instrumental methods, with the measurement process being significantly affected by factors such as instrument calibration, temperature, equilibrium, and sample preparation. Conclusion：This study systematically summarizes water activity determination methods of drugs, introduces their principles and characteristics, and aims to provide practical guidance in selecting appropriate methods based on specific needs and ensuring accurate determination of water activity in pharmaceutical products.

Objective: To summarize and analyze the recent research on the Uyghur medicine Nymphaeae Flos, and provide references for establishing its quality control system and resource conservation. Methods: Relevant domestic and international literature were reviewed and analyzed to summarize the chemical compositions, pharmacological effects, quality control, and resources status of Nymphaeae Flos. Results and Conclusion: The main bioactive chemical constituents of Nymphaeae Flos are flavonoids and polyphenols, followed by coumarins, terpenoids, amino acids, alkaloids, fatty acids, and other compounds. Modern pharmacological studies have demonstrated that it possesses significant medicinal value, including hypoglycemic, hypolipidemic, anti-inflammatory, antibacterial, antioxidant, neureprotective, hepatoprotective, preventive of acute lung injury, and renal protection effects. However, the current quality control system of Nymphaeae Flos has limitations and the existing standard indicators are single and cannot fully reflect the quality of the medicinal materials, and thus require further improvement. Concurrently, due to habitat destruction, the wild Nymphaeae Flos resources are increasingly depleted, and species conservation is urgent.

Objective: To systematically analyze the common deficiencies in pharmaceutical studies during the registration of semi-solid generic drugs, providing references for improving registration quality and promoting high-quality industry development. Methods: Based on the integrated analysis of regulatory deficiency letters from agencies such as the FDA and EMA, domestic assessment cases, and technical guidelines, an in-depth analysis were conducted across four dimensions: formulation design, manufacturing process, quality control, and stability. Results: The common problems in various modules of the registration of semi-solid generic drugs were systematically distributed: Formulation design: Inadequate assessment of critical API properties (e.g., solubility/polymorphism/particle size), weak justification of Q1/Q2 equivalence, and insufficient structural characterization of polymeric excipients. Process control: Incomplete identification of critical process parameters (CPP), lack of studies on intermediate products, absence of scale-up bridging. Quality studies: Deficiencies in impurity methods, incomplete characterization (Rheology/IVRT/IVPT). Stability: Insufficient monitoring of physical attributes, inadequate justification for shelf-life. Conclusion: The root cause of these deficiencies lies in the inadequate application of the quality by design (QbD) principles. Enhancing QbD-driven formulation/process development and establishing systematic control strategies will accelerate the review and approval process, and drive industry advancement.

Objective：To optimize the intelligent management model of drugs in wards, improve the efficiency of pharmacists and healthcare professionals, and enhance the efficacy of clinical drug management. Methods：This study was conducted in 20 wards equipped with Automated Dispensing Cabinets (ADC) in Beijing Tongren Hospital. The initial construction of the intelligent drug management model in these wards was completed between March and November 2023. From December 2023 to November 2024, SWOT-CLPV (Strength, Weakness, Opportunity, Threat - Control, Leverage, Problem, Vulnerability) analysis was employed to deeply analyze the internal strengths and weaknesses, external opportunities and threats, as well as the resulting leverage, inhibitors, vulnerabilities, and potential problems of drug management in wards. Based on these findings, optimization strategies were developed. Pre- and post-optimization data were compared, and an effectiveness analysis was conducted on the implementation effects. Results：After applying SWOT-CLPV analysis and implementing optimization strategies, the proportion of ward night medical prescriptions transferred to the emergency pharmacy decreased from 48.97% to 21.93%, while the proportion of nighttime medical orders processed through the ADC pattern increased from 51.03% to 78.07% after optimization, with statistical significance (P<0.05). The variety of base drugs in wards was decreased significantly (P<0.05). All aspects of nurses’ satisfaction have shown significant improvement (P<0.05). Conclusion：The application of the SWOT-CLPV analysis method to optimize the intelligent management model of drugs in wards has yielded preliminary success, and has reference and promotion value.

Objective：To investigate the influence of matrix effect on the accuracy of detection of pesticide residue in Chrysanthemum. Methods：Gas chromatography-mass spectrometry (GC-MS/MS) and liquid chromatography-mass spectrometry (LC-MS/MS) were used to detect the banned pesticides in chrysanthemum decoction pieces from different habitats. GC-MS/MS was performed on a DM-17MS column (30 m × 0.25 mm, 0.25 μm) with high-purity helium as the carrier gas, temperature programmed, and detected by electron impact source (EI); LC-MS/MS was performed on an Agilent SB-C₁₈ column (10 cm × 2.7 mm, 2.1 μm) with 0.1% formic acid solution (containing 5 mmol · L^-1 ammonium formate) as mobile phase A and 95% acetonitrile solution (containing 5 mmol · L^-1 ammonium formate and 0.1% formic acid) as mobile phase B. Gradient elution and electric spray (ESI) ion source detection were performed. The effects of sample matrix (direct extraction, QuEChers, and solid-phase extraction) and different matrix concentrations (0.2 g · mL^-1 or 0.5 g · mL^-1) on the detection results of pesticide residues under different pretreatment methods were investigated. Results：In the detection process of banned pesticides in Chrysanthemum, over 40% pesticides showed strong matrix effect. By reducing the matrix concentration of the sample, the matrix effect could be effectively reduced and the matrix effect difference of pesticides by more than 80% among different batches of Chrysanthemum could be reduced. Different pretreatment methods had no significant improvement in the matrix effect of most indicators, but could reduce the pollution of the matrix to the instrument. In order to reduce the influence of matrix effect on the accuracy of determination, matrix matching method should be used in daily detection. Conclusion：Matrix effect cannot be ignored in the detection of pesticides in Chrysanthemum and reducing the sample matrix concentration can effectively reduce the impact of matrix effect differences on the detection results,which provides a reference for improving the accuracy of pesticide detection method of traditional Chinese medicine.

Objective: Adjuvants for traditional Chinese herbs processing are an important part of traditional Chinese herbs, and elucidating the mechanism of processing adjuvants is a powerful starting point for promoting the modernization of traditional Chinese herbs. This article summarizes the research progress on the mechanism of adjuvants for traditional Chinese herbs processing, and provides a reference for optimizing the processing technology of traditional Chinese medicine, establishing standards for processing excipients, and supervising drug quality. Methods: The relevant literatures of traditional Chinese medicine processing adjuvants in recent years were summarized, the research methods and results adopted by them were compared and analyzed, and the existing problems and countermeasures in the current research were discussed. Results and Conclusion: Studies showed that adjuvants used in processing of traditional Chinese herbs can play roles in solubilizing, attenuating, synergizing, absorption-promoting and other aspects, consequently, affecting the effectiveness and safety of the drug. We should take full advantage of modern analytical techniques to compare the changes of chemical composition of adjuvants before and after processing, and carry out systematic research by combining pharmacodynamic and pharmacokinetic methods.

Objective：To investigate the current status of clinical pharmaceutical services in county and municipal hospitals in Gansu Province, identify existing problems, and proposes solutions to provide references for the high-quality development of clinical pharmacy services in hospitals of our province. Methods：In June 2024, a questionnaire survey method was conducted to investigate the implementation of clinical pharmacy services in secondary and tertiary hospitals under the jurisdiction of county and municipal administrative regions throughout the province. The results were statistically analyzed. Results：A total of 168 valid questionnaires were collected, with 75.6% of the respondents coming from secondary hospitals. The configuration rate of the prescription pre-audit systems was 33.3%, the staffing rate of clinical pharmacists was 67.3%. The implementation rate of clinical pharmaceutical services, regular prescription review and special prescription review was 81.0%, 79.2% and 87.5% respectively, while pharmacy clinics’ rate was 22.0%. Conclusion：The clinical pharmaceutical services in county and municipal hospitals in Gansu Province have achieved certain development, but there is a gap compared with the overall development level in China. In the future, it is necessary to further promote the high-quality development of clinical pharmacy services by strengthening information technology construction and pharmacy talent training.

Objective：To understand the overall quality status and existing problems of Bao’erning pharmaceutical preparations, to provide technical support for the supervision of Bao’erning pharmaceutical preparations, and to ensure the safety of public medication. Methods：According to the current legal standards, 43 batches of Bao’erning pharmaceutical preparations samples were inspected from 2021 to 2023, and the exploratory research was carried out from the aspects affecting the safety and efficacy of the drug, and the analysis was carried out according to qualified rate of samples and the contents of active ingredients and heavy metal. Results：A total of 43 batches of this drug were sampled and tested over 3 years. Inspection according to current standards, the 43 batches had a 100% qualified rate of samples. Exploratory research was conducted on the contents of active ingredients in Bao’erning syrup and heavy metal contents in Bao’erning granules. There were significant differences in the contents of active ingredients in different batches of Bao’erning syrup, and the contents of Pb, Cd, Hg, As, and Cu in Bao’erning granule samples were far below the limit. Conclusion：The quality of Bao’erning pharmaceutical preparations are good, but the inspection standards still need to be further improved and perfected. The two detection methods established through exploratory research are easy to operate, accurate in results, and highly sensitive, which have good reference value for improving the quality standards of Bao’erning pharmaceutical preparations.

Objective：To provide reference and insights for optimizing the continuing education system of licensed pharmacists in China. Methods：The characteristics of the continuing education system of licensed pharmacists in the United States were comprehensively introduced and analyzed by combing the relevant literature, official websites, official guidelines and reports of relevant institutions, and the countermeasures and suggestions were put forward to optimize the continuing education system of licensed pharmacists in China. Results：In the United States, licensed pharmacists hold a high professional status, with a well-established continuing education system that embodies the concept of lifelong learning. The continuing education system of licensed pharmacists in the United States fully leverages market mechanisms, with educational content and form that combine standardization and personalization, effectively promoting the continuous development of licensed pharmacists’ professional capabilities. Conclusion：China should fully learn from the continuing education system of licensed pharmacists in the United States, strengthen the top-level design and cultivate the practicing environment; establish a unified standard, optimize the management mechanism; renew the content of education and enrich the form of education; increase funding guidance and improve service guarantees.

Objective: To provide guidance for enterprises and some ideas for improving the work efficiency of raw materials filing of chemical reference substances. Methods: Study the relevant laws and regulations, sort out the filing process, and analyze it in combination with filing examples to distill the key points of filing raw materials for chemical reference substances. Results and Conclusion: The key points of the relevant requirements for filing materials and raw materials were clarified in this paper, which analyze from multiaspect and put forward suggestions. The filing of raw materials with high quality and strict requirements is crucial to the development of national standard substances, which provide the important guarantee for the quality supervision and people's medication safety.

Objective：To evaluate the batch consistency and stability of the anti-programmed death receptor 1 (anti-PD-1) monoclonal antibody by conducting a trend analysis of the test results of key quality control items. Methods：Statistical and trend analyses were performed on the detection results of 93 batches of anti-PD-1 monoclonal antibodies for key quality control items from the National Institutes for Food and Drug Control(NIFDC) and the manufacturer. The analyzed items included SEC monomer content, HIC front peak(1+2) content, biological activity, protein content, and pH value. Alert and action limits were established, and abnormal results were investigated. Results：The results of the SEC monomer content by the two laboratories were both between 99.7% and 99.9%. The protein content, biological activity and pH value were all within the action limit range. The average values of the HIC front peak(1+2) content of the enterprise and NIFDC were (5.42±0.33)% and (5.44 ± 0.34)% respectively. The biological activity and protein content by the two laboratories were statistically analyzed, and the results showed no statistical difference. Based on the aforementioned trend and statistical analyses, this study identified a year-on-year increasing trend in the HIC front peak(1+2) content detection results from the manufacturer. NIFDC promptly informed the manufacturer to initiate cause investigation and risk assessment. Conclusion：The quality monitoring strategy combined with trend analysis and statistical analysis used in this study effectively identified potential quality fluctuations during the production and testing of anti-PD-1 monoclonal antibody. This study provided critical quality assurance to ensure batch consistency and clinical safety of anti-PD-1 monoclonal antibody.

Objective：To provide references for laboratory capacity building and further promote the improvement of the laboratory management and technical capacities for medical product inspection and vaccine lot release network in China. Methods：The development process of the World Health Organization’s (WHO) National Regulatory System (NRA) assessment tool for vaccines was introduced. The capacity building process of the National Control Laboratory (NCL) for vaccines in China during the recent WHO assessment was reviewed and analyzed. The experiences and enlightenment of laboratory capacity building were summarized. Results and Conclusion：The WHO NRA Global Benchmarking Tool (GBT) has been revised and developed several times, gradually improving into a global benchmark tool covering the entire regulatory chain. With the National Institutes for Food and Drug Control (NIFDC) as the core, China has progressively established a network of vaccine lot release laboratories that comply with international standards by systematically advancing the construction of laboratory quality management systems and personnel capabilities. The construction experiences include aligning with international standards, meticulous preparation, departmental collaboration, mock internal audits, and continuous optimization. The NRA assessment is not only an international certification process but also an important mechanism for continuously improving the national vaccine regulatory system and enhancing the international level of regulatory capacities. Although the NCL in China has fulfilled the requirements of the WHO, continuous improvements are still needed in quality management, communication and coordination, and performance management, to progress towards a more advanced level of maturity.

Objective：To analyze the current status of pharmacovigilance development in the Guangdong-Hong Kong-Macao Greater Bay Area and provide references for exploring the construction of an innovative pharmacovigilance system in the Greater Bay Area. Methods：Unstructured interviews were conducted with 15 key informants respectively across the three regions of Guangdong, Hong Kong, and Macao. The collected data were subsequently coded and analyzed through the thematic framework analysis using NVivo 12 software to investigate the current status of the pharmacovigilance system in the Guangdong-Hong Kong-Macao Greater Bay Area. Results：Based on the interview records, the contents were summarized into three themes which were the basic situation of the pharmacovigilance system in the Greater Bay Area, existing problems and challenges, and recommendations. Pharmacovigilance system included regulation system, organization system, and technical processes. The existing problems mainly included the challenges faced by data information sharing and utilization, implementation of pharmacovigilance work, public participation in pharmacovigilance, and differences among the three regions. In response to the problems, experts gave suggestions on data sharing, information communication, and public engagement in pharmacovigilance. Conclusion：The pharmacovigilance systems in the three regions of the Guangdong-Hong Kong-Macao Greater Bay Area are well-established, with distinct characteristics in their legal frameworks, regulatory structures, and practical implementation. To enhance the pharmacovigilance system and achieve coordinated drug regulation in the Guangdong-Hong Kong-Macao Greater Bay Area, it is necessary to establish an information communication and data sharing platform, unify regulatory standards across the Greater Bay Area, enhance public engagement in pharmacovigilance, and strengthen talent cultivation and education.

Objective: In April 2024, the U.S. Food and Drug Administration (FDA) officially required all approved CAR-T therapeutic products to add a boxed warning, alerting patients and prescribers about the potential T-Cell malignancy risk post-treatment. This announcement has drawn global attention and made CAR-T safety a research priority. This minireview retrospected the boxed warning issuance and reviewed the latest progress on CAR-T-induced secondary primary tumors (especially T-Cell lymphomas). Methods: Based on the current understanding of CAR-T products, the study conducted a systematic review of the literature related to CAR-T therapy and secondary primary tumors, including T-Cell lymphomas, by searching public databases. The study also reviewed relevant announcements on the FDA website and other publicly available information sources to summarize the chronology of this event and the latest research progress. Results and Conclusion: By examining the clinical evidence between CAR-T therapy and secondary primary tumors, including T-Cell lymphomas, the study analyzed the potential mechanisms, and discussed how to coordinate within the area to reduce the secondary primary tumor risk, aiming to advance CAR-T optimization and offer safer and more effective cancer treatment options for the patients.

Objective：To provide references for drug production and regulatory departments to strengthen the management and enforcement of drug quality standards, standardize the formulation and revision of such standards, and improve the accuracy of drug registration information, ultimately contributing to the high-quality development of the industry. Methods：By investigating the management and enforcement of quality standards in pharmaceutical production enterprises and medical institution pharmacies, combined with the issues identified through drug supervision sampling inspections and commissioned testing, the corresponding improvement measures and suggestions were addressed for the challenges existing in drug quality standard inquiries, management and enforcement, formulation and revision, drug instruction leaflet management, and drug registration (re-registration). Results and Conclusion：The management and implementation of drug quality standards should be organically integrated with drug production, drug registration management, drug instruction leaflet management, and drug supervision. It is necessary to strengthen the learning, training, and implementation of relevant laws, regulations, and technical norms to guarantee the rigorous implementation of the most stringent standards and ensure drug safety, efficacy, quality control.

Objective：To establish a method for measuring the particle size of virus-like particles using nano-flow cytometry. Methods：The particle size of human papillomavirus (HPV) vaccine bulk solution was measured using a nano-flow cytometer (2L12C) and compared with dynamic light scattering and negative staining electron microscopy. Results：The particle size of 6 batches of HPV vaccine bulk solution was measured using the nanoparticle flow cytometry method, with average sizes of 63.35 nm, 74.87 nm, 73.62 nm, 73.07 nm, 61.85 nm, and 62.67 nm, and relative standard deviations of 1.04%, 0.81%, 0.60%, 0.52%, 0.55%, and 0.30%, respectively. The results obtained by dynamic light scattering were 57.86 nm, 120.29 nm, 117.18 nm, 112.20 nm, 75.93 nm, and 77.42 nm. There was a significant difference in the results of 3 batches between these two methods. However, the results of nanoparticle flow cytometry were close to those of negative staining electron microscopy. In the accelerated thermal test, the average particle size increased to 90 nm after 6 hours. Conclusion：The nano-flow cytometry is a rapid, accurate, and convenient method for measuring the particle size of virus-like particle vaccines bulk solution.

Object: Driven by continuous improvement of computing power, artificial intelligence (AI) models, with their outstanding data analysis and processing capabilities, are gradually transforming drug development through advanced data analysis, offering new approaches for improving drug quality. The traditional pharmaceutical regulations struggle to address AI's deep integration into manufacturing, failing to meet Good Manufacturing Practice (GMP) requirements. Current implements and potential research directions of AI models in pharmaceutical industry are discussed in order to provide theoretical frame and practical basis for future construction of the regulatory framework that aligns with the characteristics of AI models. Methods: The current applications of AI models in the pharmaceutical quality systems were explored, and the regulatory challenges in process control, risk monitoring and decision-making were analyzed, providing foundational insights for developing AI-specific regulatory frameworks. Resultsand Conclusion: Challenges in data reliability and traceability, model transparency and interpretability, dynamic adaptability and verifiability are discussed. Potential research directions from the aspects of artificial intelligence model validation requirements, large model data management standards, and hierarchical management of artificial intelligence models are explored. We aim to provide theoretical references and practical bases for future research on artificial intelligence model regulatory strategies.

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.

Objective：To comprehensively explore the application of quality risk management (QRM) in the quality management of pharmaceutical distribution enterprises, and to provide references for QRM in the pharmaceutical distribution industry. Methods：By analyzing different ways of QRM, using literature review and other methods, and combining with the current development characteristics of the industry, the application of QRM in the quality management of drug circulation was explored. Results：The awareness of QRM among domestic pharmaceutical distribution enterprises is gradually increasing, and preliminary QRM systems have been established. However, there are still some shortcomings, including insufficient corporate risk awareness, incomplete quality management systems, operational quality risks in various aspects of drug circulation, and inadequate risk awareness in supplier-client transactions. Conclusion：Despite some improvement in the QRM level of domestic pharmaceutical distribution enterprises, significant challenges remain. Risk assessment is of great significance in the quality management process of pharmaceutical distribution enterprises, which can help improve the quality management level of pharmaceutical business enterprises and strengthen safety production management. So, in practical operation, it is still necessary to continuously improve and refine risk assessment methods and tools, strengthen supervision and management, ensure the effective implementation of the quality management systems, and promote the sustainable development of drug safety management.

Objective：To evaluate the impact of the bidding access for drugs with generics available on drug accessibility, and make recommendations with a view to improving bidding access and enabling drugs to be used in a wider range of regions, to be consumed at more economical treatment costs. Methods：The article sorted out the 2020Q1-2023Q4 procurement data of 17 drugs entered in the medical insurance catalogue through bidding access in 2022 in the Menet-Key City Public Hospital Chemical Drug Terminal Competitive Pattern Database. From the aspect of drug acquisition, drug availability, defined drug dose numbers, expenditure were selected, and from the aspect of disease affordability, defined daily drug cost was selected. The changes of the paramaters above were analyzed by combining descriptive statistical analysis and interrupted time series model. Results：80% of the included cities were equipped with more than or close to 48% drugs. The quarterly average defined drug dose numbers for all types of drugs rose and exceeded 50%, and the growth rate of neurological drugs, antineoplastic drugs and immunomodulators reached 2638.88% and 1209.99%, respectively, whose growth rate ranked in the top two. The growth rates of the expenditure of neurological drugs, systemic anti-infective drugs, antineoplastic drugs and immunomodulators were higher, respectively 719.58%, 400.08% and 293.91%. The defined daily drug costs of all types of drugs decreased, more than half of which fell to>50% of the original, and the declines of blood and hematopoietic organ drugs, and neurological drugs were more significant, respectively 80.36% and 70.07%. At the same time, changes in the above paramaters were statistically significant for most drugs. Conclusion：While continuing to promote bidding access, the structure of access drugs needs to be further optimized and drug access channels should be gradually broadened.

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.

Objective：To analyze various issues in data and records management of pharmaceutical business enterprises based on on-site inspections, and to provide references for precise and efficient supervision by drug regulatory authorities and continuous optimization and improvement of enterprises. Methods：A total of 126 on-site inspection reports involving pharmaceutical distribution enterprises were reviewed. Deficiency items related to data and records management were analyzed, summarized, and categorized based on practical work experience. Countermeasures and suggestions were proposed accordingly. Results：A total of 429 deficiency items related to data and records management were identified, including 3 critical deficiencies, 194 major deficiencies, and 232 minor deficiencies. High-frequency deficiency items predominantly involved issues in two key systems: automatic temperature and humidity monitoring systems and computerized systems. The problems in the automatic temperature and humidity monitoring system were mainly manifested as questionable authenticity, missing important data, reduced accuracy, weak traceability, and insufficient standardized management. The problems in the computer system were mainly manifested as inaccuracy, incompleteness, untimely updates, difficult traceability, and blocked data interaction between systems. Conclusion：The problems in data and record management of enterprises are still prominent. Pharmaceutical regulatory authorities, industry associations, and enterprises should work together to guide and improve the situation. Pharmaceutical regulatory authorities should adhere to the combination of supervision and service, enhance the compliance ability of enterprises through policy guidance and technical support, and rely on the big data platform of pharmaceutical supervision to achieve diversified supervision of “non - on - site monitoring - dynamic early warning - targeted verification”. They should also join hands with industry associations to strengthen the construction of the platform and guide the third parties, and implement zero - tolerance supervision and deterrence for intentional malicious behaviors. Enterprises should focus on both hardware and software construction, promote automated management through the investment in modern hardware equipment, enhance subjective initiative by changing the awareness of personnel, and form a full - process closed - loop management of risk elimination through the application of risk management tools.