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 study the establishment and optimization of the pathogen targeted next-generation sequencing (tNGS) process based on the probe capture method, as well as the automated implementation of it, and to verify the analytical performance. Methods: The factors influencing the tNGS methodology were analyzed, including the probe design and production quality control, data volume and sequencing read length. The analytical performance was evaluated by using a reference panel constructed with 62 types of microbes, including various bacteria, fungi, viruses, and atypical pathogens. As well as, the differences in limit of detection, precision and cross-contamination between manual operations and automated were compared. Results: The study showed that as the probe coverage increased, the limit of detection performance increases accordingly, and the probe still maintained high specificity. The optimized tNGS demonstrated good analyze performance in terms of accuracy, limit of detection, precision, specificity linearity and so on. Under the premise of the same limit of detection performance, the automated method was superior to manual operation in precision and cross-contamination resistance performance. Conclusion: The tNGS process established in this study has good analytical performance and provides a new strategy for clinical pathogen detection. Future studies should focus on clinical sample confirmation and automated process validation to promote better application of the technology in practical clinical work.

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 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 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.

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 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.

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.

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.

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 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.

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.

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.

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 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.

Objective: To provide references for more Chinese proprietary medicines listed in China that will register and market in Singapore, by introducing the regulatory requirements of Singapore’s Chinese proprietary medicine access, and analyzing the key factors that affect the registration of Chinese proprietary medicines. Methods: By sorting out the relevant laws and regulations and technical application guidelines, risk focus reminders from the project screening stage, document preparation and review stage were provided, and further suggestions were given from the perspectives of overseas registration cooperation models and the foresight and homogeneity of registration dossiers preparation. Results and Conclusion: Singapore drug regulatory agency has formulated separate review and approval procedures for the registration management of Chinese proprietary medicines. It is recommended that domestic pharmaceutical companies should first determine the registration category and implementation path of the products intended for registration based on the company’s strategy, and then identify the rights and interests model with the partners, simultaneously improve the registration technical dossiers and carry out registration test. If necessary, communication with the Singapore regulatory agency can be conducted as early as possible.

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：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 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.

Objective: To analyze the registration history of traditional Chinese medicine (TCM) generic drugs and the registration application in the past 20 years, explore the development status of medicine with the same name and prescription, and to provide reference for their development. Methods: A systematic analysis was conducted on the changes in the registration policies of TCM generic drugs in China, as well as the general situations such as the registration applications and the approvals for production of TCM generic drugs or drugs with the same name and prescription from 2003 to 2024. The evolution of the registration policy of TCM generic drugs, the characteristics of registration declaration in each stage, and the risks and opportunities of research and development of the medicine with the same name and prescription were discussed. Results: From 2003 to 2024, the registration applications and the approvals for production of TCM generic drugs or medicine with the same name and prescription had obvious policy-driven characteristics, showing a clear three-stage evolutionary process. From 2003 to 2006, there was a rapid increase in the number of registration applications and approved production for “generic standards” with low entry barriers. From 2007 to 2021, there was a high entry barrier for “generic varieties”, and the number of registration applications and approvals plummeted and continued to be low. With the announced of the “medicine with the same name and prescription” in 2020 and the advancement of relevant regulations, both registration applications and approvals have gradually recovered. However, it has not been active since 2022. As of 2024, there have been 6 registration applications for the same name and prescription, with 1 of them approved for market launch. Conclusion: The concept of drugs with the same name and prescription is different from that of generic drugs. Although it has the meaning of the generic drug in chemical medicine, it represents a qualitative improvement in the concept of TCM generic drugs. Currently, the registration applications of drugs with the same name and prescription are mainly for individual varieties. However, in the long term, there may be some regular development model. From the perspectives of variety selection, clinical trials and research risks, the development of drugs with the same name and prescription presents both opportunities and risks.

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 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.

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 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.

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 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.

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.

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 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 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 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 explore the prospects of artificial intelligence (AI) in the drug control system based on the current development of AI technology, so as to further promot the development of drug control. Methods: The current AI technology was analyzed, and its application scenarios in the drug control system were discussed by considering the actual conditions of the system. In addition, the existing issues were analyzed and the solutions were proposed. Results and Conclusion: AI technology, as an emerging auxiliary tool, has great potential and is of great significance for improving the efficiency and quality of the drug control system. In the face of this upcoming change, it is essential to have a clear understanding, reasonable planning, and adequate preparation to ensure the sustainable development of AI technology in the drug control system.

Objective: To systematically elaborate the design and clinical trial requirements of respiratory multiple pathogen nucleic acid detection kits in China, so as to provide a reference for the development and clinical trials of related products. Methods: The approval overview of respiratory multiple pathogen were summarized. Combining the expected clinical situation and related diagnostic consensus, an in-depth analysis was conducted on the considerations in technical review process of relevant products from the aspects of the combination of pathogens covered, the applicable sample types, the expected applicable population, and clinical trial requirements. Results and Conclusion: Respiratory multiple pathogen nucleic acid detection kits play a significant role in the auxiliary diagnosis of respiratory tract infections. The product design should align with intended use, and the principal investigators of clinical trials should combine the design and intended use of the products, thoroughly studying the enrolled population, comparative methods, number of cases, and statistical analysis to evaluate the clinical performance of the products more scientifically and reasonably, and facilitate timely regulatory approval.

Objective: To explore the multidisciplinary management method of restricted drugs under the national medical insurance catalog, and to establish a pharmaceutical intervention mode to control medical insurance restricted drugs by standardized diagnosis and treatment audit center. Methods: Through the establishment of the whole process intervention mode of pre reminder and interception intervention, in-process interactive audit intervention, post prescription (medical order) comment and on-site supervision intervention, the amount of delinquent medical insurance restricted drugs involved in the flight inspection of the municipal medical insurance bureau before the implementation of the intervention mode (January 1, 2020 ~December 31, 2021) and after the implementation (January 1st, 2022 - December 31st, 2023) were analyzed and compared, as well as the reasonable payment rate of medical insurance restricted drugs in the special inspection of medical insurance, and the self-examination of suspected exceed-indication drug use. Results and Conclusion: After the implementation of the intervention mode of the standardized diagnosis and treatment audit center, the amount of delinquent medical insurance restricted drugs involved in the flight inspection of the municipal medical insurance bureau, the reasonable payment rate of medical insurance restricted drugs in the special medical insurance inspection, and the suspected exceed-indication drug use were significantly improved. By the pharmaceutical intervention in the standardized diagnosis and treatment audit center, it effectively promoted the rational use of drugs and helped the management of medical insurance restricted drugs.

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 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：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 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.

Objective: To investigate the mechanism of Rabdosia rubescens against metabolic-associated fatty liver disease (MAFLD) base on metabonomics. Methods: Male SD rats were randomly divided into groups of normal, model, fenofibrate, low-dose and high-dose Rabdosia rubescens. The MAFLD rat model was induced by a high-fat diet for 12 weeks, with daily gavage administration of the respective drug interventions. The body weight and food intake of rats were recorded. The liver index was measured. The levels of total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) in serum and liver were detected, along with the levels of malondialdehyde (MDA), superoxide dismutase (SOD), glutathione (GSH), tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the liver. Oil red O and hematoxylin-eosin (HE) staining were used to observe liver histopathology. Ultra-high performance liquid chromatography tandem mass spectrometry (UPLC/MS) technology was used to detect the level of endogenous metabolites in the serum and liver of rats, and principal component analysis and orthogonal partial least squares discriminant analysis were used to screen and identify differential metabolites. MetaboAnalyst platform was used for metabolic pathway analysis. Results: Compared with the results in the model group, the body weight and liver index of rats in the Rabdosia rubescens administration group significantly reduced (P<0.001), and the liver histopathological abnormalities improved. The levels of TC, TG, LDL-C, ALT, and AST in serum and liver significantly decreased (P<0.05, P<0.01, P<0.001). The levels of MDA, TNF-α, IL-1β, and IL-6 in the liver significantly decreased (P<0.05, P<0.01, P<0.001), and GSH and SOD levels significantly increased (P<0.05, P<0.001). A total of 41 potential differential metabolites related to MAFLD were screened by serum and liver metabonomics, and 20 differential metabolites were regulated in the Rabdosia rubescens administration group, which mainly involved 5 metabolic pathways including glycerophospholipid metabolism, arginine biosynthesis, pantothenate and CoA biosynthesis, cofactors biosynthesis, and pentose and glucuronate interconversions. Conclusion: Rabdosia rubescens effectively improved the lipid metabolism disorders caused by MAFLD and alleviated oxidative stress and inflammation in the liver, which may be related to regulating lipid, amino acid, carbohydrate, cofactors and vitamins metabolism.