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 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 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 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：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: 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 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 explore the application pathways, challenges, and development directions of artificial intelligence (AI) in empowering pharmacy services, and to provide references for promoting the high-quality development of smart pharmacy and improving healthcare service standards. Methods: By analyzing the specific AI applications in pharmacy services (such as intelligent prescription review, automated dispensing, medication management, medication consultation and education, etc.), this study examined its technical empowerment mechanism, summarized the application effects based on actual cases, simultaneously analyzed the current challenges from the aspects of technology, law and ethics perspectives. Results: AI has already shown significant value in pharmaceutical services, including the interception of unreasonable prescriptions by intelligent prescription review systems and the increase in prescription volume by automated dispensing systems. However, there were still challenges such as incomplete technical standards, insufficient data quality and system compatibility, ambiguous accountability, and data privacy risks. Conclusion: AI provides an important opportunity for the transformation of pharmacy service models, which can significantly improve service efficiency and quality. However, challenges need to be addressed through measures such as improving technical standards, establishing legal frameworks, and strengthening ethical oversight to promote the maturation of AI-pharmacist collaborative service models, ensuring patient medication safety and enhancing healthcare service standards.

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 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.

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 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 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: 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 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: By statistically analyzing the deficiencies found in routine inspections of non-compliant drug wholesale enterprises and retail chain headquarters in Guizhou Province within three years after the implementation of the “Drug Inspection Management Measures (Trial)”, this study aims to identify common issues and risk points, propose corresponding measures and suggestions, and provide references for drug supply enterprises to standardize operations and for regulatory authorities to better control risks in the drug circulation process and develop more targeted supervision strategies. Methods: A retrospective statistical analysis was conducted on the deficiencies identified in 43 non-compliant enterprises during routine inspections in Guizhou Province from 2022 to 2024. The key problematic areas were identified and analyzed. Results: A total of 440 deficiencies were recorded, including 40 critical deficiencies, 235 major deficiencies, and 165 minor deficiencies. High-frequency deficiencies were primarily concentrated in areas: quality management system documentation, storage and maintenance, organizational and quality management responsibilities, personnel and training, and facilities and equipment, accounting for 60% of the total deficiencies. Conclusion: Enterprises should continuously enhance legal and safety awareness, strengthen primary responsibility in operations, improve quality management systems, reinforce personnel training and facility management, and meet hardware requirements. Regulatory authorities should intensify the dissemination of laws and regulations, promote collaborative social supervision, expand professional teams through resource coordination, form regulatory synergy, and innovate supervision methods to improve precision and effectiveness.

Objective: To analyze the current situation and existing problems of drug supervision and sampling inspection in Shaanxi local municipalities, in order to provide reference for supervision and sampling inspection. Methods: Summarize the current situation and existing problems of drug supervision and sampling inspection, analyze the causes, and provide reasonable suggestions. Results: There were some problems in sampling inspection, such as insufficient standardization of sampling, insufficient sharing of information resources, insufficient coordination of sampling supervision, insufficient balance of coverage, and strengthening of result processing and risk prevention and control. Conclusion: It is suggested to start from strengthening personnel training, improving the information sharing mechanism, innovating the sampling mode, and strengthening exploratory research, to build a four-in-one system of “sampling-research-regulation-service”, ultimately promoting the development of sampling inspection, promoting the high-quality development of the pharmaceutical industry and public drug safety.

Objective：To provide reference suggestions for the improvement and perfection of the communication methods and relevant systems before medical device registration in China. Methods：By summarizing the consultation mechanisms employed during the pre-registration phase for medical device registration, specifically the technical consultation administered by the Center for Medical Device Evaluation (CMDE) under National Medical Products Administration (NMPA) and the pre-submission program implemented by the Food and Drug Administration (FDA) of the United States, a comparative analysis was conducted, and suggestions for improving the pre-registration communication system for medical device registration in China from a regulatory perspective were proposed. Results：There were certain differences between pre-registration technical consultation in China and pre-submission in the United States in terms of submission methods, such as information requirements for submission, response time limits, and the application of feedback results. The pre-registration technical consultation of CMDE featured featured and more efficient submission methods and shorter response time limits; whereas the FDA pre-submission had more specific requirements for submitted information, and its feedback results generally held greater evaluative authority. Conclusion：It is suggested that regulatory authorities strengthen information technology construction, use Artificial Intelligence (AI) tools to provide auxiliary support for consultation and communication; adopt a “hierarchical processing” mechanism for consultation questions, clarifying the application conditions, material requirements, time limit specifications for both simple/routine questions and complex/difficult issues; continuously optimize the technical evaluation team, consolidate professional capabilities to ensure the scientific and rigorous communication; optimize various communication channels, build a normalized multi-departmental regular communication platform, further refine the “early intervention” process, and improve the communication mechanism; strengthen the supervision and management of communication, establish a regular inspection and evaluation mechanism, routinely collect opinions and suggestions from medical device registration applicants on the communication mechanism, and continuously optimize and improve the communication system.

Objective: To provide references for further optimizing the National Drug Quality Sampling and Testing process management strategies by comparing the checklist requirements and recommended procedural framework of the Market Surveillance and Control (MC) module in the GBT assessment tool. Methods: The literature research method was adopted to summarize the checklist requirements and recommended procedural framework of the MC module in the GBT assessment tool, and key risk factors according to the proposed targeted process management optimization strategies of the National Drug Quality Sampling and Testing program were analyzed. Results: Comprehensive analysis revealed that 17 indicators were highly relevant to the National Drug Quality Sampling and Testing program, covering six aspects including legal and regulatory framework construction, organizational management structure, human resource management, procedural document management, system and data management, and risk communication and information disclosure. The analysis of the MC module shows that a good post-market quality surveillance framework should have a regulatory framework and work procedures covering the entire process from sampling, testing research, to risk assessment and mitigation; establish a clear and stable, well-defined organizational structure and be able to form regulatory decisions comprehensively and objectively; construct a personnel management and training system conducive to the implementation of post-market quality surveillance activities; build a database management platform covering the entire process of surveillance, providing trend analysis and regulatory tools to guide the prevention and control of counterfeit and substandard medical products, as well as assessment indicators tailored to different functional requirements, and simultaneously form an international risk information sharing and collaborative disposal system. Conclusion: As a specific form of post-market quality surveillance activities, the National Drug Quality Sampling and Testing program, by further refining the process management system in accordance with the above framework requirements, is conducive to forming management standards and risk management pathways with international compatible. This, in turn, enables a more profound participation in global safety governance. It is suggested to strengthen online sampling and expand international cooperation at the regulatory framework level; establish a sound decision-making consultation system in terms of organizational management structure; construct a training effect evaluation mechanism in terms of human resource management; build and enrich trend analysis tools in terms of system and data management; and enhance the communication, and reinforce an international risk information sharing and collaborative disposal system in terms of risk communication and information disclosure.

Objective: To construct a system of capability indexes and evaluate credibility and effectiveness of drug administrators in the drug management of clinical trial institutions. Methods: The Delphi method (expert correspondence inquiry) and analytic hierarchy process were employed. Relevant domestic and foreign literature was referred to. Through expert consultation and discussion within research group, a competence index system for clinical trial drug administrators was established. The AHP was applied to determine the weights of indicators at all levels. The reliability of the results was evaluated through a questionnaire survey. Results: A total of 21 experts were selected for the consultation, including 16 female experts (76.19%). The age of the experts was 38.32±6.85 years; 19 experts (90.48%) had a master's degree or above, and 9 experts (42.86%) had a deputy associate senior professional titles or above (42.86%). The average duration of their engagement in drug clinical trial work was 6.98±2.01 years. The recovery rates of the questionnaires in both rounds of expert consultation were 100%, indicating high expert engagement. The familiarity degree of the experts with the consultation content was 0.942, the basis degree of the experts' judgment was 0.933, and the authority degree of the experts was 0.937, indicating that the consultation results were relatively reliable. The coordination degree of expert' opinions was expressed by the intraclass correlation coefficient, and both the primary and the secondary indicators were higher than or equal to 0.75, indicating high reliability. A significance level of P<0.05 confirmed statistical consistency. After two rounds of consultations, the core competency evaluation scale for pharmacy dispensers was finally determined, including six primary indicators and sixty-six secondary indicators. Weight analysis revealed that among the six primary indicators, the weight value of “possession of drug clinical trial expertise” was the highest, and the weight scores of all secondary indicators under the primary indicators were also relatively high. Questionnaire survey results confirmed good internal consistency of the indicator system. Conclusion: The evaluation index system model of the ability of hospital pharmaceutical administrator constructed in this study can provide reference basis for the improvement of the ability of hospital pharmaceutical and the training selection of drug clinical trial pharmaceutical administrator.

Objective: To establish an intelligent logistics model based on rail cars in the central pharmacy and evaluate its application effectiveness. Methods: A medication delivery system utilizing the rail car logistics system was developed and refined. The traditional manual logistics model and the intelligent logistics model were compared and evaluated using metrics including drug delivery time, drug delivery error count, labor costs, and departmental satisfaction scores. Results: The central pharmacy implemented an intelligent logistics model featuring human-robot collaboration, barcode-scanning delivery, real-time alerts, and closed-loop traceability. Drug delivery time and error count decreased by 65.92% and 63.01%, respectively. Labor costs were reduced, with logistics personnel decreasing from 11 to 5. Clinical department satisfaction scores reached above 93 points. Conclusion: The intelligent logistics model based on rail car enhances drug delivery efficiency, reduces errors, and improves pharmacy service levels.

Objective: To ensure safety, efficacy and quality control of clinical trial drugs, promote the effective operation and continuous improvement of the quality management system by appling quality risk management methods and tools to the production phase of investigational medicinal products for early clinical trials. Methods: Risk management tools were applied to conduct risk analysis on the production phase of investigational medicinal products for early clinical trials, identified risk points and output control measures. Results: Different risk management modes were used to analyze and evaluate the risk from three aspects which were contamination control, critical process parameters and critical quality attributes,as well as material management. The risk points were found and effective control measures were taken to reduce the risk level. Conclusion: The effective use of quality risk management tools in the production management of investigational medicinal products for early clinical trials is conducive to ensuring the safety of drugs for clinical trials.

Objective: To study the application effects of acetamiprid colloidal gold immunochromatographic test strips from different brands in the matrix of Lycii Fructus, optimize the pre-treatment conditions for Lycii Fructus, and establish a rapid colloidal gold immunochromatographic detection method for acetamiprid in Lycii Fructus. Methods: The detection limits, specificity, sensitivity, false positive and false negative rates of three different brands of colloidal gold immunochromatography test strips in the matrix of Lycii Fructus were examined. The pretreatment conditions for Lycii Fructus, including herbal medicine forms, extraction solvents, extraction solvents volume and dilution ratios were optimized, and the performance of the optimized method was evaluated. Results: The detection limits of the three brands of acetamiprid colloidal gold test strips in the matrix of Lycii Fructus were 0.25, 0.50, and 0.50 mg · kg^-1, respectively. The results of specificity and cross reactivity were all negative, with a false negative rate of 0%, but the false positive rate was 50%. The optimal pretreatment conditions for Lycii Fructus involve extracting (1.00±0.05) g of ground sample using 4 mL of 0.01 mol·L^-1 phosphate-buffered saline (PBS). After centrifugation, 20 μL of the supernatant was diluted with 980 μL of the extraction solvent to obtain the test solution. The performance evaluation results were satisfactory. Conclusion: The colloidal gold immunochromatography method has the advantages of simplicity and rapidity in the detection of acetamiprid pesticide residues, but there are generally high false positive rates in the detection of Lycii Fructus matrices. The rapid colloidal gold immunochromatography detection method established by optimizing pretreatment conditions in this study for acetamiprid in Lycii Fructus resolved the problem of false positive, and had the advantages of accurate and reliable determination results and simplicity in operation. It is suitable for on-site rapid detection of acetamiprid in Lycii Fructus, providing technical support for the quality and safety supervision of Lycii Fructus, as well as providing a technical reference for the application of colloidal gold immunochromatography in the rapid detection of pesticide residues in traditional Chinese medicine.

Objective: To provide data references for fresh cutting and clinical research of Bo Atractylodes macrocephala Koidz.(BAMK) by analyzing and comparing fresh cutting and traditional cutting of BAMK from the same batch. Methods: The differences between decoction pieces prepared by fresh cutting and traditional cutting of BAMK were explored by the properties, identification (thin layer chromatography), and the determination of moisture, total ash, extract, volatile oil, as well as HPLC fingerprints combined with chemometrics. Results: There were no obvious differences in properties, identification, extract and volatile oil between different cutting methods. The chromatographic fingerprints of 20 BAMK decoction pieces were marked and 15 common peaks were confirmed, and six chemical components were pointed out. The similarities of the fingerprints were 0.958-0.998. PCA was used to sort the 20 batches of BAMK decoction pieces, and the results showed that the quality of decoction pieces by fresh cutting was generally greater than that by traditional cutting, while the quality stability and uniformity of decoction pieces by traditional cutting were better. OPLS-DA found 7 differential components, all of which had higher contents in fresh cutting pieces than in traditional cutting pieces, and t-test revealed that neochlorogenic acid, atracylenolide Ⅰ and atracylenolide Ⅱ were the distinguishing points between different cutting methods. Conclusion: The fresh cutting technology of BAMK has feasibility. This study can provide references for the subsequent quality standard research.

Objective：To establish the specific identification method of Rubia cordifolia and Rubia magna by the ratio of characteristic peak area through HPLC technology and statistical methods. Methods：HPLC was performed on a Thermo Accucore AQ-C₁₈ column (100 mm×2.1 mm, 2.7 μm) with a gradient mobile phase consisting of 0.1% phosphoric acid in water- acetonitrile. The flow rate was 0.3 mL·min^-1, the detection wavelength was 250 nm, the column temperature was 30 ℃, and the injection volume was 2 µL. Fingerprint chromatogram analysis was performed, the results of the peak area of the common peaks were evaluated by cluster analysis (CA) and orthogonal partial least squares discriminant analysis (OPLS-DA), and the ratio of characteristic peak area was used for evaluation. Results：The common peak area could cluster Rubia cordifolia and Rubia magna into two categories respectively through CA and OPLS-DA. It was found through the ratio of characteristic peak area that the ratio ① of Rubia cordifolia was less than 0.36 and the ratio ② was less than 0.15, while the ratio ① of Rubia magna was more than 0.36 and the ratio ② was more than 0.15. Through the analysis of 20 batches of samples, the identification of the ratio ① and the ratio ② achieved 100%, respectively. Conclusion：The established method is simple, accurate and rapid, and can be used for the authenticity identification of Rubia cordifolia and Rubia magna, effectively improve the safety of Rubia cordifolia in clinical application.

Objective: To investigate the clinical trial quality optimization path by exploring various clinical trial quality issues, and provide references for relevant personnel involved in clinical trials. Methods: By integrating the quality monitoring data of clinical trials of Tai’an Traditional Chinese Medicine Hospital (our hospital) from 2020 to 2025 (covering 32 phase Ⅰ-Ⅳ trial projects) and data from domestic and foreign literature (searching databases such as CNKI, VIP, Wanfang, Pubmed, etc.), and adopting a three-stage research framework of “problem exploration - countermeasure research - summary of ideas”, a systematic exploration of the optimization path for clinical trial quality was conducted. Results: Based on the 346 issues identified in 32 clinical trial projects in our hospital, as well as 86 clinical trial literature included in the study (including 48 articles on problem analysis, 21 on management, and 17 on quality control), through systematic analysis, the quality issues in clinical trials mainly originated from three aspects: sponsor/contract research organization (CRO) management, ethical review, and implementation of clinical research. Based on the concept of risk management, an optimization path of clinical trial quality was proposed, including comprehensively enhancing quality awareness, strengthening the sense of responsibility of clinical trial personnel, optimizing the quality control models, improving information technology, and standardizing the use of clinical trial funds. Conclusion: Based on clinical trial management experience and a review of domestic and foreign literature, this study adopted a mixed research method of literature and practice to construct a scientific and implementable quality optimization pathway, which is conducive to improving the compliance and data reliability of clinical trials.

Objective: To explore the application of near infrared spectroscopy (NIRS) technology in the identification of adulteration and weight gain in Cordyceps sinensis, in order to overcome the limitations of traditional detection methods and facilitate the rapid detection of major quality issues in the market circulation of Cordyceps sinensis. Methods: NIRS data from Cordyceps sinensis, artificial Cordyceps sinensis, Cordyceps sinensis with weight gain from magnesium sulfate and perfluorotributylamine were collected. Principal Component Analysis (PCA) and Partial Least Squares Discriminant Analysis (PLS-DA) were used for identification. Results: The accuracy of the PLS-DA discrimination model for artificial Cordyceps sinensis was 99%, and the accuracy of the PLS-DA model for Cordyceps sinensis with weight gain from perfluorotributylamine was 98%. PCA achieved accurate discrimination of Cordyceps sinensis samples with weight gain from magnesium sulfate. Conclusion: NIRS can effectively identify adulteration and weight gain in the market circulation of Cordyceps sinensis. It can overcome the limitations of traditional detection methods, such as poor timeliness and sample destruction. This technology has significant practical value for improving the quality evaluation system of Cordyceps sinensis, enhancing market supervision efficiency, and promoting the standardized development of the industry.

Objective：To investigate issues in the implementation of post-marketing quality sampling and testing requirements for pharmaceutical products and medical devices, and propose targeted optimization suggestions. Methods：Through the analysis of sampling and testing practices in recent years, critical operational deficiencies in the sampling records and voucher entry, sample return and refund process, drug inserts and labels as well as medical device registration certificates and product identifications management were deeply analyzed. Results：Based on quality control theory, risk management theory and system change theory, optimization suggestions were proposed, including unifying the standards of filling in sampling records and vouchers, establishing clear specifications for sample return and refund, implementing corporate responsibilities and enhancing supervision. Conclusion：By optimizating post-marketing sampling and testing requirements, the identified issues can be effectively solved, scientificity and standardization in pharmaceutical regulation would be further enhanced, and then, the safety in use of pharmaceutical products and medical devices would be effectively guaranteed for public.

Objective: Based on the core characteristics of radio frequency identification (RFID) technology, explored the practical paths for enhancing the intelligence level of the entire chain management of national drug reference standards, including production, warehousing, and supply. Methods: The current application status of RFID technology in the management of drug reference standards was systematically reviewed, and existing technical bottlenecks and management pain points were thoroughly analyzed. Results: Based on a comparative analysis of the current label management status of drug reference standards in foreign countries, the application of RFID technology in the management of drug reference standards in China demonstrated significant advantages. An implementation framework to accelerate the large-scale application of RFID technology was also proposed. Conclusion: The comprehensive implementation of RFID technology can significantly improve the management efficiency of national drug reference standards and provide technical support for achieving refined control.

Objective: To review the current development of skin organ-on-chips and skin organoids as novel in vitro alternative models, with a particular focus on their application potential in skin-related areas of drug research and development. Methods: By systematically outlining the progress in skin organ-on-chips and organoids technologies within the context of drug development, this study analyzed representative application cases in the construction of transdermal absorption models, skin disease models, and immune responses. Based on the analysis, corresponding developmental recommendations were proposed. Results: The research summarized advances in skin organ-on-chips and organoids technologies in mimicking skin structure and function, demonstrated their specific application examples in transdermal absorption studies and disease modeling, and confirmed the potential of these models in improving the accuracy of drug evaluation. Furthermore, it pointed out current technological challenges and proposed future development directions. Conclusion: Through integration with various cutting-edge technologies, skin organ-on-chips and organoids systems are expected to further improve the complexity and predictive performance of the models, providing critical references for the construction of more reliable and biomimetic in vitro drug evaluation models and promoting their widespread application in both basic research and translational applications.

Objective: Based on the analysis of causes for administrative penalties, this study aims to identify systemic vulnerabilities within medical institutions in drug management, to strengthen pharmaceutical quality and safety management capacity, and to ultimately establish novel regulatory mechanisms. Methods: A retrospective analysis was conducted on 202 pharmaceutical administrative penalty cases in Sanming City from 2020 to 2024, employing multidimensional analytical methods. Results: The number of pharmaceutical administrative penalty cases and associated monetary penalties in Sanming City showed an overall declining trend from 2020 to 2024. Notably, cases involving secondary-level and above public hospitals had significantly decreased in both volume and penalty amounts since 2022. In 2024, there were only two cases each for public hospitals at Level Ⅱ and above, township health centers, and community health service centers. The number of cases at community health service stations and other primary healthcare institutions decreased sharply from 51 cases in 2020 to 13 in 2024. Categorical analysis revealed that substandard drugs accounted for 32.7% of violations, while institutions’ failure to fulfill statutory obligations constituted the remaining 67.3%. Conclusion: The root cause of frequent incidents in medical institutions lies in the prioritization of medical treatment over medication quality, inadequate fulfillment of primary responsibilities, and the lack of mandatory enforcement standards. Traditional regulatory mechanisms suffer from inadequate awareness of responsibility binding, deficient grassroots oversight capacity, and ineffectual sanction mechanisms. Consequently, medical institutions should proactively establish accountability systems for pharmaceutical quality management, while regulatory authorities should establish a novel responsibility-binding mechanism by incorporating drug and medical device safety into hospital presidents’ performance-based compensation, develop a categorized guidance system to deliver proactive front-loaded support, formulate mandatory enforcement standards with aligned inspection tools, and strengthen oversight capabilities through cross-departmental and joint enforcement operations, thereby ensuring end-to-end accountability across the pharmaceutical regulatory chain.

Objective：To analyze and discuss the development trends and research frontiers of decentralized clinical trials (DCTs) in the context of digital medicine, and to provide suggestions for their standardized implementation. Methods：The CiteSpace was used to conduct cluster and time trend analysis of the literature on DCTs. Results：With the advancement of digital healthcare technologies, drug clinical trials are increasingly emphasizing participant engagement, guided by the principle of patient-centered research. Technologies such as virtual reality and artificial intelligence serve as the operational framework and essential tools for DCTs, providing the necessary technical foundation and support for their implementation. The application of DCTs have gradually expanded from cardiac rehabilitation and psychological therapy to complex disease areas such as neuroscience. Conclusion：Due to the unique characteristics of digital technologies, DCTs still face multiple challenges regarding data reliability, ethics and safety. The successful implementation of DCTs requires meticulous strategies and planning. It is recommended to enhance data management, protect the personal information of research participants, enhance the digital tool application capabilities of investigators and their teams, clarify the responsibilities of all parties, and collaboratively promote the development of DCTs.

Objective: To explore a more accurate and profound approach to distinguish the testing capabilities of laboratories by using three evaluation methods to evaluate the results of proficiency testing for the kinetic turbidimetric method of bacterial endotoxins. Methods: First, the results were collected from a round of proficiency testing program designed with repeated strategy of the kinetic turbidimetric method of bacterial endotoxins. Then, the assigned value and the proficiency testing standard deviation were calculated by using the robust algorithm A and robust algorithm S respectively under the logarithmic scale, and subsequently, three evaluation methods were utilized to assess the testing capabilities of the laboratories which were the quality acceptance criterion (ranging from 50% to 200%), the Z-scores, and the plots of ranges against averages. Results: After statistical processing of the test data under the logarithmic (log10) scale from forty laboratories, the assigned value X was 4.074 which obtained by using the robust algorithm A, and the proficiency testing standard deviation (σ_PT) was 0.042 by using the robust algorithm S. The lab capability,(1) When accessed by using the quality acceptance criterion method, the test results of all forty laboratories fell within the range of 50%-200% of the assigned value X, and thus were all categorized as satisfactory;(2) When accessed by using the Z-scores method: a. Thirty-six laboratories were rated as satisfactory, four as questionable, and none as unsatisfactory when using the mean of the intra-laboratory logarithmic results to calculate the Z-scores. b. Thirty-one laboratories were rated as satisfactory, six as questionable, and three as unsatisfactory when using each logarithmic result of the intra-laboratory to calculate the Z-scores; (3) When accessed by using the plots of ranges against averages method, twenty-five laboratories were rated as satisfactory, eight as questionable, and seven as unsatisfactory. Conclusion: Although the international community generally adopts the quality acceptance criterion method to make a final evaluation of whether the participating laboratories' capabilities (bacterial endotoxin proficiency testing) are satisfactory or not, it could be better distinguished the capability of the participating laboratories and could be more intuitively showed the bias from the assigned value and the degree of dispersion of each participating laboratory by the plots of ranges against averages method among these three evaluation methods.

Objective: To provide practical references for Chinese herbal decoction pieces manufacturers to improve the management of processing technology validation, and to support the scientific regulation of Chinese herbal decoction pieces. Methods: Domestic regulatory requirements for the process validation of Chinese herbal decoction pieces were reviewed. Based on key issues identified in processing technology validation during on-site inspections in Guizhou Province over the past two years, a risk analysis was conducted, and strategies for managing processing technology validation were discussed. Results: Over the past 20 years, China’s regulations on pharmaceutical process validation have been progressively refined, providing guidances for both validation practices and on-site manufacturing inspections. Nevertheless, inspection practices in the industrial production of Chinese herbal decoction pieces indicated that the management of processing technology validation remains insufficient on the part of both manufacturers and drug regulatory authorities. At the manufacturer level, critical deficiencies exist: manufacturers often failure to conduct validation for cleaning and slicing processes based on product quality and safety risks, and lack tailored validation strategies. At the regulatory level, outdated regulations have reduced oversight effectiveness. Conclusion: Enterprises should establish a risk-based, lifecycle validation system, conduct systematic validation based on the impact of key steps such as cleaning and slicing on product quality. Targeted validation strategies must be specifically designed for these critical processes that significantly affect product quality. Regulatory authorities should accelerate the improvement of the legal framework governing Chinese herbal decoction piece production, promoting the establishment of unified, scientific, and operable inspection standards and risk assessment mechanisms. Through coordinated efforts between manufacturers and regulators, traditional processing techniques can be transformed into quantifiable and controllable process parameters, thereby ensuring the safety, efficacy, and quality control of Chinese herbal decoction pieces for public use.

Objective: To conduct a systematic study on the regulatory requirements and market entry compliance pathways for compound traditional Chinese medicines (TCMs) entering the United States (US) market as dietary supplements, thereby providing a basis for accelerated market entry of compound TCMs in developed markets and promoting internationalization of selected compound TCMs. Methods: By sorting out and systematically studying the regulatory framework, regulatory guidelines, and marketing compliance pathways for dietary supplements in the US, as well as conducting a comparative analysis of the entry requirements for compound TCMs classified as drugs, dietary supplements, or conventional foods in the US. The application and marketing strategies for compound TCMs as dietary supplements were discussed, with practical experience incorporated. Results and Conclusion: It is feasible for selected compound TCMs to be applied in the US as dietary supplements, but it is necessary to conduct ingredient screening and safety assessment, control manufacturing and quality, and especially to strictly control the labels and claims descriptions. Listing selected compound TCMs as dietary supplements can accelerate their rapid market entry in the US, facilitate their “going abroad”, and simultaneously accumulate evidence of human use history to support their application as drugs in the US.

Objective：To explain the significance of each item set in the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, which has been formed, for variety identification, and to discuss their application in traditional Chinese medicine（TCM）identification. Methods：Based on the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, specific varieties of fruit-based medicinal materials were selected as examples for image acquisition under two scenarios: without referring to the above the specifications, and with strict compliance. By comparing and analyzing the feature presentation effect of image acquisition, the intuitive impact of the the specifications on the variety identification of fruit-based medicinal materials was evaluated. Results：After applying the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”, the feature presentation effect of image acquisition was significantly improved. In variety identification, the identification efficiency of samples processed in accordance with the specifications was enhanced, and the consistency of identification results among different professionals was also notably improved. Conclusion：Standardized image acquisition of fruit-based Chinese medicinal materials can not only improve the efficiency, accuracy, standardization, and systematicity of TCM identification, but also provide data for inspection and scientific research. Additionally, standardized image acquisition establishes a solid foundation for building reliable databases and the development of intelligent identification.

Objective: To explore the application and development of cleanroom (area) environmental testing technology in the pharmaceutical, providing theoretical support and practical references for ensuring the quality of drugs and medical devices. Methods: The application and evolution of cleanroom (area) environmental testing technology were systematically reviewed, domestic and international standards and regulatory frameworks were compared, and key technical advancements in airborne particle counting, microbial testing, and physical parameter testing were analyzed. Results: The research concludes that cleanroom environmental detection technologies ensure the safety of pharmaceutical products by controlling particulate and microbial contamination. It identifies differences in dynamic testing requirements and limit settings between domestic and international standards and regulations, and analyzes the transformation of core detection technologies toward intelligence, with a focus on real-time data integration and coordination with international standards. Conclusion: Future advancements in cleanroom (area) environmental testing will focus on the integration of intelligent testing systems, the adoption of green and energy-efficient technologies, and the establishment of international standard mutual recognition mechanisms, thereby enhancing the control of pharmaceutical clean environments.

Objective: To systematically compare the regulatory requirements for human immunodeficiency virus (HIV) antigen/antibody test kits in China and the World Health Organization (WHO), and provide references for improving the registration and regulatory strategies of HIV testing reagents in China. Methods: Technical documents and relevant literature on the regulation of HIV antigen/antibody test kits in China and WHO were reviewed, and comparisons were made from the dimensions of clinical trials, quality management, and some performance requirements. Results: The regulatory differences mainly originated from regulatory concepts, review requirements, market access mechanisms, and other aspects. The reasons for these differences were mainly the diversity of global public health needs and the different levels of technological development. Conclusion: By promoting the improvement of the regulatory system, deepening the reform of the review and approval system, and continuously optimizing the review technical guidelines, the scientificity of the review process can be improved, the launch of HIV testing reagents in China can be accelerated, and their international competitiveness can be improved, thereby better promoting the entry of such reagents into the international market and achieving global accessibility.