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 respond to the State Council's “Artificial Intelligence(AI) Plus” initiative, the study systematically investigated the objectives, key actions, and implementation pathways for “AI Plus” into drug regulation, aiming to support the establishment of an intensive, efficient, safe, and controllable “AI Plus Drug Regulation” system. Methods: The study was conducted through policy analysis of national AI strategies and their implications for drug regulation, review of current practices and challenges in the field. On this basis, combined with industry characteristics, the stage goals of implementing the “AI Plus” action were proposed in the field of drug regulation. A six-in-one key actions plan centered on the six elements of “data, computing power, models, scenarios, governance, and ecology” was constructed. Results: A three-stage target for implementation was proposed, and a framework for “AI Plus Drug Regulation” centered on the six elements was designed. Additionally, a comprehensive guarantee system, including organizational mechanisms, resource investment, and standardization specifications was established to ensure effective execution. Conclusion: The structured implementation pathways and comprehensive safeguards can facilitate the deep “AI Plus” into drug regulation, thereby providing technical support to enhance regulatory efficiency and fostering innovation in the pharmaceutical industry.

Objective: To identify the advantages and disadvantages of the regulations related to the production of traditional Chinese medicine (TCM) by conducting a benchmarking study on the annex of PIC/S GMP for herbal medicine production, and to provide a theoretical basis for China's smooth accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods: A comprehensive comparison was conducted among Chinese GMP decoction pieces, Chinese medicinal preparations annex, relevant regulations and the PIC/S GMP annex for Herbal Medicines production. An analysis and discussion were carried out on certain advantages and differences. Results: The requirements of China's GMP appendices for TCM decoction pieces and preparations, as well as related regulations, were essentially consistent with those of the PIC/S GMP annex for Herbal Medicines in all aspects. Moreover, China's TCM regulatory regulations were more comprehensive and specific in terms of plant and facilities and equipment, personnel, confirmation and verification, production management, and quality control and other requirements compared to the PIC/S GMP Herbal Medicines. Conclusion: China's relevant laws and regulations related to TCM production have a solid foundation and already meet the requirements of the PIC/S GMP annex for Herbal Medicines. Moving forward, it is essential to maintain confidence, clarify the direction, and further refine the regulatory requirements for TCM production in China.

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 establish sensitive indexes for the centralized procurement of selected drugs management. Methods: Based on the evidence, the sensitivity index of centralized procurement of selected drugs management was preliminarily established, and then 30 pharmaceutical personnel were consulted by Delphi expert correspondence method for 2 rounds of correspondence, and the results were statistically sorted out. Result: The sensitive indexes of the centralized procurement of selected drugs management constructed included 3 first-level indexes, 11 second-level indexes and 22 third-level indexes. The effective recovery rates of 2 rounds of expert letter inquiries were 91% and 100%. The authoritative coefficients of second rounds were 0.82, and the Kendall’s W was 0.434, which had statistically significant (P<0.01). Conclusion: This study constructs the sensitive indicators for the centralized procurement of selected drugs management, which meets the criteria of expert activeness, authority and consistency standards.

Objective: The rapid development of Artificial Intelligence (AI) is triggering a paradigm shift in pharmaceutical testing through its robust capabilities in data processing, analytical recognition, and content generation. This paper systematically summarized the empowerment of pharmaceutical testing by AI to provide strategic insights for implementing the national “AI Plus” initiative, advancing the modernization of pharmaceutical testing, and bolstering the high-quality development of the pharmaceutical industry. Methods: Through literature review and comprehensive analysis, this study systematically evaluated the current application status of AI in pharmaceutical testing, identified critical challenges, and proposed potential future development pathways. Results: AI has been extensively applied in three primary domains: intelligent pharmaceutical testing and data analysis, digital standards, and digital reference materials. It serves as the key driver and technological cornerstone for the development of “Smart Laboratories”. However, its in-depth application still faces challenges such as data, algorithms, talents, regulations and standards. Consequently, recommendations for implementing AI within “Smart Pharmaceutical Testing” were proposed. Conclusion: AI is revolutionizing the research and application paradigms of pharmaceutical testing and accelerating its modernization process. Future strategies should focus on aligning with the “15th Five-Year Plan” and the “AI Plus” initiative to construct a comprehensive “Testing-Regulation-Industry” support system based on the “Smart Pharmaceutical Testing” blueprint. By consolidating data foundations, refining algorithmic models, strategically deploying AI agent technologies, and promoting the construction of “Smart Laboratories”, the transformation of theoretical research into practical scenarios can be accelerated, which will empower high-level drug safety and achieve high-quality development of the pharmaceutical industry.

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 further improve the quality and efficiency of communication on innovative chemical drugs, and to increase support for innovative drug research and development, as well as strengthen technical guidance and services for applicants. Methods: Based on the relevant technical guidelines and review practices of pharmaceutical at different application stages of innovative drugs for registration, this paper puts forward suggestions on the pharmaceutical problems existing in relevant communication. Results and Conclusion: Solutions and focus points for the common problems in the communication of innovative chemical drug at different application stages for registration are proposed, hoping to provide references for drug registration applicants, improve the quality and efficiency of communication, and better serve drug innovation and development.

Objective: To explore the mechanism of action of Lianchen Decoction in treating phlegm-dampness obesity based on network pharmacology and molecular docking technology. Methods: TCMSP was used to obtain the active ingredients and target of Lianchen Decoction. Disease targets were obtained through GeneCards, TTD, and OMIM. The related targets of phlegm-dampness type were obtained by SoFDA. The network was constructed using Cytoscape3.10.1 software to screen key active ingredients and core targets through topological analysis. GO function enrichment and KEGG signaling pathway enrichment analysis were performed on potential targets using Weisheng platform. AutoDockVina software was used for molecular docking of components and targets. Results: 148 targets, 9958 targets of disease and 896 targets of phlegm-dampness were obtained. The targets were intersected and 106 potential targets were obtained. The network topology analysis showed that glycerol, citromitin and mupingaristolamide were the key active components. PPI network analysis screened out MC4R, PPARG, FTO, GHRL and other active targets. GO functional enrichment analysis showed that there were three parts: biological process, cell components and molecular function. KEGG pathway enrichment analysis showed that the target was mainly concentrated in insulin resistance related pathways. Conclusion: Lianchen Decoction may act on MC4R, PPARG, FTO, GHRL and other core targets to regulate insulin resistance pathway and insulin signaling pathway through the action of key active ingredients such as glycerol, citromitin, mupingaristolamide, and play a role in the treatment of phlegm and dampness type obesity.

Objective: To propose management strategies for sponsors, production sites, and their changes during the clinical research phase of new drugs in China, to provide reference for adapting to the new situation of drug research and development and improving China's drug regulatory policies. Methods: This study analyzed the current issues in the management of sponsors and production sites in the clinical research phase in China, drew on the management experience of foreign regulatory agencies, conducted comprehensive assessment and judgment based on risk principles, and proposed relevant management countermeasures and suggestions suitable for China's national conditions. Results and Conclusion: With the core of ensuring the safety of subjects and the goal of encouraging innovation and improving the accessibility and availability of public medication, this study proposes specific management suggestions on strengthening the responsibility of sponsors as the main body, strengthening the quality management of clinical trial drug preparation, the pilot situation of moderately relaxing the cross- border and cross-border changes of applicants/sponsors and clinical trial drug production sites.

Objective: To provide references for the selection mechanism and procedure of reference medicinal product for consistency evaluation in China and to provide ideas for generic enterprises to select the reference medicinal product. Methods: The current reference medicinal product in ANDA draft guidance by US food and drug administration (FDA), as well as the relevant requirements of reference medical product in European Union (EU), Japan and WHO were introduced in details. Some suggestions to improve the selection procedure of reference medicinal product were put forward according to the present situation of consistency evaluation of generic drugs in China. Results and Conclusion: US specifed the ideas and practical operation procedures for the selection of reference medicinal product for generic drugs, which provided new ideas to select the reference medicinal product in China. China is in the critical period of the selection reference medicinal product for generic drugs consistency evaluation. It is necessary to formulate a comprehensive and perfect selection system and mechanism of reference medicinal product, which can help to standardize the selection procedure of reference medicinal product, to speed up the process of consistency evaluation, and to enhance the scientificity and completeness of the selection of reference medicinal product for generic drugs consistency evaluation in China.

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 provide reference for improving the quality regulation system, policies, and procedures of drug clinical trials in China, ensuring the integrity, accuracy, and reliability of clinical trials data, and promoting coordinated development of quality regulation between domestic and international drug clinical trials. Methods: By sorting out the regulatory systems, supervision models, quality control and data management models of drug clinical trials in the United States, the European Union and China, the current problems in China were analyzed, and improvement strategies were proposed. Results and Conclusion: Although China has made certain achievements in the quality management of drug clinical trials, several challenges persist, including lagging informatization construction of clinical trials, difficulties in coordinating multi-center trials, and so on. To address these issues, it is suggested to adopt risk regulatory strategies based on the entire lifecycle and risk management and leverage extensive application of information technologies, drawing inspiration from the models established by the United States and the European Union, strengthen international cooperation, and promote global data mutual recognition, so as to enhance the international competitiveness of drug clinical trials in China. These measures will ensure the accuracy and reliability of trial data, thereby protect the rights and interests of participants, and ultimately increase public trust in drug clinical trials in China.

Objective：To 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 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: 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 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 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 provide references for researchers and regulatory authorities in establishing a linkage mechanism between the research and review (R&D) of medical devices. Methods: The development of the linkage between the R&D of medical devices was reviewed, and the communication and exchange mechanisms promoting the R&D and development innovation of medical devices in China and the United States were summarized. The characteristics of such linkage in terms of characteristics, objects and intervention stages, service forms and collaboration methods were analyzed, and the implementation paths of the linkage between research and review of medical devices was explored. Results and Conclusion: The linkage between the R&D of medical devices serves as a crucial strategy to fulfill the requirements of the comprehensive deepening of the regulatory reform concerning drugs and medical devices. Moreover, it aligns with the needs of innovation and development of the current medical device industry. However, there are also problems such as limited review resources and unclear scope of the linkage between research and review. In the future, the implementation path of the linkage between R&D of medical devices needs to be refined in aspects such as strengthening the main responsibilities of enterprises, clarifying the scope of the linkage between R&D of medical devices, establishing multi-level communication channels, improving the capabilities of reviewers and enhancing the awareness of proactive action among regulatory authorities.

Objective: To analyze 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: 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 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 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 trace the technological evolution of artificial intelligence (AI) in drug discovery and design, focusing on the transition from discriminative intelligence represented by predictive models to generative intelligence centered on generative models, and to analyze its role in advancing innovative drug discovery paradigms. Methods: Through systematic literature review and case studies, the applications of predictive models and generative models in drug discovery and design were compared, and the practical experiences from AI-driven pharmaceutical platforms were summarized. Results: The study demonstrated that predictive models significantly enhanced drug screening efficiency and accuracy, while generative models enabled a leap from “compounds screening” to “novel molecules design”, driving the formation of automated and closed-loop drug discovery workflows. Conclusion: AI is steering drug discovery from “predictive optimization” toward “creative design”, and is reshaping the drug discovery paradigm. Future development directions include multimodal fusion, knowledge-enhanced generation, reinforcement learning-based closed-loop optimization, quantum computing integration, and regulatory framework refinement, which will further accelerate AI-driven novel drug discovery.

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.

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 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 improve the regulatory system for radiopharmaceuticals, promote the development of the radiopharmaceuticals industry, and meet the needs of clinical medication, by reviewing the current situation and challenges of the development of domestic radiopharmaceuticals. Methods: Using literature research method and combined with work practice, this paper compared the differences in the development of the radiopharmaceutical industry at home and abroad, and analyzed the main problems faced by the domestic radiopharmaceutical industry. Results and Conclusion: Although China’s radiopharmaceutical industry has made significant progress, it still faces many difficulties and challenges, mainly including a large shortage of radiopharmaceutical professionals, a heavy reliance on imports for nuclide supply, a gap between market size and clinical demand, and the need to improve and refine regulatory policies and technical guidance principles.

Objective: To analyze the current market quality problems on the basis of investigation and inspection, to study the authenticity identification methods of the traditional Chinese medicine (TCM) bletillae rhizoma and to provide suggestions for drug supervision. Methods: Literature reviews, investigation into the producing areas and markets, and the inspection data were combined to analyze the quality problems of bletillae rhizoma and their causes, and the solutions were put forward. Results: The main quality problems of bletillae rhizoma was the adulteration of the same genus or similar species. The percentage of unqualified bletillae rhizoma was 9% according to the national sampling inspection for the TCM crude drugs and prepared slices. It was difficult for the single detection method to authenticate the bletillae rhizoma due to the complex varieties of the fakes. However, the combined characteristic technologies can distinguish bletillae rhizoma from the fakes efficiently. Conclusion: Although there are a wide variety of counterfeit bletillae rhizoma, the quality problems are still acceptable. In order to improve the quality of the TCM crude drugs and prepared slices of bletillae rhizoma, we should strengthen the source management starting from standardized production.

Objective: This article aims to study the analysis methods of visible particles test in the major Pharmacopeias worldwide and to provide some suggestions and ideas for the upgrade of the visible particles test in the Chinese Pharmacopeia. Methods: Through reviewing the major Pharmacopeias worldwide, the definition of visible particles, the manual visual inspection, and the judgment standards of visible particles were analyzed and compared, and the similarities and diff erences of the major Pharmacopeias worldwide were summarized. Results: The Pharmacopeias worldwide were differences in the definition and judgment standard of visible particles, and there were diff erences in the requirements for detecting personnel, light sources, light intensity, inspection quantity, and specific operation methods of manual visual inspection. Diff erent Pharmacopeias showed certain strengths and weaknesses, and the detection parameters were both complementary and constrained. Conclusion: It is suggested that the Chinese Pharmacopoeia should combine the advantages and disadvantages of major Pharmacopeias worldwide, meanwhile, based on the current situation of Chinese enterprises, to further improve the content of the visible particles test and ensure the quality of drugs and the safety of people's medication.

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 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 introduce the problems of hygroscopic chemical reference substances in drug regulatory application and give suggestions, in order to provide reference for better application of national drug reference substances in drug regulation. Methods: Regulations related to pharmaceutical reference substances were expounded, and the problems encountered in the use were analyzed and the hygroscopic chemical reference substances by dynamic vapor absorption analysis (DVS) were studied. Suggestions from the aspects of standard implementation, instructions, packaging and storage, weighing and moisture determination were provided. Results and Conclusion: Chemical reference substances with hygroscopic properties are a relatively special type of reference standard. Due to their hygroscopic properties affecting the stability of measurement values, they has posed several problems and challenges to drug regulation. Through the achievements of research on hygroscopicity, the improvement of reference standard instructions, and the summary of practical work experience, all parties are working together to solve the problems and better improve the application of national reference substances, in order to ensure the effectiveness of drug regulation and the safety of drug.

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 study the regulatory requirements and implementation of the change management during the clinical research of drugs in Japan, and compare it with the current construction and implementation status of relevant regulatory regulations in China, in order to provide reference for improving the regulatory system of the change management of sponsors and production sites during the clinical research of drugs in China. Methods: A systematic review and study of regulatory regulations on the change of sponsors and production sites during the clinical research in Japan was conducted. Suggestions were provided based on the current situation of change management during the clinical research in China. Results and Conclusion: In Japan, the clinical trial sponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trials both domestically and internationally. The regulatory measures in the Japanese regulatory system are of reference value to China, such as "domestic agent system for fulfilling responsibilities and obligations, comprehensive and efficient advisory services, and worldwide regulatory inspections covering the whole process".

Objective: To provide reference for improving the regulatory system of drug clinical trials and change management during clinical trials by reviewing the corresponding regulatory requirements in China and investigating the current situation of the industry. Methods: Literature research on the regulatory requirements for clinical trials and their changes in China, as well as survey on the status quo of the industry, were conducted to provide reference suggestions for the subsequent improvement of the regulatory system of drug clinical trials and change management during clinical trials in China. Results and Conclusion: The reform of drug evaluation and approval in China has been continuously improved in recent years, and there are demands for “cross-border” and changes in sponsors and production sites along with the development of the industry. Considering the practical needs of innovative development and current regulations, under controllable risk conditions, China has a certain foundation to support the "cross-border" and "cross-border changes" of sponsors and clinical trial drug production sites.

Objective: To refine and elaborate on typical types of change-related issues and specific cases, based on China’s post-marketing change management framework for drugs, providing a reference for marketing authorization holders to establish a robust post-marketing change control system and offering guidance for post-marketing change inspections of drugs. Methods: Using a literature review approach,keywords such as drug management, drug change, and post-marketing changes in pharmaceuticals were used to search on the official websites of the National Medical Products Administration (NMPA), the Center for Drug Evaluation (CDE) of NMPA, and provincial medical products administrations. A series of drug change regulations issued in China in recent years were sorted out, and the framework for drug change management in China was summarized. Statistical analysis was conducted on the drug change control deficiencies raised in FDA warning letters from 2021 to 2023. Additionally, based on the author’s recent inspection experiences, typical types of issues and specific cases related to post-marketing change management in China were identified through a survey research method. Results: China’s framework for drug change management is basically well-established. However, inspections of drugs conducted both domestically and internationally have uncovered deficiencies in the post-marketing change management by drug marketing authorization holders. These deficiencies include imperfections in the establishment of a change control management system, inappropriate categorization of change management, failure to submit supplementary applications, filings, or reports as required, exclusion of changes from the change control management system, and inadequate or insufficient research on changes. Conclusion: Marketing authorization holders should establish a scientific and reasonable internal change control system, conduct necessary research on changes, and utilize the communication mechanisms of regulatory authorities to fully discuss uncertain change categories. Drug inspectors should focus on knowledge management and summarizing inspection experience to form a systematic and comprehensive understanding of changes, and conduct targeted analysis of post-marketing change issues encountered during inspections.

Objective: To explore the trend of traditional Chinese medicine (TCM) research and development, as well as the current status of registration review and approval since the implementation of the new version of Drug Registration Regulations published in 2020, so as to provide references for the strategic layout of enterprises on the TCM product research and development. Methods: Registration application and review approval status of all the TCM preparations submitted in 2021-2024 were systematically analyzed from multiple perspectives such as quantity, type, registration classification, treatment field, dosage form and application stage. Results: The number of registration applications for TCM preparations had been increasing year by year, with the main type being new traditional Chinese medicine. The registration classification involved innovative traditional Chinese medicine, improved new drugs, ancient classic prescriptions, drugs with the same name and prescriptions, including the situation like applications for marketing of innovative medicine of natural medicine (Type 1.1). The treatment field was focused on the advantageous area of TCM, and the dosage form is mainly oral. Conclusion: Enterprises on the TCM product resarch and development should strengthen the exploration of the advantages of famous TCM prescriptions, attach importance to the secondary development of existing varieties, and comprehensively consider the strategic layout combined with the variety pipeline and their own advantages, and seize the good opportunity of high-speed and high-quality development of TCM.

Objective: To summarize and analyze the current situation of drug import filing work, explore the trend of fine-tuning the current drug import filing system in China, and provide reference for future policy formulation and optimization reform. Methods: By using literature review, data statistics, and comprehensive analysis methods, the problems existing in drug import filing were sorted out, and the main causes management status of various problems were found out. The policy trend in recent years regarding the announcement of relevant documents for drug import filing in China was studied. Results: Solutions were proposed for the existing problems, and the implementation of the new method effectively improved the current situation of drug import filing. Conclusion: This study helps to enhance understanding of the relevant laws and policies on drug import registration, and facilitates their rational application in practical work. It is suggested to flexibly adjust the review rules for the implementation of drug import filing in accordance with international development trends, in order to ensure compliance declaration by enterprises and improve the efficiency of imported drug clearance.