Objective: To introduce the rationale in drafting the CMC Technical Guidelines for Chemically Synthesized Innovative Oligonucleotide Drugs (Interim) and its main contents, thereby facilitating better understanding of this documment and promote drug development in this area. Methods: The relevant literature, regulatory status, and information on marketed products were reviewed. Multiple communications and academic exchanges between regulatory authorities and pharmaceutical manufacturers were organized to discuss the pharmaceutical technical requirements. Results: Common research methods and technical requirements in the manufacturing, characterization, quality control, and pharmaceutical comparability studies of oligonucleotide drugs were defined. Conclusion: The guidelines specify the relevant technical requirements for oligonucleotide products, facilitating the research, development, registration, and application of innovative oligonucleotide drugs.

Objective: To systematically analyze the current application status of advanced manufacturing technologies in the field of cell therapy products, international regulatory progress, and challenges faced by China, and to explore the supporting role of regulatory innovation and technological synergy in high-quality industrial development. Methods: By combining domestic and international research literature and industrial practices, this paper reviewed the representative platforms and their application characteristics of five major technological pathways: end-to-end high-throughput platforms, integrated closed systems, robotic modular systems, key unit equipment, and point-of-care manufacturing models. Furthermore, this paper analyzed the regulatory policies of major regulatory authorities such as the US, EU, and Japan, and assesses the applicability and deficiencies of China’s current regulatory framework. Results: Advanced manufacturing technologies significantly improve production efficiency and batch consistency; The FDA, EMA, and Japan have formed differentiated regulatory pathways; Although China has issued relevant guidance principles, deficiencies remain in core components (online sensors, fluid control, and disposable consumables) and AI algorithm regulation. Conclusion: China should prioritize the domestic production and large-scale application of integrated closed systems, achieve breakthroughs in key components, improve guidelines for automated process changes, explore an incentive mechanism for advanced manufacturing technology designation, and promote synergy between regulatory and technological innovation to support independent industrial innovation.

Objective: To systematically summarize the basic theories, characterization techniques, and preparation methods of cyclodextrins as the drug delivery system for further understanding the theories and applications of cyclodextrin complexation technology. Methods: The literature concerning fundamental theories of cyclodextrins published domestically and overseas in recent years was retrieved. The core scientific theories and routine characterization techniques of cyclodextrin inclusion complexes were reviewed, and determination as well as calculation approaches for complexation parameters were summarized systematically. Results: As multifunctional pharmaceutical excipients, cyclodextrins have a well-defined chemical structure yet complex composition, which renders stringent quality control essential. Concepts including degree of substitution, substitution distribution, and substitution sites should be clearly defined. Being capable of forming water-soluble host-guest inclusion complexes with numerous drug molecules, cyclodextrins markedly improve the aqueous solubility, chemical stability, and in vivo bioavailability of poorly soluble drugs. The lipophilic cavity of cyclodextrins encapsulates hydrophobic drug molecules via non-covalent interactions, and a dynamic equilibrium exists between encapsulated and free drug during the complexation process. Multiple technologies are available to prepare inclusion complexes, and diverse analytical approaches can confirm complex formation. Critical parameters including complexation ratio, equilibrium constant, complexation site, and complexation efficiency shall be characterized to lay a solid foundation for formulation design and process development. Conclusion: Given the inherent structural characteristics and drug-loading mechanisms of cyclodextrins, an in-depth understanding of their basic theories and comprehensive characterization of cyclodextrins as excipients as well as their inclusion complexes can effectively improve the efficiency of pharmaceutical formulation development.

Objective：To elucidate the connotation of drug regulatory science in the new era, thus providing a reference for establishing a scientific, law-based, international, and modern drug regulatory science system that supports the high-quality development of the pharmaceutical industry. Methods：A systematic review of the domestic and international development history of drug regulatory science was conducted to summarize China's landmark achievements in system construction and cutting-edge evaluation technologies. Furthermore, this study analyzed the current opportunities and challenges China faces in the full-chain translational evaluation of innovative drugs, the practical application of research findings, collaborative innovation, and integration into international rules. Results and Conclusion：The development paths of drug regulatory science vary between different countries, and this field has gradually improved and matured through mutual learning. Drug regulatory science has become a critical pillar driving innovation in China's pharmaceutical industry, and it has effectively promoted the rapid development of innovative vaccines, cell and gene therapy products, traditional Chinese medicine, chemical drugs, brain-computer interfaces, high-end medical equipment and other fields. In the future, it is imperative to further coordinate national pharmaceutical scientific and technological resources to conduct organized scientific research. By proactively deploying cutting-edge evaluation technologies, enhancing the translational efficiency of research findings, building a systematic collaborative innovation ecosystem, and deeply participating in the formulation of international standards and guidelines, China can continuously optimize its drug regulatory science system and effectively propel the high-quality development of the pharmaceutical industry.

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 compare the regulatory and innovation support policies for medical brain-computer interface (BCI) between China and the UK, thereby providing insights and references for the high-quality development of China’s BCI industry and the improvement of scientific regulatory practices. Methods: This study adopted text sorting and comparative analysis methods based on regulatory policies, guidelines, special regulatory reports, industrial planning documents and other relevant materials concerning the classification and application rules of BCI. It systematically analyzed the BCI regulatory framework, key regulatory requirements including enhanced clinical requirements, and innovation support measures in the UK, as well as the top-level design and local policy support for BCI regulation and innovation in China. Results: The UK implements risk-based classification regulation for medical devices, centers on recommendations from expert institutions, and carries out regulatory exploration focusing on pre-market definition, institutional capacity, clinical evidence, non-medical application scenarios and long-term use safety. China has established a full-chain top-level policy support system covering scientific research, clinical application, approval, and medical insurance. Multiple regions in China have issued targeted industrial support policies, and the world’s first invasive BCI medical device has been approved for marketing in China. Conclusion: The UK emphasizes micro-level, granular regulation, while China holds a stronger advantage in macro-level top-level design and industrial synergy. Drawing on the UK’s experience in data protection and innovation-oriented supporting supervision, China can further optimize its regulatory system and facilitate the high-quality development of BCI technology and related industries.

Objective: To systematically analyze the implementation effectiveness and regulatory science connotation of the filing system for bioequivalence trials of chemical drugs in China from 2016 to 2025. Methods: Using the 10-year data from the filing platform for bioequivalence trials of the Center for Drug Evaluation, National Medical Products Administration, this paper analyzed the phased characteristics of filed generic drugs under the consistency evaluation program and newly submitted generic drugs, sponsors, clinical research institutions, testing laboratories, and statistical analysis organizations. Results: Over the decade, there were 9504 filings of bioequivalence trials for newly submitted generic drugs and 2584 filings for consistency evaluation. The research and development landscape was characterized by concentration among leading entities, regional clustering, and overcrowding in hot therapeutic areas. Clinical and testing resources were highly concentrated in a small number of institutions, accompanied by coexisting homogeneous competition and quality risks, as well as unbalanced regional distribution of research and development capacity. Conclusion: The filing system for bioequivalence trials of chemical drugs has markedly improved the research and development efficiency and evaluation standardization of generic drugs. In the future, through measures including optimizing filing administration, strengthening full-chain quality compliance, advancing digital supervision and model-informed drug development, a transformation from access-based management to intelligent whole-process control can be realized, building up China's strength in the field of generic drugs.

Objective：To analyze the behavioral characteristics and social impacts of professional whistleblowing in the pharmaceutical field, and to explore countermeasures and suggestions under the newly revised Measures for the Handling of Complaints and Reports by Market Supervision and Administration Authorities. Methods：A comprehensive study was conducted through a review of relevant academic literature, policy documents, and judicial cases, an analysis of pharmaceutical-related complaint and report data from the National Platform of Consumer Dispute Resolution, and a summary of international experience. Results and Conclusion：Professional whistleblowing in the pharmaceutical field is characterized by profit-driven motives, specialization, and organized operations, with both positive functions and negative impacts. The Measures for the Handling of Complaints and Reports by Market Supervision and Administration Authorities introduce a number of new provisions to address professional whistleblowing. In light of the new regulations and international experience, it is recommended that a comprehensive governance framework encompassing institutional improvement, information utilization, procedural compliance, and social co-governance should be established.

Objective：To compare and analyze the differences in cleanroom environment requirements for radiopharmaceutical preparation in medical institutions between China's regulatory framework and major international regulatory systems, identify the core challenges facing China's regulatory framework, and propose recommendations for improvement. Methods：Current Chinese regulations and policies governing radiopharmaceutical preparation in medical institutions were systematically reviewed, with a particular focus on cleanroom environment requirements. The Chinese requirements were then comparatively analyzed against the specific provisions on cleanroom environments for radiopharmaceutical preparation in medical institutions stipulated in the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the guidelines issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Results and Conclusion：China's regulatory requirements for the classification of cleanroom environments for radiopharmaceutical preparation in medical institutions still require further improvement. The development of relevant regulations and policies should comprehensively take into account both the unique characteristics of radiopharmaceuticals and the practical conditions of medical institutions. It is recommended that scientifically sound standards for cleanroom classification be established according to the characteristics of different radiopharmaceutical products and their potential contamination risk levels.

Objective: To establish quality standard of Dicliptera chinensis (L.) Ness. Methods: Thin layer chromatography (TLC) was used for qualitative identification of the medicinal materials. A characteristic chromatograms of Dicliptera chinensis (L.) Ness was established using HPLC method, and the contents of four identified characteristic peaks (Vicatin-2, Vicatin-1, Schaftoside, and Isoschaftoside) were determined to provide support for the quality control of Dicliptera chinensis (L.) Ness. Results: The TLC spots of the medicinal materials were clear and well separated. A total of six characteristic peaks were identified in the characteristic chromatograms of eighteen batches of Dicliptera chinensis (L.) Ness samples. The linear relationships of the four identified characteristic peaks were good within their respective ranges (r ≥ 0.9995), with average recovery rates of 95.96% to 101.50%, and RSD of 0.66% to 1.68%. The content ranges of Vicatin-2, Vicatin-1, Schaftoside, and Isoschaftoside were 0.0631-0.6917, 0.0269-0.3814, 0.0834-1.5406, and 0.0220-0.3680 mg · g^-1. Conclusion: This method is simple, feasible, accurate and reliable, and can provide a reference for the establishment of the quality standard of Dicliptera chinensis (L.) Ness.

Objective: To systematically review the key research concerns pertaining to changes in injection packaging materials and containers, providing scientific references for drug marketing authorization holders to conduct change studies, and assisting regulatory authorities in achieving scientific and efficient review. Methods: Based on technical guidance principles and requirements for drug change management, combined with review practices, a systematic elaboration was conducted covering the current domestic and international research status, rationality of changes, assessment of equivalence and substitutability, compatibility studies, impact analysis of material changes, bridging strategies for expiration dates, and the quality of injection drugs. Results and Conclusion: Upon summarizing the research focus of changes in packaging materials and containers for injections, several issues were identified: insufficient justifications for changes, incomplete assessment of equivalence and substitutability, inconsistent quality of compatibility studies, and unscientific shelf-life bridging strategies. Additionally, changes in pharmaceutical packaging materials may impact drug quality. The established research framework offered a clear pathway for drug marketing authorization holders to conduct change-related studies, which is crucial for ensuring drug quality and enables regulatory authorities to implement scientific and efficient reviews.

Objective: To explore effective strategies for establishing a homogeneous pharmaceutical management model in tertiary Grade A public hospitals operating across multiple campuses, and to evaluate its practical outcomes, thereby providing a reference for ensuring consistent pharmaceutical care, medication safety, and enhancing the quality of pharmaceutical services. Methods: Using an action research methodology, this study took the Third People’s Hospital of Hubei Province as a case, systematically constructing a homogeneous pharmaceutical management model centered on the core principles of “uniform systems, integrated management, consistent standards, and homogeneous services.” To assess the model’s effectiveness, a comparative analysis was conducted on key indicators before and after (first half of 2024 vs first half of 2025) the implementation. The compared indicators included outpatient prescription appropriateness rate, internal medication dispensing error rate, average patient waiting time, medical staff satisfaction, and several overall efficiency metrics. Results: Following the implementation of the homogeneous pharmaceutical management model, the outpatient prescription appropriateness rate increased and remained stable above 99%. The internal dispensing error rate decreased by 30.0% compared to the same period in 2024. The average medication waiting time of patients decreased from (10.00±0.56) min to (6.33±0.12) min, with statistically significant difference (t=7.454, P<0.01). The overall distribution of medical staff satisfaction scores in the first half of 2025 was significantlyhigher than that in the first half of 2024, showing statistically significant difference (U=2708.5, P <0.001). Conclusion: The homogeneous pharmaceutical management model developed in this study, empowered by intelligent technologies, effectively broke down management and service barriers between campuses. It achieved optimized integration of pharmaceutical resources and overall improvement in service efficiency, thereby enhancing medication safety. This model can serve as a valuable reference for promoting high-quality development in multi-campus healthcare institutions.

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 draw on the experience of chronic disease pharmacy services in England’s community pharmacies, providing reference for exploring effective management strategies for chronic disease patients in China. Methods: The current status of chronic disease pharmacy services in England community pharmacies was examined, and the supporting elements for their provision were summarized. Based on this analysis, challenges in implementing chronic disease services in China’s community pharmacies were identified, and optimization recommendations were proposed. Results: In contrast to the well-established community pharmacy-centered chronic disease pharmacy management system in England, community pharmacies in China have made some progress. However, they continue to face numerous obstacles and challenges, such as insufficient policy support, inadequate professional competence, and low public awareness, making it difficult to meet the evolving demands for chronic disease pharmacy services. Conclusion: China could draw on the mature experience of England to broaden the scope of chronic disease pharmacy services through community pharmacies, supported by diversified economic incentives, strengthened continuing professional education and training, and public health education campaigns.

Objective: To systematically review the development status of the guidance system for rare disease drugs in China and provide references for its optimization. Methods: The issued drug guidance system related to rare disease drugs in China was sorted out and compared with the drug guidance systems of the U.S. Food and Drug Administration and the European Medicines Agency. Results: China's guidance system for rare disease drugs has made rapid progress in recent years, with the formation of a regulatory framework covering key aspects of research and development and substantial progress in evaluation practice. Conclusion: Suggestions for optimizing the guidance system are proposed in terms of deepening contents, arranging in cutting-edge areas, and promoting application and translation, with the aim of building a modern guidance system for rare disease drugs that aligns with international regulatory science while fully responding to domestic innovation demands.

Objective: To systematically review the structural characteristics of microbial communities in Mass Medicata Fermentata and Sojae Semen Praeparatum, and to explore their implications for the quality control and standardization system of fermented traditional Chinese medicines. Methods: A literature review was conducted to summarize and compare recent research progress and compositional features of microbial communities in Mass Medicata Fermentata and Sojae Semen Praeparatum. Results and Conclusion: The signature microorganisms of Mass Medicata Fermentata and Sojae Semen Praeparatum are relatively stable at the genus level but exhibit distinct characteristics at the species level. Accordingly, it is proposed that microbial quality control of fermented traditional Chinese medicines could adopt a unified standard at the genus level while accommodating regional specificity at the species level. Simultaneously, efforts should be made to advance the construction of core microbial resources and strengthen microorganism-centered whole-process control. This provides a theoretical basis for promoting high-quality development of the quality control system for fermented traditional Chinese medicines from a microbiological perspective.

Objective: To analyze the practical effects and existing problems of the resident inspection system for vaccine manufacturers, and provide a basis for further improving this mechanism and effectively preventing major quality and safety risks in vaccine production. Methods: This paper systematically reviews the implementation of the resident inspection system for vaccine manufacturers in Sichuan Province over a period of more than six years, and conducts in-depth analysis from the aspects of working mechanism construction, execution efficiency, and challenges faced. Results: Practice has shown that the resident inspection system has played a positive role in promptly identifying and controlling risks, and preventing major quality and safety issues in vaccine production within its jurisdiction. It has initially established a full-process management mechanism of “diary recording, weekly analysis, monthly scheduling, and quarterly consultation”. Meanwhile, the system has strengthened risk identification capabilities through approaches such as on-the-job practical learning, participation in quality meetings, and benchmarking international inspection standards. Conclusion: The resident inspection system is an effective means to enhance the supervision efficiency of vaccine production. However, it still faces challenges in terms of inspector resources, responsibility definition, long-term incentive mechanisms, and capabilities to respond to complex situations. Continuous improvements are needed in optimizing system design, strengthening capacity building, and improving guarantee mechanisms, so as to enhance the scientificity, standardization, and sustainability of the system.

Objective：To examine the technical requirements for evaluating vaccine efficacy established by regulatory authorities both domestically and internationally, and compare them with the evaluation criteria set forth in China's current regulations, thereby providing guidance for the design and management of vaccine clinical trials in China. Methods：A comparative analysis was conducted covering various aspects, including the necessity of conducting protective efficacy trials, the determination and selection of trial designs, primary and secondary endpoints, the definition and confirmation of cases, sample size calculation, follow-up duration requirements, and efficacy evaluation. Results and Conclusion：China's national guidelines provide comprehensive discussions on efficacy trials from several key aspects including trial necessity, type determination, alternative research methods, site selection, primary and secondary endpoint establishment, and efficacy analysis. These discussions are consistent with the perspectives and requirements of foreign regulations. Further exploration and analysis are recommended regarding additional design possibilities for trial and control groups, specific case identification models and their potential variations, as well as preliminary analysis strategies.

Objective: To assess the testing capabilities and quality management status of pharmaceutical quality control laboratories in Gansu Province by retrospectively analyzing the results of laboratory comparisons from 2017 to 2021, identify existing problems, and propose improvement suggestions to enhance the overall technical and management levels. Methods: Data were collected from provincial laboratory comparison reports over the five-year period. Statistical analysis was conducted on indicators such as the number of participating organizations, comparison items, and satisfaction rates. Results: Most pharmaceutical quality control laboratories in Gansu Province possessed basic technical capabilities and quality management foundations. However, issues such as non-standard operations, incomplete records, insufficient equipment configuration, and uneven personnel competence were identified in some laboratories. The overall satisfaction rate for various comparison items from 2017 to 2021 ranged from 62.5% to 100%, with the lowest satisfaction rate observed in the identification of authentic traditional Chinese medicines. Conclusion: The overall capability of pharmaceutical quality control laboratories in Gansu Province needs further improvement. Systematic enhancements in personnel training, operational standardization, record management, and equipment/reagent management are recommended to strengthen the quality management system and ensure the reliability of pharmaceutical testing.

Objective：To explore the standardization pathway for the entire industrial chain of organoid technology within the pharmaceutical evaluation system, aiming to provide theoretical references for ensuring the self-reliance and controllability of China's biopharmaceutical industry chain and facilitating the transformation of the new drug evaluation paradigm. Methods: This paper systematically reviewed the standardization directions across the organoid industrial chain, encompassing upstream reagent production, midstream resource and engineering platform construction, and downstream drug evaluation applications. Results: A two-layer standardization architecture was proposed, integrating underlying the technical systems with the upper-level drug evaluation process. Through the standardization of the underlying raw materials production, biobanks, and automated equipment platform construction, the reliability of organoid models was jointly guaranteed. Building on this foundation, a comprehensive technical system was established through the standardization of the drug evaluation processes, which facilitated the clinical translation of organoid technology. Conclusion: The construction of establishing a standardization system across the entire industrial chain is an essential prerequisite for transforming organoids from basic research tools into a regulatory-approved drug evaluation systems. The closed-loop construction of the industrial chain will significantly enhance the predictive performance of new drug R&D, providing core support for the construction of a self-reliant and controllable new in vitro drug evaluation paradigm.

Objective: To summarize and analyze recent advances in nanobody drug research, and provide references for conducting appropriate nonclinical studies and establishing assessment methods. Methods: Relevant domestic and international literature were reviewed to systematically summarize nanobody-based anti-infective drugs, anti-tumor drugs, and nanobody-engineered immune cells. The analysis focused on their structural characteristics, biological activities, pharmacological mechanisms, and proposed clinical indications. Finally, considerations for conducting nonclinical studies on these drugs are proposed. Results and Conclusion: Nanobody drugs possess advantages such as stable protein conformation, specific target recognition, strong tissue penetration, and ease of production and expression, which have garnered widespread attention in the treatment of pulmonary diseases, tumors, inflammatory conditions, and anti-infective drugs. However, the research and development of nanobody drugs also face challenges including immunogenicity risks, tumor tissue heterogeneity and drug resistance, and difficulties in assembling multivalent antibodies. Therefore, for the translational application of nanobody drugs, research institutions and developers need to conduct rigorous and well-designed experimental studies to fully assess and predict the safety and efficacy of these drugs in the human body.

The liver serves as a central organ in drug metabolism and toxicity responses, and the biomimetic fidelity of its in vitro models directly affects the efficiency of drug development and evaluation. The two-dimensional in vitro models and animal models often lack sufficient biological relevance to accurately mimic human physiological responses. This article systematically reviews the technological landscape of three-dimensional in vitro liver models, including multicellular spheroids, precision-cut liver slices, organoids, organ-on-a-chip platforms, and bio-printed liver constructs. It thoroughly discusses their application advantages in liver disease modeling, pharmacological/pharmacokinetic studies, safety evaluation, and precision medicine. From a regulatory perspective, this paper reviews the policies and practices of domestic and international new approach methodologies (NAMs). Furthermore, key challenges currently facing the field are analyzed, including insufficient functional maturity, lack of standardization, limited compatibility with high-throughput workflows, and restricted regulatory acceptance. Finally, recommendations are proposed for the standardized application of these technologies and the improvement of scientific regulatory systems.

Objective：To analyze the challenges posed by the island-wide customs closure operation of the Hainan Free Trade Port on the drug regulatory system and accordingly propose a systematic capacity-building plan, in order to provide decision-making support for ensuring drug safety in the Free Trade Port and serving high-level opening-up. Methods：Using policy analysis and logical deduction, this study examined industry transformation trends across the entire drug lifecycle, from research and development, production, distribution, to use, to systematically identify key regulatory risk points. Results：After customs closure operation, the regulatory system would face five major challenges: (1) profound transformation of the industrial model, with an urgent need to improve whole-chain regulatory systems; (2) increased regulatory challenges and insufficient support from specialized personnel; (3) intensified circulation risks and an incomplete whole-process risk prevention and control mechanism; (4) increasing industry internationalization, with a gap in alignment with international regulatory standards; (5) lagging transformation toward smart regulation and weak data-driven governance capacity. Conclusion：To better address various post-closure risks and challenges, this study proposes six countermeasures for Hainan drug regulatory authorities: (1) establish pharmaceutical regulatory legislation with Free Trade Port characteristics; (2) build a “core-reserve-think tank” tripartite regulatory talent system; (3) establish an intelligent risk prevention and control system for the entire circulation chain; (4) deepen integration into the global regulatory cooperation network; (5) develop a smart drug regulatory system driven by technology and data; and (6) explore the development of the Free Trade Port as a hub for pharmaceutical and medical device regulatory innovation.

Objective: To address the current issues of low efficiency and repetitive sampling in the inspection of imported medicinal materials, this study explores more targeted, rational, and efficient sampling methods. The aim is to provide technical support for optimizing the regulatory process and ensuring the quality of imported medicinal materials. Methods: By comparing the number of sampled packages and test samples required by different sampling methods, this study analyzes the characteristics of three sampling protocols: the Provisions for Sampling of Imported Medicinal Materials, the Methodfor Sampling of Chinese Medicinal Materials and Decoction Pieces in the Chinese Pharmacopoeia, and the SN/T1508-2005 Quarantine Protocol for Entry-Exit Plant-Derived Medicinal Materials. Results: The sampling method specified in the Provisions for Sampling of Imported Medicinal Materials tends to result in a high degree of repetitive testing, whereas the Methodfor Sampling of Chinese Medicinal Materials and Decoction Pieces in the Chinese Pharmacopoeia demonstrates greater applicability. The SN/T1508-2005 Quarantine Protocol for Entry-Exit Plant-Derived Medicinal Materials is of limited reference value for optimizing sampling plans for imported medicinal materials. Conclusion: It is recommended to establish a risk classification system based on dimensions such as the source risk of medicinal materials, varietal characteristics. A differentiated sampling method for imported medicinal materials should be developed to enhance the overall efficiency of sampling and supervision.

Objective: To explore and construct a Training Needs Analysis(TNA) model for drug inspectors,and so as to provide precise and effective training education for drug inspectors. Methods: By integrating the Goldstein framework in TNA field with the classic Kirkpatrick model of four-level training effectiveness evaluation, the TNA model for drug inspectors was constructed, which comprises five modules: defining ‘ideal’ standards, evaluating ‘current’ performance, identifying ‘shortcomings’, planning ‘action paths’, and forming a ‘closed loop’, thereby establishing a PDCA cycle. Results and Conclusion: The preliminary construction of the TNA model for drug inspectors provides a theoretical framework and operational methods for accurately identifying the training needs of drug inspectors.

Objective: To study and analyze the current situation of group standards serving drug regulation in China's pharmaceutical field, identify the practical dilemmas, and explore their underlying causes and optimization paths. Methods: Literature review, policy analysis, and comparative case study methods were adopted. On the basis of the data from the National Group Standards Information Platform and relevant policies and regulations, the development process and policy system of China's group standards were systematically reviewed. The information technology and traditional Chinese medicine fields were selected as references for comparison, and cross-field comparative analyses were conducted from the dimensions of standard quantity, adoption and transformation, and degree of internationalization. Results: The development of group standards in the pharmaceutical field faces challenges such as insufficient supply, a low adoption rate by national standards, and limited participation in international standardization. Among the 76 adoption plans announced by the National Standardization Administration in 2026, those in the information technology field accounted for over 47%, while no project from the pharmaceutical field has been included so far. Compared with the information technology and traditional Chinese medicine fields, the pharmaceutical field exhibited certain differences in four dimensions: industrial organization characteristics, institutional linkage mechanisms, standardization capacity building, and knowledge traditions. These factors together constitute the underlying reasons for the current underdevelopment of group standards in the pharmaceutical field. Conclusion: It is essential to seize the 15th Five-Year Plan window period, draw on the successful experience in the information technology and traditional Chinese medicine fields, and promote the unblocking of regulatory transformation channels, international benchmarking and capacity building, improvement of governance mechanisms, and participation of diverse stakeholders. The advantages of group standards in rapidly responding to industrial needs should be fully leveraged to accelerate the formulation of relevant standards in key emerging biomedical technologies and innovative drugs, fill gaps in the industry, guide and regulate sector development, and effectively enhance the overall capacity of group standards in the pharmaceutical field to serve drug regulation and industrial development.

Objective：To systematically state the key points in the technical review concern of metagenomic next-generation sequencing (mNGS) products for pathogens, thus providing a reference for the registration application and technical review of such products. Methods：This article states several key points—intended use, genomic databases, positive judgment values, and clinical trials—in the technical review concern of mNGS products for pathogens. Results：In response to the above-mentioned key points, this paper clarifies the standardized expression of the intended use, expounds the current status of genomic database construction and suggestions for the construction of high-quality microbial genomic reference databases, clarifies the research principles for positive judgment values, and reviews the relevant requirements of the U.S. Food and Drug Administration (FDA) and the preliminary considerations of China's National Medical Products Administration (NMPA) for clinical trials. Conclusion：Applicants should focus on the relevant requirements of intended use, genomic databases, positive judgment values, and clinical trials in plan formulation and conduct scientific and reasonable evaluation to facilitate the market approval of these products.

Objective：To analyze the application logic of organoid-artificial intelligence (AI) integration in drug research and development (R&D), and to explore the potential of this technological convergence in future drug R&D. Methods：By comparing conventional biological models with organoids, as well as conventional manual methods with AI-driven approaches of drug R&D, this paper analyzed the necessity and feasibility of integrating organoid and AI technologies in drug R&D. Taking the first small-molecule drug pipeline developed through the organoid-AI integrated approach as an example, this paper discusses the problems addressed by organoid-AI integration in drug R&D and the extent of technical implementation, puts forward the capabilities requiring further enhancement, and makes an outlook on the future development directions. Results and Conclusion：Organoids provide new opportunities for novel drug mechanism research and target discovery. Resolving the standardization and stability of organoid models is particularly critical for the development of drug pipelines requiring optimization and iteration. AI has demonstrated significant advantages in drug design, virtual screening, molecular synthesis, and crystal form prediction. However, the model capabilities in many scenarios still require continuous iterative upgrading through real-world data. Compared with the technical empowerment of drug R&D by organoids or AI alone, efficient and high-success-rate drug R&D forms a truly closed loop only through the iterative structure-activity relationship optimization enabled by the organoid-AI integration.

Knee osteoarthritis (KOA) is a disease characterized by degenerative changes of knee joint structure or traumatic structural injury, with a high disability rate and urgent clinical needs for research and development of new drugs. This review summarized the landscape of drugs for KOA. Combining the research cases of marketed drugs with relevant literature, this review summarized the characteristics of pharmacodynamic animal models for KOA and, on this basis, proposed considerations in nonclinical pharmacodynamic studies of drugs for KOA. For the nonclinical pharmacodynamic evaluation of new drugs for KOA, scientific and rational design tailored to the inherent characteristics of drugs should be adopted. Attention should be paid to the scientificity and rationality of animal model selection, including species, strain, age, sex, and pathological features of the model. In addition, consideration should also be given to the design of multi-dimensional evaluation indices covering histopathology, imaging, behavioral assessments, and biomarkers.

Objective: To systematically summarize the research progress in brain-computer interface electrode materials with different modes of in vasion, and to analyze their requirements in terms of biocompatibility, mechanical compatibility, signal acquisition, coating performance, and regulation of drug-device combination products, thereby providing references for electrode material development, clinical translation, and scientific regulation. Methods: Recent domestic and international studies on brain-computer interface electrode materials were reviewed. Flexible substrate materials, conductive materials, structural design, surface modification, and application scenarios were summarized and compared. The performance characteristics, technical advantages, and safety evaluation factors of different types of electrode materials were analyzed. Results: Novel materials and structural designs, such as flexible polymers, conductive polymers, functional coatings, and drug-loaded coatings, can improve the electrode-tissue interface, reduce inflammatory responses, and enhance signal quality. Surface modification coatings for implantable electrodes can optimize mechanical matching and reduce implantation-induced injury and foreign body reactions. Drug-loaded coatings can regulate the inflammatory microenvironment through controlled drug release and improve signal stability, while challenges remain in terms of release controllability and long-term safety evaluation. For non-invasive electrodes, hydrogel electrolytes with antimicrobial and anti-inflammatory properties can improve the stability of the electrode-skin interface, enhance wearing comfort, and improve signal acquisition quality. Targeted safety and effectiveness evaluation should be carried out for the electrode products with drug-device combination characteristics described above according to the domestic regulations on drug-device combination products, which is essential for their clinical translation. Conclusion: Different types of brain-computer interface electrode materials have their own advantages and limitations. Future studies should focus on multi-material composites, biomimetic flexible structures, anti-inflammatory coatings, multi-drug multi-layer coatings, and standardized evaluation systems to promote the safety and effectiveness evaluation as well as the clinical translation of brain-computer interface electrode materials.

Objective: To clarify the core physicochemical properties of ziprasidone hydrochloride monohydrate reference standard, verify its suitability as a reference standard, and establish scientific and standardized usage. Methods: Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), loss on drying determination, and moisture content measurement were comprehensively employed to obtain relevant data. Meanwhile, dynamic vapor sorption (DVS) analysis, X-ray diffraction (XRD) analysis, nuclear magnetic resonance (NMR) analysis, and content determination were performed on the samples before and after drying. The optimal usage was determined by comprehensively analyzing the thermal properties, moisture state, structure, and composition. Results: Systematic experiments and comprehensive analysis demonstratedthat ziprasidone hydrochloride monohydrate exhibited superior chemical and physical stability when being maintained in the monohydrate form. Conclusion: Ziprasidone hydrochloride monohydrate possesses favorable stability and requires no prior drying when being used as a reference standard. This paper provides a sufficient scientific basis for the suitability and standardized usage of this monohydrate as a reference standard.

Objective: To preliminarily evaluate the feasibility of a polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method for identifying Apocynum venetum-derived components in Compound Luobuma Granules. Methods: On the basis of a previously established PCR-RFLP identification system, SnapGene software was used to predict the lengths of the psbA-trnH amplicons and the Ssp I restriction sites of Apocynum venetum L., Apocynum pictum Schrenk, Chrysanthemum morifolium Ramat., and Crataegus pinnatifida Bunge, followed by experimental verification. To address the complex matrix, low target DNA content, and possible DNA degradation in compound preparations, magnetic bead-based DNA extraction and enrichment were combined with Touchdown PCR to optimize the amplification conditions. Three individual sachets from the same outer package of batch 221003 manufactured by pharmaceutical factory A were independently subjected to the complete analytical procedure to assess the consistency of the analytical results. Batch 260401 manufactured by pharmaceutical factory B was additionally examined to preliminarily assess the applicability of the method to products from different manufacturers. Simulated concentrated extract samples and gradient hot-water extraction experiments were employed to investigate the effects of processing on target DNA amplifiability. Results: Sequence analysis predicted a theoretical amplicon length of 336 bp for A. venetum, which was cleaved by Ssp I into fragments of 228 bp and 108 bp. A. pictum and C. pinnatifida lacked the corresponding restriction site, whereas the predicted restriction fragments of C. morifolium were 300 bp and 210 bp. The number and migration positions of the experimentally observed amplification and restriction bands were consistent with the theoretical predictions. All the three individual sachets of batch 221003 produced consistent and clearly interpretable characteristic restriction profiles of A. venetum, and batch 260401 yielded a profile consistent with that of A. venetum leaves. The target DNA-specific amplification bands gradually weakened with the increase in hot-water extraction time, although specific amplification products were still obtained after 3 h of treatment. No target-specific amplification bands were detected in any of the three independently prepared concentrated extract samples. Conclusion: The previously established PCR-RFLP identification system was extended and optimized for application to Compound Luobuma Granules. Clearly interpretable characteristic restriction profiles of A. venetum were obtained from both batches produced by two manufacturers, demonstrating the applicability of the method to the samples examined. The technical workflow comprising sequence analysis, theoretical profile prediction, experimental verification, and optimization for complex matrices may provide a reference for developing molecular biology-based identification methods for source-derived components in similar traditional Chinese medicine compound preparations.

Objective：To analyze the current status of the supervision of radiopharmaceutical use in medical institutions in China, reveal existing problems, and propose countermeasures to enhance the safety and standardization of radiopharmaceutical use. Methods：Through a literature review, comparative research, and a review of industry practice, this study analyzed the current status, development trends, and supervision system of radiopharmaceutical use in medical institutions in China. On this basis, this study initially summarized the current shortcomings in this field and proposed countermeasures. Results and Conclusion：A basic regulatory system has been established for the current supervision, with certain achievements in administrative licensing and other aspects. However, there are still issues such as the unsound regulatory details, limited technical means of supervision, shortage of supervision professionals, and a mismatch between the number of inspection institutions and industrial development and clinical needs. In the future, efforts should be made to improve regulatory standards, strengthen supervision technology innovation and talent cultivation, and enhance the construction of inspection institutions, thereby enhancing the supervision effectiveness of radiopharmaceutical use in medical institutions.

Objective：To conduct a historical and current status analysis of the management of reference standards for imported chemical drugs, identify existing problems in the management process, and propose targeted recommendations to guide pharmaceutical companies applying for importation, as well as to provide insights and directions for further strengthening and optimizing the regulation of imported chemical drugs. Methods：Desktop research was employed to review the development history of the management of reference standards for imported chemical drugs, point out and highlight problems existing in the management practices, and formulate corresponding recommendations accordingly. Results and Conclusion：At present, the regulatory mechanism for imported chemical drugs remains incomplete, the compliance with reference standards among import enterprises is insufficient, and delays in the information sharing regarding imported reference standards have become prominent, posing significant challenges in the supervision of imported chemical drugs. This article proposed to comprehensively strengthen the management and supervision of the reference standards required for the supervision of imported chemical drugs through systematic measures such as improving the regulatory framework for imported reference standards, establishing a data sharing platform for imported chemical drugs, and promoting the implementation of supporting optimization measures, so as to lay a solid foundation for the post-market drug quality control and effectively ensure public medication safety.

Objective: To focus on the cutting-edge progress of brain-computer interfaces (BCIs) and regulatory developments both domestically and internationally, providing references and insights for the technological innovation and compliant development of BCIs. Methods: By reviewing global literature and policy documents, this study analyzed and summarized the progress in key technologies, typical applications, and regulatory situations. Results and Conclusion: BCI technology has achieved significant advancements in neural interfaces, neural decoding, neural feedback, neural control, and application scenarios, while regulatory approaches in various countries showed differentiated paths in balancing innovation and risk. China should further clarify regulatory boundaries, accelerate the formulation of clinical trial guidelines, and strengthen data security governance based on international experiences and its own industrial advantages, so as to ensure the healthy and orderly development of BCI technology.

Objective: To provide references for the registration submitting indication applications to Health Canada for Traditional Chinese Medicines registered as Natural Health Products. Methods: A combination of literature research and case analysis of registered products was employed. Data were retrieved from databases including the Health Canada website and China National Knowledge Infrastructure (CNKI). The registration requirements for traditional/modern indications by the Natural and Non-Prescription Health Products Directorate (NNHPD) of Canada were investigated. A case analysis of traditional/modern indication registrations for 258 approved natural health products was conducted. Results: The registration of natural health product indications is categorized into traditional indications and modern indications. Traditional indications adopt pre-approved functional indications, while modern indications are classified into low, medium, and high risk levels based on safety assessment. Indications undergo technical review and approval according to authoritative evidence. Conclusion: Health Canada regulates natural health products with indications under an over-the-counter framework. Core evidence for the registration and review of traditional or modern indications includes national pharmacopoeias, modern clinical trials, scientific literature, historical use, and safety and efficacy data. Therefore, accurate risk level assessment and proper classification of indications are essential for successful registration of Traditional Chinese Medicines.

Objective: To systematically review the principles and progress of light scattering particle size analysis, summarize its applications in the pharmaceutical field, and provide references for the correct use of this method and technological development. Methods: Through literature research, the development history of the light scattering method was reviewed. Its instrument hardware, optical models, inversion algorithms, calibration procedures and pharmaceutical applications were described. The challenges and future directions it faces were also analyzed. Results: The light scattering method has been widely applied in drug research and development, manufacturing and quality control. However, its proper application requires a deep understanding of its principles and parameter settings. Currently, there are still challenges such as incomplete theoretical models for non-spherical particles, difficulties in multiple scattering correction, non-uniform calibration standards, and insufficient adaptation to extreme conditions for online monitoring. Conclusion: Future research should strengthen the integration of the light scattering method with multi-technique hyphenation, artificial intelligence-assisted analysis, reference particles development, and online monitoring applications. This will contribute to more accurate, efficient, and intelligent development of pharmaceutical analysis and the pharmaceutical industry.

Objective：To systematically analyze the updates of domestic and international pharmaceutical water quality standards and explore the breakthroughs of the Pharmacopoeia of the People's Republic of China 2025 edition (ChP 2025) and the advances in new technologies, thus providing technical references for pharmaceutical production. Methods：Through the comparison of pharmaceutical water quality standards and production processes among the United States Pharmacopeia-National Formulary (USP-NF), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and ChP 2025, as well as literature analysis, this article systematically reviews quality standards, production processes, contamination control, and testing technologies. Furthermore, it summarizes the application progress of new technologies such as membrane separation, electrodeionization (EDI), and metal-organic frameworks (MOFs) in water treatment and testing. Results and Conclusion：ChP 2025 has aligned with international standards in terms of quality requirements, replacing some conventional chemical tests with conductivity and total organic carbon (TOC) measurements. It has introduced new general chapters on elemental impurities and microbial monitoring, improving the quality control system, and for the first time allows validated non-distillation processes for the production of water for injection. New technologies such as membrane separation, EDI, and MOFs show promising application prospects in water treatment and testing. In the future, pharmaceutical water quality control will move toward intelligent monitoring and green water treatment technologies.

Objective：To establish a limit testing method for aconite diester-alkaloids in Ershiwuwei Shanhu Pills, and to improve their quality standards. Methods：The sample of Ershiwuwei Shanhu Pills was purified by a mixed-type cation exchange reverse-phase adsorption resin solid-phase extraction column to prepare the test solution; The liquid chromatography method was carried out on a Waters XBridge^® C₁₈ (4.6 mm × 250 mm, 5 μm) chromatographic column with a gradient elution mobile phase consisting of methanol, acetonitrile, and 0.1% phosphoric acid aqueous solution, at a flow rate of 1.0 mL · min^-1. The column temperature was maintained at 30 ℃, and detection was performed at wavelength of 235 nm. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to confirm the components of aconite diester-alkaloids in Ershiwuwei Shanhu Pills. An ACQUITY UPLC ® BEH C₁₈ (1.7 μm, 2.1 mm × 100 mm) column was used with gradient elution mode and 0.1% formic acid (containing 5mmol · L^-1 ammonium formate) - methanol as mobile phase. The electrospray ionization source was in positive ion mode, and the monitoring mode was multiple reaction monitoring. Results：In liquid chromatography, the negative solution showed no interference and was well separated from adjacent chromatographic peaks. Aconitine showed a good linear relationship (R²>0.9998) within the range of 102.376-4128.048 ng, with an average recovery rate of 93.8%, RSD=2.3% (n=6). Mesaconitine and hypaconitine were not detected in all 17 batches of samples. In 5 batches of samples, the same chromatographic peak at the corresponding position with the aconitine reference substance was detected and all of which were below the established limit. In the liquid chromatography-tandem mass spectrometry method, all three types of aconite diester-alkaloids had good specificity, and the negative solution had no interference here. The confirmed results were consistent with those of the liquid chromatography method. Conclusion：The established method can accurately determine the content of aconite in Ershiwuwei Shanhu Pills, with strong specificity and high sensitivity, which can provide a reference for the safe and effective quality control of Ershiwuwei Shanhu Pills.

Objective：To analyze the policy landscape and current applications of artificial intelligence (AI) in the domain of regulatory review for medicinal products, application typical implementation scenarios and representative case studies, identify principal challenges and propose regulatory and governance recommendations. Methods：Policy documents, regulatory guidelines and academic reports from domestic and international drug regulatory authorities were retrieved, focusing on AI-related practices of international institutions including the US Food and Drug Administration, the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the National Medical Products Administration of China. By reviewing artificial intelligence applications across the drug lifecycle, the application scenarios relevant to regulatory review and the principal challenges faced in drug evaluation were summarized. Results：Internationally, various regulatory agencies have issued AI-related guidance and initiated AI-assisted review pilots. AI has demonstrated potential to improve efficiency and support decision-making in multiple regulatory review tasks, including automated parsing of scientific literature and submission dossiers, knowledge retrieval, chemistry-manufacturing-and-controls quality assessment (e.g., the Knowledge-Aided Assessment and Structured Application system of the US Food and Drug Administration), auxiliary analysis of clinical trial data, and post-market pharmacovigilance activities (e.g., Individual Case Safety Report information extraction and signal detection). At the same time, widespread challenges remain: insufficient model credibility and interpretability, low quality of training data, privacy and compliance constraints, unclear accountability and liability, fragmentation of international regulatory approaches, and gaps in the data-science capacity of review staff. Conclusion：AI can promote the intelligent transformation of drug regulatory review, but its safe, reliable and sustainable deployment depends on complementary technical standards and regulatory systems. It was recommended to strengthen algorithmic auditability and interpretability requirements, promote data standardization and multisource data governance, clarify legal and ethical responsibilities, establish risk-oriented model validation system, and promote international regulatory coordination and capacity building for review personnel.