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 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 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 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 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 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 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 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 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 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 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 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 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 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 further understand the overall output, research subjects and content in the field of innovative drug medical insurance negotiation in China, and enrich the research methods in this field. Methods: Using the methods of co-occurrence analysis, cluster analysis and emergence analysis of CiteSpace, the relevant literature from the CNKI database spanning 2015 to 2024 in the field of innovative drug medical insurance negotiation in China were analyzed by metrology and visualization. Results: A total of 266 articles were included after retrieval and screening. The overall output of research results showed an increasing trend. “China Medical Insurance” was the main journal publishing articles in this field. Universities, as the main output body of the main results, played a dominant role in this field with scholars from China Pharmaceutical University and its units being the main force and support in this field. Through keyword co-occurrence and cluster analysis, relevant studies mainly involved the access strategies of medical insurance catalog, pricing standards of negotiated drug, and the implementation effect of medical insurance policies. Through keyword emergence and evolution analysis, related researches have been continuously refined and extended. The negotiation on innovative drugs and medical insurance access and their further subdivision research direction were the hot spots and key research contents now and in the future. Conclusion: The overall development trend of the field of innovative drug medical insurance negotiation in China is good, but the cooperation between scholars and institutions is not close enough. It is suggested that all research subjects should strengthen communication and cooperation based on grasping the constantly changing policy requirements and social demands in the future, and promote the further development of medical insurance negotiation of innovative drugs in China.

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 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 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 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 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.

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 propose targeted technical suggestions for the regulatory attributes and classification of tissue engineered medical products (TEMPs) from the perspective of medical device classification. Methods: Relevant regulatory policy requirements for TEMPs in China were sorted out. The regulatory attributes and classification elements were analyzed, and suggestions for determining different regulatory pathways were proposed based on the product composition and as-released state. Results and Conclusion: On the basis of the existing regulatory framework, this paper exploratorily proposes the basis for determining four regulatory pathways for TEMPs, namely as a new biomedical technology, a drug, a medical device, or a drug-device combination product.

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 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.

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 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 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.

Objective：To improve the standardization and normalization of the in vitro evaluation of immune cell therapies and accelerate their clinical transformation process. Methods：An evaluation strategy for the anti-tumor effects of immune cell therapies, based on tumor organoid and organoid-on-chip models was formulated, through analyzing the characteristics of the evaluation of the effectiveness of immune cell therapies and the application potential of organoid and organ-on-chip technologies, and referring to internationally advanced guidelines for organoid and organ-on-chip evaluation, as well as the latest domestic and international research findings. Results and Conclusion：A consensus was formed on the application of tumor organoid and organoid-on-chip models in the evaluation of the anti-tumor effects of immune cell therapies. This consensus addressed their advantages, biological requirements, characterization criteria, experimental design and limitations: First, tumor organoid and organoid-on-chip models provide a more reliable and efficient tool for evaluating the efficacy of immune cell therapies. Second, the cell types and origins used in the model, culture conditions, and the tumor microenvironment should be taken into consideration before the evaluation. Third, the evaluation must include morphological, histopathological, genetic and biological functional characterization of tumor organoids, together with validation of anti-tumor effects. Fourth, the assay should set up appropriate control groups, determine the optimal ratio of effector cells to target cells, and select appropriate detection endpoints. Fifth, this approach still faces challenges such as insufficient pathological relevance and standardization of the models. In the future, it is necessary to further enhance the pathological relevance and standardization of tumor organoid and organoid-on-chip models to improve their predictive ability and to better facilitate the development and transformation of immune cell therapies.

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

Objective：To systematically review the historical evolution and modern research progress of the processing and quality evaluation of Chebulae Fructus, thereby providing a basis for the standardization of its processing techniques. Methods：A systematic comparative analysis was conducted for the first time on the processing methods, chemical composition changes, and pharmacological effects of Chebulae Fructus in traditional Chinese medicine and various ethnic medicine systems by reviewing ancient materia medica texts and modern research literature. Results：Processing significantly affects the content of tannins, phenolic acids, and polysaccharides in Chebulae Fructus, thereby enhancing its pharmacological activities such as anti-ulcerative colitis and antioxidant effects. The processing methods of ethnic medicine are distinctive, exhibiting both connections and differences with those in the traditional Chinese medicine system. Conclusion：It is suggested that the quality standards should be established for processed Chebulae Fructus by combining with modern technologies and theories. This study provides a scientific basis for the standardization of the processing techniques and clinical application of Chebulae Fructus, as well as data support for the revision of processing standards in the Chinese Pharmacopoeia.

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

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

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