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 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 enhance the quality and efficiency of drug review by leveraging artificial intelligence (AI), facilitate the connection between drug review and AI application in drug research and development (R&D) stages, identify potential risks in drug access procedures, free up reviewers' time from non-technical evaluation tasks, and tilt limited review resources towards clinical urgent innovative technologies and the development of new technical standards, thereby better guiding the innovation of pharmaceutical industry and protecting and promoting public health. Methods: Combining practical work, some application scenarios for AI in drug access procedures were proposed, and the current risks and challenges were analyzed. Some insights and recommendations on regulatory frameworks, data quality, and other aspects were provided. Resultsand Conclusion: While AI has been widely and successfully applied in compound screening, target discovery, and computer-aided drug design, its use in supporting drug access remained at an early exploratory stage. Its inherent complexity, dynamic nature, and heavy dependence on data posed significant challenges to its application in existing regulatory frameworks. Nevertheless, the effective application of AI in drug access procedures holds great promise for improving the quality and efficiency of drug review.

Objective: To explore the application potential and challenges of artificial intelligence (AI) in drug clinical trials, analyze relevant regulatory practices and trends in the United States and the European Union, and provide references for the application of AI in China's drug clinical trial field. Methods: Searched for current regulations, normative documents, and technical guidelines in the United States and the European Union, as well as cases and related literature published on the official websites of regulatory agencies. Discussed the application potential and challenges of AI in drug clinical trials, along with regulatory practices and insights from Europe and the United States. Resultsand Conclusion: AI has gradually begun to be applied in key aspects of drug clinical trials, but it faces issues such as data quality, model performance, ethical risks, and regulatory lag. By summarizing and analyzing relevant regulatory activities in the United States and the European Union, as well as the application of AI in regulation, we conclude that future regulation may focus on ethical compliance and patient safety, establish continuous supervision and accountability systems, and promote standards for trustworthy AI, data governance, and model evaluation. When deploying AI systems in key clinical trials, it is essential to clarify target scenarios, assess decision-making weights and consequences, ensure reproducibility and traceability of results, and conduct training. Collaboration and education play important roles in regulatory practices. Based on these findings, propose recommendations for China, including conducting regulatory science research, strengthening data governance standardization, and promoting the innovation of regulatory tools, to facilitate the standardized and healthy development of AI in China's drug clinical trials.

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: Amid the global wave of transformation in the pharmaceutical industry, advanced manufacturing technologies (AMTs) such as continuous manufacturing and Process Analytical Technology (PAT) have become the core drivers in developing new drug production models, where a data-driven approach is central to this transformation. However, certain aspects in the digitalization of advanced manufacturing in China still require further strengthening and refinement. We aim to explore a systematic approach for promoting the coordinated development of digitalization and standards in China's biopharmaceutical advanced manufacturing through research on the synergy between standardization and AMTs digitalization, providing insights to support industrial advancement. Methods: Firstly, the challenges in the digitalization of advanced manufacturing in China's pharmaceutical field were analyzed. Secondly, the approaches taken by governments in the United States, Europe, and Japan to strategically guide standardization through national strategies were examined. Finally, the successful experiences of international authoritative standards organizations in the coordinated development of standards in relevant fields, and the implementation pathways of mature universal standards were deeply analyzed and discussed. Resultsand Conclusion: It is proposed that standards serve as the “common language” linking technical rules and industrial ecosystems. The synergistic innovation of standards with advanced technologies represents a key development direction. Establishing a standards system across three dimensions: universal foundational common standards, key technology standards, and industry application standards, and conducting standardization work, are of significant importance for systematically advancing the high-quality development of digitalization and standard synergy of China's biopharmaceutical advanced manufacturing.

Objective: The application of patent big data analysis in the field of drug regulation and decision-making was explored by using patent data as a source of technical information. Methods: Taking transdermal patches as an example, a patent search expression was constructed to obtain relevant patent data. For the structured data part of the patent, descriptive analysis (statistical analysis, trend analysis) and other methods were adopted; for the unstructured data of the patent, text mining was used, and the LDA topic analysis model and TF-IDF word frequency statistics were employed; for the citation network relationship between patents, the main path analysis method and K-means clustering algorithm were adopted. Results: Through patent data analysis, information on the subject categories of transdermal patches, technological development trajectories, and technological evolution trends were obtained. Based on the in-depth understanding of the technological trajectory and development trend, three typical application scenarios were established: first, to provide a global perspective and build a technological panorama; second, to conduct trend prediction and hotspot mining based on the path of technological evolution; third, to refine and form the technological risk points based on the characteristics of specific technologies, to form the regulatory concerns and regulatory considerations. Conclusion: For the first time, we associated the application of patent analysis with drug regulation and decision-making. Through the mining and analysis of massive patent data, it can quickly identify the technical composition, technical evolution path, development trend, and regulatory risks of transdermal patches, providing more abundant information for policy-making and technical development, as well as a more effective and precise basis for decision-making.

Objective: To explore the key issues in the future research of formulated granules and provide scientific references for in-depth research and development of formulated granules. Methods: The characteristics of quality control for formula granules was summarized, and the quality inspection results and exploratory research of formula granules in the national drug sampling over the past three years was reviewed. Results: From 2022 to 2024, a total of 12 varieties of formula granule were sampled, involving 391 batches, of which 386 batches were qualified, with a qualification rate of 98.7%. Compliance testing indicated an overall good quality status. Exploratory research mainly focused on the authenticity and safety of raw materials used in granule production. Conclusion: The key issues in future research on formula granules should be approached from the perspective of regulatory science, combining the scientific principles, technical standards, and policy requirements of drug regulation. Particular emphasis should be placed on the following aspects: the consistency of the material basis with clinical decoctions and equivalence evaluation, quality uniformity control, technical breakthroughs for challenging varieties and the establishment of quality grading standards.

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

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

Objective：Based on the current development status of generic drugs in the Yangtze River Delta region, feasible suggestions were proposed to optimize the regulatory services for generic drugs. Methods：Through enterprise symposiums and questionnaires, a comprehensive study was conducted on the entire life cycle of generic drugs to fully understand the current development status of the generic drug industry in the Yangtze River Delta region. The policy implementation effects and actual industry demands in the entire process of generic drug research and development, registration and application, review and approval, and post-marketing supervision were analyzed, and suggestions were made. Results：Although China’s regulatory system for generic drugs is becoming increasingly complete and the quality of generic drugs in the Yangtze River Delta region has significantly improved, there is still room for improvement in the research and development and support of generic drugs, the review and approval process, and post-marketing supervision of generic drugs. Conclusion：By strengthening policy incentives for generic drugs, optimizing regulatory service processes, achieving full life cycle management, and strengthening local regulatory cooperation, the research and development efficiency and quality of generic drugs can be improved, and the high-quality development of generic drugs can be further promoted to a new level.

Objective：To provide an overview of the application of the Quality by Design (QbD) approach in the formulation and evaluation of oral films, with the aim of providing references for researchers. Methods：This article combines the main elements, implement steps and auxiliary tools of QbD with the research and development of Oral Films combined with the conception of QbD, introducing the quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), critical material attributes (CMAs) of Oral Films. Results and Conclusion：QbD involves a well-defined approach with predefined objectives to develop the product or process based on quality risk management and sound science. It comprises the defining of quality target product profile (QTPP) and critical quality attributes (CQAs), risk assessment (RA), design of experiment (DoE), design space (OS), control strategy (CS), process analytical technology (PAT). Oral films are rapid dissolution, easy to use, accturate dosage, and portable dosage forms that do not require water to be ingested. It can be used for individuals who require special needs, such as for treating psychosis, schizophrenia, mania, and dysphagia. Hence, it holds tremendous potential in terms of patient compliance, convenience, and pharmacotherapy. The concept of QbD has been widely used in the field of conventional dosage form, but less in oral films. Compared with traditional methods, QbD makes greater use of scientific knowledge in risk management, identifying the operational space of key material properties and key process parameters that affect key quality attributes, and continuously conducting full life cycle management. This is more conducive to enabling manufacturers and regulatory authorities to understand the production process and related change information of the product.

Objective：To provide a reliable analytical method for the quality control of enteric-coated tablets, the coating thickness and uniformity of pancreatic kininogenase enteric-coated tablets were determined using Raman spectroscopy imaging, and the differences in coating formulations and processes were analyzed. Methods：The tablets were sectioned, and the cross-sections were analyzed by Raman spectroscopy imaging to compare spectral characteristics of coating materials from different manufacturers. Coating thickness was measured using workstation software, with three tablets per batch were assessed from both front/back and side surfaces. Scanning electron microscopy (SEM) was additionally employed to verify Raman spectroscopy imaging results. Results：A total of seven tablet batches from six domestic and foreign manufacturers were analyzed. The coating thickness of products from manufacturers A, B, and C was similar, ranging from 62.3 μm to 69.3 μm. In contrast, the coatings from E and F were significantly thicker, at 113.0 μm and 127.5 μm, respectively. Manufacturer D’s product had the thinnest coating (40.2 μm). Notably, the coating of manufacturer C (non-uniform) and D (too thin) both exhibited insufficient acid resistance. Conclusion：The coating formulation, thickness, and uniformity significantly influence the acid resistance of pancreatic kininogenase enteric-coated tablets. Raman spectroscopy imaging provides accurate measurements of coating thickness and enables objective evaluation of coating processes.

Objective：To establish a high-performance liquid chromatography (HPLC) method for the determination of the content of sodium hydrocortisone succinate and its preparations using hydrocortisone hemisuccinate as the reference standard. Methods：The hygroscopicity, stability, and other physical and chemical properties of sodium hydrocortisone succinate and hydrocortisone hemisuccinate were investigated. The national reference standard of hydrocortisone hemisuccinate was calibrated according to the method specified in the 2020 edition of the second part of the Chinese Pharmacopoeia for sodium hydrocortisone succinate. A HPLC method for the determination of the content of sodium hydrocortisone succinate and its preparations was developed using a Waters Xbridge C₁₈ column (4.6 mm×250 mm, 5 μm) with a mobile phase consisting of acetonitrile-water-phosphoric acid (330∶670∶1) at a flow rate of 1.0 mL · min^-1, column temperature of 30 °C, detection wavelength of 254 nm, and injection volume of 20 μL. Results：Sodium hydrocortisone succinate exhibits strong hygroscopicity and thermal instability, whereas hydrocortisone hemisuccinate demonstrates low hygroscopicity and excellent stability, making it suitable as a reference standard for content determination. A national reference standard for hydrocortisone hemisuccinate was developed and calibrated using the mass balance method, with a determined content of 99.6%. A specific, robust, and precise method for the determination of the content of sodium hydrocortisone succinate and its preparations was established using hydrocortisone hemisuccinate as an external reference standard. The method was validated for specificity, robustness, and precision. The method was also validated by simultaneous analysis of the content of multiple batches of raw materials and formulations using the newly established method and the standard method, and there was no significant differences in the results. Conclusion：Hydrocortisone hemisuccinate can be used as a reference standard for the determination of sodium hydrocortisone succinate content, with better stability. The developed method is suitable for the quantitative analysis of sodium hydrocortisone succinate and its preparations.

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 identify the systemic risks to regulatory consistency and product safety stemming from inconsistencies in the implementation of general cosmetics filing and administration procedures across provincial medical products administrations in China. The research seeks to support the effective execution of territorial regulatory responsibilities for cosmetic safety at the provincial level, and to promote the modernization of regulatory functions, shifting from passive accepting applications to proactive guidance and service. Methods：Through an in-depth analysis of core regulatory documents and public data from cosmetic filing review practices, this study deconstructs local regulatory responsibilities into three dimensions: procedural, technical, and systemic. This framework reveals the risk transmission mechanisms resulting from regional discrepancies. Furthermore, a Failure Mode and Effects Analysis (FMEA) was applied to quantitatively assess the key risk points within the technical review process of filing documentation. Based on this analysis, the study proposes a modernization path for smart governance centered on data-driven approaches and risk management, which integrates capacity building, intelligent systems, and proactive services. Results：The findings revealed an imbalance in the technical capabilities and systemic oversight among local regulatory authorities when performing their unified statutory duties. While most regions can adequately fulfill procedural responsibilities, significant disparities existed in the execution of technical responsibilities, such as the review of product formulation label claims. The FMEA assessment identified “Improper technical review of safety assessment data”, which is directly related to technical responsibility capabilities, as the highest-priority systemic risk, with a Risk Priority Number (RPN) of 480. Conclusion：Provincial medical products authorities should proactively fulfill their territorial regulatory responsibilities, shift their focus from the passive receipt of documents to the active construction of an intelligent review system based on risk and big data. By strengthening the capacity of technical review teams, optimizing internal review processes and tools, and enhancing proactive services and pre-filing empowerment for applicants, regulatory bodies can guide and solidify the primary responsibility of enterprises for product quality and safety. This approach will ultimately lead to a dual enhancement of both regional regulatory efficiency and industrial development within the framework of national unified regulations.

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

Objective：To study the inclusion status of fruit-based Chinese medicinal materials in the 2020 edition of the Chinese Pharmacopoeia, the Chinese Ministry of Health’s Drug Standards for Chinese medicinal materials, the Quality Standards for 43 Imported Chinese Medicinal Materials Including Catechu, and 40 local Chinese medicinal material standards was studied; A retrieval table for the shape characteristics of a total of 216 primitive and 200 varieties of fruit based Chinese medicinal materials registered in the 2020 edition of the Chinese Pharmacopoeia and local standards for traditional Chinese medicinal materials, was compiled. Methods：The sources, types, and maturity of fruit based Chinese medicinal materials in the current standard were sorted out, statistically analyzed, summarized and expressed in the form of charts. On this basis, a retrieval table for fruit based Chinese medicinal materials was compiled in combination with the results of morphological research results and plant taxonomy. Results：The current standards included a total of 200 varieties of fruit-based medicinal materials, belonging to 216 species across 63 families. If counted by the principle of one source corresponding to one medicinal part, there were a total of 237 fruit-based Chinese medicinal materials. Analyzed by medicinal material varieties, in terms of origin, the larger number of varieties were from the Rosaceae family with 18 varieties, followed by the Rutaceae family with 15 varieties and the Cucurbitaceae family with 13 varieties. There were 35 varieties of medicinal materials with multiple sources, accounting for 17.5%, and 165 varieties with single source, accounting for 82.5%. Analyzed by medicinal material sources, in terms of fruit types, the largest number was of single fruits, with 201 pieces, accounting for 84.81%. According to the statistical analysis of medicinal parts, the proportion of intact fruits was the highest, with 194 pieces, accounting for 81.86%. According to the maturity level of fruits, the proportion of mature fruits was the highest, with 178 pieces, accounting for 75.11%. The compiled retrieval table covered 140 genera from 63 families, with a total of 532 entries. This retrieval table had certain scientific and practical significance. Conclusion：This study provides an experimental basis for the classification and identification of fruit based traditional Chinese medicinal materials, as well as the classification and morphological research of medicinal plants. It also has certain significance for the development, utilization, and protection of natural resources of traditional Chinese medicinal materials, as well as the market and intelligent supervision of traditional Chinese medicinal materials.

Objective：To provide solid data support for the identification of fruit-based Chinese medicinal materials by focusing on the classification, as well as the morphological structural characteristics of fruit-based Chinese medicinal materials, and by summarizing and analyzing specific examples, combined with modern imaging technologies to characterize the key features. Methods：The study drawed upon botany theories and the unique attributes of Chinese medicinal materials, which offer a solid theoretical foundation for the classification and analysis of fruit-based Chinese medicinal materials. A series of cutting-edge imaging techniques, including stereomicroscopes, digital imaging technology, optical microscopes, and digital scanning sectioning instruments, were further used to observe and characterize the type characteristics of 200 varieties of fruit-based Chinese medicinal material varieties (covering 216 original sources) as delineated in current standards. Results：Based on classification of fruit types, through high-precision observation and analysis on the morphological structural characteristics, as well as the internal structures of representative varieties, corresponding high-definition imaging characterization features were generated, providing an intuitive and reliable visual basis for identification work. Conclusion：Through systematic classification of fruit-based Chinese medicinal materials and the application of integrating modern imaging technologies, this study can provide data support for the standardized management of Chinese medicinal materials, establish a foundation for the development of intelligent identification systems, aids in elevating the overall level of the Chinese medicinal materials industry, and promote the modernization of traditional Chinese medicine (TCM). By conducting in-depth research on the type characteristics and generating digital data of fruit-based Chinese medicinal materials, reliable references can be provided for regulatory authorities, enterprises, clinicians, pharmacists, and ordinary consumers. This, in turn, will significantly reduce the misidentification rate, ensure the authenticity and quality stability of medicinal materials, and thus ensuring the safety and efficacy of public medication at the source.

Objective：To study comprehensive taxonomic, morphological, and anatomical studies of fruit-based Chinese medicinal materials, involving the summarization, exemplification, and high-definition imaging characterization of their fundamental shared traits, so as to provide a basis for the identification and classification of these medicinal materials. Methods：By applying modern imaging technologies such as stereomicroscopes, digital imaging technology, optical microscopes, and digital scanning sectioning instruments, the relevant morphological and structural characteristics of 200 variety of fruit-based Chinese medicinal materials（covering 216 original sources）collected from current standards were observed（with reasonable dissection if necessary）, analyzed, induced, summarized, exemplified, and characterized by high-definition imaging characterization. Results and Conclusion：Combining the characteristics of traditional Chinese medicine （TCM）, this study exemplified and conducted imaging characterization of the developmental process of fruit-based Chinese medicinal materials, along with the structures of their exocarps, mesocarps, and endocarps. It provided an experimental foundation for the identification, classification, standardized, and intelligent research of fruit-based Chinese medicinal materials. Additionally, this study contributed certain digital data for the Chinese medicinal materials market and intelligent supervision.

Objective：To systematically study on the tissue types of fruit-based Chinese medicinal materials and list their applications in the microscopic identification of Chinese medicinal materials. Methods：Morphological and anatomical studies were carried out on the fruit-based Chinese medicinal materials in the current standards, and their tissue types were studied, summarized and classified. Examples were selected for illustration, and images were collected in accordance with the “Research on Digital Characterization Norms for Traditional Identification Features of Fruit-Derived Medicinal Materials”. Results：The different characteristics and functions of the cells in the protective tissues, parenchyma tissues, mechanical tissues, conducting tissues and secretory structures of the fruit tissues were compared and their applications in the microscopic identification of Chinese medicinal materials were listed. Conclusion：The study of the tissue types of fruit-based Chinese medicinal materials not only deepens the understanding of their characteristics, but also promotes the development of Chinese medicinal material taxonomy, anatomy and identification. It also provides guidance for the quality and safety of medicinal materials. The application of tissue types in the microscopic identification of Chinese medicinal materials provides objective and quantifiable indicators for quality control, thereby better promoting the modernization of traditional Chinese medicine.

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

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

Objective: To provide guidance for enterprises and some ideas for improving the work efficiency of raw materials filing of chemical reference substances. Methods: Study the relevant laws and regulations, sort out the filing process, and analyze it in combination with filing examples to distill the key points of filing raw materials for chemical reference substances. Results and Conclusion: The key points of the relevant requirements for filing materials and raw materials were clarified in this paper, which analyze from multiaspect and put forward suggestions. The filing of raw materials with high quality and strict requirements is crucial to the development of national standard substances, which provide the important guarantee for the quality supervision and people's medication safety.

Objective: To analyze the cases of administrative penalties for medicines based on the Measures for the Supervision and Administration of the Quality of Drug Distribution and Use as the basis for penalties in China, summarize their patterns and provide warnings for medical institutions. Methods: Statistical analysis of drug administrative penalty instruments with medical institutions as parties in 2024, using retrospective analysis methods. Results: A total of 79 administrative penalties for pharmaceuticals were screened with medical institutions as the parties and the Measures for the Supervision and Administration of the Quality of Drug Distribution and Use as the basis for the penalties, with the main source of the cases being routine inspections of professional practices. Among them, 28 cases violated the Drug Administration Law of the People’s Republic of China at the same time, and 51 cases violated the Measures for the Supervision and Administration of the Quality of Drug Distribution and Use only, and the causes of violation mainly included failure to carry out purchase and acceptance inspection and failure to carry out storage and maintenance of drugs in accordance with the regulations. Analyzing the magnitude of the amount of penalties imposed in the cases, 27 cases (84.38%) were mainly non-punishable for the first violation, while 38 cases (80.85%) were mostly lightly punished for the second violation. Conclusion: Medical institutions should strengthen the legal awareness, recognize the common violations in drug management and be warned. By paying attention to details, they should conduct routine drug inspections and management to avoid serious violations resulting from negligence. This ensures quality management in the drug usage process and fortifies the drug safety barrier.

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

Objective: To simultaneously determine the contents of forsythoside A and forsythin in Fufang Yuxingcao Tablets, and to analyze their contents statistically, in order to effectively control the quality of the medicinal material Forsythiae Fructus and ensure the quality of the preparation. Methods: The analysis was performed on a Waters XBridge C₁₈ column (4.6 mm×250 mm, 5 μm) using acetonitrile-0.1% phosphoric acid as the mobile phase in gradient elution mode. The flow rate was set at 1.0 mL · min^-1. The column temperature was maintained at 30 ℃. The detection wavelengths for forsythoside A and forsythin were 330 nm and 277 nm, respectively. The contents of forsythoside A and forsythin in Fufang Yuxingcao Tablets were simultaneously determined. The cluster analysis, principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA) were performed on the measurement results. Results: Forsythoside A and forsythin were found to exhibit good linearity within their respective concentration ranges. The mean recovery rates were determined to be 97.92% and 98.96%,respectively. The RSDs of repeatability were 0.61% and 0.60%,respectively. The method satisfied the quality control requirements. There were significant differences in the content of forsythoside A among different enterprises, and the consistency of forsythin content was relatively good. Multivariate statistical analyses showed that forsythoside A was differential constituents that affect the quality of Forsythiae Fructus. Conclusion: The HPLC combined with multivariate statistical analyses established in this study has the advantages of high sensitivity, good accuracy, and strong specificity. It can be used for the simultaneous determination of two constituents in the preparations, providing a reference for the quality evaluation research and product quality improvement of Fufang Yuxingcao Tablets.

Objective: In April 2024, the U.S. Food and Drug Administration (FDA) officially required all approved CAR-T therapeutic products to add a boxed warning, alerting patients and prescribers about the potential T-Cell malignancy risk post-treatment. This announcement has drawn global attention and made CAR-T safety a research priority. This minireview retrospected the boxed warning issuance and reviewed the latest progress on CAR-T-induced secondary primary tumors (especially T-Cell lymphomas). Methods: Based on the current understanding of CAR-T products, the study conducted a systematic review of the literature related to CAR-T therapy and secondary primary tumors, including T-Cell lymphomas, by searching public databases. The study also reviewed relevant announcements on the FDA website and other publicly available information sources to summarize the chronology of this event and the latest research progress. Results and Conclusion: By examining the clinical evidence between CAR-T therapy and secondary primary tumors, including T-Cell lymphomas, the study analyzed the potential mechanisms, and discussed how to coordinate within the area to reduce the secondary primary tumor risk, aiming to advance CAR-T optimization and offer safer and more effective cancer treatment options for the patients.

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

Objective: To develop a standardized Burkholderia cepacia complex (referred to as “Bcc”) testing method for the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, thereby enhancing the national standards for China's pharmaceutical microbial contamination control and improving regulatory oversight. Methods: A systematic methodological evaluation of Bcc detection protocols was conducted by referring to the international standards for pharmaceuticals, cosmetics, and related products. By collaborating with 11 drug control laboratories under a national pharmaceutical standards enhancement initiative, critical parameters were optimized, including enrichment conditions, selective media, and confirmatory assays. Methodvalidation was performed using both spiked and real-world samples, followed by iterative revisions based on interlaboratory verification. Results: The reference strains for quality control, an optimized enrichment and isolation system, and selective culture media with improved specificity were specified in the finalized Chinese Pharmacopoeia 2025 Edition Bcc test method. Additionally, a definitive species-level taxonomic list of Bcc members was incorporated to facilitate accurate strain identification. Conclusion: On the basis of aligning with global regulatory standards, the establishment and inclusion of the Bcc test method addresses critical gaps in China's pharmaceutical microbiological quality control. Its adoption in the Chinese Pharmacopoeia 2025 Edition represents a pivotal advancement in the compendium's microbial standards, ensuring enhanced detection of opportunistic pathogens in pharmaceutical products.

Objective: To strengthen the implementation of the main responsibility for microbial control of pharmaceutical water, and to enhance the guidance on the full life cycle microbial monitoring and control of pharmaceutical water in the industry, the “Guideline for Microbiological Monitoring and Control of Pharmaceutical Water” was established. Methods: Four institutes for drug inspection and many pharmaceutical manufactures were organized to sort out the key points of the guideline through the investigation of testing methods, exploration of the application of rapid microbial methods, comparison of regulations and standards, questionnaire surveys, and on-site investigations of enterprises. Results: A full-chain technical framework covering the microbial characteristics, monitoring methods, process control, and risk prevention and control of pharmaceutical water was constructed Chinese Pharmacopoeia 2025 Edition has newly added the “Guideline 9209 for Microbiological Monitoring and Control of Pharmaceutical Water”. Conclusion: This guideline is an important supplement to the revision and implementation of product standards and general rules for pharmaceutical water, and also represents a significant measure for aligning Chinese Pharmaceutical water standard system with international advanced technical concepts.

Objective: To address the deficiencies in the selection, validation, and application of disinfectants by pharmaceutical manufacturers, and in line with the core concept of “whole-process control” in the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, to establish a scientific and operational guideline for the evaluation of disinfectant efficacy. Methods: By integrating domestic and international pharmacopoeia standards (USP, JP) and national standards (GB/T series), technical specifications were systematically formulated, covering the classification of disinfectants, methods for efficacy evaluation, and criteria for result determination. Results: The application scope of chemical disinfectants in the pharmaceutical environment was clarified, and two test methods, the suspension method and the carrier method were listed, and the threshold for determining disinfection efficacy was set based on international standards (a reduction of ≥3 in the lg value for bacterial or fungal vegetative cells, and a reduction of ≥2 in the lg value for spores or spores). Conclusion: The establishment of this guideline has promoted the improvement of the microbial contamination control standard system and provided technical support for the microbial safety management in the pharmaceutical production process.

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

Objective: Adjuvants for traditional Chinese herbs processing are an important part of traditional Chinese herbs, and elucidating the mechanism of processing adjuvants is a powerful starting point for promoting the modernization of traditional Chinese herbs. This article summarizes the research progress on the mechanism of adjuvants for traditional Chinese herbs processing, and provides a reference for optimizing the processing technology of traditional Chinese medicine, establishing standards for processing excipients, and supervising drug quality. Methods: The relevant literatures of traditional Chinese medicine processing adjuvants in recent years were summarized, the research methods and results adopted by them were compared and analyzed, and the existing problems and countermeasures in the current research were discussed. Results and Conclusion: Studies showed that adjuvants used in processing of traditional Chinese herbs can play roles in solubilizing, attenuating, synergizing, absorption-promoting and other aspects, consequently, affecting the effectiveness and safety of the drug. We should take full advantage of modern analytical techniques to compare the changes of chemical composition of adjuvants before and after processing, and carry out systematic research by combining pharmacodynamic and pharmacokinetic methods.

Objective：To propose new ideas of the mechanisms of drug regulatory science research in China by leveraging the platform of the drug regulatory science research in the National Medical Products Administration. Methods：Firstly, both domestic and international literature on drug regulatory science were reviewed and relevant practices and experiences in this field were summarized. Then discussion sessions were organized. At last, existing challenges faced by China’s drug regulatory research mechanisms were analyzed to propose related suggestions for improvement. Results and Conclusion：The current challenges in mechanisms of drug regulatory science research in China include: scattered scientific research resources, insufficient grasp of the difficulties and pain points in innovative drug development, the lack of obvious role in promoting the transformation of innovative achievements, an urgent need for cultivating the compound talents in regulatory science, and a necessity to further deepen international cooperation with regulatory science organizations. Based on the above situation, it is recommended to establish the following mechanisms, including a multi-participation research mechanism, a convenient and efficient information-sharing mechanism, a cross-integrated system for talents team coordinated and improved, a coordinated training and communication network, a perfect graduate student selecting and training mechanism, and a mutual benefit and win-win international cooperation mechanism. These initiatives aim to accelerate the promotion of technological innovation and achievement transformation, form a novel New Quality Productive Forces, and serve the research and development of new drugs and drug marketing,so as to make drug regulatory research become a bridge between basic innovation and industrial transformation, and become the leader and booster of the development of the drug industry.

Objective：To provide references for optimizing the registration classification management of therapeutic biological products in China. Methods：The achievements since the implementation of the new registration classification of therapeutic biological products in China were analyzed through literature research; the issues and directions that need to be optimized in the new registration classification of therapeutic biological products in China were understood through questionnaire surveys. Results and Conclusion：The survey indicates the following issues need to be optimized in the implementation of new drug registration classification: the definition of registration category 1 (novel drugs); the recognition of clinical advantage of registration category 2 (improved drugs); classification overlap in registration category 3. Accordingly, this paper provides comments and suggestions regarding the above issues, including to introduce the concept of integrity of safety and effectiveness data as the key benchmark for novel drugs, to focus on the clinical value of improved drugs, and to further clarify the definition and scope of some drug registration classification.

Objective：To comprehensively explore the application of quality risk management (QRM) in the quality management of pharmaceutical distribution enterprises, and to provide references for QRM in the pharmaceutical distribution industry. Methods：By analyzing different ways of QRM, using literature review and other methods, and combining with the current development characteristics of the industry, the application of QRM in the quality management of drug circulation was explored. Results：The awareness of QRM among domestic pharmaceutical distribution enterprises is gradually increasing, and preliminary QRM systems have been established. However, there are still some shortcomings, including insufficient corporate risk awareness, incomplete quality management systems, operational quality risks in various aspects of drug circulation, and inadequate risk awareness in supplier-client transactions. Conclusion：Despite some improvement in the QRM level of domestic pharmaceutical distribution enterprises, significant challenges remain. Risk assessment is of great significance in the quality management process of pharmaceutical distribution enterprises, which can help improve the quality management level of pharmaceutical business enterprises and strengthen safety production management. So, in practical operation, it is still necessary to continuously improve and refine risk assessment methods and tools, strengthen supervision and management, ensure the effective implementation of the quality management systems, and promote the sustainable development of drug safety management.

Objective：To establish a method for measuring the particle size of virus-like particles using nano-flow cytometry. Methods：The particle size of human papillomavirus (HPV) vaccine bulk solution was measured using a nano-flow cytometer (2L12C) and compared with dynamic light scattering and negative staining electron microscopy. Results：The particle size of 6 batches of HPV vaccine bulk solution was measured using the nanoparticle flow cytometry method, with average sizes of 63.35 nm, 74.87 nm, 73.62 nm, 73.07 nm, 61.85 nm, and 62.67 nm, and relative standard deviations of 1.04%, 0.81%, 0.60%, 0.52%, 0.55%, and 0.30%, respectively. The results obtained by dynamic light scattering were 57.86 nm, 120.29 nm, 117.18 nm, 112.20 nm, 75.93 nm, and 77.42 nm. There was a significant difference in the results of 3 batches between these two methods. However, the results of nanoparticle flow cytometry were close to those of negative staining electron microscopy. In the accelerated thermal test, the average particle size increased to 90 nm after 6 hours. Conclusion：The nano-flow cytometry is a rapid, accurate, and convenient method for measuring the particle size of virus-like particle vaccines bulk solution.

Objective：To analyze the key quality characteristics of widely used aluminum adjuvants and their influencing factors, and to propose suggestions for further optimization in quality control, so as to provide a reference for improving the quality standard of aluminium adjuvants. Methods：Based on the international and domestic research results in recent years, the current quality standards of aluminum adjuvants at home and abroad were taken as the starting point, and the different production processes of aluminum hydroxide and aluminum phosphate adjuvants were analyzed. Results：For the quality control of aluminium adjuvants, it was necessary to pay attention to the quality characteristics of aluminium adjuvants, including structure, zero-charge point, particle size and distribution, and phosphorus-aluminium ratio. Meanwhile, the formulation system and residual impurities in the production process would affect the quality characteristics of aluminium adjuvants. Conclusion：Aluminium adjuvants, as one of the most widely used adjuvants in the field of vaccines, should be paid more attention to their quality characteristics, which are directly related to the safety and efficacy of vaccines, and are greatly affected by the production process.

Objective：To optimize the intelligent management model of drugs in wards, improve the efficiency of pharmacists and healthcare professionals, and enhance the efficacy of clinical drug management. Methods：This study was conducted in 20 wards equipped with Automated Dispensing Cabinets (ADC) in Beijing Tongren Hospital. The initial construction of the intelligent drug management model in these wards was completed between March and November 2023. From December 2023 to November 2024, SWOT-CLPV (Strength, Weakness, Opportunity, Threat - Control, Leverage, Problem, Vulnerability) analysis was employed to deeply analyze the internal strengths and weaknesses, external opportunities and threats, as well as the resulting leverage, inhibitors, vulnerabilities, and potential problems of drug management in wards. Based on these findings, optimization strategies were developed. Pre- and post-optimization data were compared, and an effectiveness analysis was conducted on the implementation effects. Results：After applying SWOT-CLPV analysis and implementing optimization strategies, the proportion of ward night medical prescriptions transferred to the emergency pharmacy decreased from 48.97% to 21.93%, while the proportion of nighttime medical orders processed through the ADC pattern increased from 51.03% to 78.07% after optimization, with statistical significance (P<0.05). The variety of base drugs in wards was decreased significantly (P<0.05). All aspects of nurses’ satisfaction have shown significant improvement (P<0.05). Conclusion：The application of the SWOT-CLPV analysis method to optimize the intelligent management model of drugs in wards has yielded preliminary success, and has reference and promotion value.