Objective：To provide a reference for practitioners to better understand and accurately implement the standards for compound and single herb preparation of traditional Chinese medicine (CSHP) in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I). Methods：The main contents and characteristics of the additions and revisions of the standards for CSHP in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I) were analyzed and summarized. Results and Conclusion：In Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I), 28 new monographs of CSHP have been added, over 200 monographs have been revised, and 19 monographs are no longer included. The standards for CSHP are added or revised to ensure the safety, effectiveness, and quality controllability of medication, which continuously improves the overall level of standards, refines the formation mechanism of standards, and strengthens the technical support role of scientific supervision. The new edition of Chinese Pharmacopoeia could provide stronger technical supports for further promoting the improvement of quality standards for CSHP, promoting the high-quality development of the Chinese medicine industry and ensuring the safety of people’s medication.

Objective: To study the establishment and optimization of the pathogen targeted next-generation sequencing (tNGS) process based on the probe capture method, as well as the automated implementation of it, and to verify the analytical performance. Methods: The factors influencing the tNGS methodology were analyzed, including the probe design and production quality control, data volume and sequencing read length. The analytical performance was evaluated by using a reference panel constructed with 62 types of microbes, including various bacteria, fungi, viruses, and atypical pathogens. As well as, the differences in limit of detection, precision and cross-contamination between manual operations and automated were compared. Results: The study showed that as the probe coverage increased, the limit of detection performance increases accordingly, and the probe still maintained high specificity. The optimized tNGS demonstrated good analyze performance in terms of accuracy, limit of detection, precision, specificity linearity and so on. Under the premise of the same limit of detection performance, the automated method was superior to manual operation in precision and cross-contamination resistance performance. Conclusion: The tNGS process established in this study has good analytical performance and provides a new strategy for clinical pathogen detection. Future studies should focus on clinical sample confirmation and automated process validation to promote better application of the technology in practical clinical work.

Objective: To provide suggestions and references for the pharmaceutical research of genome editing systems in advanced therapy medicinal products. Methods: Based on the pharmaceutical research, combined with the requirements of relevant regulation and guidance domestically and abroad, this article focused on the upstream design, production and quality research, use and risk management of genome editing systems. Results and Conclusion: In recent years, genome editing systems represented by CRISPR/Cas9 have risen rapidly as scientific research hotspot, and have been widely used in many fields such as medicine, agriculture, biotechnology and so on. In the field of therapeutics, genome editing systems can not only be used as active pharmaceutical ingredients or drug substances in vivo, but also play a therapeutic role after editing cells in vitro and returning to the human body. So it is an important concern in the evaluation of advanced therapy medicinal products. This article raised the current considerations for pharmaceutical research, hoping to promote the clinical transformation and application of genome editing products.

Objective: To research and analyze the basic knowledge, product application and regulatory policy of collagen, a popular medical device material, in order to provide references for the research and development, production and marketing of collagen-based medical devices. Methods: Literature search was conducted to understand the information and industrial situation of collagen. The licensed status of collagen-based medical devices were sorted out and the development direction and trend of the industry were analyzed. The relevant standards and policy documents were sorted out to grasp the key points of regulation. Results and Conclusion: With reference to 70 relevant literatures, 1009 collagen-based medical devices have been licensed in China, involving guidelines, regulatory documents and standards, which were a total of 25. Collagen-based medical devices have been developed for more than 140 years globally, and are widely used in the fields of wound treatment, tissue repair and regeneration, and medical aesthetic implantation due to their excellent biocompatibility and functionality. The market presents two types of collagen, animal source and recombinant, which complement each other. Domestic regulation is advancing with the times, and a number of collagen-based regulatory standards and technical review principles have been introduced to provide protection for the healthy and standardized development of the collagen-based medical device industry.

Objective: Microbial Data Deviation (MDD) investigation plays a key role in validating the effectiveness of pharmaceutical microbial test. However, the current guidelines on pharmaceutical MDD investigations in China still need to be improved, which poses certain difficulties for the pharmaceutical industry in carrying out MDD investigations. This article aims to provide a reference for the implementation of pharmaceutical MDD investigations and the improvement of relevant standards. Methods: The concept, road map, and methods were summarized by comparing the domestic and international standards related to MDD investigation including national pharmacopeias, GMP guidelines and PDA technical reports, etc. Also, the related study cases were analyzed to reveal the history and current status of MDD investigation. Results: The concept and characteristic of MDD were illustrated. Some technical processes and root cause of MDD investigation were as similar as Out of Specification (OOS) investigation, but the former is more complicated like in stuff composition. It is suggested to construct a serious of standard operating procedures before conducting MDD investigation, and conduct microbial risk assessment when performing root cause investigation and correction and preventive action. Conclusion: Currently, MDD investigation has been a necessary step in pharmaceutical microbial test. This paper provides a reference for investigating and surveying in establishing a MDD investigation system and for the pharmaceutical quality control and improvement.

Objective: To sort out the similarities and differences of the implementation documents of the policy of wholesale and retail integration of drug business in 12 provinces, including Jiangsu, Guizhou, Hainan, Shanxi, Chongqing, Shandong, Jiangxi, Inner Mongolia, Guangxi, Guangdong, Hunan and Hubei, so as to provide references for drug business enterprises and relevant regulatory authorities and promote the high-quality development of the industry. Methods: From the policy implementation document release time, subject requirements, drug business license issuance methods, quality management system, institutions and responsibilities, personnel requirements, facilities and equipment requirements, computer system requirements and other aspects of the above-mentioned local drug business wholesale and retail integration policy implementation documents for detailed comparative analysis. Results: It is clear that the implementation documents of the policy of the integration of drug business wholesale and retail in the above provinces require the integrated wholesale and retail enterprises are the same legal entity, but there are differences in the requirements of drug business license issuance, quality management system, institutions and responsibilities, personnel requirements, facilities and equipment requirements, computer system requirements and other aspects. Conclusion: Through a comparative analysis of the implementation documents of the above-mentioned drug wholesale and retail integration policies in various places, suggestions for the development of enterprises are put forward to provide strong support for the development of the industry.

Objective: The 2025 edition of the Pharmacopoeia of the People's Republic of China is about to include a general principles of Human Antibody-Drug Conjugates (ADC) for human use. This section will elaborate and discuss the manufacturing and testing of ADC products, providing guidance for specific implementation in the industry. Methods: Based on the relevant regulations and guidelines of WHO, ICH, the National Pharmacopoeia Commission, and the Center for Drug Evaluation of the National Medical Products Administration, the discussion and consideration on the general principles of ADC were put forward. Results and Conclusion: In the pharmacopoeias of Europe, America, and other countries, there are currently no overall requirements for the production and quality control of Antibody-Drug Conjugates (ADC). The “Guiding Principles for Pharmaceutical Research and Evaluation Techniques of Antibody-Drug Conjugates” issued by the Center for Drug Evaluation of the National Medical Products Administration is the first guideline that has been introduced for the standardized production and quality control of such drugs. Based on the reference to relevant regulations and the guidance of establishing international standards, this article mainly discusses the general principles and basic requirements that need to be followed in the research and development, preparation process, and quality control of relevant drug products involved in the general principles of ADC. This aims to provide a reference for the relevant industries.

Objective: To analyze the composition and influencing factors of pharmacy personnel in secondary and tertiary hospitals across 31 provinces in China, and their association with resident population and regional GDP, in order to provide a scientific basis for optimizing pharmacy personnel allocation and improving pharmaceutical care quality. Methods: A multicenter cross-sectional survey design was adopted, covering 1130 hospitals in provinces represented by members of the Chinese Hospital Association's Pharmacy Committee. Data on pharmacy personnel numbers, professional title distribution, education levels, and departmental allocations (2021-2022) were collected via SoJump, which were analyzed correlation with resident population and regional GDP data from the National Bureau of Statistics. Non-parametric correlation statistical tests (two-tailed Spearman test) were applied. Results: The average proportions of pharmacists in tertiary and secondary hospitals in 31 provinces in 2022 were 4.21% and 5.15%, respectively, with 0.65 and 0.66 clinical pharmacists per 100 beds. Resident population showed positive correlations with actual available number of beds, annual number of discharged patients, average number of discharged patients per pharmacist, annual outpatient volume, average outpatient volume per pharmacist, average daily number of outpatient prescriptions, average number of outpatient prescriptions handled per pharmacist per day, total number of personnel involved in dispensing Chinese and Western medicines in outpatient and emergency departments and number of personnel in PIVAS and number of clinical pharmacists per 100 beds. Negative correlations were observed with the related factors of pharmacists specializing in quality and medication safety, informatics and clinical pharmacies. Regional GDP significantly correlated with pharmacist education, professional titles, and staffing in outpatient and emergency pharmacies as well as PIVAS. Conclusion: Current pharmacy personnel allocation in Chinese hospitals faces challenges such as insufficient staffing, unbalanced professional title structures, and delayed development of clinical pharmacy.

With the rapid development of the global pharmaceutical industry and the advancement of precision medicine concepts, special dosage forms of drugs continue to emerge. These types of drugs are often embedded in special materials or contain special excipients, resulting in difficulties in sample dissolution, filtration, and removal of antibacterial properties, which is a challenge in establishing sterility testing methodology. This article focuses on three dimensions：key parameter optimization, the construction of specific methodology for special dosage forms (microsphere preparation, liposome preparation, protamine containing preparation, ophthalmic gel preparation and chitosan based preparation) and application of rapid microbial detection technology, in order to provide references for the establishment of sterile testing methods and quality control of special dosage forms of drugs.

Objective: To put forward improvement suggestions in view of the risks arising in the process of online drug sales. Methods: Combining the current development status of online drug sales and the regulatory situation of existing laws and regulations, an empirical analysis of various issues that need to be improved throughout the entire process of online drug sales was conducted. Results: In view of the current problems that there are many risk points exposd in the process of online drug sales, and to enhance compliance of online drug sales with current regulations and address operational loopholes, it is imperative to refine regulatory requirements, improve corporate management practices and strengthen social collaboration. Conclusion: Quality control of the entire process of online drug sales could guarantee the continuous compliance of the process of online drug sales, ensure the safety and effectiveness of the process of drug use, and better protect public health.

Objective：To construct an intelligent management and pharmaceutical service model for inpatient pharmacy, and systematically evaluate its application effectiveness. Methods：Based on the operational improvements and practices in the inpatient pharmacy, this study focused on the intelligent management and service across key pharmaceutical processes, including drug requisition, dispensing, delivery, and medication guidance. It elaborated on the operational status of specific systems and platforms, such as the intelligent drug requisition system, pre-prescription review system, automated drug dispensing platform, closed-loop drug delivery management system, home-based pharmaceutical logistics delivery service, core database for post-discharge medication guidance, and “Internet+” medication consultation services. Additionally, a comparative analysis was conducted to evaluate the error rates and work efficiency before and after the implementation of the intelligent management and pharmaceutical service model. Results：After implementing the intelligent management and pharmaceutical service model, the number of drug requisition personnel was streamlined from 6 to 3. There were significant reductions in the average total completion time of requisition plans, the total number of missed medication items, and the monthly total number of drug requisition submissions [(164.9 ± 3.4) vs. (63.2 ± 1.9) min (P<0.05); (21 ± 3.4) vs. (0 ± 0.0) items (P<0.05); (129 ± 6.9) vs. (35 ± 1.9) times (P<0.05)]. The number of inappropriate solvent selection orders for injectable medications dropped to zero. The average medication delivery time in the inpatient pharmacy was reduced by 69 minutes, and delivery efficiency improved by 39.3%. Patients’ awareness of safe medication use at home increased significantly. Conclusion：The whole-process intelligent management and pharmaceutical service model of the inpatient pharmacy has significantly shortened the drug dispensing and delivery time, improved the working efficiency of pharmacists, reduced the risk of medication errors, and ensured the safety of patients’ medication.

Objective: To explore the application practice of product technical requirement documents for medical devices, and provide optimization suggestions for future applications. Methods: The evolution process of medical device regulations was sorted out. The background and status as well as the existing problems of product technical requirements for medical devices in the current regulatory use process were sorted out. Results and Conclusion: As a technical document bearing product quality characteristics, medical device product technical requirements run through product development, registration and post-market supervision, and is an important regulatory tool for medical device supervision. The technical requirements of medical device products play an important role in the process of improving the supervision of medical devices. With the continuous improvement of the development level of the industry, the technical requirements of products should be further modified and improved in order to meet the needs of the development of the industry and supervision.

Objective: To establish and validate a method for the detection of free sulfhydryl concentration in monoclonal antibody drugs by using a 96-well enzyme-labeled plate, which can determine the free sulfhydryl concentration in monoclonal antibody drugs in a fast, stable and easy way. Methods: Determination of free sulfhydryl groups in monoclonal antibody drugs was based on Ellman method, and the specificity, linearity, intermediate precision, accuracy and robustness of the method were validated. Results: The specificity of the method was proved to be good. Ellman’s reagent reacted only with free sulfhydryl groups in monoclonal antibody samples and reduced L-glutathione standards. The theoretical and measured free sulfhydryl concentration of the samples were linearly correlated in the range of 0-45.5 µmol · L^-1, with a coefficient of determination (R²)>0.99. Six assays of three batches of samples were detected independently by two experimenters on three working days, the mean values of free sulfhydryl concentration were 2.34, 2.42, and 2.48 mol · mol^-1, and the RSDs were 1.28%, 2.07%, and 2.42%, respectively. The average recoveries of the three concentration levels of spiked solutions (10, 20 and 40 µmol · L^-1) from the three batches of stock solutions were all in the range of 97.59% to 107.51%, and the RSD were less than 15%. The mean value of free sulfhydryl concentration detected by different serial number instruments was 2.40 mol• mol^-1 and the RSD was 1.67%. The assay was carried out 15 min and 3 h after the addition of Ellman reagent, the free sulfhydryl concentrations were 2.44 and 2.39 mol · mol^-1, respectively, and the recovery of free sulfhydryl content after 3 h was 97.95%. Conclusion: The method meets the requirements and can be used for quality control of free sulfhydryl concentration in monoclonal antibody drugs.

Objective: To identify issues in the process of Good Manufacturing Practice (GMP) compliance inspections for pharmaceuticals and to further improve inspection quality by providing suggestions and references for formulating inspection policies. Methods: Research is conducted on GMP compliance inspection policies formulated by national and provincial drug regulatory authorities, and rationalized suggestions were proposed based on routine inspection work. Results and Conclusion: Currently, there are problems with GMP compliance inspections, such as a mismatch between regulatory strength and the number of tasks, inadequate coverage of long-term inspections in some production lines, and unclear requirements for GMP compliance inspections of entrusted production. This article proposes corresponding suggestions in four aspects: standardizing and unifying inspection standards, improving relevant inspection policies, integrating inspection resources for better coordination, and conducting risk assessments to optimize the scope of inspections, so as to enhance the quality of GMP compliance inspections.

Objective: To analyze the current quality status of traditional Chinese medicine (TCM) decoction pieces, with the goal of continuously improving their quality and ensuring public safety and health in medicinal usage, based on national sampling inspection data from 2019 to 2023. Methods: Various research methods including data analysis, case studies, literature reviews, market research, and interviews were employed to analyze the sampling inspection data. Combined with factual survey results and current situation analysis, a comprehensive assessment of the influencing factors and potential risks of TCM decoction piece quality was conducted. Results and Conclusion: Addressing issues such as inadequate quality awareness, complex source control, weak industrial chains, lack of traceability and prevention mechanisms, and limited standards, it is recommended to strengthen quality awareness across the entire industry chain, implement green source quality control, integrate traditional and modern technologies, promote intelligent storage and transportation, improve traceability and evaluation systems, accelerate the transformation of achievements, and enhance supervision.

Objective: To explore more scientific and efficient methods for conducting drug pre-approval inspection under newly-revised Provisions for Drug Registration and other series of regulations and technical requirements, provide reference for the high-quality development of drug pre-approval inspection in China. Methods: By reviewing the development history of drug pre-approval inspection in China and the new changes in drug pre-approval inspection under new regulations, this study analyzes the challenges faced by drug pre-approval inspection in China under the new situation and explores corresponding strategies. Results: Under the new regulations, there have been changes in drug pre-approval inspection, including the work to be organized and carried out by CFDI, initiation mode adjusted from mandatory inspections to risk-based initiation, inspection procedure adjusted from series to parallel, organizational form adjusted from organized by NMPA and drug administration of province respectively to joint inspection, establish evaluation and inspection sub-centers, and special drug inspection center; under the new situation, drug inspection faces challenges in initiation program and procedure of inspection, construction of inspector team, collaboration and risk transmission mechanisms, applicant's registration quality and risk management awareness. Conclusion: It is recommended that regulatory agencies further refine initiation program and procedure of inspection, improve effective communication mechanisms and form a closed-loop management system for risk identification, transmission, and control, strengthen the construction of the inspector team and enhance the professional level of inspectors. At the same time, it is recommended that drug registration applicants should enhance the awareness of the first person in charge, improve quality of drug research and development application and risk awareness, actively cooperate with the work of inspection and strengthen the key competitiveness. The ultimate goal is to enhance the comprehensive strength of drug pre-approval inspection in China.

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 explore the improvement direction of the regulations and policies on confirmatory studies on post-marketing of conditional approval of drug in China and the United States, as well as the considerations of research and development (R&D) enterprises in building development strategies of confirmatory studies, and for the industry's reference. Methods: By comparing the requirements of relevant regulations and policies of confirmatory studies on post-marketing of conditional approval of drug in China and the United States, and the practice of the studies in the two countries, with the analyzing of real cases, the design schemes of post-marketing confirmatory studies in China and the United States were classified and summarized, and then the optimization direction of the policy and implementation in China and the United States was further discussed. Results and Conclusion: The requirements for the initiation time, completion time and the interpretation of research results of post-marketing confirmatory studies in China and the United States have been tightened simultaneously, and the criteria have become clearer, however, the slow progress of confirmatory studies is still a challenge faced by the regulatory authorities in both countries. Although randomized controlled trials are recommended by the Food and Drug Administration (FDA) and Center for Drug Evaluation (CDE) of NMPA for confirmatory study design, there is still room for experimentation and breakthrough in the use of single-arm trials for R&D enterprises.

Objective: To analyze the core mechanisms and outcomes of China's “Hong Kong and Macao Medicine and Equipment Connect” policy and the Lecheng Pilot Zone policy, and summarize their implications for the reform of anti-tumor drug regulation in other regions of China, and propose targeted recommendations. Methods: A multi-source retrieval strategy was adopted, integrating policy documents published by the National Medical Products Administration and local government websites from 2018 to 2024, as well as literature from academic databases. Policy text analysis and quantitative data were combined to conduct a comparative study from the dimensions of policy connotation, system, implementation effects, and social value. Results: The “Hong Kong and Macao Medicine and Equipment Connect” policy streamlined the drug registration and market approval process, promoted the development of the pharmaceutical industry, improved patient access to innovative drugs, and optimized pharmaceutical service models in medical institutions, reflecting the significant social value of this policy. The “Special Medical Treatment” policy of the Lecheng Pilot Zone, through multi-departmental collaboration, advanced the “ultra-streamlined approval” reform for drugs, reduced patient waiting times, and facilitated drug clinical evaluation and innovation in the pharmaceutical industry, serving as a model for drug regulatory reform in China. Conclusion: The successful implementation of China's “Hong Kong and Macao Medicine and Equipment Connect” policy and the Lecheng Pilot Zone policy has provided valuable experience for the reform of anti-tumor drug regulation in other regions of China. Drawing on these two policies, recommendations include enhancing the innovation capacity of anti-tumor drugs, optimizing their market approval processes, promoting policy innovation and pilot initiatives, strengthening international cooperation and exchange, and introducing insurance mechanisms. China should continue to deepen drug regulatory reforms, advance the internationalization of drugs, improve patient access to medications and quality of life, and promote the overall health level of society.

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

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

Objective: To provide reference for optimizing and improving the supervision of informed consent in clinical trials in China by drawing on the informed consent clauses in European Union's and American regulations. Methods: The informed consent clauses in drug clinical trials regulations between China, America and European Union were compared to identify the differences among them, and the suggestions were put forward to improve the regulations of informed consent in China. Results: The core management elements of the informed consent process in the regulations of China, America and European Union were basically the same, but there was some different emphases in terms of the level of detail, language, signing process, etc. Conclusion: It is suggested that China should improve the legal system of informed consent, formulate a consensus on informed consent, strengthen the awareness of subject protection of researchers and further enhance the management of ethical review and quality control, so as to promote the improvement of the legal system of informed consent and the protection system of subjects' rights.

Objective: To analyze and summarize the application status, and existing issues of intelligent sensory technology in the field of traditional Chinese medicine (TCM) in recent years. Methods: Relevant literature was reviewed and combined with personal work experience to conduct induction and summation. Results: This article outlined the principles, advantages, and application scopes of commonly used intelligent sensory technologies; summarized the current research status of intelligent sensory technology applications in TCM quality control, identification of TCM materials and decoction pieces from different origins, parts, harvesting periods, and storage periods, as well as applications in TCM processing and taste masking of TCM preparations; and discussed the limitations of intelligent sensory technology in the field of TCM and its future development directions. Conclusion: Intelligent sensory technology has unique application advantages and has been preliminarily explored in various aspects of the TCM field. However, further research is still required for its practical application in TCM production.

Objective: To establish a flow-through cell method for determining the release rate of bupivacaine multivesicular liposomes, and to explore the release mechanism of the multivesicular liposomes. Methods: Phosphate buffer solution (pH 7.0, containing 1% bovine serum albumin) was used as the release medium, with a volume of 100 mL. A dialysis tube with a molecular weight cut-off of 100 kDa was used in conjunction with a 22.6 mm tablet cell. The water bath temperature was maintained at 25 ℃. The flow rate was 16 mL · min^-1.The model-dependent methods were applied to fit the release curves of bupivacaine multivesicular liposomes produced by different manufacturing processes, to compare the similarity of the release curves, and to explore the release mechanism of the multivesicular liposomes. Results: The BiDoseResp mathematical model provided a good fit for the release curves of the three preparations produced by different manufacturing processes. Statistical analysis showed that the variances of the mean values for parameters A2 and h2 among the three preparations are homogeneous (P=0.391 > 0.05,P=0.151 > 0.05). The LSD test in multiple comparisons revealed that there was no significant difference in parameter A2 between batch 1 and the original product, while there were significant differences in parameter A2 between batch 2 and both the original product and batch 1 (P < 0.05). However, there were no significant differences in parameter h2 among the three preparations. The release of bupivacaine in liposomes involved both diffusion and erosion processes. As the drug was released from the liposomes, the liposomes themselves underwent structural rearrangement and dissolution. Conclusion: The flow-through cell method for determining the release rate of bupivacaine multivesicular liposomes is established, and its release curves can reflect the release characteristics of multivesicular liposomes. It can also preliminarily distinguish the release behavior of multivesicular liposomes produced by different manufacturing processes. This method provides a reference for the screening of generic drug quality control and consistency evaluation.

Objective: To provide references for more Chinese proprietary medicines listed in China that will register and market in Singapore, by introducing the regulatory requirements of Singapore’s Chinese proprietary medicine access, and analyzing the key factors that affect the registration of Chinese proprietary medicines. Methods: By sorting out the relevant laws and regulations and technical application guidelines, risk focus reminders from the project screening stage, document preparation and review stage were provided, and further suggestions were given from the perspectives of overseas registration cooperation models and the foresight and homogeneity of registration dossiers preparation. Results and Conclusion: Singapore drug regulatory agency has formulated separate review and approval procedures for the registration management of Chinese proprietary medicines. It is recommended that domestic pharmaceutical companies should first determine the registration category and implementation path of the products intended for registration based on the company’s strategy, and then identify the rights and interests model with the partners, simultaneously improve the registration technical dossiers and carry out registration test. If necessary, communication with the Singapore regulatory agency can be conducted as early as possible.

Objective: To analyze the key focuses of sterile production environmental monitoring and common defects in inspection, with the aim of providing references for improving the environmental monitoring capacity of sterile drug production enterprises and providing inspection ideas for the GMP sterile inspection of the environment. Methods: The regulations and contents of sterile drug production environmental monitoring were summarized, and the common confusing aspects in environmental control and air conditioning purification system confirmation during sterile inspection were analyzed. The establishment and implementation of the full life cycle environmental monitoring procedure were proposed, and the typical defects of environmental monitoring from the perspective of GMP sterile inspection were summarized. Results: Environmental monitoring and environmental control, air conditioning purification system confirmation correspond to different regulatory requirements and have their own monitoring focus. From the perspective of inspection, typical defects of environmental monitoring include imperfect establishment of environmental monitoring procedures, inaccurate assessment of risk points, doubts about the authenticity of monitoring data, and failure to make effective use of monitoring data. The establishment and implementation of the environmental monitoring procedure based on the full life cycle concept is a key link in ensuring the quality of sterile drugs. Conclusion: In order to ensure the quality of sterile drugs,sterile drug production enterprises need to comprehensively evaluate the implementation of environmental monitoring and improve the relevant program content. Sterile drug production environment monitoring is a key focus of GMP sterile inspection. As drug regulatory agency, adhering to the full life cycle inspection approach in inspection is an important inspection technique for objectively evaluating the sterile drug production enterprises' sterile protection capacity.

Objective: To provide countermeasures and suggestions as references for regulatory authorities and enterprises by analyzing current status, influencing factors and existing problems of self-testing for in vitro diagnostic reagent registration since the implementation of self-testing system for registration. Methods: Based on the results of investigations and differences between requirements of self-testing for registration and finished product inspection of enterprises, a comprehensive analysis was conducted on the factors influencing self-testing for registration and the implementation status. Results and Conclusion: In order to better leverage the role of the self-testing system for registration in the innovation of medical device products and the high quality development of the industry, it is recommended that enterprises strengthen their own capacity building and enhance their quality management levels. Regulatory authorities should also intensify supervision and guidance, continuously promote the construction of the inspector team, and constantly refine the relevant regulations. These efforts will help ensure product quality and safety, thereby safeguarding the health of the public.

Objective: To analyze the registration history of traditional Chinese medicine (TCM) generic drugs and the registration application in the past 20 years, explore the development status of medicine with the same name and prescription, and to provide reference for their development. Methods: A systematic analysis was conducted on the changes in the registration policies of TCM generic drugs in China, as well as the general situations such as the registration applications and the approvals for production of TCM generic drugs or drugs with the same name and prescription from 2003 to 2024. The evolution of the registration policy of TCM generic drugs, the characteristics of registration declaration in each stage, and the risks and opportunities of research and development of the medicine with the same name and prescription were discussed. Results: From 2003 to 2024, the registration applications and the approvals for production of TCM generic drugs or medicine with the same name and prescription had obvious policy-driven characteristics, showing a clear three-stage evolutionary process. From 2003 to 2006, there was a rapid increase in the number of registration applications and approved production for “generic standards” with low entry barriers. From 2007 to 2021, there was a high entry barrier for “generic varieties”, and the number of registration applications and approvals plummeted and continued to be low. With the announced of the “medicine with the same name and prescription” in 2020 and the advancement of relevant regulations, both registration applications and approvals have gradually recovered. However, it has not been active since 2022. As of 2024, there have been 6 registration applications for the same name and prescription, with 1 of them approved for market launch. Conclusion: The concept of drugs with the same name and prescription is different from that of generic drugs. Although it has the meaning of the generic drug in chemical medicine, it represents a qualitative improvement in the concept of TCM generic drugs. Currently, the registration applications of drugs with the same name and prescription are mainly for individual varieties. However, in the long term, there may be some regular development model. From the perspectives of variety selection, clinical trials and research risks, the development of drugs with the same name and prescription presents both opportunities and risks.

Objective: To provide references for promoting research and development and improving regulatory measures of radiopharmaceuticals in China by a comprehensive analysis of the global regulatory system for radiopharmaceuticals. Methods: Literature review and comparative analysis were used in this study. By collecting and organizing regulations and guidelines related to radiopharmaceuticals in the United States, European Union, Canada, and China, as well as the structure, functions, and regulatory strategies of their regulatory systems, the characteristics and differences of each country were analyzed. Combining the development trends of the global radiopharmaceutical industry, the new regulatory trends and their potential impacts on the industry were explored. Results and Conclusion: Although there is heterogeneity in the regulation of radiopharmaceuticals, countries are faced with challenges in ensuring the safety, efficacy, and quality control of these drugs. With the rapid advancement of medical technology and the evolving industry demands, there is a pressing need for regulatory frameworks to adopt more flexible and innovative strategies. The global regulatory landscape for radiopharmaceuticals is increasingly focused on expediting the development and approval of innovative drugs, establishing new technological guidelines, simplifying approval processes, and enhancing international coordination and standardization.

Objective：Taking the active pharmaceutical ingredient A as an example, the risk assessment methods and strategies for reducing the microbial limit tests quantity were studied. Methods：By using a data model based on the Poisson distribution, the probability of misjudgment of results under different test amounts was simulated, and the impact of reducing the test quantity on the accuracy of the test results was analyzed. Different influencing factors and scoring rules were set for two dimensions: the quality stability of the active pharmaceutical ingredient and the degree of its impact on the pharmaceutical preparation. A risk assessment strategy was proposed to evaluate the microbial contamination risk of the active pharmaceutical ingredients. Results and Conclusion：When the manufacturing process of the active pharmaceutical ingredient A was stable and controllable, a test quantity of 10 mg could be used for accurate result judgment, which could meet the requirements for identifying and controlling the microbial contamination risk of this active pharmaceutical ingredients. The evaluation methods and strategies used in this paper can help determine the test quantity and test method when the microbial limit tests quantity of raw materials cannot meet the requirements of the pharmacopoeia.

Objective: To provide a reference for improving the regulatory system of radiopharmaceutical in China. Methods: The particularities, regulatory elements and pain points of all aspects of whole life cycle of radiopharmaceuticals were sorted out,and suggestions were put forward by comparing the domestic and foreign regulatory literatures and combining with comprehensively analysis of expert discussions and interviews as well as questionnaire inquiries. Results and Conclusion: Based on the particularity of radiopharmaceuticals, suggestions were put forward on improving the radiopharmaceutical regulatory system in China, including general suggestions on legal and regulatory frameworks, and the regulatory suggestions at each aspect of the whole life cycle such as research and development, registration, production, circulation, use and environmental impact assessment.

Objective: To review the development of national drug standard material label management and explore ways for improvement. Methods: The development of national drug standard material label management was reviewed, existing problems were analyzed, and a scientific and intelligent management strategy was proposed based on international experiences and technology trends. Results and Conclusion: After more than three decades of development, national drug standard material label management has achieved a leapfrog development from 3 varieties in 1956 to more than 5000 varieties in 2024 through improving the technical review system, optimizing the production process, and strengthening stability research. However, there are still problems such as label contents and forms, printing equipment and technologies, and information management system. By optimizing label contents and forms, introducing RFID technology, and drawing on international advanced experiences and standards, the transition of label management from standardization to intelligence is achieved. Drug standard material label management is an important part of ensuring drug quality and safety. Scientific, intelligent, and international management should be continuously promoted to provide solid and strong support for building a solid line of defense for drug quality and safety.

Objective: To analyze the public disclosure data of innovative medical devices released on the official website of the CMDE from 2014 to August 2024, and to provide reference for colleagues in the medical industry. Methods: Through combing and analyzing the application pass rate, regional distribution and type distribution since 2014, the change trend and common problems were analyzed from the perspective of review, as well as relevant suggestions were put forward. Results: It was found that a total of 535 medical devices were approved into the innovation review process, with a pass rate of 19.25%. Most of the medical devices included in the innovation channel are active and passive products, which are mostly concentrated in the high-end fields with high technical content and urgent clinical needs, most of the applicants are concentrated in Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang 5 regions. The common problems in the volume review process mainly focus on the application form, invention patent, and research and development data. There are many problems in each review requirement in the expert review process. Conclusion: It is suggested that enterprises should pay attention to the training of registered personnel and strengthen the study of relevant laws and regulations, and the regulatory authorities should strengthen the cooperation of all units, and do a good job in the relevant training of evaluation experts and applicants.

Objective: To verify the feasibility of bacterial endotoxin testing for aspartic acid (for injection) and establish a method for bacterial endotoxin testing. Methods: According to the requirements of General Rule 1143 in VolumeⅣof the 2020 edition of the Pharmacopoeia of the People's Republic of China, two manufacturers'horseshoe crab reagents were utilized for bacterial endotoxin interference pre-test and interference test, and bacterial endotoxin test was conducted on the samples. Results: The concentration of aspartic acid (for injection) at 1.2 mg · mL^-1 or less did not interfere with the bacterial endotoxin test, and the bacterial endotoxin limit was set at 50 EU · g^-1. Six batches of samples were inspected and the results met the requirements. Conclusion: The established bacterial endotoxin test can be used for the bacterial endotoxin test of aspartic acid (for injection).

Objective：To reduce the quality risks in the multi-product co-production of CAR-T cell therapy products by CDMO enterprises and ensure product quality. Methods：Based on the characteristic that the operation procedures of the proposed co-produced CAR-T cell therapy products were roughly the same, failure mode, effects and criticality analysis (FMECA) method was adopted, combined with the literature analysis method and expert interview method, to establish a quality risk management model for co-production of CAR-T cell therapy products in CDMO enterprises. Results and Conclusion：The established process was applied to the proposed co-produced products. Using the feasibility assessment table, applicability assessment table, risk assessment and control table of the process, the new risks brought by multi-product co-production were evaluated from the aspects of personnel, machinery, materials, methods and environment. After adding control measures for medium and high risks, the final co-production risks could all be acceptable. After applying the process, the risk index of the co-production link had significantly decreased. The model provided a reference for the improvement of the risk management effect of co-production of CAR-T cell therapy products in CDMO enterprises.

Objective: To enhance the importance of packaging quality control of traditional Chinese medicine(TCM) decoction pieces through the analysis of factors such as the use of packaging materials, material types, quality safety and regulations, and to provide protection for the safety of the use of TCM decoction pieces. Methods: Combined with the current situation of TCM decoction pieces packaging and various commonly used packaging materials, the impact of packaging materials on the quality and safety of TCM decoction pieces was deeply analyzed, and relevant laws and regulations were sorted out to address the standardization of TCM decoction pieces packaging and regulatory suggestions were put forward. Results and Conclusion: There are various packaging forms of Chinese herbal powders, including small packaging of Chinese herbal powders, direct oral powdered herbal products, and granule herbal formula products. Common packaging materials include polyethylene (PE), pharmaceutical composite film (PET/VMPET/PE, PET/Al/PE), and polyterephthalate (PET). During the process of contact between packaging materials and Chinese herbal powders, adsorption, permeation, and migration of toxic and harmful substances may occur, which has a certain impact on the stability and safety of Chinese herbal powders. Although China has enacted a series of related regulations, the packaging of Chinese herbal powders has not yet been standardized, the packaging is not well-regulated, and the packaging materials are not compatible with the properties of Chinese herbal powders. There is also a lack of a comprehensive quality evaluation system. It is suggested that standardized quality specifications and quality control indicators be established for Chinese herbal powder packaging materials, which will promote Chinese herbal powder manufacturers to establish and improve their quality management systems, and drive the stable and high-quality development of traditional Chinese medicine.

Objective：To analyze the challenges and difficulties faced by drug regulatory inspections with the widespread application of informatization and intelligent equipment in the field of drug production, and to propose suggestions on how to improve the capabilities and level of production inspection. Methods The documents issued by drug regulatory agencies and international drug cooperation organizations in various countries were analyzed, and the current development status and existing problems of intelligent manufacturing of drugs in China were investigated. Results and Conclusion：China’s drug enterprises have begun to implement intelligent manufacturing in some scenarios, but have not yet formed a scale and integration. There are still many challenges in regulatory inspection, it is suggested to continuously exert efforts in issuing relevant inspection guidelines, improving the professional quality of inspectors, continuously exploring the application risk management, and developing regulatory science, etc., to jointly promote the intelligent manufacturing of drug production in China to the world.

Objective: To 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 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 compare the pharmacokinetic differences of a total of 9 ganoderic acids(Ganoderic acid C2, C6, G, B, A, D2, C1, Luwdenic acid A and Gancderenic acid D) in rats after multiple administrations of sporoderm-broken and sporoderm-removed Ganoderma lucidum spore powder. Methods：Normal SD rats were randomly divided into sporoderm-broken G. lucidum spore powder group, sporoderm-removed G. lucidum spore powder high-dose group and low-dose group with 6 rats in each group, and were administered orally for 7 consecutive days, blood was taken from the inner canthus of the eye on the 7^th day at 0, 0.1, 0.2, 0.5, 1, 2, 3, 4, 6, and 12 h. Blood concentration was determined by UPLC-MS/MS, and the pharmacokinetic parameters were calculated by Winnonlin 8.1 pharmacokinetic software. Results：In the sporoderm-removed G. lucidum spore powder group, the time to peak (T_max) of 9 ganoderic acids was around 1 h, the half-life (t_1/2) was less than 6 h, and the accumulation factor (R_ac) was around 1.00, whereas no ganoderic acid was detected in the sporoderm-broken G. lucidum spore powder group. Compared with the sporoderm-removed G. lucidum spore powder low-dose group, the maximum concentrations (C_max) of 9 ganoderic acids in the high-dose group was significantly higher (P < 0.05 or P < 0.01), and the mean area under the blood concentration-time curve (AUC_0-t) was higher than that of the low-dose group by about 10-40 times. Conclusion：Sporoderm-removed G. lucidum spore powder maintains rapid absorption after multiple administrations, with no significant accumulation observed. Its bioavailability is significantly superior to that of sporoderm-broken spore powder, and it exhibits distinct dose dependency.