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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Objective: To 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.

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 clarify the importance of quality control of pharmaceutical excipients by reviewing the incidents of ethylene glycol and diethylene glycol pollution and related regulatory requirements. Methods: Through sorting out the pollution incidents of ethylene glycol and diethylene glycol, as well as the relevant regulatory requirements issued by the United States and the World Health Organization, and combining with the warning letters of ethylene glycol and diethylene glycol pollution issued by the FDA, this paper puts forward some suggestions on the quality control of pharmaceutical excipients. Results and Conclusion: Glycerin and other pharmaceutical excipients by ethylene glycol, diethylene glycol pollution will produce more serious drug pollution events. The World Health Organization has repeatedly issued global medical alerts, FDA has also repeatedly warned against ethylene glycol, diethylene glycol pollution. The quality of pharmaceutical excipients and the quality of drugs is closely related. This paper analyzes the causes of ethylene glycol and diethylene glycol pollution, and puts forward suggestions on the quality system construction of excipient manufacturers, the control of excipient circulation links, the quality responsibility of drug manufacturers, the development and improvement of testing methods and equipment, and the coordination and cooperation of global regulatory authorities. It hopes to provide references for the industry to further improve the quality management and control of pharmaceutical excipients.

Objective: To enable more relevant scholars to understand the development and record of the species of Hirudo (leeches) through a more clear historical context, and to use relevant Chinese names and nicknames more strictly in various scenarios in the future. Methods: By collecting domestic research literature related to three medicinal leeches included in pharmacopoeia from the early days of the founding of the People's Republic of China to the present day, as well as family and genus, combining with some earlier foreign records and the data of the present main shared database, the family and genus classification of several leeches, species merger and separation, and the corresponding Chinese names and Latin scientific names were sorted and analyzed. Results: Since the founding of the People's Republic of China, Hirudo has been included in the Pharmacopoeia of the People's Republic of China since 1963. With the in-depth research of leeches, the classification of leeches has been adjusted continuously. At present, the family and genus classification of leeches has gradually differentiated into two relatively independent usage habits, and there are some problems such as misuse of Chinese names. Conclusion: In order to ensure the accuracy of the source of species and prevent the ambiguity between research and use, it is suggested that pharmacopoeia should be supplemented by a variety of notes to confirm the original source. In addition, a new round of survey and sorting of leeches should be one of the important topics for leeches research.

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: International ADR monitoring has developed for many years, and a mature drug reporting quality assessment method has been formed, but there has never been a scientific, systematic, and quantitative evaluation method for the quality of cosmetics adverse reaction reports, both domestically and internationally. In order to improve the quality of cosmetic adverse reaction report, strengthen the analysis evaluation, the basis of risk early warning, a standard method for assessing the quality of adverse reaction reports for cosmetics was established for the first time by drawing on international experience in monitoring adverse drug reactions. Methods: Based on the international quality assessment method of ADR reporting, this study established and operated the "manual sampling score addition" and "computer case-by-case multiplication weight reduction method", which enabled the method of cosmetics report quality assessment in China to achieve a leap from scratch and from existence to excellence. Results: After the application of the report quality evaluation method, the status quo and level of the report quality across the country were mastered by scoring, and the problems and deficiencies of the monitoring work were found out, and then targeted measures such as formulating technical guidelines and providing training guidance were taken to improve the quality of the report. Conclusion: Adverse reaction report is the foundation of adverse reaction monitoring work. Through quantitatively evaluating report quality, identifying the problems and deficiencies, continuously improving the quality of report, a true, complete and accurate information basis is provided for the subsequent analysis evaluation and risk early warning, which provide strong technical support for China's cosmetics regulation and public health safety.

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 explore novel quality control strategies based on digital and intelligent technologies, analyze their innovative applications in the quality control of chemical drugs, traditional Chinese medicines (TCM), and biotechnological drugs, and thereby promote the digital and intelligent transformation of China's drug quality control system. Methods: By systematically reviewing the innovative applications of digital and intelligent technologies in the quality control of chemical drugs, TCM, and biotechnological drugs, relevant technical methods and implementation strategies were summarized. Current challenges in the digital and intelligent transformation, such as data quality and model interpretability, were also analyzed. Resultsand Conclusion: In the quality control of chemical drugs, digital and intelligent technologies have been implemented in areas such as polymorph screening, impurity analysis, production processes supervision, and appearance identification. Regarding the quality control of TCM, these technologies were also extensively applied in appearance authentication, manufacturing processes control, and quality evaluation. Furthermore, within the quality control system for biotechnological drugs, digital and intelligent technologies were integrated into the assessment of safety, stability, and efficacy. The integration of such technologies represented a crucial pathway for enhancing drug quality and safety levels, as well as facilitating the transformation of drug quality control models. In the future, it will be necessary to further address existing shortcomings in data quality and model interpretability, in order to establish a more systematic and accurate drug quality control system, thereby providing support for the digital and intelligent advancement of China's pharmaceutical industry.

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: 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 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 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 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 promote the strategic deployment of “Intelligent Drug Regulation” in China, advance the practical innovation of “Artificial Intelligence(AI) Plus” models in the field of drug regulation, and to explore the application pathway of “AI Plus” in the field of drug inspection. Methods: Based on the Dify work platform, the study constructed the workflow for summarizing historical defects in the inspected unit and the chatflow for matching unknown defect clauses and determining their classification. The workflow integrated functional nodes, including database retrieval, data segmentation, iterative learning, and summarization, and evaluated its operational effectiveness by dividing defects into three classification levels (low, medium, and high) based on the defect base number. The chatflow completed the matching and classification determination of defect clauses through knowledge base retrieval and the semantic reasoning of large language models. It compared the accuracy of unknown defect clauses matching and the consistency of defect classification between human experts and large models based on the research data from the knowledge base and test sets. Results: The workflow performed well in low-, medium-, and high-defect baseline groups, enabling intelligent summarization of historical defects in inspected units. The chatflow achieved high accuracy in matching of unknown defect clauses, and its defect classification criteria were stricter than those of manual judgment, enabling intelligent matching and classification of unknown defect clauses. Conclusion: The workflow established in this study can intelligently summarize the historical defects of the inspected units, and chatflow can intelligently match and classify unknown defect clauses. It not only provided a useful exploration for the implementation of intelligent tools for drug inspection, but also provided important technical references for the construction of “Intelligent Drug Regulation” system and the integration framework of large language models in the field of drug regulation and the innovation of “AI Plus” regulation models in China.

Objective: To summarize and review the development trajectory and the supervision of China's pharmaceutical packaging industry, analyze the trends in conjunction with the prevailing environment, and to offer insights to inform the industry's growth. Methods: The analysis was anchored in the evolution of product types, the distinctive industrial production features of pharmaceutical packaging materials and the management system adapted across various historical periods in China. It integrated the broader development context of the industry to elucidate current trends and anticipate future challenges and opportunities. Results: Spanning seven decades, China's pharmaceutical packaging industry has experienced significant growth, particularly bolstered by national supervision and guidance over the past twenty years. The industry has transformed from nascent to robust, with the economic sector now formally recognizing "Pharmaceutical Excipients and Packaging Materials Manufacturing". The diversity and complexity of pharmaceutical packaging materials have expanded, evolving from rudimentary to sophisticated and from singular to a multitude of options. Their functionality has advanced from basic containment to personalized, convenient drug delivery solutions, aligning with the rigorous safety demands of a rapidly growing economy and elevated public health standards. Underpinned by state policies, the industry is gravitating towards intelligent, pharmaceutically compatible, and eco-friendly development. Conclusion: After seventy years of evolution, China's pharmaceutical packaging industry has transitioned from a phase of emulation to one of innovation. It has established itself as a vital component of the nation's strategic industries and stands poised to underpin the high-quality development of China's pharmaceutical sector.

Objective: To explore the coping strategy to the full process production site supervision of the entrusted enterprise by Marketing Authorization Holder (MAH) under the new situations. Methods: By combing the extension inspectd of entrusted production enterprises outside the province by pharmaceutical contract manufacture (hereinafter referred to as the B-certificate) MAH in Guangdong Province, the problems and reasons for the full process production site supervision of the entrusted enterprise were deeply discussed, and the corresponding improvement suggestions were put forward, according to the quality management of drug production and the relevant provisions on strengthening the management of holders after listing. Results: After combing the status of entrusted production extension inspections, it was found that three aspects problems of holders about key personnel configuration, understanding of the entire process supervision and production risk assessment, which were manifested in the lack of rich work experience of personnel, the lack of rigorous supervision methods throughout the entire process, and the incomplete assessment of production risks. Conclusion: The B-certificate MAH should focus on key personnel to fulfill their main responsibilities, improve management processes to standardize supervision behavior, strengthen risk assessment to identify safety hazards, so as to ensure the number and qualifications of key personnel match the production scale, form a closed-loop quality management system for the entire production process, carry out comprehensive and precise risk assessment, and firmly establish awareness of drug quality and safety.