Objective: To provide ideas and lay the foundation for the composition of quality evaluation model of Lycium barbarum L.. Methods: Based on the literature in recent years, the chemical composition, quality influencing factors, existing standards and the research progress of quality evaluation model of L. barbarum L. were reviewed and summarized. Results and Conclusion: The types of active ingredients of L. barbarum L. were complex, including lycium barbarum polysaccharides, carotenoids, flavonoids and vitamins, etc., and the quality was affected by factors such as place of origin, species, planting and processing methods. The pharmacopoeia standard of L. barbarum L. mainly uses betaine and lycium barbarum polysaccharide as quality control indicators, while the existing commodity specification grade division mainly uses the fruit size as the evaluation basis, which has certain limitations. The existing researches on quality evaluation of L. barbarum L. explored the weight coefficients of multiple quality parameters of L. barbarum L. through gray correlation analysis, hierarchical analysis and discriminant analysis, etc., and then established a quality evaluation model to score the quality of L. barbarum L. comprehensively. Provide ideas for the establishment of scientific and unified quality evaluation standard of L. barbarum L..

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 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 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 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: To strengthen the management of practice access for licensed pharmacists, improve the registration system for licensed pharmacists, and help the high-quality development of the team. Methods: Using the literature research method, the relevant laws and regulations and documents were searched and analyzed. Results and Conclusion: The registration process of licensed pharmacists in China is stable and orderly on the whole, which meets the needs of licensed pharmacists and their units. However, there is still a gap between the requirements of the administrative licensing list management, the management of qualification recognition needs to be strengthened, the management of practice access needs to be improved, and there are practical problems such as unclear legal responsibility provisions and lax accountability for violations of the registration system. Based on the current situation of China's social development and the actual construction of the rule of law, we put forward proposals to promote legislation, fill the blank of administrative license basis, implement the current registration system focused on qualification recognition, practice behavior management system based on practice access, in order to further improve the system of licensed pharmacists, mobilize the initiative of licensed pharmacists, achieve precision, science, rule of law, promote team building, maintain drug safety, and protect public health.

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: 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: 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 provide references for further quality improvement of traditional Chinese patent medicines by extracting and analyzing the Unqualified information of Compound Danshen Tablets released by the National Medical Products Administration (NMPA) from 2016 to 2022. Methods: The data were extracted from the interface of “National Drug Sampling Database” on the NMPA official website. The research keyword was “Compound Danshen Tablets”. Through classification analysis, the data of Unqualified quality of Compound Danshen Tablets and unqualified batches of products from the involved pharmaceutical production enterprises were statistically analyze. Results: A total of 54 unqualified records of this product were retrieved, involving 46 batches of products from 24 manufacturing enterprises. 63.0% of the batches were Unqualified due to assay of content and 34.8% of them were unqualified due to weight variation. Among the 29 batches which were unqualified due to assay of content, the top unqualified items were content of Panax notoginseng (34.5%), content of Tanshinone IIA (20.7%) and content of Salvianolic acid B (20.7%). The phenomenon of Unqualified products was concentrated in certain production enterprises. Among the 24 enterprises involved, 6 (25.0%) of the enterprises had 3 or more batches of Unqualified products, involving 24 batches of Unqualified products which accounted for 52.17% of the total unqualified batches. Conclusion: The number of unqualified batches and items of Compound Danshen Tablets has been decreasing from 2017 to 2022, indicating that the overall quality of Compound Danshen Tablets was gradually improving. However, quality risks still exist. It is still necessary to remind the enterprises to continue strengthening internal quality control and improve the management of transportation and storage processes to avoid quality issues caused by environmental factors such as humidity. It is recommended that the regulatory authorities should strengthen the sampling and exploratory work and further improve the quality standard of Compound Danshen Tablets to ensure the safety of public medication.

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 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 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 provide a theoretical foundation for the rational development and comprehensive utilization of Scutellaria amoena C. H. Wright which is a valuable ethnic medicinal resource, and to enhance the quality control and clinical safety of Scutellaria species. Methods: This study reviewed the chemical constituents, pharmacological activities, and potential biological effects of Scutellaria amoena C. H. Wright, evaluated its current applications in traditional medicine, identified existing issues, and proposed corresponding strategies. Results: The dried roots of Scutellaria amoena C. H. Wright primarily contain flavonoids, which are largely consistent with those in Scutellaria baicalensis, with higher levels of baicalin. Furthermore, Scutellaria amoena C. H. Wright demonstrates a range of potential biological activities, including anti-aging, anti-tumor, anti-atherosclerotic, lipid-lowering, blood glucose-lowering, immune-enhancing, and cognitive-improving effects. Conclusion: Due to its rich chemical profile and broad spectrum of biological activities, Scutellaria amoena C. H. Wright has substantial potential for further development. The strategies proposed in this study will support the advancement of research and clinical application of Scutellaria amoena C. H. Wright, thereby facilitating its effective development and clinical use.

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 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: 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 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 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.

Objective: To analyze the logic of changes in regulatory policies for online sales of prescription drugs, which could provide references for policy optimization. Methods: The regulatory policies for online sales of prescription drugs in China were reviewed, and based on the multiple-streams theory, the evolution of regulatory policies for online sales of prescription drugs in China was analyzed from the perspectives of three streams: problems, policies, and politics, as well as the opening of policy windows. Results: China's regulatory policies for online sales of prescription drugs had gone through three periods: comprehensive prohibition, tortuous exploration, and prudent opening up. Research had found that the multiple-streams theory had strong explanatory power for the regulatory policies of online sales of prescription drugs in China, political streams were a key factor driving issues into the policy agenda. Conclusion: In the process of multiple-streams analysis, it is found that there are problems with the identifi cation lag and homogeneity of policy proposals in China's regulatory policies for online sales of prescription drugs. In the future, improvements should be made in strengthening problem feedback, coordinating policy formulation, and improving the mechanism for expressing interests.

Hepatitis B is a contagious disease that poses a severe threat to human health, caused by the infection of the Hepatitis B Virus (HBV). HBV infection is a prevalent worldwide, resulting in significant public health issues. Currently, with the administration of vaccines, and the treatment of antiviral drugs, the infection rate of HBV has been reduced. However, the eradication of HBV remains a major challenge. HBV markers are the primary indicators for diagnosing HBV infection, monitoring the progression of the disease, and evaluating the efficacy of antiviral treatment. Clinically, HBV markers mainly include traditional serological markers, virological markers, and new markers. In recent years, new markers have been developed which can more accurately evaluate the activity of HBV infection and the efficacy of antiviral therapy, and are of great value in monitoring the treatment of chronic hepatitis B. In this paper, the clinical significance and research progress of HBV markers, especially new markers, are reviewed, in order to provide references for accurate diagnosis, treatment and clinical prognosis of HBV.

Objective: In order to provide suggestions for Chinese medicine manufacturers to carry out research on sterilization of traditional Chinese medicine, and to provide reference for the implementation of relevant supervision by the pharmaceutical supervision department. Methods: The regulatory requirements of traditional Chinese medicine sterilization and the conventional sterilization process of traditional Chinese medicine were sorted out, and typical problems were summarized and analyzed based on the cases of traditional Chinese medicine review and inspection. Results: There were some typical problems in the research of sterilization process of traditional Chinese medicine, such as unreasonable selection of sterilization conditions, insufficient research verification, improper research management and insufficient process control. Conclusion: It is suggested that enterprises should strengthen material management, strengthen production process control, determine the sterilization method of traditional Chinese medicine based on drug characteristics, and do a good job in change research and management to ensure the rationality and compliance of changes.

Objective: To investigate the impact of different production processes on insoluble particles and explore methods to improve the control level of insoluble particles in imported and domestic infusion through the analysis of quantity and morphology of insoluble particles in 36 batches of sodium chloride basic infusion. Methods: The number of insoluble particles between 2-10 μm was analyzed by light obscuration method and microflow imaging (MFI), and the results were statistically analyzed. Results: The percentage of insoluble particles in 2-10 μm channels was greater than 90%. The average and range of insoluble particles in products made by ISBM were smaller than those made by BFS, however, there was no significant difference between them. The packaging had a significant impact on the number of insoluble particles. The average value of insoluble particles in the upright polypropylene infusion bag (double valve) samples was the lowest, which showed a significant difference compared to the other three kinds of packaging. The production line had a significant impact on insoluble particles. Under the same process method and packaging conditions, the results of different production lines were different. The average value of insoluble particles analyzed by MFI was linearly correlated with the light obscuration method. The sources of insoluble particles may include rubber plug debris, plastic particles, and fibers. Conclusion: There is a significant difference in the number of insoluble particles in different products between 2-10 μm, indicating that attention should be paid to the control of insoluble particles (<10 μm). This study provides strategies to improve the safety of domestic and imported basic infusion.

Objective: To provide a basis for the promotion and application of measurement uncertainty evaluation in domestic pharmaceutical analysis, this review sorts and summarizes the measurement uncertainty guidelines on pharmaceutical analysis that can be referenced from international to national. Methods: The history of measurement uncertainty, the main evaluation methods and the scope of application of various guidelines were summarized mainly through searching, reviewing and comparing guidelines. Results: International measurement uncertainty guidelines can be roughly divided into two categories based on the different methods used to evaluate measurement uncertainty: Bottom-up approach and Top-down approach. Multiple national guidelines are formulated based on the corresponding international guidelines issued earlier, and this review also outlines the relationship between current international and national guidelines. In addition, this review introduces a series of documents on measurement uncertainty evaluation published by drug regulatory agencies in various countries and regions. Conclusion: Whether it is the guidelines related to measurement uncertainty evaluation or laboratory quality management documents, even the relevant introductions in various national and regional pharmacopoeias, they are all a summary of a large number of practices. Carefully reading the relevant content can help pharmaceutical analysts better understand and apply the measurement uncertainty evaluation, and promote its continuous development in pharmaceutical analysis.

Objective: To analyze the potential quality risks in extracting human Prothrombin Complex Concentrate (PCC) from human plasma and producing other blood products, providing risk warnings and control measures to relevant enterprises and regulatory authorities to ensure public drug safety. Methods: Through a comprehensive review of literature and practical experience, the production process and quality control of PCC extraction from human plasma, along with its combination with plasma to manufacture other blood products, were analyzed. The safety and efficacy of producing human serum albumin (HSA) and intravenous immunoglobulin (IG) through the PCC process were also assessed. Additionally, the study compared the risks associated with switching from the direct production of HSA and IG to a process involving PCC extraction and its combination with plasma from the perspectives of process parameters, personnel, equipment, documents, and regulations. Based on this analysis, control measures were proposed. Results and Conclusion: The preparation process, raw material selection, and quality control of PCC, particularly the optimization of key process parameters, are crucial for the quality of both PCC and subsequent plasma-derived products. This study provides risk warnings and relevant recommendations for enterprises and regulatory authorities to refer to through the analysis of PCC preparation process, raw material characteristics and process change risk.

Objective: To analyze the new drugs approved by the U.S. FDA in 2023 and compare them with the new drug approvals in China during the same year, providing a reference for the pharmaceutical industry. Methods: By reviewing the "2023 New Drug Approval Summary Report" released by the US FDA CDER, the "2023 Drug Evaluation Report" released by China's CDE, Drugs@FDA database, drug approvals published by the NMPA, and publicly available information on marketed drugs from the CDE, combined with relevant literature, data on new drugs approved by the FDA in 2023 were collected and statistically analyzed, and compared with the relevant situation in China. Results and Conclusion: In 2023, the FDA approved a total of 55 new drugs, including treatments for various medical fields such as oncology, genetic/rare diseases, and neurological disorders. 51% of the new drugs received orphan drug designation, 36% of the new drugs were recognized as "first-in-class", and 65% of the new drug approvals utilized at least one expedited program. Furthermore, the companies that have been approved for new drugs cover a wide range, from large pharmaceutical giants to small and medium-sized biotechnology firms, with varying numbers of new drug approvals. China approved 74 new drugs, and the breadth and diversity of disease fields are comparable to those of the FDA. However, the innovation of new drugs and the development of rare disease drugs need to be improved. 38% of the new drug approvals in China included at least one expedited marketing process. The time required for new drug review has decreased compared to 2022, but the one-time pass rate has also decreased, reflecting the increasing strictness of regulation. Pharmaceutical companies need to improve the quality of their application materials, and regulatory authorities need to improve drug regulation laws, strengthen the training and education of drug regulatory personnel, and enhance their professional level and international perspective.

Objective: To comprehensively summarize the pharmacovigilance work of traditional Chinese medicine (TCM) in China, sort out the problems existing in the development and propose solutions, and so as to provide references for establishing a pharmacovigilance system in line with the characteristics of traditional Chinese medicine and improving the level of safe use of traditional Chinese medicine. Methods: By combing the historical development and current situation of TCM pharmacovigilance, this paper analyzed the new technologies applied in TCM pharmacovigilance in recent years, discussed the problems existing in the development of TCM pharmacovigilance, and proposed solutions from the aspects of TCM safety research, TCM quality evaluation and clinical vigilance system construction. Results and Conclusion: At present, there are still some problems in the practical work of pharmacovigilance of traditional Chinese medicine in China, such as the lack of guiding principles for post-marketing safety research of traditional Chinese medicine, the quality evaluation system and the imperfect pharmacovigilance system of traditional Chinese medicine in medical institutions. The regulatory authorities, medical institutions and conventional Chinese medicine production enterprises must work together to accelerate the introduction of guidance documents for the safety research of traditional Chinese medicine and the improvement of the pharmacovigilance system of traditional Chinese medicine in medical institutions, strengthen the research on the quality evaluation system of traditional Chinese medicine and the scientific supervision of pharmacovigilance, and implement the responsibilities of traditional Chinese medicine decoction pieces production enterprises, so as to jointly promote the construction of the pharmacovigilance system of traditional Chinese medicine.

Objective: Based on ultra-high performance liquid chromatography tandem quadrupole time-offl ight mass spectrometry (UHPLC-QTOF-MS^E) analysis and digital quantization, a data Identification model was constructed by combining with the Random Forest (RF) algorithm to realize the digital Identification of the species of Chinese tortoises, Brazilian tortoises, Taiwanese tortoises, alligator tortoises, and soft-shelled turtles. Methods: After sample pretreatment, different sources and batches of tortoiseshells were analyzed by UPLCQTOF- MSE. The peak positions were corrected, extracted, and quantified based on the mixed samples to obtain the data pairs of Exact Mass-Retention Time (EMRT) refl ecting the information of peptide ions. Then the information about important peptide ions was obtained based on feature screening of information gain rate, combined with RF for data modeling. At the same time, the models were evaluated according to parameters such as accuracy (Acc), precision (P), and area under the curve (AUC) in internal cross-validation. Finally, the Identification validation analysis of tortoiseshell species was carried out based on the optimal model. Results: Based on the feature screening of information gain rate, the 71 characteristic polypeptide information were obtained and the established RF model has excellent Identification effect, with the accuracy, precision and AUC all greater than 0.950 and the correct rate of external identification validation was 100.0%. Conclusion: Based on the UHPLC-QTOF-MS^E analysis and combined with the RF algorithm, the digital identification of the species of the Tortoiseshell can be realized efficiently and accurately, which can provide reference and help for quality control and the species Identification of the Tortoiseshell.

Objective: To investigate the prescription and medication rules and the mechanism of action of TCM internal treatment of gout by using the application of data mining and network pharmacology. Methods: Data mining was used to collect the prescriptions for the treatment of gout, and the frequency, association rules and cluster analysis were carried out to summarize the medication rules and core drug pairs. The targets of action of drugs and diseases were predicted, and the core targets and core pathways were obtained by network pharmacology. Results: A total of 204 articles were screened out. 210 prescriptions were included. The total frequency of medicines used was 2415, and 30 high-frequency medicines were obtained (with a frequency ≥20). The association rules were analyzed to obtain 8 association rules, and the clustering analysis obtained 4 effective clustering groups. Eventually 9 core drugs were gained. Network pharmacological analysis showed that 95 core targets were involved in the treatment of gout, 12 core targets and 10 core pathways. Conclusion: Data mining shows that the mainly TCM syndrome type of gout is damp-heat and amassing poison. Treatment is mostly with heat-clearing and dampness-eliminating herbs. The network pharmacology predicts the key mechanism of the core drug in the treatment of gout.

Objective: By analyzing the information of biopharmaceuticals approved by FDA for marketing in 2013-2023 and combining with practical experience, some suggestions are provided from the aspects of necessity, feasibility and trial design of safety pharmacology study of biopharmaceuticals, in order to provide supports for their entry into clinical trials. Methods: In this paper, 133 applications for biopharmaceuticals licensing approved by FDA during 2013-2023 were summarized, including non-clinical safety pharmacology, pharmacological and toxicological information, adverse reactions in clinical studies and other data. The necessity and feasibility of safety pharmacology tests were discussed by analyzing the reasons for conducting safety pharmacology tests alone, concomitantly with and without conducting safety pharmacology tests, and discussed the concerns of safety pharmacology studies of biopharmaceuticals by analyzing whether there are relevant animal species, target-related risks and key points of core battery tests. Results and Conclusion: Based on the information of biopharmaceuticals approved by FDA for marketing between 2013 and 2023 and the requirements of relevant guidelines on safety pharmacology of biopharmaceuticals, this paper concludes that biopharmaceuticals rely on pharmacological effects, the presence of relevant animal species, target characteristics, indications, and relevant drug market information to determine whether to conduct non-clinical safety pharmacology trials, including conducting them separately, conducting them concurrently, or exempting safety pharmacology studies, and developing a reasonable safety pharmacology trial plan. Safety pharmacology assessments of biopharmaceuticals are often conducted concomitantly with general toxicology studies, and this trend is becoming increasingly apparent. In view of the cost-effectiveness and 3R principles of animal welfare, it is recommended to integrate the safety pharmacology study of biopharmaceuticals into the repeated-dose toxicity study, but attention should be paid to the complexity of study design, including the challenges of animal number, sampling frequency, toxicokinetic blood collection interference and animal acclimation difficulty, to ensure the accurate determination of key indicators such as ECG and blood pressure, so as to ensure the high efficiency of the study.

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 provide constructive suggestions for the radiation safety management of radioactive drug testing laboratories in drug inspection institutions. Methods: A brief analysis was conducted on the demand for radioactive drugs in the market and the current development status of inspection laboratories. The relevant concepts, classifications, and regulations of radiation safety management were outlined, and the requirements for the construction, licensing, retirement, and daily radiation safety management of radioactive laboratories were summarized. The common causes of radiation accidents in recent years were statistically analyzed, and the risks of radiation safety management in radioactive drug inspection laboratories were discussed. Targeted solutions were proposed. Results and Conclusion: The radioactive drug testing laboratory should aim at the forefront of international construction, strictly implement the "three simultaneities" of radiation project construction, continuously improve the radiation safety management system, adhere to strict education, training and assessment, equip with high standard facilities and equipment, continuously consolidate the foundation of radiation safety management, and promote the rapid development of new quality and safety productivity in radioactive drug inspection.

Objective: To clarify the management attributes and scientific connotation of Chinese herbal medicines, and to explore the scientific management and high-quality development path of Chinese herbal medicines. Methods: Through literature analysis and practical cases study, the management attributes and problems existing in supervision of Chinese herbal medicines are clarified, and the regulatory paths and methods of Chinese herbal medicines are discussed in combination with questionnaire survey. Results and Conclusion: Chinese herbal medicines have multiple identities in practice, and the attributes of Chinese herbal medicines are not clearly defined in laws and regulations. Therefore, separate regulations on the management of Chinese herbal medicines should be established to clarify the attributes of Chinese herbal medicines. Regarding the universality and particularity of Chinese herbal medicines use, it is suggested to scientifically define Chinese herbal medicines from the perspective of life cycle and strengthen the collaborative management of Chinese herbal medicines. At the same time, scientific classification management of Chinese herbal medicines should be carried out to ensure the safety of people's medication and promote the scientific management of Chinese herbal medicines.

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 study and establish a quality control method for some critical quality attributes of the domestic anti human epidermal growth factor receptor 2 (HER2) monoclonal antibodies. Methods: Based on the product characteristics and effects mechanism of trastuzumab, the quality attributes were evaluated and graded. And some critical quality attributes of 7 batches of the domestic anti-HER2 monoclonal antibody were detected using 7 batches of reference trastuzumabs as the control. The charge heterogeneity was analyzed by ion exchange-high performance liquid chromatography (IEC-HPLC). Biological activity was determined by BT474 cell proliferation inhibition assay. Bio-Layer Interferometry (BLI) was used to measure antigen-antibody affinity, monoclonal antibody affinity with FcRn, and Surface Plasmon Resonance (SPR) was used to measure the affinity of monoclonal antibody with FcγRⅢa. Thermal stability was evaluated by Differential Scanning Calorimetry (DSC). Results: The mean±3SD values of IEC main peak areas percent and EC50 of 7 batches of original trastuzumabs were (73.87±2.21)% and (0.20±0.06) μg·mL^-1, respectively. The results of the domestic anti HER2 monoclonal antibodies were (73.54±3.24)%, (0.20±0.05) μg·mL^-1, respectively. The KD values of antigenantibody affinity, antibody-FcγRⅢa affinity and antibody-FcRn affinity were 1×10^-10, 1×10^-6, 1×10^-7, respectively. The results of 7 batches of the domestic anti-HER2 monoclonal antibodies were 1×10^-10, 1×10^-6, 1×10^-7, respectively. The thermal stability mappings of the domestic anti-HER2 monoclonal antibodies were consistent with those of the original trastuzumabs. Conclusion: A method for quality study of anti-HER2 monoclonal antibody is developed, which provides a reference for quality control of this class domestic monoclonal antibody.

Objective: To investigate the current situation of the medical institutions to implement the drug price monitoring and management, and to understand the awareness and attitude of medical staffs towards Red-Yellow-Green monitoring and other pharmaceutical price regulation measures, in order to provide reference for standardizing and improving drug price monitoring and management. Methods: A questionnaire survey was conducted in the sample medical institutions, and semi-structured interviews were conducted with relevant personnel. On the basis of descriptive statistical analysis, inferential statistical analysis was conducted on the implementation differences of medical institutions at different levels. Results: A total of 370 valid questionnaires were collected from 25 medical institutions. Among which, 76.8% of the respondents believed that the current drug prices showed a stable to declining trend, and the perception of the price reduction rate of tertiary medical institutions was greater than that of secondary medical institutions (P=0.034) and sub-secondary medical institutions (P=0.005). Medical staff generally believed that the drug price regulation policy had a certain impact on their prescription behavior, mainly affecting the proportion of drug proportion (n=323, 87.3%), centralized procurement (n=294, 79.5%) and basic drugs (n=294, 79.5%). Clinical effect (n=178, 48.1%) and drug price (n=147, 39.7%) were the priority factors for medical staff to prescribe. The interviews showed that the drug management personnel of medical institutions did not have a proper understanding of the Red-Yellow-Green price monitoring policy, and some medical institutions had not established a complete and transparent internal management system. Conclusion: The drug price control policy has been effectively implemented, maintaining reasonable prices in the drug market and promoting rational drug use in medical institutions. However, the complexity of different drug regulatory policies has a certain limiting effect on doctors' prescribing behavior. It is suggested that different policies should be well coordinated and refined, medical institutions should establish a transparent price monitoring system, and strengthen the training of medical staff .

Objective: To improve the production and supply efficiency of reference drug and ensure the market and regulatory needs. Methods: The usage of reference drug in the document standards involving the National Reimbursement Drug List and the National Essential Medicines List was sorted out. The trend relationship between the frequency of use and supply of reference drug in the Chinese Pharmacopoeia was analyzed, and representative influencing factors for risk assessment were selected. Results: The optimizing early-warning strategies can quickly focus on in-short-supply reference drug, improve the supply of reference drug, and ensure the accurate seamless connection between batches. Conclusion: Through the identification of risk factors influencing the early-warning, and the analysis of the data of the use in the national standards and market demand of reference drug, the aim of optimizing the early-warning work is achieved, which provides a reference for effectively enhancing the production and supply efficiency of herbal reference drug.

Objective: To investigate the implementation status of the Chinese Good Manufacturing Practice (GMP) Investigational Medicinal Products Appendix (hereinafter referred to as the "Chinese Appendix") since its release, to understand the problems existing in the implementation process, and to provide suggestions for effective implementation of the Chinese Appendix. Methods: The implementation status of enterprises in different provinces was summarized by means of online questionnaire and on-site investigation, and the implementation of relevant requirements and existing problems were analyzed. Results: There were 100 enterprises participating in the survey from 10 provinces, with a wide and representative product coverage. Research showed that most enterprises had already complied with the requirements of the Chinese Appendix, but a few enterprises had shortcomings in establishing quality management systems (8%), conducting collinear evaluations (9%), establishing the clinical trial drug files (15%), evaluating the similarity between control drugs and experimental drugs (10%), retaining samples (24%), and releasing (21%). Conclusion: It is recommended that the applicants earnestly fulfill their main responsibilities, implement the requirements of the Chinese Appendix and organize more professional training to improve the comprehensive level of enterprise personnel. The drug regulatory authorities should issue relevant guidances documents to conduct special inspections or sampling inspections of drugs used in clinical trials based on risks, and promote the implementation of the requirements of Chinese Appendix

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 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.