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 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 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 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 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.

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 summarize the clinical trials of chemical modified new drugs that have been published, in order to provide a reference for the subsequent clinical trials of chemical modified new drugs. Methods: Based on drug clinical trial registration and information publicity platform of the Center for Drug Evaluation of National Medical Products Administration and combined with third-party databases such as Yaozhi and Insight, the clinical trial in for mation of chemically modified new drugs during the period from January 1st, 2020 to December 31th, 2023 was retrieved, and statistical analysis was conducted using excel and other method to study the development of clinical trials. Results: From January 1st, 2020 to December 31th, 2023, the number of clinical trials announcements of chemical modified new drugs had increased year by year, and a total of 548 announcements had been made in three years. Clinical trials for 2.2 types of chemical modified new drugs accounted for more than 50%, which was the highest, and clinical trials for 2.1 types of chemical modified new drugs accounted for the least. The stages of clinical trials were mainly phase I clinical trials. Conclusion: The chemical modified new drugs can draw on the clinical development data of the marketed products, reduce part of the clinical trial research, and shorten the research and development cycle, which is the hot spot of new drug research and development.

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 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: 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: 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 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 explore the establishment of pharmaceutical clinic service model in Peking Union Medical College Hospital (hereinafter referred to as our hospital). Methods: The management system, operating procedures, service contents and quality control system of pharmaceutical clinic service in our hospital were summarized by consulting domestic and foreign literature, conducting investigation and research, and combining with hospital practice experience; the challenges of the development of pharmaceutical clinic service were analyzed, and the suggestions for promoting the development of pharmaceutical clinic service were put forward. Results: The pharmaceutical clinic service model in our hospital has been initially established. The clinic service types include offline pharmaceutical clinic and Internet pharmaceutical clinic. The treatment channels include patients' independent registration and transfer treatment within hospital. There are 12 specialties, including drug therapy management of pregnancy and lactation, diabetes, coronary heart disease, anti-thrombotic therapy, respiratory diseases, multiple chronic diseases, digestive diseases, neuropsychiatric diseases, immune system diseases, lung cancer and anti-tumor, nutritional pharmacy, and comprehensive pharmacy. The customized electronic form can not only meet the needs of pharmaceutical clinic work, but also realize the mutual examination of medical records with clinical treatment. As of October 31, 2023, 426 patients were admitted to offline pharmaceutical clinic, of which 92 cases were transferred within hospital, accounting for 21.6%; the internet pharmaceutical clinic received 543 patients, which eff ectively solved the problem of drug use for clinical patients. Conclusion: The online and offline pharmaceutical clinic service model can better meet the medical needs of patients, realize the transformation of patient-centered pharmaceutical care.

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 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 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 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 potential mechanism of action of Matricaria chamomilla L. in the treatment of asthma by using network pharmacology and molecular docking techniques, based on the analysis of the chemical components of Matricaria chamomilla L. by the previous UHPLC-Q-Orbitrap-MS technique. Methods: Based on the results of chemical composition identification of Matricaria chamomilla L., Swiss Target Prediction was used to excavate the active ingredients and corresponding action targets; OMIM, GeneCards, TTD, PharmGkb and DisGeNet databases were used to obtain the targets of asthma; the common targets of active ingredients and disease targets were obtained after screening. The Venny Diagram was constructed for the common targets of the effective active ingredients and the disease targets obtained after screening; the target protein-protein interaction (PPI) network was established using the STRING database; the common targets of "Matricaria chamomilla L. active ingredient-asthma disease" were analyzed by GO annotation and KEGG signal pathway enrichment using Metascape database. The network model of "Matricaria chamomilla L. active ingredient-asthma target-pathway" was established by Cytoscape software; molecular docking verification of the key active ingredients in Matricaria chamomilla L. and the core protein of the target protein interaction was performed by Autodock and PyMol software. Results: 30 active ingredients from Matricaria chamomilla L., and 52 common targets were identified for Matricaria chamomilla L. in the treatment of asthma, among which the core targets were TNF, MMP-9, STAT3, PTGS2, EGFR, TLR4, NOS2, JAK1, PLAUR, PTGS1. Signaling pathways were mainly enriched in JAK-STAT, IL-17, NF-κB, arachidonic acid metabolism, etc. The molecular docking results showed that the core target TNF and core components docking results were less than 0 kcal·mol- 1, and the results showed a good binding activity. Conclusion: Matricaria chamomilla L. may act synergistically through multiple components, multiple targets and multiple pathways to treat asthma, providing a theoretical basis for molecular mechanisms of Matricaria chamomilla L. in the treatment of asthma.

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.

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: To introduce the relevant guidlines for remote regulatory assessments issued by FDA and analyze the warning letters issued based on remote regulatory assessments to provide references for the industry. Methods: This paper introduced the remote interactive evaluations guidelines and remote regulatory assessments guidelines issued by FDA, and analyzed the warning letters issued based on remote regulatory assessments from the aspects of defects and the time of issuing warning letters, and put forward reference opinions. Results: Warning letters issued by the FDA based on remote regulatory assessments have unique characteristics in terms of defect terms and timing compared to warning letters issued by inspections. Conclusion: As a new regulatory tool, remote regulatory assessments has its unique advantages and disadvantages, and it also brings new challenges to both regulatory authorities and pharmaceutical manufacturers.

Objective: Through in-depth thinking on the construction of professional and specialized team of drug inspectors in China, to provide reference and inspiration for joining the PIC/S international organization as soon as possible, realizing the internationalization of drug inspection in China, and promoting the internationalization of China's pharmaceutical industry. Methods: By comparing the modules required for inspectors in the PIC/S audit checklist, the requirements of PIC/S for inspectors were summarized, the current situation of the team for inspectors in China was analyzed, and the construction of China's professional and specialized team of drug inspectors was deeply considered. Results and Conclusion: In order to accelerate the establishment of a professional and specialized team of drug inspectors to meet the requirements of PIC/S, the scale of professional and full-time inspectors should be expanded, and the hierarchical and classified management of inspectors should be deeply promoted. At the same time, a high-quality inspector training model to enhance their inspection capabilities should be establishsd. In addition, a professional title evaluation system with professional characteristics should be established, with improving the salary guarantee mechanism and incentive mechanism for inspectors to fully mobilize their enthusiasm and initiative to improve their abilities. These measures will provide a solid guarantee for China's early accession to PIC/S.

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 analyze the problems existing in the drug re-registration work in Shandong Province and put forward relevant suggestions, so as to provide technical reference for promoting the scientific standardization of drug re-registration work and improving the review and approval efficiency of drug reregistration work. Methods: Based on the current laws and regulations of drug re-registration in China, the investigation of 50 chemical manufacturers in Shandong Province and the situation of drug re-registration in Shandong Province in recent years, the technical review of chemical drugs (preparations and raw materials) re-registration in Shandong Province was discussed and analyzed. Results and Conclusion: In the drug reregistration works in Shandong Province, there were mainly problems such as the lack of close connection with the reevaluation of listed drugs, the untraceable process of drug approval, and the centralized deadline declaration of approval document number. It is suggested that measures such as unifying technical review standards, deepening the management of conditional approval of listed drugs, optimizing the management of re-registration cycle, and strengthening the main responsibility of enterprises can better play the role of post-listing supervision of drug re-registration.

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 explore how real-world study (RWS) generate real-world evidence to support regulatory decisions for the marketing of medical devices based on ethical and regulatory compliance. Methods: Based on the relevant policies, guiding principles, and research status of RWS in clinical research of medical devices both domestically and internationally, the requirements of RWS in clinical evaluation of medical devices were analyzed from the aspects of key points of research scheme design, real-world data quality control, data statistical analysis and case analysis. Results and Conclusion: RWS provides strong support for the marketing of medical devices due to its relaxed patient enrollment criteria, broad population coverage, and large sample size. The scientifi c and logical design of clinical trial program, the traceability and quality control throughout the implementation process, as well as the appropriate use of statistical analysis methods are the key for transforming real-world data into real-world evidence. Promoting the application of RWS in medical device clinical trials will facilitate the marketing of medical devices and promote the healthy and rapid development of the entire medical device industry.

Objective: To explore the current registering situation of drug clinical trial institutions in Fujian Province after the implementation of the registering system of drug clinical trial institutions in December 2019. Methods: Based on the data of the national drug clinical trial institution registering management information system platform and the drug clinical trial registration and information publicity platform, the current situation of drug clinical trial institutions in Fujian Province was systematically analyzed from the aspects of the number and geographical distribution of registering institutions, the level of registering institutions, the major of registering institutions, the main investigators of registering institutions and the status of drug clinical trials. Results and Conclusion: The total number of drug clinical trial registering institutions in Fujian Province was relatively low, which reflected the insufficient attention of medical institutions to drug clinical trials in Fujian Province, the uneven geographics distribution of institutions and the uneven number of clinical trials. Currently, there are still many medical institutions with the registering qualification in Fujian Province. It is suggested that regulatory authorities should increase the support for the construction of drug clinical trial institutions, and encourage more qualified medical institutions to participate in the registering of institutions, to carry out drug clinical trials, while the registering institutions must pay more attention to the quality of clinical trials to promote the healthy development of clinical trials.

Objective: To improve the laws and regulations construction of credit supervision of drug production enterprises, improve the integrity awareness of drug production enterprises in China, and provide suggestions and references for promoting integrity production activities. Methods: The existing problems were analyzed and reasonable suggestions were put forward through research on the construction of credit supervision laws and regulations of drug production enterprises in China. Results and Conclusion: China's drug production enterprise credit supervision laws and regulations construction was not perfect, mainly reflected in the credit reward and punishment mechanism was not perfect, the joint punishment mechanism was not perfect; the credit rating method lacked specific and unified standards; the provisions on the disclosure of credit information were not specific enough; the role of the pharmaceutical industry association was not fully played. Based on this, this paper puts forward corresponding suggestions from four aspects: credit reward and punishment mechanism, credit rating evaluation system, credit information disclosure system and external support system, so as to strengthen the laws and regulations construction of credit supervision of drug production enterprises in China.

Objective: To summarize and analyze the postgraduate training programs in Pharmacoeconomics in the United States and provide suggestions for the training of postgraduates in Pharmacoeconomics in China. Methods: Through the information collected on the PharmGrad website in the United States and the official websites of colleges and universities, the content related to the training of postgraduates in Pharmacoeconomics was sorted out. An Excel database for analysis was constructed, and a comparative analysis was made from three aspects of the training objectives, training process, and curriculum settings in the training programs of colleges and universities. Results: A total of 22 US colleges offering master's and doctoral programs in Pharmacoeconomics were included, including schools of pharmacy and schools of public health and so on. There were apparent differences between the training objectives of master and doctoral students in different colleges and universities. In general, the training goals were clear. Throughout the training process of postgraduate students, a multi-purpose training method was adopted to realize the diversification of the training process, including conducting seminars, independent research in Pharmacoeconomics, and providing internship opportunities. In terms of offering courses, the courses could be divided into seven categories as a whole. Each institution focused on different types of courses and had higher requirements for the depth of learning content of the corresponding courses. Conclusion: The US Pharmacoeconomics postgraduate training system is mature and complete. The training of domestic Pharmacoeconomics postgraduate talents can learn from the relevant experience to establish a targeted postgraduate training system for Pharmacoeconomics, especially cultivating postgraduate students' ability to conduct Pharmacoeconomics research, enriching the core curriculum and increasing the indepth of teaching.

Objective: Gas chromatography-triple quadrupole mass spectrometry (GC-MS/MS) was used to quantitatively analyze terpinen-4-ol, α-pinene, methyleugenol, elemicin, safrole and myristcin in 16 batches of volatile oil of nutmeg. Combined with anti-inflammatory activity dose-effect analysis, the quality of the active ingredients in nutmeg was evaluated. Methods: CO₂ supercritical extraction method was used to extract the volatile oil of nutmeg, and a GC-MS/MS method was established to analyze the six components in nutmeg. Methodological investigation was conducted and the content of six components in 16 batches of volatile oil samples was determined. Gas chromatographic conditions: J&W DB-17ms gas column (30 m×0.25 mm, 0.25 μm); temperature rise procedure: 50 ℃, keep for 1 min, rise to 150 ℃ at the rate of 10 ℃·min^-1, keep for 3 min; then it was raised to 250 ℃ at the rate of 20 ℃·min^-1 and keep for 3 min. Inlet temperature 280 ℃; the carrier gas was nitrogen, the fl ow rate was 1 mL·min^-1, the shunt ratio was 10:1, and the sample size was 1 μL. The infl ammation model of Raw264.7 macrophages induced by lipopolysaccharide (LPS) was established in 16 batches of volatile oil, and the pharmacodynamic analysis was performed. The volatile oil samples were analyzed by principal component analysis (PCA-X) and Pearson coefficient was positive compounds as contributing components. Results: There was a good linear relationship between terpinen-4-ol, α-pinene, methyleugenol, elemicin, safrole and myristicin in the corresponding concentration range. RSD of the six components ranged from 0.18% to 0.90% for precision test, 1.53% to 2.90% for repeatability test, and 2.11%-2.94% for stability test. The average recoveries (n=9) were 98.32%, 99.41%, 94.79%, 98.82%, 96.14%, 97.81%, and RSD was 1.51%, 1.62%, 1.87%, 0.71%, 1.82%, 1.31%, respectively. The contents of terpinen-4-ol, α-pinene, methyleugenol, elemicin, safrole and myristicin in 16 batches of volatile oil samples ranged from 4.674-12.432 mg·g^-1, 2.316-11.121 mg·g^-1, 0.201-4.653 mg·g^-1, 1.047-10.488 mg·g^-1, 201.776-402.163 mg·g^-1, 7.888-39.570 mg·g^-1, respectively. The results showed that there was a correlation between the anti-infl ammatory activity and the content of six components. The anti-infl ammatory activity of methyleugenol, elemicin and myristicin contributed, and elemicin contributed the most. Conclusion: A dose-effect relationship analysis was established for the anti-inflammatory activity of six components in 16 batches of volatile oil of nutmeg. The method is simple and rapid, and provides a basis for the quality control, safe and effective application of nutmeg.

Objective: To evaluate the contribution of uncertainty in the releasing rate determination process of fluvastatin sodium sustained-release tablets. Methods: The experiment was conducted according to General Rule 0931 in Volume Ⅳ of the 2020 edition of Chinese Pharmacopoeia, and a mathematical model was established to analyze the source of uncertainty in the determination of fluvastatin sodium sustained-release tablets and calculate the synthetic uncertainty and extended uncertainty with reference to the relevant provisions of JJF 1059.1- 2012. Results: The synthetic uncertainties of fluvastatin sodium sustained-release tablets at 0.5 h, 2 h, 4 h and 8 h were 0.02205, 0.03034, 0.03520 and 0.02979, respectively. The extended uncertainties were (5.9±0.26)%, (23.2±1.40)%, (54.8±3.86)%, (108.0±6.44)% (k=2, confidence interval 95%), respectively. Conclusion: At 0.5 h, 2 h, 4 h sampling points, the uncertainty contribution of fluvastatin sodium releasing rate in fluvastatin sodium sustained-release tablets comes mainly from the parallel determination of samples. At 8 h sampling point, it is mainly derived from the preparation of the test product solution. The uncertainty of the analysis method was quantified in this experiment, which provided a more scientific basis for the inspection of the releasing rate of controlled release tablets.

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: To construct the evaluation index system of statins in medical institutions and promote the evaluation and selection of clinical statins more systematicly, scientificly and standardizedly. Methods: Referring to "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (2021 version trial)", combined with the characteristics of statins and clinical experience, a multi-criteria and multi-dimensional evaluation index system for statins was constructed by using the Delphi method. Results: On the basis of the established initial evaluation index system, the evaluation index system of statins was finally determined through two rounds of expert questionnaire consultation, including 6 first-grade indexes, 23 second-grade indexes and 44 third-grade indexes. The familiarity of the two rounds of expert correspondence was 0.81, the coefficient of judgment was 0.94 and 0.95, and the coefficient of authority was 0.84 and 0.88, respectively. The reliability was 0.95 and 0.98, respectively. Conclusion: The evaluation index system of statins established in this study is scientific and authoritative, which can provide an important basis for the selection and rational use of statins catalog in medical institutions, accelerate the high-quality development of pharmaceutical services, and the control of unreasonable drug expenses.

Objective: To establish the method for the identification of different origin of Magnoliae Officinalis Cortex based on multi-component quantitative analysis and chemometrics. Methods: Ultra performance liquid chromatography (UPLC) was used to determine the contents of eight chemical components, namely syringin, magnocurarine, magnoflorine, magnoloside B, magnoloside A, honokiol, magnolol and piperitylmagnolol, in different original Magnolia Officinalis cortex. Cluster analysis, principal component analysis, Fisher discriminant analysis, and orthogonal partial least squares discriminant analysis were used to screen key identification indicators for different original Magnolia Officinalis Cortex, and a identification model was established. Results: The contents ratios of magnoloside B to magnoloside A and honokiol to magnolol could be used as the key indexes for the preliminary identificaiton of the origin, and the Fisher's Linear Discriminant Functional Score could be clearly distinguished the different origins. Conclusion: The combination of multi-component quantitative analysis and chemometrics can identify different origin of Magnoliae Officinalis Cortex, which can provide a reference for the identification of multi-basal origin herbs.

The presence of visible particulates in injection products is one of the common issues today, and has always been a hotly debated topic among global regulatory agencies and the industry. Although there is a certain consensus in the industry regarding the definition and judgment criteria of visible particulates, there are still different understandings and mastery scales in practical production processes regarding how to control them. In addition, there is a lack of authoritative references and guidelines for companies in terms of skill requirements for inspectors and equipment validation, such as standard substances for visible particulates and related technical guidance documents. These have a significant impact on the production and quality control of domestic injection products. The aim of this study is to conduct a literature survey on "visible particulates in injections" by collecting and organizing relevant domestic and international literature to analyze and summarize the research progress in this field, providing references for improving the quality of injection products.

Objective: Saffron is the dried flower of Carthamus tinctorius L, an annual herb of Asteraceae family. As a traditional ethnic medicinal herb with high development and utilization value, this study aims to provide a scientific basis for the modern study of saffron and theoretical support for its new drug development and quality evaluation. Methods: Using keywords such as ‘saffron’, ‘chemical composition’, ‘pharmacological effect’, ‘biological activity’ , ‘clinical application’ and ‘quality standards’, etc., relevant searches were conducted on databases of CNKI, Wipo, Wanfang and Pubmed. The chemical composition, pharmacological effect and clinical application of saffron were summarized. Resluts: A total of more than 200 relevant literatures were searched, of which more than 90 were valid. It was found that the chemical constituents in saffron mainly contain flavonoids, alkaloids, quinone chalcones, alkynes, subarginine amines, and some other classes of compounds; they have antioxidant, antifibrotic, protection of endothelial function of the vasculature, anticoagulant and other pharmacological effects. In the clinic of Mongolian medicine, saffron is mainly used for the prevention and treatment of blood fever, gynaecological diseases, liver diseases, clearing heat and detoxification, etc. Conclusion: The current research on the chemical composition of saffron has been relatively comprehensive, while its pharmacological research mainly focuses on the treatment of coronary heart disease, angina pectoris and other aspects. In the clinical treatment of Mongolian medicine, saffron is usually used in combination with heat-clearing and detoxification drugs, but there is no clear report on its toxic side effects.

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 evaluate and analyze the risk changes of cross-border changes in sponsors or production sites, and provide reference for the management of cross-border changes in sponsors and production sites. Methods: Based on the initial risk assessment results of different combination modes of the sponsors and production sites, and the risk re-evaluation results after implementing risk control measures, a comparative analysis was conducted on the changes in the "risk index level" before and after the changes occur between different combination modes. Results and Conclusion: Based on the results of the initial risk evaluation, the risk index levels of two change scenarios were lower after the change than before the change, and based on the results of the risk re-evaluation, the risk index levels of four change scenarios were lower after the change than before the change.

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.