Objective: To compare the regulatory policies of various provinces on the storage and transportation of drug third-party logistics, and to put forward feasible suggestions for strengthening the supervision of drug third-party logistics. Methods: By searching the websites of the National Medical Products Administration and provincial medical products administration, the regulatory policies on drug third-party logistics storage and transportation were obtained, the policies of diff erent provinces and the relevant provisions of the Good Supply Practic were compared and analyzed, and suggestions were put forward. Results: Through comparison, it was found that the policies of various provinces on storage and transportation mainly focused on the storage area, storage facilities and equipment, cold storage quantity and volume requirements, cold storage power supply guarantee, temperature and humidity monitoring system, storage management system, vehicle quantity and vehicle equipment, transportation vehicle management, special drug transportation, transportation management system and other aspects. However, there were some diff erences in the specifi c regulations of diff erent provinces. Moreover, the policy documents of most provinces still had problems: storage management policies were not unifi ed, storage areas were not clearly divided, storage facilities and equipment provisions were not specific, transport-related policies were not comprehensive, and provisions were not made to ensure the normal temperature environment during the transportation of normal temperature drugs. Conclusion: Drug regulatory authorities should strengthen the scientifi c supervision of drug third-party logistics, and establish a unifi ed third-party logistics management system. Drug third-party logistics enterprises should strengthen the construction of infrastructure and equipment, and strive to improve their own storage and transportation level. All relevant parties should make joint eff orts to promote the healthy and orderly development of the pharmaceutical third-party logistics industry.

Objective: Supervision of pharmaceuticals through sampling and testing is challenging when it comes to online marketing. Practical operations of sampling and testing need to be adapted and theory study needs to be improved for the new situation of drug regulation. Methods: In this pilot project of online sampling and testing of pharmaceuticals, we created and executed the scheme based on the features of internet pharmaceuticals shopping. Existing problems and risks were analyzed involving procedure, prescription and logistics, and practical solutions were offered. Results and Conclusion: Related legislation needs to be revised to adapt online sampling and testing, credentials of sampling and acquisition of prescription need to be standardized. We propose to check the authenticity, optimize procedure of mixed batches, and setup a dynamic inspection mechanism.

Objective: To review and summarize the development and regulatory inspection documents ofimmune cell therapy products, and provide reference for the production and supervision of such products.Methods: The production characteristics of immune cell therapy products were organized and analyzed, andregulatory guidelines and reference documents in China were introduced, some key points that need to be takeninto account by on-site inspections for this type of products were also summarized. Results and Conclusion:Compared with traditional drugs, cells as drug have multiple unique characteristics. Therefore, there are challengesin production management, quality control, and systemic contamination risks caused by diff erent products to beproduced on the same line. This article proposes suggestions for on-site inspection and risk assessment of immunecell therapy products from the perspective of provincial regulatory authorities, combined with the productionprocess of immune cell therapy products. We hope to further improve the post-marketing supervision system ofimmune cell therapy products.

Objective: To establish the identifi cation method with specifi city for Calophyllum membranaceum Gardn. et Champ. Method: A comparative study was carried out on Calophyllum membranaceum Gardn. et Champ and its congener Calophyllum antillanum Britt and Calophyllum inophyllum L to determine the identification characteristics of Calophyllum membranaceum Gardn. et Champ by using the characteristics, microscopic thin-layer chromatography (TLC) methods. Results: The character identification of Calophyllum membranaceum Gardn. et Champ was that the leaves were oblong lanceolate and hairless on both sides. The leaves of Calophyllum antillanum Britt. were rectangular round to oval, both main veins and branchlets were densely rusty-red pilose. The Calophyllum inophyllum L. leaves were broadly oval or obovate oval, hairless on both sides. The microscopic characteristics of Calophyllum membranaceum Gardn. et Champ powder could be observed leaf epidermal cells, fi bers and so on, no non-glandular hairs. More non-glandular hairs could be seen in Calophyllum antillanum Britt. The vertical wall of the lower epidermal cells of Calophyllum inophyllum L. leaves was wavy curved and thickened in a bead shape. The TLC identifi cation results showed that there was one more characteristic spot than other varietiesin the same genus. Conclusion: The established method for the identifi cation of Calophyllum membranaceum Gardn. et Champhas special property, which could distinguish between genuine and mixed counterfeit goods of Calophyllum membranaceum Gardn. et Champ.

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 conduct the in vivo toxicity study of repeated administration of oncolytic virus drug HSV-1/hPD-1 in cynomolgus macaques, and to find out the safety dose range, so as to provide informative references for subsequent clinical trials. Methods: Thirty cynomolgus macaques were randomly divided into three groups including control group, HSV-1/hPD-1 low and high-dose groups (1.0×10⁸ , 4.0×10⁸ pfu), with five animals per sex per group. The monkeys were intramuscularly injected twice a week for consecutive six weeks following an eight-week recovery phase. Animals were observed clinical symptoms daily and irritation of injective sites on days 1 and 2 post injection. Body weight was measured once weekly and food consumption was visually estimated daily. Other toxicological parameters including safety pharmacology (body temperature, blood pressure, electrocardiogram), clinical pathology (hematology, coagulation, biochemical, urinalysis), immunology (T lymphocyte, cytokine, immunogenicity), histopathology and organ weight were scheduled to be detected at the quarantine period, after the fi rst dosing, the end of dosing and recovery period. Results: All animas tolerated well and didn’t show obvious changes in clinical signs, injective irritation, body weight, food consumption, and pharmacology and clinical pathology indexes. On day 41, increased CD3⁺ CD4⁺ T lymphocytes were inspected in low dose animals. From days 13 to 97, antibody against HSV-1 vector, expressed PD-1 protein and antiantibody were continuously detected in low and high dose animals, which were considered correlation with immunostimulation and immunogenicity attributed to test articles. The histopathological fi ndings were recoverable minimal to moderate mixed cell infiltration in injection site of low and high dose animals and unrecoverable minimal myelin/axonal damage in sciatic nerve of high dose animals. The change of organ weight wasn’t detected in both groups. Conclusion: After repeated administration of oncolytic virus drug HSV-1/hPD-1, cynomolgus macaques showed good tolerance in vivo, and the no-observed-adverse-eff ect-level (NOAEL) of the test substance was 1.0×10⁸ pfu. Our research data could be used to support subsequent clinical trials.

Objective: To evaluate comprehensively the quality of Begonia evasiana, Begonia sinensis, Begonia pedatifida, Begonia smithiana and Begonia henryi by using UPLC-Q-TOF-MS technology conbined with chemometric. Methods: Chromatographic separations were conducted on a ACQUITY UPLC HSS T3 C₁₈ column (2.1 mm×100 mm, 1.8 μm) with acetonitrile-0.1% aqueous formic acid as mobile phase by gradient elution. The column temperature was 30 ℃, the fl ow rate was 0.2 mL·min^-1, and the detection wavelength was 254 nm. The positive and negative ions were scanned simultaneously by the electric spray ion source (ESI), and collected in MSE mode. The UPLC/Q-TOF-MS characteristic maps of five kinds of Begonia medicinal materials were established, their common peaks were confi rmed and assigned, principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA) were used to analyze the data statistically. Results: The common characteristic peaks were 15, 13, 12, 12 and 15 for Begonia evasiana, Begonia sinensis, Begonia pedatifida, Begonia smithiana and Begonia henryi, respectively, and a total of 29 compounds were identifi ed. There were signifi cant diff erences in the quality of the fi ve medicinal herbs of the genus Begonia, among which the chemical composition differences between the Begonia henryi and the other four medicinal herbs were significant. The chemical composition diff erences between the Begonia evasiana and Begonia sinensis were relatively small, and the chemical composition differences between the Begonia pedatifida and Begonia smithiana were relatively small. 8 chemical markers that contributed significantly to the differentiation of the five medicinal materials were also screened, including proanthocyanidin B2, epicatechin, cucurbitacin D or its isomers, cucurbitacin D glucoside, and cucurbitacin B as potential identifi cation characteristic chemical markers, while proanthocyanidin B1, catechins, and rutin were potential content diff erential chemical markers. Conclusion: The method directly and accurately refl ects the overall quality and chemical composition diff erences of these fi ve medicinal materials, and has important guiding significance for establishing scientific and reasonable quality evaluation methods and safe drug use of the genus Begonia medicinal materials, and also provides references for the overall quality evaluation and control and standard revision of begonia.

Objective: To study the chemical constituents of the leaves of Desmodium caudatum (Thunb.) DC., a medicinal plant of legume, in order to provide material basis for the establishment of quality standard system for D. caudatum. Methods: After the leaves of Desmodium caudatum (Thunb.) DC. were extracted by 70% ethanol, the chemical constituents of the leaves of D. caudatum were separated and purifi ed by macroporous adsorption resin column chromatography, silica gel column chromatography, and preparative high performance liquid chromatography (HPLC), and their structures of the compounds were identifi ed according to the physicochemical properties and spectral data of the monomers obtained. Results: Thirteen compounds were isolated from the leaves of D. caudatum, these compounds were identifi ed and identifi ed from the leaves of Desmodium caudatum (Thunb.) DC.: desmodol (1), citrusinol (2), 8-prenylquercetin (3), dihydrokaempferol (4), neophellamuretin (5), yukovanol (6), quercetin (7), kaempferol (8), vitexin (9), swertisin (10), soyasapogenel B (11), hibiscone A (12) and hibiscone D (13). Among them, compounds 7, 8, 12 and 13 were the constituents contained in various medicinal parts of D. caudatum. Conclusion: Compounds 7, 8, 12 and 13 can be used as candidate quality control onstituents of D. caudatum.

Objective: To identify the Juniperus Folium of Mongolian medicine and its adulterants by DNA barcode technology. Method: The DNA extraction and amplifi cation of 11 samples of Juniperus Folium and the adulterants Sabina Folium were carried out by using the internationally recognized barcode sequences ITS2, psbA-trnH, matK and rbcL. Codon Code Aligner was adopted to align the sequence, and MEGA software was used to analyze the mutation sites and Neighbor-Joining (NJ) cluster of the splice sequence, and its average intra-specifi c and inter-specifi c genetic distance were calculated. Results: The success rates of PCR amplifi cation products of the four primers were ITS2 100%, psbA-trnH 100%, rbcL 100% and matK 0%, respectively. The ITS2 sequences and psbA-trnH sequences could distinguish the Juniperus Folium and its adulterants by comparison of variation sites. The results of NJ cluster analysis showed that the psbA-trnH sequences of Juniperus Folium and its adulterants could be clustered into one branch respectively, and the average interspecifi c genetic distance of psbA-trnH sequences was signifi cantly greater than the average intraspecifi c genetic distance. Conclusion: The psbA-trnH sequences can effectively distinguish Juniperus Folium from Sabina Folium, and can be used as barcode sequence to identify Juniperus Folium and the adulterants Sabina Folium, which will provide support for the identifi cation of Mongolian medicinal materials Juniperus Folium and the adulterants Sabina Folium.

Objective: To obtain the potential active ingredients and protein targets of Ligularia hodgsonii Hook. in the treatment of cough, and to explore the possible mechanism of action by Network Pharmacology. Methods: The chemical constituents of Ligularia hodgsonii Hook. were retrieved from PubMed and other data platforms, then the potential targets screened out through SwissADME and SwissTargetprediction. Cough related targets were obtained by using GeneCards. Key targets were obtained from STRING and Cytoscape, which were used to construct and analyze PPI network. Metascape platform was used for GO biological function process and KEGG metabolic pathway enrichment analysis. Results: Total of 23 key targets was obtained by multi-platform analysis, and most of the corresponding components were eremophilane-type sesquiterpenes. GO analysis obtained biological processes such as positive regulation of protein phosphorylation and regulation of inflammatory response, cellular component such as cell membrane and synapse, molecular function such as protein kinase binding and protein domain specifi c binding. The results of KEGG enrichment showed the signal pathways related to infl ammation.Conclusion: Ligularia hodgsonii Hook. has many active ingredients, which may improve cough symptoms and functions via multi-component multi-target manner and multi-pathway. The underlying mechanism may involve related pathways of infl ammation and immunity.

Objective: To put forward reasonable suggestions for further improving the review and filing ofdrug instructions. Methods: From the perspective of confirming the inspection standards by institute for drugcontrol, the problems encountered by institute for drug control in determining the implementation standardsaccording to the drug instructions were analyzed, combined with personal work experience and thinking. Results:The [executive standards] item specifi ed in some drug instructions lacked the indicative documents for standardrevision, was not revised in time, and had non-standard writing. Conclusion: It is suggested that enterprisesshould update the drug instructions timely and accurately, and the drug supervision department should strengthenthe dynamic management of the drug instructions in the daily supervision work.

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 provide a reference for improving the professional qualifi cation examination system for licensed pharmacists in China. Methods: The current licensed pharmacist (pharmacist) qualification examination system policies, management institutions, registration conditions, examination content, examination forms and qualifi cation standards in the United States, the United Kingdom, Japan and Singapore were collected and analyzed, and suggestions based on the development status of China's licensed pharmacist qualification examination system were put forward. Results and Conclusion: China should speed up the legislative process of licensed pharmacists, constantly improve the qualification examination system of licensed pharmacists, establish the eff ective connection between pharmacy education and pharmacy practice in colleges and universities, and cultivate qualified licensed pharmacists with clinical practice ability and the ability of providing accurate pharmaceutical care.

Objective: To propose several suggestions for improving China's pharmaceutical excipient management system by comparing the core elements of China's pharmaceutical excipient joint review and the Drug Master File system in the United States. Methods: A comparative study was made on the six core elements of China's pharmaceutical excipient joint review system and the US DMF registration, including registration scope, registration subject, registration data requirements, integrity review, joint review, and change management. Results and Conclusion: The core elements of China's pharmaceutical excipient joint review system were basically consistent with the US DMF registration system. However, it is not diffi cult to fi nd that there is room for further improvement in the management of pharmaceutical excipient in China at some conceptual and practical levels, including the risk-based management concept that needs to be further implemented, the signifi cance of registration status needs to be further clarified, and the change management of excipients that can be further optimized.

Objective: To explore the construction of a centralized prescription review intervention model for Shenzhen community health service centers based on the three-way linkage of “Internet+ hospital-community”, and evaluate its eff ect to provide reference for promoting rational drug use in the community. Methods: According to the centralized prescription comment intervention mode of "Internet+ hospital-community", the prescriptions of 10 community health service centers in Futian district of Shenzhen city was reviewed and interfered with by clinical pharmacists in superior hospitals within the medical union for 1 year, and the results of comments before and after intervention were statistically analyzed. Results: The usage rate of antibiotics decreased from 7.65% before the intervention to 2.93%, and the diff erence was statistically signifi cant (P＜0.01).The average amount of prescriptions decreased from RMB 94.17 yuan to RMB 80.72 yuan, and the diff erence was statistically signifi cant (P＜0.05). the rational rate of prescription increased from 87.40% to 95.60%, The percentage of inappropriate prescriptions dropped from 12.20% to 4.30%, and the difference was highly statistically significant (P＜0.05). The proportion of money used for essential drug increased from 51.20% before intervention to 52.04% after intervention. Conclusion: The implementation of the centralized prescription review intervention model of “Internet+hospital-community” in community health service centers has a signifi cant eff ect on the continuous improvement of various core indicators of prescriptions. It has positive signifi cance for improving rational drug use in community medical institutions.

Mesothelin is a tumor associated antigen, a glycoprotein which is highly expressed in over 30% of cancers and only expressed at low levels in a small amount of normal tissues. It is a widely studied cancer immunotherapy target. At present, a variety of immunotherapeutic products targeting mesothelin have shown good safety in clinical researches, especially adoptive cell therapy targeting mesothelin has been developed rapidly in recent years. This article introduces the research progress and trends of solid tumors immunotherapy targeting mesothelin from several aspects, including biological characteristics of mesothelin, clinical trials results of immunotherapy, as well as challenges and response strategies of CAR-T cell immunotherapy.

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 provide recommendations for transformation and application of new Chinese medicinedrug in medical institutions. Methods: The related literatures of development of new Chinese medicine drugand achievements transformation under the production-study-research system were researched, combined withmy own work practice, the current difficulties in the transformation and application of new Chinese medicinedrug in medical institutions were analyzed. Results and Conclusion: As resultes, there were few articles on thedevelopment of production-study-research of new Chinese medicine drug. Based on the analysis and summaryof relevant literature, it was pointed out that the diffi culties in the transformation and application of new Chinese medicine drug in medical institutions were the lack of varieties with high added value, imperfect transformationsystem of new Chinese medicine drug, the lack of fi nancial support for the transformation and application of new Chinese medicine drug, and uneven service institutions for the application and transformation of scientifi c andtechnological achievements. We should inherit and carry forward the theory and advantages of traditional Chinesemedicine, innovate and develop the "fi st" products of traditional Chinese medicine preparations, and strengthen thecooperation of between government and enterprise research, so as to accelerate the innovation and development ofnew traditional Chinese medicine drugs in medical institutions.

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 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 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 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: 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 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: 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.

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

Objective: To 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 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.

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: To explore the strategy in improving the quality management level of holders of pharmaceutical contract manufacturing (B certificate) under the new regulatory requirements. Methods: By sorting out the found defects in the inspection of B certificate of pharmaceutical contract manufacturing in the previous year, the essential reasons for the defects in Bcertificate enterprises were analyzed, and feasible suggestions were put forward in combination with the new regulations. Results and Conclusion: After combing 136 defects, it was found that the problems of the holders mainly about three aspects (personnel and institution, quality assurance system, documents and records) were summarized into missing responsibility, communication loss and execution loss. It is suggested that the B-certificate holders should clarify the responsibilities of both parties, improve the communication system, link up the implementation procedures, and implement the main responsibility of the whole life cycle of drug.

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 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: The Good Regulatory Review Practice (GRRP) Working Group has been working for 7 years to draft and publish 8 coordination guideline documents. This article aims to summarize and study the essence of a series of documents, and explore the development and advantages of international regulatory coordination of medical devices. Methods: The work situation of GRRP and the main content of the guideline document are sorted out, and the international experience and consensus gathered in the document are analyzed, as well as the implementation of the series of documents in China and member regulatory regions are explored. Results and Conclusion: The coordinated guideline documents developed by the International Medical Device Regulators Forum (IMDRF) GRRP working group on regulatory responsibilities, the structure and process of decision-making by conformity assessment bodies, and product safety and effectiveness has been fully implemented in China, which meets the new needs of China's medical device innovation regulatory development and reflects China's proactive efforts in international regulatory coordination.