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 Methods: The current reference medicinal product in ANDA draft guidance by US food and drug administration (FDA), as well as the relevant requirements of reference medical product in European Union (EU), Japan and WHO were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

Objective: To 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 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 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 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: 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: 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 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 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 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 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 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 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 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 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: Profciency test is an important means to reflect the effectiveness of laboratory quality management system, which has the function of forecasting and early warning for hidden risks. The objective of the paper was to analyze the causes and cases of common suspicious or unsatisfactory results, to summarize the results of self-examination and rectification, common reasons and key control points that caused deviation of result, and to analyze the risk points and put forward countermeasures accordingly. Methods: Through the analysis of specifc cases, the representative key points and diffculties of the actual testing were found out, inferences were drawn and the lessons learned were summed up. Results and Conclusion: Although the deviation of individual results had a certain chance, could it reflect the risks of routine testing activities. Attention should be paid to the process of self-examination and rectifcation. The causes of failure should be analyzed and countermeasures should be put forward so as to avoid the same mistakes in the testing activities, which was a useful and important measure to ensure the laboratory quality and to achieve the continuous improvement of the levels of the quality control and inspection brought by profciency test.

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

Objective: To compile standards for information data of drug control institutes, to solve the problems of incomplete, irregular, and low-quality data in order to realize sharing information, mining data value and to promote informatization. Methods: According to the business of control institutes and practice of informatization, the paper carried out the research on the compilation of standards from the aspects of content, principle and process with reference to the practice of developing relevant standards. Results and Conclusion: This study finished the compilation of the local standards for drug control data in Guangdong Province, which can provide references for the development of similar standards in the field.

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 study the regulatory requirements and implementation of the change management during the clinical research of drugs in the United States, and compare it with the current construction and implementation status of relevant regulatory regulations in China, in order to provide reference for improving the regulatory system of the change management of sponsors and production sites during the clinical research of drugs in China. Methods: A systematic review and study of regulatory regulations on the change of sponsors and production sites during the clinical research in the United States was conducted. Suggestions were provided based on the current situation of change management during the clinical research in China. Results and Conclusion: The regulatory system for drug clinical trials in the United States adopts a combination of approval and inspection, and allows sponsors and production sites to exist in different countries (cross-border) under the premise of controllable risks by strengthening the sponsor responsibility system. In recent years, China's drug review and approval reform has been continuously deepening, and a regulatory system for changes during clinical trials has been initially established. In the future, the relevant requirements for changes during clinical trials in China can be refined in stages to support industrial development.

Objective: To analyze the acceptance and use of donated medicines in Optical Valley Branch of Tongji Hospital during COVID-19, and to provide reference for the management of medicine donation in medical institutions, so as to promote the standardization of medicine donation management in China. Methods: Information about the donated medicines received by hospital between February 9, 2020 and March 30, 2020 was collected, including the source of donation, approved drug name, expiration date, quantity, and utilization. Several classification systems, databases and references were used to identify the properties of donated medicines, including the World Health Organization Systemic Anatomical Therapeutics and Chemical Classification Systems, A New Chinese Patent Medicine Manual, the data system of National Medical Products Administration, the National Essential Medicine List, China Medical Insurance Drug Catalogue Inquiry System, COVID-19 medical handbook and so on. Results: During the epidemic, a total of 85 kinds of donated medicines were received in our hospital, of which 68 (80%) were donated by enterprises, which were the main source of donated drugs. In terms of the suitability of the varieties of the donated medicines, 55 (64.7%) kinds of the donations were deemed as suitable, and 30 (35.3%) were not. In terms of the shelf-life, 77 (90.6%) kinds of the donations had a remaining shelf-life of more than 12 months, 6 (7.0%) between six and eleven months, while 2 (2.4%) kinds of the non-frying granule of traditional Chinese medicine did not have expiry date. In terms of the total utilization rate, 8 (9.4%) kinds were 100% utilized, 25 (29.4%) between 50% and 100%, 16 (18.8%) between 10% and 50%, 17 (20%) between 0% to 10%, and 19 (22.4%) were not utilized at all, and the utilization rates of donated medicines used by patients were relatively low. Conclusion: Problems existed in the field of donation appropriateness, shelf-life, donation quantity and utilization. National guidelines on medicine donation should be formulated in China lines to regulate donation behavior. Meanwhile, medical institutions should establish management system to select and use the donated medicines in a scientific and rational manner.

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

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

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

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

Objective: To provide reference through comparative research and analysis of regulations, for improving China's drug clinical trials and change management during clinical trials, especially for the sponsor change or production site change, and their change management during clinical trials. Methods: The regulatory requirements and implementation of European Union(EU) drug clinical trial applications and change management during clinical trials were collected and studied. Suggestions were provided by comparing them with the present regulatory framework and situation of China. Results and Conclusion: In EU, the clinical trial sponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trials both domestically and internationally. The EU clinical trial regulatory system is relatively mature and complete which are of reference value to China, such as a unified clinical trial application portal website and clinical trial information database, an integrated system of scientific and ethical in parallel review procedures, the qualification and responsibility for the sponsors and their legally designated representatives, and measures of supervision and risk control for production sites of investigational drugs as well as their changes.

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

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

Objective: To improve the 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 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.

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: To introduce the management organization structure and quality control requirements for the research, production and distribution of pharmaceutical reference standards in order to guarantee the quality and supply. Methods: The research, production and management workflow for pharmaceutical reference standards were analyzed based on the requirements of ISO 17034 international standards. The quality factors that should be controlled in all aspects of research, production and management were also analyzed. The importance of complying with the requirements was emphasized. Results: An effective mechanism for the quality control of the research, production and distribution and continuous supply of pharmaceutical reference standards was established and improved. Conclusion: In order to ensure the quality and availability of pharmaceutical reference standards, it is necessary to strengthen the management of each process of workflow of the pharmaceutical reference standards.

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.