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An introduction to the Medical Dictionary for Regulatory Activities and its use Anna C Zhao-Wong, ZHU Lilin Chinese Journal of Pharmacovigilance    2022, 19 (1): 74-78.   DOI: 10.19803/j.1672-8629.2022.01.16 Abstract （935）      PDF（pc） （1733KB）（1511）       Knowledge map    Save Objective To introduce the Medical Dictionary for Regulatory Activities (MedDRA) Terminology, a medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the use of MedDRA in the regulatory area. Methods The need for an international standard terminology in the 1990s was traced, the structure and maintenance of MedDRA were illustrated, the milestones of MedDRA's growth and development were listed, including its recent actions to meet the challenges of the COVID-19 pandemic, and the future developments of MedDRA were outlined. Results and Conclusion MedDRA by ICH resulted from the need for an international standard terminology that could meet the regulatory needs in pharmaceutical research and development. MedDRA has been used in the registration, documentation, safety monitoring and oversight of medicinal products through each phase of the pipeline, from clinical trials to post-marketing surveillance. The structure and maintenance model of MedDRA can facilitate its use. Since its inception as a user-driven terminology, MedDRA has grown in volume and expanded in scope under the care of the Maintenance and Support Services Organization (MSSO) to meet the needs of users and of evolving regulatory reporting and to keep up with the advances of medicine. Reference | Related Articles | Metrics | Comments（0）

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Annual report of national adverse drug reaction monitoring (2022) Chinese Journal of Pharmacovigilance    2023, 20 (6): 712-719.   DOI: 10.19803/j.1672-8629.20230168 Abstract （1657）      PDF（pc） （3455KB）（1266）       Knowledge map    Save Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public. Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (2): 0-0.   Abstract （236）      PDF（pc） （430KB）（1190）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China LIU Min, PEI Xiaojing, WANG Haixue Chinese Journal of Pharmacovigilance    2022, 19 (2): 176-179.   DOI: 10.19803/j.1672-8629.2022.02.13 Abstract （1048）      PDF（pc） （1261KB）（1112）       Knowledge map    Save Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects. Reference | Related Articles | Metrics | Comments（0）

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Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis ZHANG Jian, FANG Huihua Chinese Journal of Pharmacovigilance    2024, 21 (2): 185-189.   DOI: 10.19803/j.1672-8629.20230140 Abstract （113）      PDF（pc） （1543KB）（1072）       Knowledge map    Save Objective To establish the standard for evaluation of clinical use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis. Methods According to the National Pharmacopoeia of the People’s Republic of China (2020 edition), the Drug Catalogues for National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2021), the Guidelines for Clinical Application of Proprietary Chinese Medicine for Coronary Heart Disease (2020 edition) and the Guidelines for Clinical Application of Proprietary Chinese Medicine for Heart Failure (2021), all TCM injections for promoting blood circulation and removing blood stasis were sorted out. According to drug instructions, guidelines and clinical use, the indicators for evaluation were identified, and the standard for evaluation was established using the Delphi method. Data on TCM injections for promoting blood circulation and removing blood stasis used in the Department of Cardiology between January 1 and June 30, 2022 was collected. The Technique for Order Preference by Similarity to an Ideal Solution was used for evaluation. Results A total of 21 indications of TCM injections for promoting blood circulation and removing blood stasis were included before primary and secondary evaluation indexes were established in terms of indications, solvents, usage and dosage, excipients, compatibility and special populations. According to the results of evaluation, 107 patients (89.17%) with Ci≥60% were identified from among 120 patients receiving TCM injections for promoting blood circulation and removing blood stasis, indicating that the usage of these TCM injections in the Department of Cardiology was generally proper. Conclusion The establishment of a standard for evaluation can help improve the rationality of the way in which TCM injections for promoting blood circulation and removing blood stasis are used. Reference | Related Articles | Metrics | Comments（0）

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Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi, FENG Xin Chinese Journal of Pharmacovigilance    2024, 21 (4): 361-365.   DOI: 10.19803/j.1672-8629.20240057 Abstract （221）      PDF（pc） （2126KB）（774）       Knowledge map    Save Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion (RSA) with Chinese patent medicines, so as to provide reference evidence for the rational use of medicines in the clinic, and a basis for the decision-making in the clinical practice and healthcare. Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA. Relevant software was used to manage the literature, extract the basic information of the drugs and studies, and carry out visual comparative analyses in the form of textual descriptions and charts. Results A total of 95 research articles on Chinese patent medicines were screened out, including 2 systematic reviews and 93 clinical studies. 11 types of Chinese patent medicines were involved, including 1 Chinese medicine injection. The drugs with a higher number of clinical studies were Zishenyutai pills, Gushenantai pills, and Baotailing preparation. Since 2005, the number of related studies has been on an overall elevated trend, and has been carried out in 24 regions of China, the largest number of studies with sample sizes of 51~100 cases included 67 (72.04%); the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines, with a total number of studies amounted to 75 (80.65%). At present, there is no uniform clinical treatment protocol and efficacy judgement standard, and some studies (43.01%) recorded the occurrence of adverse reactions during drug administration in patients. Conclusion Chinese patent medicines have good suitability for the treatment of RSA, and their effectiveness in combination with western medicines is clear. However, there are problems such as lack of content in the drug instruction, timing and duration of medication and outcome evaluation indexes are not standardised, insufficient attention to medication safety, insufficient embodiment of Chinese medicine characteristics , which needs to be improved in the future. Reference | Related Articles | Metrics | Comments（0）

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Discussion on the Monitoring and Analysis of Cluster Adverse Drug Events by Drug Marketing Authorization Holders YANG Le, TIAN Chunhua, XIA Dongsheng, DON Duo, FAN Rong, ZHANG Meiling Chinese Journal of Pharmacovigilance    2021, 18 (10): 940-943.   DOI: 10.19803/j.1672-8629.2021.10.09 Abstract （693）      PDF（pc） （1134KB）（773）       Knowledge map    Save Objective To provide reference for drug marketing authorization holders (MAH) to monitor and analyze cluster adverse drug events (referred to as "cluster events"). Methods The main characteristics and causes of cluster risks/events were analyzed, introduces Monitoring methods of cluster risks, setting rules for early warning signals, key points of on-site investigation, cluster risks/event analysis were introduced. Results and Conclusion MAH can identify and judge cluster risk signals in the adverse drug reaction(ADR) database by establishing monitoring methods, to confirm and control potential drug quality risks or use risks in advance, and maximize the protection of public medication safety. Reference | Related Articles | Metrics | Comments（0）

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Management of individual adverse drug reaction reports LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing Chinese Journal of Pharmacovigilance    2023, 20 (9): 975-977.   DOI: 10.19803/j.1672-8629.20230264 Abstract （633）      PDF（pc） （1185KB）（760）       Knowledge map    Save Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations. Reference | Related Articles | Metrics | Comments（0）

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Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing Chinese Journal of Pharmacovigilance    2024, 21 (2): 121-126.   DOI: 10.19803/j.1672-8629.20230388 Abstract （309）      PDF（pc） （1550KB）（736）       Knowledge map    Save Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg-1·d-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg-1·d-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg-1·d-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg-1·d-1 and from 1.2 to 2.4 mL·kg-1·d-1, respectively, which were equivalent to 0.4-0.8 mL·kg-1·d-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg-1·d-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12. Reference | Related Articles | Metrics | Comments（0）

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Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions GAO Yunjuan, ZHAO Xu, BAI Tiankai, BAI Zhaofang, WANG Jiabo, SONG Haibo, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 1-5.   DOI: 10.19803/j.1672-8629.20230772 Abstract （744）      PDF（pc） （1327KB）（713）       Knowledge map    Save Objective To explore how to quickly discover and accurately identify drug safety risks from a vast number of adverse reaction reports from domestic and foreign Chinese and Western medicines. The aim is also to make scientific and effective predictions and control measures for these risks. Methods Drug-induced liver injury data was taken as an example, and the process of discovering, evaluating, confirming, and controlling risks associated with drugs were discussed. Results A preliminary exploration was conducted, leading to the establishment of an integrated strategy and method system for “large-scale adverse reaction monitoring and discovery - multi-model recognition and analysis- disease-symptom-toxicology verification.” This system has been successfully applied in identifying and analyzing drug-induced liver injury. Conclusion This strategy offers a fresh perspective for the continuous development and innovation of drug safety evaluation. It also provides technical support for ensuring public safety in medication and promoting the healthy development of the Chinese and Western medicine industry. Reference | Related Articles | Metrics | Comments（0）

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Key points of investigation and report of suspected death of adverse drug reaction LIU Saiyue, LYU Xiaoqin, ZHOU Yun Chinese Journal of Pharmacovigilance    2023, 20 (9): 971-974.   DOI: 10.19803/j.1672-8629.20230307 Abstract （595）      PDF（pc） （1263KB）（682）       Knowledge map    Save Objective To guide the drug marketing authorization holder (MAH) to standardize the investigation and report of death cases, so as to provide a basis for in-depth evaluation of drug safety. Methods This paper refers to the requirements of domestic and foreign regulatory guidelines, elaborated the key points of field investigation and internal investigation of suspected death cases of adverse drug reactions known to MAH, as well as the comprehensive analysis of death cases. Results Field investigation includes basic information of cases, drug use, adverse reactions, diagnosis and treatment of patients, and medical institutions. Internal investigation and evaluation can be carried out from the whole process of production and quality control. In addition to the investigation and disposal, the investigation report can provide comprehensive analysis and evaluation combined with the previous safety analysis of the variety. Within the prescribed time limit, the investigation content should be summarized and analyzed to form the investigation report, and submitted as required. Conclusion To standardize the investigation and report of death cases, MAH needs to improve the pharmacovigilance system, and multi-department interaction and efficient disposal, so as to provide reliable basis for risk assessment and risk control, and better guide clinical safe drug use. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (4): 0-0.   Abstract （324）      PDF（pc） （473KB）（669）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (6): 0-0.   Abstract （292）      PDF（pc） （482KB）（664）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Evaluation index system of MAH pharmacovigilance work JIA Jinsheng, WANG Qing, LIU Hongliang, HOU Yongfang Chinese Journal of Pharmacovigilance    2023, 20 (10): 1090-1094.   DOI: 10.19803/j.1672-8629.20230508 Abstract （527）      PDF（pc） （2882KB）（662）       Knowledge map    Save Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work. Reference | Related Articles | Metrics | Comments（0）

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The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu Chinese Journal of Pharmacovigilance    2022, 19 (2): 180-184.   DOI: 10.19803/j.1672-8629.2022.02.14 Abstract （640）      PDF（pc） （1355KB）（649）       Knowledge map    Save Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured. Reference | Related Articles | Metrics | Comments（0）

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Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature ZHU Lan, ZHU Yan, LIU Lihong, SHAO Bo, LIU Hongliang, XIONG weiyi Chinese Journal of Pharmacovigilance    2021, 18 (12): 1155-1158.   DOI: 10.19803/j.1672-8629.2021.12.12 Abstract （541）      PDF（pc） （1092KB）（637）       Knowledge map    Save Objective To summarize problems with post-marketing adverse drug reaction (ADR) reports collected from literature in China and give related advice to marketing authorization holders (MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed. Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2D guideline. Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance, completeness and timeliness, and MAHs need to make more efforts to improve the quality of such reports. Reference | Related Articles | Metrics | Comments（0）

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Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC ZHOU Yuanhua, WU Liangyong, ZHANG Liwen, DONG Shunling, YAO Shangchen, XU Mingzhe, ZHANG Xianhua Chinese Journal of Pharmacovigilance    2023, 20 (4): 365-369.   DOI: 10.19803/j.1672-8629.20230094 Abstract （114）      PDF（pc） （1350KB）（577）       Knowledge map    Save Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C18 column(250 mm×4.6 mm, 5μm) using. 0.02 mL·min-1 ammonium acetate solution-acetonitrile(95∶5, V/V) as mobile phase at a flow rate of 1.0 mL·min-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140~114.0 μg·mL-1（r=1.000 0）and 1.082~108.2 μg·mL-1（r=1.000 0）, respectively.The limit of quantification (LOD) were 0.220 9 ng and 0.202 1 ng, and the limit of quantification (LOQ) were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4% (n=9) and 100.7% with an RSD of 0.5% (n=9) .In 21 samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations. Reference | Related Articles | Metrics | Comments（0）

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Implementation of periodic benefit risk evaluation reports in China TIAN Chunhua, WU Guizhi Chinese Journal of Pharmacovigilance    2023, 20 (12): 1382-1384.   DOI: 10.19803/j.1672-8629.20230579 Abstract （460）      PDF（pc） （1254KB）（576）       Knowledge map    Save Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2022, 19 (9): 1044-1044.   Abstract （462）      PDF（pc） （857KB）（567）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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The practice and consideration of pharmacovigilance during clinical trials in China CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao Chinese Journal of Pharmacovigilance    2022, 19 (10): 1050-1054.   DOI: 10.19803/j.1672-8629.20220242 Abstract （607）      PDF（pc） （671KB）（564）       Knowledge map    Save Objective To compare the construction of pharmacovigilance between United States and European Union, especially on the monitoring and managing of the safety signal; to meditating the future development direction of pharmacovigilance of China during the clinical trial. Methods The organizational framework, law and regulation system, the concept and management of safety signal for the implementation of pharmacovigilance between United States and European Union were compared, combined with the implementation experience of relevant work in China, suggestions for improving the level of pharmacovigilance during clinical trials in China were put forward. Results and Conclusion The pharmacovigilance system of United States and European Union are relatively perfect, the monitoring of safety information and mechanism of risk management are relatively mature. The pharmacovigilance system of clinical trial of China has been basically in place. The advance foreign experience can be referenced and through strengthening the law and regulation and organization system, carrying out focusing monitoring to improve the level of informationization to improve the level of pharmacovigilance of clinical trial in China. Reference | Related Articles | Metrics | Comments（0）