Background: Active vaccine safety surveillance (AVSS) stands as a top priority for the World Health Organization (WHO), serving as a critical indicator of the fourth maturity level for national regulatory agencies. Objective: This review aims to define the minimal data scope for association studies in vaccine safety, providing a reference framework for implementing AVSS systems worldwide, especially in low-and middle-income countries. Methods: The study systematically searched PubMed, Embase, and Web of Science for cohort and case-control studies related to AVSS published between January 1, 2018, and September 7, 2022. Guided by the WHO and Council for International Organizations of Medical Sciences guidelines (CIOMS), we developed a 4D framework for Minimum Data Sets (MDSs), including "Vaccine," "Outcome," "Demographic Data," and "Covariate." Variables with a frequency of at least 5% were included in the MDS. Results: Of the 123 included studies, 102 (82.9%) were cohort studies and 98 (79.7%) originated from high-income countries, covering populations across the entire life course. The MDS for COVID-19 vaccines identified 54 variables, while the MDS for maternal populations included 96 variables. WHO guidelines were found to align better with practical applications compared to CIOMS guidelines, though both require further optimization based on the MDS findings. However, metadata for these essential variables were inadequately described across the studies. Conclusions: The proposed MDS provides clear guidance and concise requirements for AVSS data scope. Establishing a globally standardized MDS and comprehensive metadata based on these findings is essential to enhancing the global vaccine safety ecosystem.

新年千帆竞渡春风暖,兔迎盛世启新程.在各位编委、审稿专家、作者和读者的关怀和支持下,《中国药物警戒》走过饱含汗水和辛劳的2022年,迈入充满希望的2023年. 回望过去一年,《中国药物警戒》坚持以"创新"为引领、以"突破"为动力、以"升级"为目标、以"责任"为坚守,踔厉奋发、勇毅前行,各项工作取得了可喜的成绩:聚焦学术热点,不断增加期刊发稿;搭建交流平台,高效举办学术会议;服务科学研究,数次拜访科研团队;打造精品论文,创办多个优质专栏;加快成果传播,持续发力网络首发;展现专家风采,邀约数篇专家论坛.

目的 论述人工智能在美国药物警戒中的应用现状,以期为我国的药品上市后监管工作提供借鉴.方法 通过查阅文献,从药品上市后监管视角,系统介绍人工智能相关定义和性能指标,美国食品药品监督管理局(FDA)应用人工智能的背景,FDA在人工智能的实践进展和考量,以及在药物警戒工作中的挑战等.结果 近10 余年,FDA已广泛探索人工智能在药物警戒中的应用,现阶段FDA主要专注于人工智能处理和评价提交至FDA不良事件报告系统中的个例安全性报告(ICSRs),并在ICSRs关键信息提取和分析、ICSRs关联性评价等方面取得了主要进展.结论 借鉴FDA经验,建议我国加快引入人工智能技术、加强相关人员培训和人才培养与引进、建立人工智能社会技术与管理体系、促进人工智能领域国际领域交流和合作.

高风险植入类无源医疗器械的上市后监测是医疗器械风险管理的重要环节,通过对高风险医疗器械上市后安全性信号的监测和评价,最大限度地控制医疗器械潜在的风险,保证医疗器械安全、有效地使用,避免发生群体性严重后果,是医疗器械生产、经营、使用机构和技术监测部门的共同职责。为了更好地促进和辅助高风险植入类无源医疗器械的上市后监测,本专家共识采用系统性文献回顾、专题小组讨论和专家咨询过程,系统梳理国内外医疗器械上市后风险监测现状,并提出适宜于我国国情的高风险植入类无源医疗器械上市后风险监测模式和高风险医疗器械风险监测关键技术。

Drug‐related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug‐related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China's pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China's medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision‐making. In conformity with the health‐centred drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China's marketing authorization holders (MAHs) must strengthen their pharmacovigilance capabilities as the primary responsible departments for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of a patient‐based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.

作为真实世界数据的重要组成,常规收集的健康医疗数据（RCD）已广泛应用到上市后药品安全性评价。但如何生成高质量的RCD证据支持上市后药品安全性监管决策,在研究设计和分析上还存在挑战。本专家共识通过阐明RCD的定义、应用,并针对研究设计、数据分析提出基于RCD的上市后药品安全性评价基本要求及注意事项,以期促进我国高质量的研究证据的生产及应用。

Drug-induced liver injury (DILI) is a type of bizarre adverse drug reaction (ADR) damaging liver (L-ADR) which may lead to substantial hospitalizations and mortality. Due to the general low incidence, detection of L-ADR remains an unsolved public health challenge. Therefore, we used the data of 6.673 million of ADR reports from January 1st, 2012 to December 31st, 2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation. Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system. By cleaning and standardizing the data fields by the dictionary of synonyms and English translation, we resulted 94,593 ADR records reported to liver injury and then created a new database ready for computer mining. The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years. The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men. The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population, despite known underreporting situation in spontaneous ADR reporting system. The percentage of herbal and traditional medicines (H/TM) L-ADR reports in the whole number was 4.5%, while 80.60% of the H/TM reports were new findings. There was great geographical disparity of reported agents, i.e. more cardiovascular and antineoplastic agents were reported in higher socio-demographic index (SDI) regions and more antimicrobials, especially antitubercular agents, were reported in lower SDI regions. In conclusion, this study presented a large-scale, unbiased, unified, and computer-minable L-ADR database for further investigation. Age-, sex- and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.

亲爱的读者朋友,新年好!《中国药物警戒》又呈现在大家面前了! 《中国药物警戒》是国家药品监督管理局主管、国家药品监督管理局药品评价中心(国家药品不良反应监测中心)主办,国内外公开发行的中国科技核心期刊.创刊18年载,一直秉承"学术性、引领性、实用性、服务性"的办刊宗旨,始终坚持促进中国药物警戒事业不断向纵深开展,为保护和促进公众健康发挥着积极的作用.在主管部门的正确领导下,在编委、专家、作者、读者的大力支持下,期刊工作成效显著.

目的 通过分析我国医疗器械不良事件监测工作现状以及面临的机遇和挑战,提出新时代构建我国医疗器械警戒体系的思考.方法 立足中国国情,结合我国医疗器械产业发展现状和深化审评审批制度带来的监管理念变革情况,通过查阅文献资料、对比分析等方法,对我国医疗器械上市后监测评价工作面临的机遇和挑战进行分析.结果 结合国内外监管法规现状,提出加快完善医疗器械上市后监测评价体系、提高上市后医疗器械风险管控能力、构建我国医疗器械警戒体系的思路.结论 以监管科学为引领,探索推动医疗器械警戒制度的建立,是新时期、新形势、新体制下医疗器械监管的重要课题.

Background Pharmacovigilance is a science that plays a significant role in reducing ADRs and helps predict adverse reactions to drugs in community. To safely use drugs in treatment and prevention of disease, adverse drug reaction has been paid more attention. Objectives To evaluate the future needs of existing systems, the paper investigated the current state of pharmacovigilance and the reporting of ADR in Chinese hospitals. Methods This cross-sectional, questionnaire-based study involved 10,063 pharmacists, doctors, and nurses from primary, secondary, and tertiary hospitals in all 31 provinces of China. It was commissioned by the National Centre for ADR Monitoring of China and conducted in March 2020. Three areas were assessed: sociodemographic characteristics of participants, awareness of the pharmacovigilance system, and the current state of hospitals' reporting of ADRs. Chi-square tests were used to calculate P values. Results Health care professionals had heard the term "pharmacovigilance" previously (89.40%) and knew the reporting object (68.47%), content (65.94%), and range (64.83%) of pharmacovigilance. Most hospitals dispatched responsible professionals (87.64%) and departments (86.25%) to monitor ADR reporting. A total of 58.66% of tertiary medical, 45.25% of secondary, and 38.90% of primary hospitals extracted ADRs from a hospital information system. Moreover, 53.09% of tertiary medical, 38.93% of secondary, and 23.89% of primary hospitals had established a prescription automatic screening system to warn about risks for ADRs. Health care professionals' reports (99.92%) and patient feedback (77.99%) were included in most hospitals' ADR reporting. Conclusions Chinese health care professionals generally have good awareness of pharmacovigilance, and pharmacovigilance is relatively more advanced in China compared to other developing countries.

Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China’s pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China’s medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision-making. In conformity to the health-centered drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China’s marketing authorization holders（MAHs）must strengthen its pharmacovigilance capabilities as the primary responsible department for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of patient-based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.

中药临床应用较广泛,安全性涉及多种复杂因素:既有成分复杂、毒性成分及毒性机制不明确的因素,不合理联合用药、超剂量、超疗程、辨证失误等使用因素,也涉及药材种植的污染残留、炮制不当等导致的质量缺陷.药品上市后研究的主要内容是严重不良反应风险,近年来文献报道涉及中药的严重不良反应主要是注射剂的过敏反应、口服中成药的药源性重要脏器损伤等.如何早期发现、科学评价、及时防控涉及中药的严重不良反应风险,成为中药风险评价与风险管理的关键内容.本文梳理了中药风险评价的主要内容,分析了中药的特点,并以何首乌为例,对中药风险的识别、评估、控制提出了意见建议.

立足我国药品监管新使命、新理念、新制度、新形势,对我国药品上市后监测评价工作面临的机遇和挑战进行分析,并结合国内现状与国际发展,提出了加快完善监测评价制度体系、持续提升监测评价体系能力、着力防控药品安全风险、研究上市后监测评价新方法、努力打造高效能信息化系统等方面的思考.

上市后研究是发现、评价并防控药品在广泛人群使用风险的重要手段.近年来,我国实施药品审评审批制度改革,创新药和附条件批准药品更需要通过上市后研究,充分认识其风险获益,保障用药安全.同时,随着信息技术的发展,电子健康数据逐渐从计算机化病案和电子诊疗数据发展到电子病历和个人医疗记录等形式,成为上市药品安全性研究的主要数据来源.本文梳理了国内外有关药品安全性主动监测的进展,介绍我国对于安全性主动监测的探索,并对电子健康数据用于上市药品安全性研究涉及的相关问题进行探讨.

真实世界数据研究近年来发展迅速,但目前对其认识和理解仍然还存在诸多误区。为推动真实世界数据研究的标准化,本文对真实世界数据的分类进行了更新和进一步明确,提出了真实世界数据研究的两种常用模式,构建了研究型数据体系框架,尤其厘清了对登记数据库的误区和问题,对真实世界数据研究的未来发展方向进行了展望。

Objective To provide evidence for the establishment of an essential medicines list,we investigated the institutional medicine supply in rural hospitals and community health service centers in Chengdu.Methods The trained investigators collected medicine sales records and information about the management of institutional pharmacies. Through in-depth interviews with the pharmaceutical personnel,we inquired into the drug supervision and supply networks in rural areas.Then we performed secondary research based on a comparative analysis of drug classification, administration and pharmacies in developed countries.Results Seven township hospitals/community health service centers had pharmacies,facilities,storage,and a clean environment.Three of them used electrical databases to manage medicine sales records.Five township hospitals and 5 village medical rooms purchased medicines from the drug supervision and supply networks every week.In this way,they ensured the quality and accessibility of drugs in rural areas. In the urban community health service centers,medicines were supplied based on the traditional commercial distribution system.Conclusion Rational allocation of health resources to set up institutional pharmacies and village medicine rooms is important.The supervision of village medical rooms must be stricter.We should expand the use of electrical databases and integrate the supervision and supply networks with the supply system of the essential medicines.