本文聚焦推进我国药品监管国际化工作的目标与要求，通过系统梳理美国、日本、欧盟药品监管机构在国际监管事务中的战略规划、重点任务及实践举措，总结其在国际协调、国际传播、合作机制、战略安排等方面的药品监管实践经验，提出对我国药品监管国际化工作的思考与启示，旨在为我国建设更加科学、高效、现代化的药品监管体系提供支撑。

面对生命科学的不断发展和国际地缘政治的急剧变化，全球药品监管环境正处在深刻变革阶段。在传统意义上依托国际标准加强合作，不断提升监管能力的基础上，全球药品监管机构正在探索从协调、趋同直至信赖的通路。为此，世界卫生组织（WHO）在原有的产品预认证和国家监管机构（NRA）评估以及所谓严格监管机构（SRA）认定模式基础上，于 2017 年提出“WHO 列名机构（WLA）”新概念。WLA 以全球基准评估工具（GBT）和绩效评估（PE）为核心，旨在为国际药品及疫苗监管构建一个统一、透明和科学的评估平台，并据此推进全球药品监管实质性合作。本文详细回顾了 WLA 的产生背景与演变历程，系统介绍 GBT 和 PE 两大评估工具的构建、内容与实施流程，并对各国和地区监管机构在 WLA 评估中的实践路径进行分析。最后探讨了 WLA 在推动全球药品监管信赖、提升监管质量及保障国际药品供应中的战略意义。

目的 ： 人工智能（AI），特别是自然语言处理（NLP）和大语言模型（LLM），有望显著提升药物警戒场景的工作效率，以应对不良反应报告数量持续增长带来的行业挑战。本文旨在系统梳理部分国际药品监管机构和国际组织在药物警戒场景关于 AI 技术的监管政策和具体应用情况，以期促进 AI 技术在该场景的健康发展。方法 ： 本文通过系统性的文献回顾，对比分析美国、欧盟、英国、日本的药品监管机构在相关领域的政策法规制修订情况及国际组织相关文件的发布情况，并梳理上述药品监管机构及国际组织在药物警戒场景中运用 AI 技术的最新进展。结果 ：NLP 和 LLM 技术在药物警戒全生命周期中展现出广阔的应用前景。国外监管机构及国际组织已经在不良反应识别、规范上报、评价处置以及风险信号识别评估等不同阶段，积极探索 AI 技术的应用。然而，AI 技术本身存在固有的局限性，如数据偏移及可靠性等问题，这给其实际应用带来了挑战。全球药品监管机构和国际组织正通过起草并发布指导文件等方式，促进 AI 在药物警戒中的合规应用，各类指导原则均强调了人类监督、模型验证和风险控制的重要性。结论 ：为充分发挥 AI 的优势并克服其局限性，有必要建立合理的监管机制，以确保 AI技术能够安全、有效地应用于药物警戒场景。

临床试验质量是药品审评审批关键考量之一。去中心化临床试验（DCT）是一种创新的临床试验模式，旨在提高试验效率、增加患者参与度并提高数据质量。为确保DCT 的实施质量，从方案设计到临床研究执行应遵循以患者为中心的原则，贯彻质量源于设计理念，需充分考虑风险因素，制定风险管理计划，从而保障试验参与者的权益、研究的可行性及结果的可靠性。为推动DCT 在我国的应用，并为其基于风险的质量管理提供参考依据，中国药品监督管理研究会组织行业专家制定本共识，共涉及当前行业内应用较多的5 种DCT 元素的质量管理实践，包括药物直达试验参与者、远程访视与评估、电子知情同意、就近使用医疗资源、临床效果和安全性信息远程监查。旨在为行业同仁提供借鉴和参考，共同探索和实践分享以更好地保障DCT 的科学性、规范性和试验参与者权益。本文介绍了DCT 方案设计、DCT 元素的选择和应用、DCT 数据全流程管理、相关方协调、与监管部门沟通以及DCT 风险管理概述相关理论的实践应用，并以药物直达试验参与者元素为核心进行案例说明。

药品监管国际协调合作是应对当前全球药品监管难题和挑战的关键之举。国际组织、监管机构积极推进药品监管协调、趋同和信赖，加强国际监管合作，提高监管效能以加快优质医药产品上市。本文基于世界卫生组织对全球监管合作水平层级的划分，从监管协调和趋同、信赖、认可 3 个维度系统性梳理全球药品监管国际协调合作实践，研判当前发展趋势，并提出关于推进我国药品监管国际化的思考。

Real-world data (RWD) refers to data collected from real-world medical settings, and real-world evidence (RWE) is evidence derived from such data. Both hold unique value in the field of regulatory science. In areas such as drug review and approval, drug safety evaluation, RWE can serve as supplementary evidence to support regulatory decision-making, providing substantial support for regulatory work. This paper analyzes the application of RWE by regulatory agencies worldwide and discusses its practical characteristics in different countries and regions, drawing on successful examples. Despite the growing application of RWE, challenges remain in its utilization, including insufficient standardization, inadequate privacy protection, and high complexity in interpretation. To address these challenges, it is recommended to establish data privacy protection frameworks, enhance data standardization, and improve professionals' data analysis capabilities. The development of RWD and RWE can be further advanced by improving policies and regulations, promoting technological innovation, and deepening cross-field cooperation. This will strengthen their application in drug regulation and better serve public health needs.

《中国药典》2025 年版的实施标志着中药饮片标准体系建设进入新阶段。本文在梳理中药饮片产业现状与发展痛点的基础上，系统梳理了《中国药典》2025 年版中中药饮片标准的修订背景、制度逻辑与技术变革，分析了该版药典在品种收载、质量通则、检测方法、安全性控制等方面的重要调整，体现出标准建设在确保安全的同时更加突出质量一致性与临床适用性的导向。在此基础上，本文进一步重点探讨了全过程质量控制、多模态融合检测、智能识别与数据决策等关键技术路径，解析了新一代中药饮片质控范式的数智化特征与构建要点。同时，面向《中国药典》2030 年版规划及全球中医药市场的发展需求，中药饮片标准将加快从静态规范向动态协同、从国内适配向国际互认的跃升，构建具有中国特色、国际表达力与全球公信力的标准框架，助力中药饮片迈向全球化、现代化、智能化发展新阶段。

嵌合抗原受体T 细胞（CAR-T）疗法作为生物医药领域的一种新型抗肿瘤精准靶向疗法，近年来在恶性肿瘤治疗方面取得了突破性进展，并在全球范围内快速发展，其监管政策也不断完善。本文系统梳理了CAR-T 产品的研究进展，总结了其在研发策略、质量控制、监管法规等方面的概况，以期为推动免疫细胞治疗领域的规范化发展提供参考。同时，通过分析中美两国的主要相关监管政策，旨在为行业参与者提供更为多元的视角。在此基础上，本文进一步提出未来研究方向和监管思考，以期促进细胞治疗领域的健康发展。

This study examines 25 new active substances (NASs) that were approved by all six major regulatory agencies between 2019 and 2023 and subsequently approved by the National Medical Products Administration (NMPA) by January 2025. Of these NASs, 64% were chemical drugs and 36% were biologics, with antineoplastic and immunomodulating agents accounting for 60% of the total. Expedited review pathways were most frequently used by the U.S. Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), and the NMPA, resulting in NMPA review timelines comparable to those of other regulatory authorities. The analysis shows that, due to differences in companies' global submission strategies, 70% of NASs were first approved by the FDA or approved within one month of their first global approval, whereas submissions to the NMPA exhibited substantial variability. This variability contributed to delays in the market launch of the 25 NASs in China. Further in-depth analysis of the Chinese regulatory submissions indicates that Class 1 chemical NASs were submitted to the NMPA a median of 151 days earlier than their first global approval, yet experienced the longest approval times. In contrast, Class 3.1 therapeutic biologics showed the longest submission delays but the shortest NMPA approval times. Notably, some companies have begun to submit applications to the NMPA earlier than to other regulatory authorities, reflecting the growing importance of China in global regulatory strategies.

In 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the final version of E6 (R3): Guideline for Good Clinical Practice, which establishes data governance as an independent chapter and restructures the global clinical trial data management framework based on the concepts of Quality by Design (QbD) and Risk-Based Quality Management (RBQM). The National Medical Products Administration (NMPA) has announced that the ICH E6 (R3) guideline will apply to all clinical trials initiated after March 31, 2026. Facing challenges in the implementation of this guideline among domestic pharmaceutical enterprises, including conceptual misalignment, insufficient business adaptation, unclear role transformation, and lack of standardized procedures for newly introduced processes, this paper draws on practical experience from nearly 100 domestic and international multicenter clinical trials. It systematically analyzes the historical evolution and global innovation logic of the guideline, and focuses on three key modules: blinding maintenance (including randomization), data life cycle management, and computerized system validation (CSV). Common operational gaps and key risk control priorities are also summarized. Furthermore, this study proposes a four-dimensional implementation framework encompassing documentation, systems, processes, and risk management. Differentiated implementation strategies are designed for enterprises of different scales and project types, and compliance transition rules between ongoing and newly initiated projects are clarified. It also provides a dedicated audit trail review (ATR) scheme, key role adjustment requirements, and a system assurance mechanism characterized as monitorable, auditable, and optimizable are proposed. By establishing a closed-loop framework from conceptual interpretation and problem identification to implementation pathway design and assurance mechanisms, this paper aims to provide pharmaceutical enterprises with practical and compliant guidance, thereby supporting Chinese innovative drugs in overcoming international regulatory barriers and accelerating global development.

目的：概述主动监测模式在医疗器械上市后监测中的应用进展，提出基于“深度监测”范式构建医疗器械主动监测体系的方法学建议。方法：检索全球医疗器械主动监测相关文件及文献，梳理医疗器械上市后监测的发展，总结主动监测的现状、特点及技术手段，提出“深度监测”的新范式。结果：在自发报告模式的基础上，各国和地区逐步探索建立主动监测模式，主动监测模式在一定程度上可弥补自发报告模式存在漏报和迟报的局限性。基于“深度监测”范式，构建一个涵盖多层次、多维度、全覆盖的多源数据主动监测体系，有望更有效、及时地识别并确认医疗器械不良事件。结论：建议基于“深度监测”范式构建医疗器械上市后主动监测体系，探索多源数据联动的医疗器械上市后主动监测和安全性评价。

本文旨在梳理我国化学药品注册分类制度的变迁并分析我国化学药品改良型新药发展概况，以期为相关企业和监管部门提供参考。通过运用统计分析法，梳理并分析2016~2024 年我国改良型新药临床试验申请、临床试验批准、上市许可申请和上市许可批准四方面工作特点，以了解我国改良型新药发展概况。结果显示，抗肿瘤和免疫调节药物、神经系统用药等是当前研发热点；药品剂型分布主要集中在片剂、胶囊剂、膜剂等。建议相关企业制定科学合理的改良型新药战略布局；合理选择对照药品，提供充分的临床证据；申报全程保持与监管部门的紧密沟通，及时提交申报资料。监管部门可持续加强对药品临床优势的评估，促进国际交流；提供研发指导，促进产学研合作。

本文探讨政府数字化转型的要求、方法与路径，梳理药品监管数字化转型的进展与成效，并明确未来方向。重点分析了政府数字化转型的5 个关键要素，阐述了政府信息化4 个阶段的演进路径及数字化转型的典型过程，并进一步聚焦药品监管领域，详细介绍了其数字化转型的内涵、战略规划和实践成果，包括体系建设、大数据建设、网络安全保障、产业发展促进等方面的成效。最后，基于2025 年这一关键节点，从深化体制机制改革与推进智慧监管能力两大维度，提出下一步努力方向，以期为推动药品监管现代化、服务中国式现代化建设提供参考。

本文基于相关政策法规，围绕医疗器械注册中的技术审评与研审联动机制的专业技术环节，分析和阐述了注册申请人的主要需求和审评机构的职能要求。在技术审评中，需要确保审评规则和要求对注册申请人具有可预测性，并对因技术发展等因素而产生的规则调整予以及时告知；审评机构依托其专业认知，对申报产品的受益与风险作出科学评估，为行政审批提供依据。研审联动机制是针对创新医疗器械的行政指导行为，通过分析中美相关创新机制经验发现，不同层级的创新产品可适用不同机制，并可以沟通交流的方式解决注册申请人在研发和注册阶段面临的关键问题，从而实现审评重心前移。研审联动机制的有效实施，以注册申请人接受其产生的预期效果为前提，同时依托于审评机构的专业评价能力。从技术审评到研审联动的拓展，体现了监管部门职能的完善和转变。由于行政许可与行政指导在行政客体、目的及效力上存在差异，使得研审联动机制中的权责边界不如技术审评清晰，更需要审评机构以专业能力“柔性”指导。二者在行政上的关联性，也为研审联动机制的完善提供了方向与参考。

目的：通过国家药品抽检探索性研究发现典型案例，揭示中药制剂生产过程中工艺时间偏差对质量的影响机制，提出系统性风险控制及监管优化建议，为完善药品全生命周期质量管理体系提供实践参考。方法：以G 省某复方鱼腥草片涉嫌违规事件为样本，通过飞行检查锁定工艺缺陷（水洗至提取间隔达21.5 h），结合法定检验与探索性研究方法平行验证，及酶促水解动力学分析，建立时间- 质量关联模型，追溯生产前处理工序时间失控导致黄芩苷异常转化的关键环节。结果：水洗至提取间隔时间超过10 h 会显著提高汉黄芩苷峰与黄芩苷峰的峰面积比值，导致产品物质基础变化，而现行《药品生产质量管理规范》（GMP）对中药制剂前处理时间缺乏明确控制要求。结论：探索性研究作为连接质量监管与工艺优化的桥梁，其作用显著，但方法验证与政策配套仍需进一步深化。建议修订GMP《中药制剂》附录，增补工序时间控制要求，推动峰面积比值法等探索性方法向法定标准转化，强化企业上市后研究主体责任。

母乳喂养对母婴健康具有显若益处，但乳头疼痛和皺裂常导致母亲放弃纯母乳喂养。羊脂膏作为预防和治疗乳头皲裂的常用产品，其安全性至关重要。然而，羊脂膏的主要原料羊毛脂在生产过程中可能受到农药残留的污染，这些残留物对婴儿健康构成潜在威胁。本研究旨在评估 14 款市售羊脂膏产品中的农药残留现状，以固相萃取(SPE)法结合气相色谱串联质谱法(GC-MS/MS)和液相色谱串联质谱法(LC-MS/MS)，检测142种农药残留量。结果，仅有1款产品未检出农药残留，其余产品均检出农药残留，其中有机氯类农药，有机磷类农药和拟除虫菊酯类农药的检出率分别为7.14%，71.43%和85.71%。参考美国药典(USP)改良羊毛脂(modfied lanolin)标准，部分产品存在农药残留超限问题。根据欧盟药典(EP)羊毛脂(wool fat，即 lanolin)限量标准，14.28%羊毛脂产品单个有机磷类农药残留超出限量，21.43%的羊毛脂产品单个拟除虫菊酯类农药和农残总量残留超出限量，本研究强调了提高羊毛脂精炼工艺和加强农药残留质量控制的必要性，以确保产品的安全性，保护婴儿健康。

Objective: Based on the cutting-edge trends presented at the 2025 International Pharmaceutical Federation (FIP) World Congress of Pharmacy and Pharmaceutical Sciences, this study aims to provide strategic insights for licensed pharmacists in China to address challenges and achieve the new era and achieve high-quality development. Methods: Through literature review and comparative analysis, this study systematically examines the latest developments highlighted at the FIP World Congress and comprehensively assesses the current status of licensed pharmacists in China, thereby formulating targeted suggestions. Results: The findings indicate profound transformations in global pharmacy practice. Firstly, pharmacists' roles are shifting from medication providers to "guardians" of health services. Secondly, service models are evolving from standardized delivery toward personalized and value-based care. Thirdly, artificial intelligence and big data are advancing from auxiliary tools to "super assistants" that empower pharmaceutical practice. Fourth, the establishment of a collaborative global medication safety network has emerged as a new cornerstone. In contrast, China's licensed pharmacist workforce continues to face structural challenges and transformation pressures in workforce distribution, service capability, technological application, and institutional support. Conclusion: Global pharmacy is undergoing a value from drug-centered care to patient-centered care. Correspondingly, China urgently needs to clarify pharmacists' professional responsibilities at the institutional level, strengthen personalized service and data analysis capabilities at the competency level, and promote deep integration of artificial intelligence with pharmaceutical care at the technological level. These efforts will help systematically build a high-quality licensed pharmacist workforce to meet the strategic goals of the "Healthy China" initiative.

Atopic dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease characterized by eczematous lesions, frequently accompanied by xerosis and intense pruritus. Some patients may also present with concomitant atopic disorders. This disease affects individuals across all age groups, significantly impairing physical and psychological health, reducing quality of life, and imposing a substantial economic burden. This article systematically reviews the pathogenesis of AD, focusing on skin barrier dysfunction. It further elaborates on the structure and components of the skin barrier associated with AD, analyzes the applications and limitations of emollients, explores the multifaceted barrier-repairing effects of vernix caseosa, and highlights the development and therapeutic potential of vernix caseosa-mimetic technologies, aiming to provide new perspectives for advancing the treatment of AD.

To explore the application of artificial intelligence (AI) in enhancing the effectiveness of clinical quality management systems (cQMS), this study, in line with global regulatory requirements, analyzes how AI can transform cQMS from a traditional, manual model into a data-driven and intelligent system by optimizing document management, risk prediction, and automated processes, thereby improving the efficiency, compliance, and data quality of clinical trials. The results indicate that AI can significantly enhance cQMS efficiency and risk control capabilities; however, its implementation still faces challenges related to technical integration, data governance, model validation, and regulatory adaptability. AI is a key enabler of cQMS modernization, shifting it from a passive compliance tool to a proactive platform for risk early warning and continuous improvement. Its future development requires collaborative efforts among regulatory authorities, industry, and technology providers.

由于细胞治疗产品具有独特的活细胞属性与高度个体化特征，其生产过程与传统生物制品存在显著差异，建立并执行细胞治疗产品生产质量管理规范（GMP），对保障其临床安全性、有效性及质量可控性至关重要。本文聚焦欧盟《先进治疗药品生产质量管理规范指南》（以下简称 ATMP GMP 指南）与我国《细胞治疗产品生产质量管理指南（试行）》，梳理比较二者的制定历程、适用范围及核心内容，总结欧盟 ATMP GMP 指南的核心特点。随着我国细胞治疗产品质量管理经验的持续积累，建议适时修订《细胞治疗产品生产质量管理指南（试行）》，拓展其适用范围并提升文件层级，可考虑将其上升为部门规章或列为 GMP 专项附录，重点完善供者筛选与检测、产品召回与重配等关键环节的管理要求，以进一步规范生产过程，推动行业规范化发展。

随着中医药现代化进程的加速，真实世界研究（RWS）在中药研发与评价中的作用日益凸显。基于真实世界数据的中药研究，能够有效整合临床诊疗实践中的多源异构数据，为中药疗效评价、新药发现及人用经验转化提供科学依据。然而，如何高效采集、治理并利用这些数据，成为制约中医药高质量发展的关键问题。本文结合政策导向、技术实践与行业需求，构建了一个用于中药 RWS 的电子源数据采集、治理与转化智能管理平台，探讨中药 RWS 电子源数据采集与治理平台的核心架构与实施路径。

儿童药与罕见病用药因企业研发热情低、技术挑战大等问题研发困难，国家先后出台多项政策鼓励两类药物研发。为了进一步鼓励创新，落实国家药品监督管理局关于“提前介入、一企一策、全程指导、研审联动”的要求，国家药品监督管理局药品审评中心成立专项工作小组，并先后推出“ 关爱计划”与“星光计划”两项试点工作。“关爱计划”以罕见病药物为抓手，围绕“ 以患者为中心”，制定覆盖药物研发全生命周期的实施框架，明确各阶段“以患者为中心”的工作要点，其共纳入10 个试点品种，分别开展了自然病史研究、患者体验数据收集、开发应用患者报告结局量表、去中心化临床试验等工作，为罕见病药物研发积累了丰富的监管经验。“星光计划”针对儿童抗肿瘤药物研发，参考国际经验制定实施框架，助力企业自评估研发条件，提供多环节技术指导，实施周期3 年，旨在提升研发效率，满足儿童用药需求，该计划自启动以来，已纳入4 个试点品种。以试点工作的形式推动重点领域药物研发，是国家药品监督管理局药品审评中心新的工作尝试，未来，随着新技术应用与多方联动强化，将进一步推动两类药物研发，助力“健康中国2030”。

本研究通过规范研究与实证分析相结合的方法，系统分析了化学药品5.1 类和治疗用生物制品3.1 类在我国的临床试验要求现状。通过对2016~2024 年获批的341 个化学药品5.1 类和99 个治疗用生物制品3.1 类的注册数据分析发现：约50% 以上的两类药品需要通过常规临床试验路径获批，即在中国开展完整的临床试验；通过桥接试验或豁免临床路径获批的药品，也分别有约75% 和60% 以上需要开展上市后研究。从临床开发时间看，化学药品5.1 类从关键临床试验开始到申请上市的平均用时为861 天，超过化学药品1 类的679 天；治疗用生物制品3.1 类为618 天，与治疗用生物制品1 类的617 天基本相当。研究表明，化学药品5.1 类和治疗用生物制品3.1 类在我国承担了与1 类创新药相当甚至更重的临床试验负担，建议考虑在知识产权和数据保护、监管标准国际化、参比制剂管理等方面建立更加平衡的制度体系，促进创新药物的及时可及。

国际人用药品注册技术协调会（ICH）发布的《E8 ：临床研究的一般考虑》，为临床研究的设计和实践提供了国际通用的原则和规范。随着信息技术的进步和全球化进程的加速，临床试验领域经历了根本性的变革。2021 年 10 月，在时隔 24 年后，ICH 对 E8 指导原则进行了更新，发布《E8（R1）：临床研究的一般考虑》。此次更新提出了质量源于设计的理念，强调在研究设计和实施过程中识别关键质量因素并进行风险管理 ；鼓励不同利益相关方参与药物研发 ；倡导临床研究设计的多样性和数据来源的广泛性。其目的是在确保研究参与者权益的前提下，回答科学研究问题，同时保证数据的完整性和结果的可靠性，进而推动药品监管机构对试验数据和结果的认可。随着我国临床试验数量逐年增加，且更深入地参与到全球研发进程中，ICH《E8（R1）：临床研究的一般考虑》对我国临床研发行业的指导具有深远的意义。

Affected by factors such as healthcare system reform and large-scale equipment renewal policies, the scale of centralized procurement of medical equipment in China has grown rapidly in recent years. The categories of procurement have expanded from conventional CT and monitoring products to high-end large medical equipment such as MRI, DSA, and surgical robot, with the breadth and intensity of coverage continuing to deepen. At the same time, issues have arisen such as the rigidity of centralized procurement rules and a "low price only" approach. This article closely tracks the current status and characteristics of centralized procurement of medical equipment in China and analyzes the changing trends under equipment renewal policies. With the national-level initiative to rectify "involuntary" competition, and as medical institutions increasingly prioritize product quality, clinical utility, and after-sales service, centralized procurement is gradually entering a regulated stage where quality and price are both valued.

Article 23 of the revised Drug Administration Law of the People's Republic of China (2019) provides the statutory foundation for China's compassionate use system. However, due to its principle-based nature and the absence of detailed implementing rules, the system still faces multiple practical challenges, including "difficulty in accessing medication" for patients, "fear of prescribing" among physicians, "supply challenges" for enterprises, and "approval difficulties" for regulators. From a legal perspective, this paper systematically analyzes core legal issues of the system in terms of the nature of rights, review mechanisms, liability allocation, and procedural effectiveness. The study argues that compassionate use, in its legal nature, constitutes a right to request rather than an absolute substantive right to access, constrained by factors such as drug availability, scientific rationale, procedural compliance, and the principle of equal rights to life and health for patients. To address these challenges, this paper proposes systematic optimization paths based on the mature experiences of jurisdictions such as the United States, the European Union, Japan, and Canada. The aim is to provide a reference for constructing a Chinese framework for compassionate use that embodies humanitarian care while adhering to scientific rigor and the principles of the rule of law.

With the rapid growth in the volume of clinical trial data, data science professionals face increasing challenges in efficiently cleaning and reviewing clinical trial datasets. This paper presents the design of a risk-based clinical data management progress report. Based on two key dimensions (data quality and maturity), the proposed approach performs both qualitative and quantitative analyses of risks in data management and incorporates a statistical analysis module to construct a multidimensional risk assessment matrix. The framework aims to improve the efficiency of data cleaning and review, assist research teams in promptly identifying specific data trends and potential monitoring risks, and ultimately support the optimization of clinical strategies.

近年来，以大语言模型为代表的人工智能（AI）技术快速发展，为各行业智能化转型提供了新的技术支撑。本文从技术与业务适配性的角度出发，分析了当前药品监管领域智能化面临的挑战、AI 技术在药品监管业务中的应用潜力以及 AI 技术与药品监管业务的融合方法。通过国内外典型案例研究，重点探讨了在药品监管领域辅助审批、日常监管、公众服务和决策支持等关键业务场景 AI 赋能的技术路径及应用效果。得出 AI 技术可显著提升监管效率，但需解决数据安全、业务适配等关键问题的结论，并提出构建国家级药品监管大语言模型平台、完善协同创新机制等思考，为推进药品监管智能化转型提供参考。

Large animal studies for medical devices is a pivotal step in the transition from basic research to clinical application. Their scientific design and standardized execution directly influence the effectiveness of registration submissions. Based on domestic and international regulatory requirements, including the Guidelines for Registration Review of Animal Studies on Medical Devices, this paper systematically constructs three core dimensions for evaluating large animal studies: safety assessment, effectiveness validation, and performance analysis. Firstly, the paper briefly elaborates on the role of large animal studies within regulatory policies, industrial development, and scientific evaluation systems, clarifying their necessity as a "gatekeeper" in preclinical evaluation. Secondly, focusing on the core element of experimental design, it provides a detailed analysis of key control points, including study subject assessment, scientific selection of animal models, sample size estimation, control group settings, and the construction of evaluation indicators, while emphasizing standardized management of raw records. Finally, from the perspectives of GLP compliance, data integrity assurance, and whole-process quality control, the paper explores implementation pathways to ensure the scientific rigor and regulatory acceptability of experimental data. This study aims to provide a systematic reference for protocol design for medical device R&D enterprises and research institutions, thereby enhancing the reliability and translation efficiency of preclinical evaluations.

Brain-computer interface (BCI) technology, a cutting-edge field arising from the interdisciplinary integration of life sciences, information science, and related disciplines, is currently at a critical stage of transition from basic research to clinical translation and industrial application. This article systematically reviews the developmental trajectory of BCI technology, with particular emphasis on its clinical progress and future prospects in areas including motor function restoration, assisted communication, sensory compensation, assessment of disorders of consciousness, identification of cognitive impairment, and the diagnosis and treatment of neurological and psychiatric disorders. In the context of China's recently introduced policies supporting the BCI industry, the paper further examines the current characteristics of BCI technology in medical device evaluation and approval, as well as ethical governance. From the perspective of regulatory science, it proposes developmental pathways such as establishing a risk-based classification framework, strengthening specialized review capacity, and promoting multi-stakeholder collaborative governance, aiming to facilitate the safe, effective, and responsible integration of BCI technology into clinical practice and public health.

药品使用阶段的风险管理是保障患者用药安全和提升药品监管效能的关键环节。面对日益复杂的临床用药环境和不断涌现的风险挑战，传统的单一主体治理模式的局限性已有所显现。协同治理理论强调多元利益相关者在共同目标驱动下的互动、合作与责任共担，为创新药品使用风险管理模式提供了重要的理论支撑和实践路径。本文阐述了协同治理理论的核心内涵与关键机制，深入分析了其在药品使用风险管理领域的高度契合性与潜在优势，并提出了基于上市后研究构建多主体协作机制的必要性和实施路径。以医院药物警戒研究协作组的实践为例，具体探讨了在协同治理框架下，医疗机构参与药品上市后研究与风险管理的组织模式、运行机制及初步成效。研究结果表明，协同治理理念的应用有助于打破传统监管壁垒，促进药品风险管理从单向管理向多元共治的模式转变，从而提升药品安全监管效能和药物警戒的实证研究能力。

Based on 2025 trade data on meat products between China and the United States and cases of U.S. refusals of Chinese food imports, this study examines the importance of contaminant control in meat exports. By reviewing the U.S. Food and Drug Administration (FDA) document Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed and related regulations, a comparative analysis was conducted of the maximum residue limits (MRLs) for toxic and hazardous substances (particularly pesticide and veterinary drug residues) in meat products in China and the United States. The findings reveal significant differences between the two countries in the MRLs for certain pesticides (e.g., pyrimethanil, difenoconazole) and veterinary drugs (e.g., ractopamine, gentamicin). Accordingly, this paper recommends placing greater emphasis on the sensory quality of meat and hygiene control throughout the production, strengthening compliance management of veterinary drug residues in products such as pork liver and kidneys, and encouraging export enterprises to continuously monitor updates to U.S. regulations in order to improve export compliance and reduce trade risks.

诱导多能干细胞（iPSC）衍生的细胞治疗产品是一类新型的细胞药物，其利用 iPSC 高度自我更新、多向分化潜能等优势，具备通用化、量产化的开发潜力，并可通过基因编辑进一步强化细胞功能，具有较好的成药和应用前景。由于 iPSC 具有多能干性，如在其衍生细胞产品中残留有未分化或未完全分化的 iPSC，可能有形成畸胎瘤的风险，这是该类新型产品的监管关注重点之一，但就相关的分析方法及控制策略目前尚未形成行业共识。本研究针对 iPSC 衍生细胞治疗产品中的 iPSC 残留控制的监管需求，进行了基于新型数字聚合酶链式反应（PCR）技术的分析方法的开发、验证、应用及评估，并基于课题实践经验形成了对 iPSC 残留控制策略的建议，以期帮助研发企业建立适宜的分析方法用于产品质量控制和风险评估，加速 iPSC 衍生细胞治疗产品的开发、申报及其监管体系的完善，促进产业高质量发展。

前蛋白转化酶枯草溶菌素9（PCSK9）抑制剂是一类新型降脂药物，该类药物的发现改变了以往血脂异常的治疗方式，其突破不仅在于长时间维持低密度脂蛋白胆固醇水平降低的状态，更在于显著降低主要心血管事件的风险。靶向PCSK9 单克隆抗体药物药动学和药效学的准确表征高度依赖于准确的生物分析方法，设计合理且验证充分的生物分析方法可为其临床研发项目中的科学决策提供坚实的数据基础。本文围绕靶向PCSK9 单克隆抗体药物生物分析的3 大核心维度，即血药浓度分析、PCSK9标志物分析及抗药抗体分析，系统梳理其检测原理、方法差异、关键问题及优化策略，旨在为同类药物生物分析方案设计、方法学验证及临床药理学评价提供参考，并为该类药物的临床研发提供借鉴。

Objective: This study aims to analyze the filing status and clinical trial activities of drug clinical trial institutions in China in 2025, identify existing challenges, and provide a reference for their high-quality development. Methods: Using individual drug clinical trial institution as the unit of analysis, data on institutional filings and registered drug clinical trials in 2025 were retrieved from the official website of the National Medical Products Administration (NMPA) and other relevant platforms. Results: A total of 1891 drug clinical trial institutions were filed nationwide in 2025, of which 47% were located in eastern China. Among them, 1312 institutions conducted drug clinical trials, with institutions in eastern China accounting for 49%. A total of 579 institutions did not participate in any drug clinical trials during the year, representing an institutional idle rate of 31%. Among the institutions conducting clinical trials, 390 served as lead trial sites, with institutions in eastern China leading 62% of all clinical trials. In addition, 336 institutions conducted bioequivalence (BE) trials, of which 48% were located in eastern China. Conclusion: The development of drug clinical trial institutions in China in 2025 was characterized by regional disparities in distribution, imbalances in resource utilization, and insufficient capacity to fully meet the demands of innovative drug development. Future efforts should focus on resource integration and capacity enhancement, while accelerating the establishment of a clinical trial ecosystem aligned with the evolving needs of innovative drug research and development.

药品补充检验方法是国家药品标准体系的重要组成部分，通过法定授权填补常规标准在打击药品掺伪、掺杂、掺假等行为时存在的技术盲区，兼具强制性与时效性。本文系统梳理了中药补充检验方法的法律地位、拟解决的核心问题、制定的关键技术要点及审评审批流程，识别出目前中药补充检验方法主要在限度制定合理性、关键控制指标专属性、审评审批流程等方面存在值得探讨商榷的问题。基于此，本文提出建立通用性中药补充检验方法、进一步完善审评审批流程及优化风险预警机制等思考，从而切实发挥中药补充检验方法在打击非法造假行为方面的有力作用。

Objective: This study aims to examine international regulatory experience in artificial-intelligence (AI) medical devices, assess the current status and limitations of China’s regulatory framework, and propose actionable pathways toward a scientific, flexible, and transparent lifecycle regulatory system. Methods: A comparative research approach was adopted, selecting the United States, the European Union, and Japan as representative cases. Their regulatory models were reviewed across four dimensions: approval pathways, prospective algorithm change mechanisms, risk classification, and post-market surveillance, and analyzed in conjunction with China’s recent medical device policies and practices. Results: The United States is characterized by flexible review mechanisms and strong support for innovation; the European Union emphasizes risk prevention and regulatory transparency; and Japan, while maintaining a prudent regulatory foundation, has introduced prospective change management and data-driven post-market monitoring. China has established an initial regulatory framework supported by guidance documents, standards, and technical review requirements, and has made progress in the application of real-world data/evidence (RWD/RWE). Nonetheless, gaps remain in developing prospective regulatory pathways for algorithm updates, refining risk classification and technical specifications, and strengthening interdepartmental coordination. Conclusion: China should draw on international experience to further refine its risk classification system, establish pre-review and dynamic management mechanisms for prospective algorithm changes, promote the systematic use of real-world data, strengthen cross-sector collaboration, and pilot regulatory sandbox initiatives. In particular, it is necessary to build a full lifecycle regulatory framework centered on a closed-loop model of “approval–update–use–monitoring”, thereby improving iterative efficiency while ensuring safety and effectiveness and forming replicable and scalable regulatory practice.

In July 2024, the National Medical Products Administration (NMPA) issued the Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs, which shortened the review and approval timeline for Class 1 innovative drug clinical trial applications from 60 working days to 30 and, for the first time, explicitly required that clinical trials be initiated within 12 weeks after approval. Taking a pilot project at a clinical trial institution in Shanghai as a case study, this article summarizes practical experience in effectively integrating the policy with clinical operations and explores the opportunities and challenges it presents to multiple stakeholders, including clinical trial institutions, regulatory authorities, sponsors, and contract research organizations (CROs), during policy implementation. The study aims to provide practical references and insights for further optimizing China's clinical trial review and approval system for innovative drugs, deepening regulatory reform, and accelerating the research and development of innovative drugs.

On May 13, 2026, the Center for Drug Evaluation, National Medical Products Administration (NMPA) officially released the 2025 Annual Drug Review Report (hereinafter referred to as the Report). According to the Report, China’s drug review and approval system continued to improve in 2025. A total of 20,149 various drug registration applications of various categories were accepted throughout the year, representing a year-on-year increase of 3.00%, while 19,375 applications were completed for review, up 6.11% year-on-year. Both figures reached a five-year high. A total of 76 innovative drugs were approved for marketing during the year, including 11 drugs with novel mechanisms of action or new targets. Meanwhile, 48 orphan drugs and 138 pediatric drugs were approved. A large number of urgently needed clinical drugs were rapidly approved through expedited pathways such as priority review and conditional approval. Overall, China’s independent pharmaceutical R&D capacities have continued to improve, and its drug review and approval system has become increasingly aligned with international standards, effectively accelerating the R&D and commercialization of innovative drugs.

Objective: This study aims to investigate the focal points and development pathways of China's "Three Extensions" policy within the Volume-Based Procurement (VBP) system, analyze existing challenges during its implementation, and provide targeted suggestions for policy optimization. Methods: Based on Kingdom's Multiple Streams Framework (MSF), this study systematically analyzes how the problem, policy, and politics streams interact to open the policy window for the "Three Extensions" initiative. It further explores the driving forces behind policy formation, identifies implementation challenges, and proposes optimization pathways. Results: The "Three Extensions" policy emerged from the coupling of multiple streams. The problem stream comprised inadequate medicine accessibility in primary healthcare institutions, dysfunctional pricing mechanisms in retail pharmacies, and low participation among private healthcare providers. The policy stream consisted of policy communities, accumulated experience from the VBP program, and local pilot practices. The politics stream encompassed governance philosophy, public sentiment, and bargaining among stakeholders. Conclusion: Future optimization should prioritize regional coordination, the development of incentive mechanisms, and the integration of intelligent information platforms, thereby promoting the transformation of the VBP system from "price governance" to "systemic governance".