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。

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.

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。

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。

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.

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.

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。

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.

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。

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。

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.

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。

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。

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。

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.

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。

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”。

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。

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.

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.

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.

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.

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.

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.

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.

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.

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。

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.

In recent years, the ethical concerns and technical limitations associated with animal testing have become increasingly prominent. The reduction or replacement of animal testing in drug development has emerged as a key focus for regulatory authorities worldwide. This article introduces the objectives, research content, progress, timeline, and overall regulatory framework of the project Exploration of Strategies for Reducing or Replacing Animal Testing in Nonclinical Drug Research, conducted under the National Key Laboratory of Regulatory Science for Pharmaceuticals. Particular attention is given to the application of new approach methodologies (NAMs) as alternatives to, or reductions in, animal testing. The paper aims to enhance public understanding of China's regulatory developments in this area and to encourage coordinated efforts between regulators and industry stakeholders to advance the systematic implementation of animal testing reduction or replacement strategies.

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 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".

With the continuous expansion in scale and increasing complexity of clinical trials, traditional clinical data management approaches can no longer meet the demands for efficiency, transparency, and regulatory compliance. These limitations become particularly evident during regulatory inspections. To address these challenges, this article introduces the Clinical Data Total Management System (CDTMS) developed by the author's team. CDTMS integrates eight core modules and achieves interoperability with systems such as Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), External Data Management (EDM), Pharmacovigilance (PV), and intelligent Medical Coding systems (MedCoding). By filling critical gaps in clinical data management, CDTMS provides an effective solution for improving data quality, enhancing operational efficiency, and ensuring compliance. Over the past six years, CDTMS has been implemented in more than 500 projects within the author's organization, significantly improving the level of data management automation, operational efficiency, and overall work quality. Preparation time for regulatory inspections has been substantially reduced, and no major issues have been identified during quality audits. This article presents the development background and core modules of CDTMS, highlights its practical achievements and advantages, and discusses its future potential in enabling "instant inspection readiness" and comprehensively improving clinical data management quality.

This paper introduces the origin, development, and evolution of Predetermined Change Control Plans (PCCPs) for artificial intelligence-enabled device software functions. It also presents the scope and application of the PCCP guidance issued by the U.S. Food and Drug Administration (FDA), including its use for both new devices and post-market approved devices. In addition, the implementation, expansion, and international harmonization of the PCCPs are discussed, with the aim of providing references for other regulatory authorities in developing relevant regulatory policies.

Objective: This study aims to analyze the public notices issued by the National Medical Products Administration (NMPA) in 2024 regarding the detection of prohibited ingredients in cosmetics, summarize high-frequency risk points, evaluate potential hazards, and analyze underlying causes, so as to provide a scientific basis for cosmetic safety supervision. Methods: A statistical analysis was performed on 74 batches of non-compliant products reported in 7 NMPA notices issued between January and December 2024. The analysis covered multiple dimensions, including product category, place of origin, sampling location, objections raised by labeled enterprises and corresponding verification results, and types of prohibited ingredients detected. Relevant considerations were put forward in combination with health risk assessment and regulatory practice. Results: High-risk product categories included skin care products (28.38%), of which infant and children's skin care products accounted for 12.16%, hair dye products (25.68%), shampoo and hair care products (13.51%), anti-acne products (10.81%), and freckle-removing and whitening products (8.11%). Production sites were mainly concentrated in Guangdong Province (87.84%), while sampling covered 22 provinces (autonomous regions and municipalities directly under the central government). Beauty salons, hairdressing establishments, and e-commerce platforms were identified as high-risk distribution channels. A total of 30 prohibited ingredients were detected, including 7 types of antibiotics, 8 types of hormones, and 3 types of hair dyes, which may pose risks such as hepatotoxicity, sensitization, carcinogenicity, and the induction of drug resistance. Conclusion: The illegal addition of prohibited ingredients in cosmetics in 2024 was characterized by concentration in functional products, pronounced regional clustering, and diverse hazard profiles. On this basis, this paper proposes the establishment of a full-chain regulatory system, strengthened production traceability, enhanced regulation of distribution channels, and improved technical testing, together with a safety governance framework integrating enterprise self-discipline, targeted regulatory oversight, and social co-governance, so as to ensure high-quality development of the cosmetics industry and public safety in cosmetic use.

In the internationalization of China's innovative drug R&D, multilingual adaptation of the electronic data capture (EDC) systems for clinical trials has become a key factor in overcoming bottlenecks in cross-border data exchange. To address the low efficiency, high cost, and prominent compliance risks in traditional EDC multilingual processing, this study proposes a solution combining an independent translation engine with core function adaptation. First, clarify core requirements through functional design, such as multilingual storage, real-time switching, and closed-loop quality control. A translation engine is then developed using large language model (LLM) as the key technology, supported by data interfaces and log traceability to enable implementation. Application validation shows that this approach shortens the translation cycle of the EDC "shell structure + data" from 14 weeks to 5 weeks, reduces labor costs by 80%, and achieves a core medical terminology translation accuracy of ≥99.5%. The solution meets the language requirements of global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for localized submission materials, thereby supporting data management for global clinical trials of innovative drugs.

As one of the core components of X-ray computed tomography (CT) scanner, CT X-ray tubes are regarded as critical high-value consumables due to their relatively short service life and high replacement costs. Currently, China's CT X-ray tube market exhibits a high degree of dependence on imports, with foreign brands commanding a large market share. Accelerating technological breakthroughs and advancing the domestic substitution of CT X-ray tubes have become crucial strategic priorities for achieving greater autonomy and controllability in high-end medical equipment in China. With strong policy support, China's CT X-ray tube industry has achieved remarkable progresses in recent years. However, the market penetration of domestically produced CT X-ray tubes remains limited, and downstream stakeholders' willingness to purchase and confidence in using domestic CT products still need to be strengthened. Based on the current status of industry development and domestic substitution in China, this paper analyzes the opportunities and challenges facing the CT X-ray tube sector and discusses future development trends, aiming to provide insights for accelerating domestic substitution.

Objective: This study evaluates the status of on-site licensing inspections for cosmetic manufacturers in Guangzhou following the implementation of the Inspection Key Points and Determination Principles for Cosmetic Good Manufacturing Practices (hereinafter referred to as the Inspection Key Points). It further analyzes the main challenges faced by manufacturers in complying with the new requirements and provides evidence-based recommendations for improving quality management in the cosmetic industry. Methods: On-site inspection data from 617 cosmetic manufacturers in Guangzhou in 2023 were analyzed using descriptive statistics and root cause analysis. The study focused on the distribution of deficiency items, the occurrence patterns of high-frequency non-compliance clauses, and their underlying causes. Results: The failure rate of licensing inspections reached 46.35% after the new regulations took effect. Most deficiencies were concentrated in four areas: quality assurance and control, facility and equipment management, material and product management, and production process management. Conclusion: In the initial stage of the new regulation, cosmetic manufacturers in Guangzhou faced substantial compliance pressure. On-site inspections revealed systemic weaknesses, including inconsistent quality management system operations, substandard production conditions, and inadequate management practices. To address these issues, manufacturers should strengthen their quality management systems and invest in infrastructure improvements, while regulatory authorities should optimize tiered and categorized supervision mechanisms, provide stronger industry guidance, and enhance information transparency.

The innovative drug industry is a strategic pillar industry in China. The Regulations for the Implementation of the Drug Administration Law explicitly emphasize a "clinical value-oriented" approach. Taking unmet clinical needs as the starting point and patient benefit as the endpoint has become an international consensus; however, constrained by bottlenecks in the elucidation of disease pathogenesis, this concept has long failed to be translated into an actionable paradigm. By integrating AI technologies, this paper proposes a paradigm shift from first-in-class (FIC) to first-in-disease (FID). The core of this reconstruction is to shift the criterion of pioneering status from molecular structural novelty to therapeutic value in disease treatment. It demonstrates how AI and multi-omics enable systematic dissection of disease pathogenesis and operationalize a disease-driven R&D logic and embed this new paradigm within China's framework for high-quality innovative drug industrial development. From the dimensions of "precision manufacturing" and "scientific decision-making," this paper categorize AI-driven computational tools into two modules: chemistry models, which focus on molecular design, and biological models, which focus on the dissection of disease pathogenesis. This classification constitutes a functional abstraction aligned with the entire R&D chain. On this basis, the paper proposes that "the synergistic advancement of the dual models is the critical pathway to implementing the clinical value-oriented approach." It then analyzes the pain points of the R&D-clinical disconnect arising from insufficient synergy, and offers multidimensional recommendations to support the high-quality development of the industry.